Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19
Phase: NA
Conditions: COVID19
Sponsor: EmitBio Inc.

A Phase I/II Randomized, Dose Escalation Study to 
Evaluate the Safety and Antiviral Activity of the RD-
X19 Device in SARS-CoV-2 Infected Individuals with 
Uncomplicated COVID-19 
NCT04662671
28 October 2020

A Phase I/II Randomized, Dose Escalation Study to 
Evaluate the Safety and Antiviral Activity of the RD-
X19 Device in SARS-CoV-2 Infected Individuals with 
Uncomplicated COVID-19 
This supplement contains the following items: 
•
Original Protocol*
•
Protocol Amendment 1 (current)*
•
Clarification Memorandum #1
•
Clarification Memorandum #2
•
Statistical Analysis Plan Version 2.0 (current)*
•
Statistical Analysis Plan Amendment 1
*Redacted

Page 1 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
CLINICAL TRIAL PROTOCOL 
A Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and 
Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals 
with Uncomplicated COVID-19 
Protocol Number: EB-P12-01 
Investigational Countermeasure: RD-X19 
Specific Indication: Treatment of Uncomplicated COVID-19 
Target Respiratory Disease Pathogen(s): SARS-CoV-2 
Phase: I/II 
Name and Address of Sponsor:           
Name and Address of CRO: 
EmitBio Inc.
 Symbio, LLC   
Suite 470, 4222 Emperor Blvd 
 21 Perry Street 
Durham, NC 27703 
Port Jefferson, NY 11777 
Tel: + 1 (843) 540-3569 
Tel: +1 (631) 403-5125 
GCP Statement: This trial will be performed in compliance with (c)GCP. 
The information in this document is confidential and is proprietary to EmitBio Inc and/or 
KnowBio LLC. It is understood that information in this document shall not be used other than 
for the direct purpose of executing this protocol without the expressed written permission of 
EmitBio Inc or KnowBio LLC. 

 
Page 2 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 
1 
INSTITUTIONAL STATEMENT OF COMPLIANCE 
 
Each institution engaged in this research will hold a current Federal Wide Assurance (FWA) 
issued by the Office of Human Research Protection (OHRP), and/or will be guided by the 
review and deliberations of an Institutional Review Board (IRB)/Independent or Institutional 
Ethics Committee (IEC) that must be registered with OHRP as applicable to the research. 
 
The study will be carried out in accordance with the following as applicable: 
• United States (US) Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of 
Human Subjects 
• Food and Drug Administration (FDA) Regulations: 21 CFR Part 50 (Protection of 
Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical Investigators), 21 
CFR Part 56 (IRBs), 21 CFR Part 11, and 21 CFR 812 (Investigational Device 
Exemptions) 
• The International Council for Harmonization (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH) E6(R2) Good Clinical Practice 
(GCP), and the Belmont Report: Ethical Principles and Guidelines for the Protection of 
Human Subjects of Research, Report of the National Commission for the Protection of 
Human Subjects of Biomedical and Behavioral Research 
• Any additional applicable Federal, State, and Local Regulations and Guidance

Page 3 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
2 
INVESTIGATOR’S AGREEMENT 
This signature provides the necessary assurance that this study will be conducted according to all 
stipulations of the protocol, including statements regarding confidentiality, and according to local 
legal and regulatory requirements, US federal regulations, and ICH E6(R2) GCP guidelines. 
Principal Investigator Signature: 
Signed: _____________________________ Date: _________________ 

 
Page 4 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
3 
TABLE OF CONTENTS 
1 
INSTITUTIONAL STATEMENT OF COMPLIANCE ..................................................... 2 
2 
INVESTIGATOR’S AGREEMENT .................................................................................... 3 
3 
TABLE OF CONTENTS ....................................................................................................... 4 
4 
PROTOCOL SUMMARY ..................................................................................................... 6 
4.1 
EXECUTIVE SUMMARY ........................................................................................................ 6 
 Study Goals ................................................................................................................... 6 
 Study Design ................................................................................................................. 7 
 Objectives and Endpoints ............................................................................................. 9 
 Inclusion and Exclusion Criteria ................................................................................. 10 
4.2 
STUDY SCHEDULE OF ACTIVITIES ...................................................................................... 13 
5 
INTRODUCTION ................................................................................................................ 14 
5.1 
BACKGROUND AND STUDY RATIONALE ............................................................................ 14 
 EmitBio™ RD-X19 Device Characteristics ............................................................... 15 
5.2 
RISK/BENEFIT ASSESSMENT ............................................................................................. 15 
 Known Potential Risks ............................................................................................... 15 
 Known Potential Benefits ........................................................................................... 16 
6 
STUDY DESIGN ................................................................................................................... 17 
6.1 
OVERALL DESIGN .............................................................................................................. 17 
6.2 
OBJECTIVES AND ENDPOINTS ............................................................................................ 19 
6.3 
SCIENTIFIC RATIONALE FOR THE STUDY ........................................................................... 20 
 Justification for Doses ................................................................................................ 20 
7 
STUDY POPULATION ....................................................................................................... 21 
7.1 
INCLUSION CRITERIA ......................................................................................................... 21 
7.2 
EXCLUSION CRITERIA ........................................................................................................ 22 
7.3 
STUDY VOLUNTEER SELECTION, RETENTION & COMPENSATION ...................................... 24 
 Recruitment................................................................................................................. 24 
 Retention ..................................................................................................................... 24 
 Compensation Plan for Subjects ................................................................................. 24 
 Costs ........................................................................................................................... 24 
8 
STUDY DEVICE................................................................................................................... 24 
8.1 
REGULATORY CONSIDERATIONS ....................................................................................... 24 
 Preliminary Regulatory Pathway for EmitBio™ RD-X19 ......................................... 24 
 Proposed Label Claim/Indication for Use: ................................................................. 25 
 Medical Device Quality System: ................................................................................ 25 
8.2 
STUDY DEVICE AND USE ................................................................................................... 25 
 Device Description ..................................................................................................... 25 
8.3 
USE / STORAGE & MAINTENANCE / ACCOUNTABILITY ...................................................... 28 
 Acquisition and Accountability .................................................................................. 28 
 Device Storage and Maintenance ............................................................................... 28 
 Preparation for Use and Use ....................................................................................... 28 
8.4 
MEASURES TO MAXIMIZE STUDY SUBJECT COMPLIANCE ................................................. 28 
8.5 
DEVICE DISCONTINUATION ............................................................................................... 28 
 Study Pausing Criteria ................................................................................................ 28 

 
Page 5 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 Subject elects to discontinue ....................................................................................... 29 
 Investigator Decision to Discontinue Subject Use of Device..................................... 29 
 Follow-up of Study Subjects Who Discontinue Device Use ...................................... 30 
9 
STUDY ASSESSMENTS AND PROCEDURES ............................................................... 30 
9.1 
SCREENING ASSESSMENTS ................................................................................................ 30 
 Screening Procedures.................................................................................................. 30 
 Procedures for Abnormal Clinical Laboratory Values or Findings ............................. 32 
9.2 
SAFETY AND OTHER ASSESSMENTS ................................................................................... 32 
 Definition of Adverse Event (AE) .............................................................................. 33 
 Solicited Adverse Events - Reactogenicity ................................................................. 34 
 Unsolicited Adverse Events ........................................................................................ 34 
 Adverse Event Reporting ............................................................................................ 34 
 Definition of a Serious Adverse Event (SAE) ............................................................ 35 
 Serious Adverse Event Reporting ............................................................................... 35 
 Regulatory Reporting of Device-related SAEs ........................................................... 36 
 Classification of an Adverse Event ............................................................................. 36 
 Severity of Adverse Events ........................................................................................ 36 
 Relationship to Study Intervention ............................................................................. 37 
 Time Period and Frequency for Event Assessment and Follow-Up ........................... 37 
 Adverse Event Reporting to Study Subjects ............................................................... 37 
 Pregnancy Reporting .................................................................................................. 37 
9.3 
EFFICACY ASSESSMENTS ................................................................................................... 37 
 Efficacy assessments .................................................................................................. 37 
10 STATISTICAL CONSIDERATIONS ................................................................................. 38 
10.1 STATISTICAL HYPOTHESES ................................................................................................ 38 
10.2 POWER AND SAMPLE SIZE: ................................................................................................ 38 
10.3 POPULATIONS FOR ANALYSES ........................................................................................... 38 
10.4 STATISTICAL ANALYSES .................................................................................................... 39 
 Efficacy Analyses ....................................................................................................... 39 
 Safety Analyses .......................................................................................................... 40 
11 OPERATIONAL CONSIDERATIONS AND SUPPORTING DOCUMENTS ............. 40 
11.1 ETHICAL CONSIDERATIONS ............................................................................................... 40 
 Informed Consent Process .......................................................................................... 41 
 Confidentiality and Privacy ........................................................................................ 42 
 Clinical Monitoring .................................................................................................... 42 
 Quality System............................................................................................................ 42 
 Data Collection and Management Responsibilities .................................................... 42 
 Source Documents ...................................................................................................... 43 
 Study Record Retention .............................................................................................. 43 
 Protocol Deviations .................................................................................................... 43 
 Publication and Data Sharing Policy .......................................................................... 44 
 Conflict of Interest Policy ......................................................................................... 44 
 Research Related Injuries .......................................................................................... 44 
12 APPENDIX 1 ......................................................................................................................... 45 
13 APPENDIX 2 ......................................................................................................................... 46 

Page 6 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
4 
PROTOCOL SUMMARY 
4.1 Executive Summary 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknow cause.  Coronavirus ribonucleic acid (RNA) was quickly identified in 
some of these patients. As of October 11, 2020 there were approximately 37 million confirmed 
cases wordwide (>7.7 million in the US) and over 1,075,000 deaths (~215,000 in the US). The 
only FDA approved intervention currently is Remdesivir for hospitalized subjects with COVID-
19. Other interventions currently being used are through the Emergency Use Authorizations
(EUA), against SARS-CoV-2 / COVID-19.    Social distancing and personal protective equipment
constitute our only viable countermeasures to help reduce incidence of community acquisition and
transmission of SARS-CoV-2. Vaccine candidates are being developed at an unprecedented
speed, however their efficacy and safety is unknown and will not be fully defined for many
months. Remdesivir, Convalescent Immune Plasma and SoluMedrol are all used to treat patients
hospitalized with COVID-19, but none has received marketing approval as a therapeutic for
uncomplicated COVID-19.  Therefore, there remains an urgent public health need for rapid
development of novel measures for prevention and treatment of SARS-CoV-2 and COVID-19.
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent 
 Study Goals 
This is a randomized, sham-controlled dose escalation and bioeffect study.  The primary goal of 
the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected individuals with 
outpatient COVID-19 at two dosing schedules, and to assess the reduction of SARS-CoV-2 viral 
load in each dose group compared to sham controls.  This is an efficacy hypothesis-generating 
study; sample size is based on convenience. However, there is adequate power to detect large 
differences in group SARS-CoV-2 reduction effects. The primary safety measure is absence of 
device-related serious adverse events or patterns of severity  ≥2 device-related adverse events. 
Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by 
review of potential adverse events (AEs) and targeted physical examination, as required. 
Volunteers will be encouraged to contact designated clinical trial staff for AEs of a medically-
urgent nature as soon as is practically possible and to seek immediate medical care, if needed. 
Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline 
and at Day 8 or early termination (and potentially during unscheduled) clinic visits. 
Methemoglobin assessments will be performed at baseline and Day 8. 

 
Page 7 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 Study Design 
Subjects will provide informed consent prior to initiating any screening procedures.  Subjects 
meeting all screening criteria will be eligible for enrollment and randomization into the study.  
This study plans to enroll into two treatment arms within two escalating dose cohorts:  
• 
Cohort 1: 128 J/cm2 total dose RD-X19, Sham 
(5 minutes per treatment, 2X/Day for a duration of 4 days) 
• 
Cohort 2: 224 J/cm2 total dose RD-X19, Sham  
(5 minutes treatment, 2X/Day for a duration of 7 days) 
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to 
the RD-X19 treatment arm or the sham treatment arm within each cohort.  Subjects will be 
randomized in a 2:1 ratio (20 RD-X19 : 10 sham) per dose cohort. The double-blind, sham-
controlled treatment period of four (4) days of dosing for Cohort 1 is shown in Figure 1 below; 
increased weekly doses of light with twice daily dosing will occur in Cohort 2 for a treatment 
duration of seven (7) days.  Light will be administered locally to the mouth and throat only, 
aiming to eliminate viral load in these targeted portions of the upper respiratory tract.  
Assessments of treatment response will occur on study days 3 and 5, with the final determination 
of efficacy made on day 8 (inclusive).   
Study Subject safety will be monitored throughout the study by the Investigator and supported by 
regular review by the Sponsor’s Chief Medical Officer.   
Upon completion of all subjects in Cohort 1, the results of an unblinded interim analysis will be 
reviewed by a safety monitoring team and a recommendation will be made to the sponsor on 
whether the committee recommends proceeding with enrollment for the next cohort at the next 
planned dose or whether enrollment should continue in the next cohort at a reduced dosing 
frequency (e.g. once daily). The study is designed to evaluate at least 2 dosing schedules, 
ascending, or descending based on safety of each previous cohort.    
 
 

Page 8 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Figure 1: Study Design 
The interim analysis at the conclusion of Cohort 1 will consist of the following evaluations: 
•
A planned efficacy evaluation of the time weighted average change in SARS-CoV-2
viral load from baseline will be conducted as an assessment of benefit to the
subjects.
•
Safety evaluations, performed by an independent safety monitoring team as outlined
in the committee charter, are to ensure that each dose level under evaluation is safe.
Specific criteria for safety review will include:
o
Number of subjects experiencing laryngospasm, bronchospasm or anaphylaxis
within 2 hours after use of the RD-X19 Device that is considered related to RD-
X19.
o
Number of subjects experiencing an allergic reaction such as generalized urticaria
(defined as occurring at three or more body parts) within 72 hours after
administration of light that is considered related to RD-X19.
o
Number of subjects experiencing an SAE or Grade 3 AE, in the same SOC
grouping of Preferred Terms based on Medical Dictionary for Regulatory
Activities (MedDRA) coding, considered to be related to RD-X19.

 
Page 9 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 
Objectives and Endpoints 
Table 1: Objectives and Endpoints (Outcome Measures) 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Safety Assessments 
• AEs and SAEs* 
 
 
 
• Methemoglobin  
• The primary safety measure is absence of 
device-related serious adverse events or 
any patterns of severity ≥2 device-related 
adverse events.* 
 
• Mean change in methemoglobin from 
baseline to Day 8/ET. 
Efficacy Assessments 
• viral load  
 
 
 
 
 
 
 
 
 
• viral infection 
 
 
 
 
 
 
 
 
 
• symptoms 
 
• Time weighted average change in 
viral load from baseline by RT-
qPCR from Day 1 to Day 8 
 
• Geometric mean viral load as 
measured in saliva on day 1, 3, 5, 
and 8 by RT-qPCR* 
• Proportion of subjects 
demonstrating viral load reduction 
≥ 95% by RT-qPCR (at each 
visit)* 
• Time to clearance of viral 
infection in saliva, defined as a 
negative test (Ct value ≥32) via 
RT-qPCR. 
• Proportion of subjects 
demonstrating clearance of viral 
infection, defined as a negative 
test (Ct value ≥32) via RT-qPCR 
on Day 8/ET. 
 
• Median time to alleviation of symptoms 
as measured by the time when all eight 
symptoms (cough, sore throat, nasal 
congestion, 
headache, 
chills/sweats, 

Page 10 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
•
COVID-19 composite severity
score.
muscle or joint pain, fatigue, and nausea) 
had been assessed by the subject as none 
(0) or mild (1).
Exploratory Assessment(s) 
•
viral load by viral titer (at each
visit)
• Geometric mean viral load as
measured in saliva on day 1, 3, 5,
and 8 by TCID50 for replication 
competent virus. 
*- indicates planned analysis for independent monitoring committee review between cohorts. 
Inclusion and Exclusion Criteria 
A subject must meet all the following criteria to be eligible for inclusion in this study: 
1.
Positive for SARS-CoV-2 antigen via nasal swab detected using BD Veritor™ Plus System.
2.
Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3
days and have either a) fever of at least 100 °F or b) at least two moderate or severe
symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain,
fatigue, and nausea) at the time of screening.
3.
Provides written informed consent prior to initiation of any study procedures.
4.
Be able to understand and agrees to comply with planned study procedures and be available
for all study visits.
5.
Agrees to the collection of nasopharyngeal swabs, oral saliva specimen collection and venous
blood specimens per protocol.
6.
Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or
mouthwashes of any kind during the study.
7.
Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
8.
No uncontrolled disease process (chronic or acute), other than COVID-19 signs and
symptoms*.
9.
No physical or mental conditions or attributes at the time of screening, which in the opinion of
the PI, will prevent full adherence to, and completion of, the protocol.
*The following COVID-19 onset of signs and symptoms generally appear 2-7 days after exposure
to SARS-CoV-2:

Page 11 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
•
Cough
•
Sore throat
•
Nasal Congestion
•
Headache
•
Chills/sweats
•
Muscle or joint pain
•
Fatigue
•
Nausea
Severity of each COVID-19 symptom will be assessed based on definitions used for graded 
adverse events: 
•
None (Grade 0): Not present
•
Mild (Grade 1): Events that are usually transient and may require only minimal or no
treatment or therapeutic intervention and generally do not interfere with the subject’s
usual activities of daily living.
•
Moderate (Grade 2): Events that are usually alleviated with additional specific
therapeutic intervention. The event interferes with usual activities of daily living
causing discomfort but poses no significant or permanent risk of harm to the research
subject.
•
Severe (Grade 3): Events interrupt usual activities of daily living, or significantly
affects clinical status, or may require intensive therapeutic intervention. Severe events
are usually incapacitating.
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1.
Positive urine pregnancy test at screening.
2.
Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or
appropriate sub-investigator, precludes study participation.
3.
Presence of self-reported or medically documented uncontrolled significant medical or
psychiatric condition(s) other than COVID-19.
4.
Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen,
hepatitis C virus antibody, or HIV-1 antibodies at screening.
5.
Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1
month of Study Day 1.
6.
COVID-19 signs associated with acute respiratory distress or imminent serious medical
outcomes.^^
7.
BMI ≥36.

 
Page 12 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
8. Has participated in another investigational study involving any intervention for SARS-CoV-
2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational 
product within 30 days of screening.  
9. Currently enrolled in or plans to participate in another clinical trial with an interventional 
investigational agent that will be received during the study period. 
10. History of hospitalization within the past 60 days. 
11. History of systemic antiviral therapies within the past 30 days. 
12. History of oral corticoid steroid use within the past 14 days or steroid injection within the past 
6 months. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are 
not exclusionary. 
13. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized 
urticaria, angioedema, other significant reaction) to nitrites, nitrates or sun exposure.  
14. Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the 
investigator would interfere with device use, or intra-oral metal body piercings that cannot be 
removed for the duration of the study. Metal orthodontia is permitted as braces will be 
covered by the device mouthpiece. 
 
^^Potential Study Subjects Presenting with any of the following should be referred for immediate 
medical care and are not eligible for the study 
• Fever > 104o F 
• Cough with sputum production 
• Rales and/or rhonchi 
• Difficulty breathing or respiratory distress defined by a respiratory rate ≥30 per 
minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 
<300. 
• Persistent pain or pressure in the chest 
• Confusion 
 
 

Page 13 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
4.2 Study Schedule of Activities 
Study Procedures 
Screening, 
Enrollment & 
Randomization 
Follow-up Period 
(Visit Window) 
Study Days 
1 
2 
3 
5 
(-1 to +1) 
8/ET 
(-1 to +1) 
Informed Consent 
X 
COVID19 Screening & SARS-CoV-2 Rapid Antigen Test 
X 
Medical History & Physical Examination 
X 
Changes since 
last visit only 
 Changes since 
last visit only 
Changes since 
last visit only 
X 
Oropharyngeal Assessment 
X* 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
X 
Urine Pregnancy Test 
X 
X 
Concomitant Medication History/New 
Baseline 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Comprehensive Metabolic Panel & CBC 
X 
X 
Vital Signs 
X 
X 
Methemoglobin 
X 
X 
Adverse Event Assessment / Reactogenicity 
Baseline 
X 
X 
X 
X 
Demographics, Inclusion / Exclusion Review 
X 
Diary Dispensation/Collection 
X 
X 
Treatment at Site 
X** 
X** 
X** 
Saliva collection for viral assays (2 specimens) 
X 
X 
X 
X 
COVID-19 Clinical Score 
X 
X 
X 
X 
Collect RD-X19 Device 
NA 
Cohort 1 
Cohort 2 
*On Day 1 to be evaluated 30 minutes after first illumination at site. **Only one treatment will be done on site,
other treatment will be done at home, i.e. if afternoon appointment, subject will complete morning treatment at
home and afternoon treatment administered at the site.  For scheduling purposes, recommended interval between
treatment is approximately 8 – 12 hours but not < 4 hours.

 
Page 14 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
5 
INTRODUCTION 
5.1 Background and Study Rationale 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknow cause.  Coronavirus ribonucleic acid (RNA) was quickly identified in 
some of these patients. As of October 11, 2020 there were approximately 37 million confirmed 
cases wordwide (>7.7 million in the US) and over 1,075,000 deaths (~215,000 in the US). The 
only FDA approved intervention currently is Remdesivir for hospitalized subjects with COVID-
19.  Other interventions currently being used are through the Emergency Use Authorizations 
(EUA), against SARS-CoV-2 / COVID-19.  Social distancing and personal protective equipment 
constitute our only viable countermeasures to help reduce incidence of community acquisition and 
transmission of SARS-CoV-2. Vaccine candidates are being developed at an unprecedented 
speed, however their efficacy and safety is unknown and will not be fully defined for many 
months. Remdesivir, Convalescent Immune Plasma and SoluMedrol are all used to treat patients 
hospitalized with COVID-19, but none has received marketing approval as a therapeutic for 
uncomplicated COVID-19. Therefore, there remains an urgent public health need for rapid 
development of novel measures for prevention and treatment of SARS-CoV-2 and COVID-19. 
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent. 
 
 
 

Page 15 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
EmitBio™ RD-X19 Device Characteristics 
Table 2. 
Characteristic 
Target 
Route of Administration 
Oral Illumination 
Device Configuration 
Hand-held, rechargeable 
Blue Light Source 
Non-coherent, light emitting diode (LED) array 
UVA Content (315 nm – 400 nm) 
<1% 
UVB Content (280 nm - 315 nm) 
not detectable* 
UVC Content (100 nm - 280 nm) 
not detectable* 
Target Exposure Area 
Oropharynx and surrounding tissues 
Exposure Time 
5 min per treatment, 2X/day, ~8 hrs apart 
Total Daily Dose (@ 83 mm) 
16 J/cm2    (Joules = Watts x seconds)
Depth of Tissue Penetration 
< 0.5 mm 
Temperature (IEC 60601-1) 
< 48 °C (for durations <10 min) 
*UVA/UVB not detectable in Labsphere 1M Integrating Sphere equipped with CDS-610 Mini CCD Array Spectrometer
5.2 Risk/Benefit Assessment 
Known Potential Risks 
The potential risks of participating in this trial are those associated with having blood drawn and 
mild, transient, local reactions as measured in RD19-01-3Q20 , a Phase I Open Label, Acute 
Safety Study of the EmitBio™ RD-X19 Device.  
Drawing blood may cause transient discomfort and fainting. Fainting is usually transient and 
managed by having the subject lie down and elevate his/her legs. Bruising at the blood draw site 
may occur but can be prevented or lessened by applying pressure to the blood draw site for a few 
minutes after the blood is taken. 
Extensive evaluation of the RD-X19 and similar energy-based devices routinely used for oral and 
skin care purposes resulted in the Sponsor, after careful consideration, making the determination 
that RD-X19 was a “Not Significant Risk” (NSR) device per FDA guidelines.  
Eye exposure is to be avoided. Direct illumination of unprotected eyes can result in damage to 
the retina, and especially the macula. Other eye structures can also experience thermal injury. 
Study staff must ensure volunteers understand to never point the RD-X19 device toward their or 
anyone else's eyes. 
RD19-01-3Q20  Phase I Trial 
This was a first-in-man Phase I study that evaluated the acute safety and tolerability of the RD-
X19 device among 25 healthy volunteers between the ages of 18 and 45. A single dose (9 
joules/cm2) and schedule (3 minutes twice a day, separated by at least 4 hours, preferably 8 to 12 

 
Page 16 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
hours apart) was evaluated for 14 consecutive days. In total, subjects received a weekly dose of 
128 J/cm2 per week for a time weighted average of 750 mJ/cm2 h-1.   
No SAEs were observed during the study. No AEs based on laboratory findings were observed 
during the study. 
Twelve (12) study subjects reported a total of 3 distinct AE terms (local site reaction, headache, 
nausea) and 23 total AEs. Of the 23 total AEs, 22 were classified as mild (grade 1) with a single 
headache classified as moderate (grade 2). No AE required treatment or alteration to the study 
subject’s participation in the trial. No study subject withdrew from the trial because of an AE. 
All AEs were of short duration, with resolution typically reached the same day or within 24 hours. 
Since study subjects used the RD-X19 device approximately every 12 hours for 14 contiguous 
days, there was a continuous temporal association with RD-X19 device use and incident AEs 
during the course of RD19-01-3Q20. By definition, all local site reactions were attributed to the 
device; all were mild and transient and there was no pattern of increasing frequency with repeated, 
cumulative dosing.  
Population-based epidemiological data for headaches and nausea were considered when 
establishing device attribution. Approximately 40% of the general adult population have weekly 
headache and over 30% suffer from intermittent bouts of nausea of unknown origin.  Given the 
frequencies of headache and nausea reported in RD19-01-3Q20  are less than those reported in 
population-based epidemiological studies, the relationship with the RD-X19 device cannot be 
determined.  
In summary, the RD19-01-3Q20 Phase I trial demonstrated that EmitBio™ RD-X19 is a safe 
device, consistent with the sponsor’s and IRB’s original conclusion that RD-X19 is a NSR device. 
Risks to Privacy 
Subjects will be asked to provide personal health information (PHI). All attempts will be made to 
keep this PHI confidential within the limits of the law. However, there is a chance that 
unauthorized persons will see the subject’s PHI. All study records will be kept in a locked file 
cabinet or maintained in a locked room at the participating clinical trial site(s). Electronic files 
will be password protected. Only people who are involved in the conduct, oversight, monitoring, 
or auditing of this trial will be allowed access to the PHI that is collected. Any publications from 
this trial will not use information that will identify subjects by name. 
Organizations that may inspect and/or copy research records maintained at the participating 
clinical trial site(s) for quality assurance (QA) and data analysis include groups such as the IRB 
and the FDA. 
A description of this clinical trial will be posted on http://www.ClinicalTrials.gov. This web site 
does not include information that can identify subjects. 
There may be other risks, discomforts or side effects that are entirely unknown at this time. 
 
Known Potential Benefits 
There is no guaranteed benefit to study participants. Use of EmitBio™ RD-X19 is intended to 
reduce viral load of SARS-CoV-2 and alleviate the symptoms associated with uncomplicated 
COVID-19. There is also the potential for benefit to society resulting from insights gained from 

 
Page 17 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
participation in this study due to the widespread, and accelerating, threat of SARS-CoV-2 and 
COVID-19.  
6 
STUDY DESIGN 
6.1 Overall Design 
Volunteers will provide informed consent prior to initiating any screening procedures.  Those 
meeting all screening criteria will be eligible for enrollment and randomization into the study.  
Study subjects will be enrolled into treatment and control arms within two cohorts:  
• Cohort 1: 128 J/cm2 total dose RD-X19, Sham 
(5 minutes per treatment, 2X/Day for a duration of 4 days) 
• Cohort 2: 224 J/cm2 total dose RD-X19, Sham  
(5 minutes per treatment, 2X/Day for a duration of 7 days) 
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to 
the RD-X19 treatment arm or the sham treatment arm within each cohort.  Study subjects will be 
randomized in a 2:1 ratio (20 RD-X19 : 10 sham) per dose cohort. The double-blind, sham-
controlled period will last 8 days.  Assessments of study subjects will occur on study days 1, 2, 3, 
5 and the final assessment visit on Day 8. Since CMP and CBC results will not be available until 
study day 2, all volunteers who have significant abnormalities will be immediately contacted and 
advised of the abnormality, discontinued from active participation in the protocol and advised 
regarding appropriate medical follow-up outside the study. All such study subjects will be 
replaced with a new volunteer.  This is a randomized, adaptive, group sequential dose finding 
study.  The primary goal of the study is to evaluate the efficacy and safety of the RD-X19 device 
in SARS-CoV-2 infected individuals with outpatient COVID-19.  The primary efficacy outcome 
is the time weighted average change in SARS-CoV-2 viral load assessed via RT-qPCR. Safety 
assessment will include the incidence of device-related serious adverse events or patterns of 
severity ≥2 device-related adverse events. 
 
 
 

Page 18 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Figure 1: Study Design 
The interim analysis at the conclusion of Cohort 1 will consist of the following evaluations: 
•
A planned efficacy evaluation of the time weighted average change in SARS-CoV-2
viral load from baseline will be conducted as an assessment of benefit to the
subjects.
•
Safety evaluations, performed by an independent safety monitoring team as outlined
in the committee charter, are to ensure that each dose level under evaluation is safe
through 4 days of treatment.  Specific criteria for safety review will include:
o
Number of subjects experiencing laryngospasm, bronchospasm or anaphylaxis
within 2 hours after use of the RD-X19 Device that is considered related to RD-
X19.
o
Number of subjects experiencing an allergic reaction such as generalized urticaria
(defined as occurring at three or more body parts) within 72 hours after
administration of light that is considered related to RD-X19.
o
Number of subjects experiencing an SAE or Grade 3 AE, in the same SOC
grouping of Preferred Terms based on Medical Dictionary for Regulatory
Activities (MedDRA) coding, considered to be related to RD-X19.
Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by review of 
potential adverse events (AEs) and targeted physical examination, as required. Volunteers will be 
encouraged to contact designated clinical trial staff for AEs of a medically-urgent nature as soon as is 
practically possible and to seek immediate medical care, if needed. 
Metabolic, liver, kidney and hematological laboratory evaluations will be performed at screening and 
at Day 8 or early termination (and potentially during unscheduled) clinic visits.  
Study Subject safety will be monitored throughout the study by the Investigator and supported by 
regular review by the Medical Monitor and an external Data Monitoring Committee.    

Page 19 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
6.2 Objectives and Endpoints 
Table 1: Objectives and Endpoints (Outcome Measures) 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Safety Assessments
•
AEs and SAEs*
•
Methemoglobin
•
The primary safety measure is absence of
device-related serious adverse events or
any patterns of severity >2 device-related
adverse events.*
•
Mean change in methemoglobin from
baseline to Day 8/ET.
Efficacy Assessments 
•
Viral load
•
Viral infection
•
Symptoms
• Time weighted average change in
viral load from baseline by RT-
qPCR  from Day 1 to Day 8 
• Geometric mean viral load as
measured in saliva on day 1, 3, 5,
and 8 by RT-qPCR* 
• Proportion of subjects
demonstrating viral load reduction
≥ 95% by RT-qPCR (at each 
visit)* 
• Time to clearance of viral
infection in saliva, defined as a
negative test (Ct value ≥32) via 
RT-qPCR. 
• Proportion of subjects
demonstrating clearance of viral
infection, defined as a negative 
test (Ct value ≥32) via RT-qPCR 
on Day 8/ET. 
•
Median time to alleviation of symptoms
as measured by the time when all eight
symptoms (cough, sore throat, nasal
congestion, 
headache, 
chills/sweats,

Page 20 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
•
COVID-19 composite severity
score.
muscle or joint pain, fatigue, and nausea) 
had been assessed by the subject as none 
(0) or mild (1).
Exploratory Assessment(s) 
•
Viral load by viral titer (at each
visit)
• Geometric mean viral load as
measured in saliva on day 1, 3, 5,
and 8 by TCID50 for replication 
competent virus. 
*- indicates planned analysis for independent monitoring committee review between cohorts. 
6.3 Scientific Rationale for the Study 
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent. 
Justification for Doses 
In repeated experiments, including experiments conducted by third party external laboratories, it 
has been determined that the light emitted by the EmitBio™ RD-X19 device provides for potent 
antiviral activity against SARS-CoV-2.  Reduction in cell-free virus of ≥1000 fold and inhibition 
of viral replication of ≥99% have been observed in repeated experiments conducted by the 
sponsor and external expert laboratories.  Dose dependent effects are observed ranging from as 
little as a single 7.5 J/cm2 exposure up to complete antiviral activity at 30 J/cm2 measured 24 
hours after exposure.  Multiple cell types including human respiratory epithelial cells and 3D 
epithelial tissue in culture show high viability at single doses of visible blue light up to 120 
Joules/cm2. These repeated experiments, conducted in multiple labs with multiple cell types, along 
with years of medical use of licensed devices with comparable wavelengths and energy, support 
the doses proposed in this protocol for dose finding to achieve optimal efficacy and safety.  

 
Page 21 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
As in the Phase I study of RD-X19, a schedule of two treatments per day, separated by a 
recommended 8-12 hours will be evaluated.  The Phase I study evaluated a dosing schedule of 9.2 
J/cm2, 3 minutes twice daily for a total duration of 14 days (257 J/cm2 total).  A total weekly 
exposure of 128 J/cm2 was found to be well tolerated with minor application site adverse events.  
In light of these data, the current study will begin with the total energy exposure capped at 128 
J/cm2 which has been shown to be safe in the Phase I trial, and explore the delivery of 16 J/cm2 
BID for a duration of 4 days (Cohort 1 – 128 J/cm2 total dose).  Pending review of safety and local 
application site reactogenicity, a second Cohort of and 16 J/cm2 BID for a duration of 7 days (224 
J/cm2 total dose) will be evaluated.  The dosing schedule and duration has been selected to 
provide a reduction in viral load and symptomatic relief as rapidly as possible in COVID-19 
patients while still maintaining an acceptable safety margin for each individual treatment session. 
If patterns of ≥ grade 2 device-related adverse events are observed, dosing will be reduced to one 
exposure/day for the remainder of treatment time. If serious or severe device-related adverse 
events are observed, further treatments at that dose will be terminated. 
Strict safety oversight will provide rapid detection of significant device/dose-related adverse 
events warranting pausing or halting the trial. 
7 
STUDY POPULATION 
The study population is individuals infected with SARS-CoV-2 who have symptoms associated 
with COVID-19 that is either not under active medical treatment or is being treated as an 
outpatient. Study subjects must be symptomatic for 3 days or less and have a positive COVID-19 
antigen test using the BD VeritorTM Plus System.  Study subjects will be randomized to treatment 
arm within dose in a 2:1 ratio according to a fixed schedule using a permuted block design.  The 
targeted number of subjects randomized per dose is 30 (20 volunteers to the RD-X19 arm, 10 
subjects to the sham arm). This is a sample size of convenience as this is a hypothesis generating 
study.   
The target population should reflect the subject population with uncomplicated  COVID-19 in the 
community at large.  
Subject Inclusion and Exclusion Criteria must be confirmed by a study clinician, licensed to make 
medical diagnoses.  
7.1 Inclusion Criteria 
A subject must meet all the following criteria to be eligible to participate in this study:  
1. Positive for SARS-CoV-2 antigen via nasal swab detected using BD Veritor™ Plus System. 
2. Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3 
days* and have either a) a fever of at least 100 °F or b) at least two moderate or severe 
symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint 
pain, fatigue, and nausea) at the time of screening. 
3. Provides written informed consent prior to initiation of any study procedures. 
4. Be able to understand and agrees to comply with planned study procedures and be available 
for all study visits. 

 
Page 22 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
5. Agrees to the collection of nasopharyngeal swabs, oral saliva specimen collection and venous 
blood specimens per protocol. 
6. Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or 
mouthwashes of any kind during the study.  
7. Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment. 
8. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and 
symptoms*. 
9. No physical or mental conditions or attributes at the time of screening, which in the opinion of 
the PI, will prevent full adherence to, and completion of, the protocol. 
 
*The following COVID-19 onset of signs and symptoms generally appear 2-7 days after exposure to 
SARS-CoV-2: 
• Cough 
• Sore Throat 
• Nasal Congestion 
• Headache 
• Chills/sweats 
• Muscle or joint pain 
• Fatigue 
• Nausea  
 
Severity of COVID-19 symptoms will be assessed based on definitions used for graded adverse 
events: 
• None (Grade 0): Not present 
• Mild (Grade 1): Events that are usually transient and may require only minimal or no treatment 
or therapeutic intervention and generally do not interfere with the subject’s usual activities of 
daily living. 
• Moderate (Grade 2): Events that are usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living causing discomfort but 
poses no significant or permanent risk of harm to the research subject. 
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. Severe events are usually 
incapacitating. 
7.2 Exclusion Criteria 
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1. Positive urine pregnancy test at screening. 

 
Page 23 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
2. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or 
appropriate sub-investigator, precludes study participation. 
3. Presence of self-reported or medically documented uncontrolled significant medical or 
psychiatric condition(s) other than COVID-19.  
4. Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen, 
hepatitis C virus antibody, or HIV-1 antibodies at screening.  
5. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 
month of Study Day 1. 
6. COVID-19 signs associated with acute respiratory distress or imminent serious medical 
outcomes. ^^ 
7. BMI ≥36. 
8. Has participated in another investigational study involving any intervention for SARS-CoV-
2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational 
product within 30 days of screening.  
9. Currently enrolled in or plans to participate in another clinical trial with an interventional 
investigational agent that will be received during the study period. 
10. History of hospitalization within the past 60 days. 
11. History of systemic antiviral therapies within the past 30 days. 
12. History of oral corticoid steroid use within the past 14 days or steroid injection within the past 6 
months. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are not 
exclusionary. 
13. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized 
urticaria, angioedema, other significant reaction) to nitrites, nitrates or sun exposure.  
14. Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the 
investigator would interfere with device use, or intra-oral metal body piercings that cannot be 
removed for the duration of the study. Metal orthodontia is permitted as braces will be 
covered by the device mouthpiece. 
 
^^Potential Study Subjects Presenting with any of the following should be referred for immediate 
medical care and are not eligible for the study: 
• Fever > 104o F 
• Cough with sputum production 
• Rales and/or rhonchi 
• Difficulty breathing or respiratory distress defined by a respiratory rate ≥30 per minute, heart 
rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 <300. 
• Persistent pain or pressure in the chest 
•  Confusion 

 
Page 24 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
7.3  Study Volunteer Selection, Retention & Compensation 
 
Recruitment 
Potential subjects will learn about the study via IRB-approved recruitment strategies, including 
direct mailing, recruitment from an IRB-approved trial registry, digital advertisements and local 
advertisements/flyers. Pre-screening maybegin with a brief IRB-approved telephone call from 
study staff. Information about the study will be presented to potential subjects and questions about 
their health and ability to comply with the study visit schedule will be asked of potential subjects 
to presumptively determine eligibility. Appointments will be made at the clinical trial unit for 
potential subjects who are interested in the study for further screening procedures and additional 
protocol-specific information. 
 
Retention 
Study retention strategies will include education and explanation of the study schedule and 
procedures during screening and enrollment visits and restriction of enrollment to persons who 
can attend all study visits. Participating subjects will be reminded of subsequent visits during each 
visit, and study staff will contact subjects prior to appointments. Study staff will contact subjects 
who miss appointments to encourage them to return for completion of safety evaluations. 
 
Compensation Plan for Subjects 
Subjects will be compensated for their participation in this trial. Compensation will take into 
consideration both the urgency and importance of developing new treatments for this COVID-19 
pandemic and local IRB guidelines, and will be ultimately subject to local IRB approval. 
Reimbursements will be disbursed at specific timepoints during the study with the total amount 
contingent on completing study procedures. 
 
Costs 
There is no cost to subjects for the research tests, procedures/evaluations or study device while 
taking part in this trial. Procedures and treatment for clinical care may be billed to the subject, 
subject's insurance or third party. 
8 
STUDY DEVICE 
8.1 Regulatory Considerations 
 
Preliminary Regulatory Pathway for EmitBio™ RD-X19 
The Food and Drug Administration (FDA) plays a critical role in protecting the United States 
from threats such as emerging infectious diseases, including the COVID-19 pandemic. To date, 
the agency has utilized various mechanisms to expand access for drugs, grant emergency use 
authorization (EUA) for certain diagnostic and treatment approaches and has issued policies for 
medical devices without premarket notification during the COVID-19 public health emergency. 
Risk management activities have been completed according to EmitBio’s SOP for Risk 
Management and a Risk Management Plan was developed, which are compliant with the 
applicable 21 CFR part 820 regulations, ANSI AAMI ISO 14971, and ISO TR 24971.  A Hazard 

Page 25 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Analysis, including a Failure Effects Mode Analysis, of the device characteristics and use was 
performed based on ANSI AAMI ISO 14971.   
The risks identified, mitigation measures and control strategies, in combination with a review of 
all available nonclinical and clinical safety information, has led the company to conclude that the 
RD-X19 operating at the proposed fluence levels is a Nonsignificant Risk Device.   
Per the FDA guidance document titled “Significant Risk and Nonsignificant Risk Medical Device 
Studies,” NSR device studies do not have to have an Investigational Device Exemption (IDE) 
application approved by FDA prior to initiation.  
EmitBio™ conducted RD19-01-3Q20 under 21 CFR 812 as a Non-Significant Risk (NSR), 
Minimal Risk protocol. The Institutional Review Board agreed with EmitBio™ based on the 
protocol and supporting documentation submitted with the protocol and granted final approval to 
conduct the study on September 1, 2020. 
Proposed Label Claim/Indication for Use: 
The RD-X19 device is intended for use as a treatment to reduce viral load in the upper respiratory 
tract in subjects ages 12 to 65 who have tested positive for SARS-CoV-2 and who have symptoms 
consistent with uncomplicated COVID-19 for no more than 3 days. 
Medical Device Quality System: 
EmitBio™ will operate under an established Quality Management System, with a commitment for 
continuous improvement and effectiveness, in accordance with the requirements of the customers 
and applicable international standards. Specifically, the EmitBio™ Quality Management System 
is compliant with the requirements of the FDA Quality Systems Regulations (QSR). 
8.2 Study Device and Use 
 
Device Description 
The RD-X19 device emits safe, visible blue light to eliminate invading pathogens and stimulate 
host defenses in the oropharynx and surrounding tissues. The RD-X19 device does this without 
additional photosensitizers or chemical reagents that are typically employed with traditional 
photodynamic therapeutics. Specifically, selected wavelengths of light have been evaluated across 
the visible spectrum, and it was discovered that safe, visible blue light emitted from non-coherent 
LED sources could perform the following functions: 
•
kill cell-free virus by several orders of magnitude,
•
inhibit viral replication post infection,
•
stimulate host immune response through the instantaneous release of the body’s
bound stores of nitric oxide as well as upregulate nitric oxide production in
epithelial tissue.
The device consists of three components: (1) Aluminum housing, (2) Light Engine, and (3) Light 
Delivery Assembly.  Each of those components are described briefly below.  Each of the building 

Page 26 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
blocks described are designed to allow the assembled device to meet specific criteria based on 
targeted safety and efficacy. 
Figure 3. Fully assembled RD-X19 device. 
1. Aluminum Housing - The aluminum housing measures approximately 16 cm x 3.5 cm x
3.5 cm.  It has been engineered for function and ease of manufacturing and designed for
ergonomics.  With regard to functionality, the aluminum housing provides durable support
for the light engine, the light delivery system, and the battery to provide for long-lifetime
operation and effective heat dissipation.  With respect to ergonomics, the housing
incorporates a right angle, providing a comfortable transition from the light engine to the
light delivery assembly as well as for single-handed use.
2. Light Engine - Completely located inside of the aluminum housing, the light engine
consists of five major sub-components:
•
Battery - The 3500 mAh lithium ion rechargeable battery can be quickly and
routinely charged via a micro USB charging cable for everyday use.
•
Treatment actuator - The actuator is a high reliability (300,000 cycle rating)
instantaneous contactor that both starts the auto-timed treatment and provides a
user-controlled method to stop the treatment before completion if needed.  In
addition, the treatment actuator contains LED indicators to inform the user of
device state (e.g. charging, fully-charged, treatment in progress, device
malfunction).
•
Treatment control board - The treatment control board governs the electronic
operation of the device to both measure charge state of the battery and provide for
battery charging, both while isolating the user from the AC power source.  It also

Page 27 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
provides the LED array with a calibrated amount of electrical power which the 
LEDs convert into the targeted optical power.  Finally, at the heart of the treatment 
board is a microprocessor that monitors parameters such as battery health and time 
between treatments while also automatically stopping the optical treatment after a 
specified duration.  
•
LED Array - The LED array incorporates a series of safe, visible blue LEDs
soldered on a metal core circuit board.   The quantity and characteristics (e.g.
optical power and wavelength) of the individual LEDs in the LED array have been
chosen to promote for maximum therapeutic index against viral pathogens and for
photobiomodulation of nitric oxide.  At the use conditions contemplated, the LED
useful lifetime is expected to be greater than 100,000 treatments.
•
Optical Lens - After emission from the LEDs, the light passes through the optical
grade, glass lens.  The diameter, focal length, and thickness of the lens have been
chosen to homogenize the emission from the LED array while optimizing
transmission of the light.
3. Light Delivery Assembly - The light delivery assembly shapes the light while transferring
the optical energy from the LED array to the host tissue and is the only component that
comes into contact with the oral cavity.  It measures approximately 8 cm x 6.5 cm x 4.0
cm and consists of two primary sub-components, the light guide (LG) and the light guide
positioner (LGP).
•
Light Guide (LG) - After passing through the lens, the pre-shaped beam enters the
LG.  The LG further shapes the beam for final delivery to the host tissue while also
shielding the user from any edge high intensity light.  While the oropharynx can be
sufficiently exposed through proper head positioning, the LG also incorporates a
shaped element to assist the tongue in staying out of the light path.  When the
device is in use, the LG is anchored securely to the aluminum housing via spring
clips.  The clips not only allow for secure anchoring, but they also provide for easy
removal and cleaning of the LG.
•
Light Guide Positioner (LGP) - Through its relationship to the LG and the oral
cavity – specifically to both the upper and lower teeth – the LGP ensures that the
light emitting from the LED array and shaped by the lens and LG is directed
toward the oropharynx.   As an important consideration, since both the LG and the
LGP are in contact with the oral cavity, both have been shown to be both safe for
daily repeat dosing 2 weeks in duration and the fabricated sub-components been
made with materials that have been previously evaluated under ISO 10993.
There are two primary accessories required for use of the device.  The first accessory, the AC 
adapter, is used to for recharging the device.  The AC adapter is plugged into wall voltage and 
then connected to the device via a micro USB cable between device uses.  The user is prompted, 
via indicator lights, when recharging is necessary, in progress, and complete.  The second 
accessory, the stand, is used for storing the device between uses.  The stand is portable, and the 
device is held in an upright position when placed in the stand. 

Page 28 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
8.3 Use / Storage & Maintenance / Accountability 
 Acquisition and Accountability 
The sponsor will provide clinical sites with RD-X19 devices packaged in appropriately labelled 
containers containing all components as well as instructions for use by study participants.  Each 
RD-X19 device will be stamped on its power unit with a serial number.  Study staff will ensure 
that each device’s serial number is assigned to a specific study subject and the link between device 
serial number and study subject study number will be maintained on an accountability log.  
Subjects will be requested to bring their device to the clinic for each scheduled visit.  Upon 
termination of a subject’s participation in the trial, all RD-X19 devices and components must be 
returned to the study site and then to the study sponsor. 
 Device Storage and Maintenance 
All RD-X19 devices will be stored in a locked device storage room at the clinical trial site until 
needed for assignment to an enrolled study volunteer.  Upon acquisition by the study subject, 
devices should be stored in a dry climate-controlled environment in the original container in 
which it was provided.   
The device should be stored securely out of the reach of children who may mistakenly misuse the 
device, especially illumination of eyes – which is always to be avoided. The mouthpiece of the 
device is removable for rinsing with mild soap and warm water.  The device tongue depressor and 
power housing may be cleaned with a soft cloth that has been dampened in mild dish detergent 
diluted in water; pieces should then be dried with a soft cloth.  The optic device can be wiped 
gently with a dry cloth suitable for cleaning optical glasses. 
 Preparation for Use and Use 
[Refer to Appendix 1: RD-X19 User Instructions] 
8.4 Measures to Maximize Study Subject Compliance 
Randomization between active treatment and sham control devices has been set at 2:1 to provide 
higher probability of the subjects being randomized to the investigational treatment during the 
study duration. 
Subjects will receive appropriate compensation for the disruption to normal daily activities created 
by this protocol that also considers the frequency with which they are requesting to travel to the 
site, the twice daily journaling and treatment regimen, and the number of biospecimens scheduled 
to be collected for virology assessments.   
Additionally, the subjects will be educated on the role of their individual contribution in clinical 
research as it relates to developing a solution for the COVID-19 pandemic on a global scale. 
8.5 Device Discontinuation 
Study Pausing Criteria 
EB-P12-01 enrollment will be paused if any of the following events occur: 

 
Page 29 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
• Any subject experiences an SAE after use of the RD-X19 Device that is considered 
related to RD-X19. 
• Any subject experiences laryngospasm, bronchospasm or anaphylaxis within 2 hours 
after use of the RD-X19 Device that is considered related to RD-X19. 
• Two (2) or more subjects experience an allergic reaction such as generalized 
urticaria (defined as occurring at three or more body parts) within 72 hours after 
administration of light that is considered related to RD-X19. 
• Three (3) or more subjects experience a Grade 3 AE (systemic and/or clinical 
laboratory abnormality), in the same SOC grouping of Preferred Terms based on the 
Medical Dictionary for Regulatory Activities (MedDRA) coding, considered to be 
related to RD-X19. 
Enrollment may resume only after external safety review of the SAE/AEs that caused the pause to 
the study.  Given the frequency of visits and the duration of the protocol, study device use may 
continue after assessing the safety and AEs for individual subjects at either regulatory scheduled 
or an unscheduled site visits. 
 
Subject elects to discontinue 
A study volunteer may elect to discontinue participation in the trial at any time. Investigative staff 
will ask the volunteer to return for an early termination evaluation, but they are under no 
obligation to do so. All study subjects must return the RD-X19 device at study termination and 
study staff must verify that the device serial number matches the study subject to whom it was 
assigned. 
 
Investigator Decision to Discontinue Subject Use of Device 
A subject may be removed from the study for the following reasons post initial device use; 
however, whenever possible the subject should be followed for safety evaluations per protocol: 
• 
Study non-compliance to protocol requirements that in the opinion of the participating 
clinical site PI or appropriate sub-investigator poses an increased risk (e.g., missing safety 
labs) or compromises the validity of the data. 
• 
Lost to follow-up. (A subject will be considered lost to follow-up if he or she fails to 
appear for a follow-up assessment. Extensive effort (i.e., generally three documented 
contact attempts via telephone calls, e-mail, etc., made on separate occasions) will be 
made to locate or recall the subject, or at least to determine the subject’s health status. 
These efforts will be documented in the subject’s study file.) 
• 
Medical disease or condition, or new clinical finding(s) for which continued 
participation, in the opinion of the participating clinical site PI or appropriate sub- 
investigator, might compromise the safety of the subject, interfere with the subject’s 
successful completion of this study, or interfere with the evaluation of safety. 
• 
If any AE, clinical laboratory abnormality or situation occurs such that continued 
participation in the study would not be in the best interest of the subject. 
• 
The occurrence of a SAE. 

 
Page 30 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
• 
 If the subject is using the device in any manner inconsistent with instructions and 
protocol directives and procedures. 
 
If the subject agrees, every attempt will be made to follow all AEs through resolution or 
stabilization. 
Subjects who withdraw or are lost to follow-up after signing the informed consent form (ICF) and 
use of the RD-X19 device will not be replaced. Subjects who withdraw or are withdrawn from this 
study after signing the ICF but before use of the device may be replaced. 
The reason for subject discontinuation or withdrawal from the study will be recorded on the 
appropriate e-CRF. 
 
Follow-up of Study Subjects Who Discontinue Device Use 
Discontinuation of study device use does not constitute discontinuation from the study, and the 
study procedures for early termination should be completed as indicated by the Study Schedule of 
Activities. If a clinically significant finding is identified, including, but not limited to, changes 
from baseline, after enrollment, the participating clinical trial site PI or qualified designee will 
determine if any change in subject management is needed. Any new clinically relevant finding 
will be reported as an AE. 
9 
STUDY ASSESSMENTS AND  PROCEDURES 
9.1 Screening Assessments 
 
Screening Procedures 
At the screening visit, and prior to any other study-related activities, the participating clinical site 
PI or appropriate sub-investigator will provide the subject with detailed study information and will 
obtain written informed consent (see section 11.1.1 for more details). 
 Subject numbers will be assigned with the three-digit numerical site number beginning with 
numbers greater than one hundred (e.g. 101) followed by an alphanumeric cohort identifier (e.g. 
C1) and finally a two digit unique numerical identifier assigned with each new subject (e.g. 01). 
Example Subject Number: 101-C1-01 
 
COVID-19 Screening 
Eligible subjects presenting with uncomplicated COVID-19 must have an oral temperature of at 
least 100 ˚F or have at least two moderate or severe symptoms (cough, nasal congestion, or sore 
throat, headache, chills/sweats, muscle or joint pain, fatigue, or nausea) and consent to be 
randomized within 3 days of first symptom onset. The subjects will self-assess their COVID-19 
symptoms as none (0), mild (1), moderate (2), or severe (3) during screening.  
Additionally, subjects who identify with symptomatology associated with COVID-19 will be 
screened by taking a nasal culture and analyzed for the presence of SARS-CoV-2 by the BD 
Veritor™ Plus System.  The Veritor™ System for rapid detection of SARS-CoV-2 is a 
chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens. 

 
Page 31 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
There is a small amount of risk to subjects who report mild-to-moderate symptomatology 
consistent with COVID-19 may have an unknown health problem or co-morbidity at the time of 
screening that can lead to worsening of condition or hospitalization during study. 
General Screening 
Some or all of the following assessments are performed during the screening visit to determine 
eligibility requirements as specified in the inclusion and exclusion criteria: 
o Obtain medical history focusing on conditions per protocol exclusion criteria. 
o Review all pre-study medications, vitamins, supplements, and 
therapies up to 14 days prior to the start of screening that could impact 
the use of, or response to, the device and record on the appropriate e-
CRF.  Subjects are allowed to use over-the-counter medications and 
remedies to alleviate symptoms (e.g. acetaminophen, ibuprofen, 
cough drops, etc. and should be recorded.) 
o Measure vital signs (HR, BP, and oral temperature) and 
height and weight for determination of BMI. 
o Perform full physical examination which will include assessments of 
the following organs and organ systems: skin, head, ears, eyes, nose, 
and throat (HEENT), neck, lungs, heart, liver, spleen, abdomen, 
extremities, lymph nodes (axillary and cervical), and nervous system. 
o Obtain blood and urine for clinical screening laboratory evaluations: 
▪ Comprehensive Metabolic Panel (fasting or non-fasting) 
▪ CBC with differential 
▪ Urine pregnancy test (in women of childbearing potential) 
o Review inclusion and exclusion criteria. 
The overall eligibility of the subject to participate in the study will be assessed once all screening 
values are available. The screening process can be suspended prior to complete assessment at any 
time if exclusions are identified by the study team. 
Study subjects who qualify for inclusion will be immediately randomized for their day 1 visit. 
If a physiologic parameter, e.g., vital signs, is outside of the protocol-specified range, then the 
measurement may be repeated once if, in the judgment of the participating clinical site PI or 
appropriate sub-investigator, the abnormality is the result of an acute, short-term, rapidly 
reversible condition (e.g., stress, anxiety or “white coat syndrome”) or other source of error. A 
physiologic parameter may also be repeated if there is a technical problem with the measurement 
caused by malfunctioning, or an inappropriate measuring device (i.e., inappropriate-sized BP 
cuff). 
A subject may be re-screened if there is a transient disease status (e.g., absent signs and symptoms 
associated with mild COVID-19), or if a protocol eligibility criterion that is not met at the initial 
time of screening, will be met by rescreening of all assessments within the next 2 days using the 
same subject number. 
No subjects may be screened more than twice due to a screening failure result as defined above. 

Page 32 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Subjects will be provided the results of abnormal clinical laboratory test values or abnormal 
clinical findings necessitating follow-up with their primary care provider. 
Procedures for Abnormal Clinical Laboratory Values or Findings 
If in the judgement of the PI the finding poses a previously unknown risk to the subject or leads to 
a diagnosis of a disease or condition that would have been disqualified the subject for enrollment, 
the subject will be withdrawn from the study immediately.   
All abnormal clinical findings that occur post randomization and the first use of the RD-X19 
device will be considered AEs. 
9.2 Safety and Other Assessments 
Study procedures are specified in protocol section 4.2. A study clinician, licensed to make medical 
diagnoses as the participating clinical site PI or appropriate sub-investigator, will be responsible 
for all study-related medical decisions. 
o Medical history:
o
A complete medical history will be obtained by interview of
subjects at the screening visit. Subjects will be queried regarding a
history of significant medical disorders of the head, ears, eyes,
nose, throat, mouth, cardiovascular system, lungs, gastrointestinal
tract, liver, pancreas, kidney, urologic system, nervous system,
blood, lymph nodes, endocrine system, musculoskeletal system,
skin, and genital/reproductive tract. A history of any allergies,
cancer, immunodeficiency, psychiatric illness, substance abuse, and
autoimmune disease will be solicited.
o
At all subsequent visits an interim medical history will be obtained
by interview of subjects and any changes since the previous clinic
visit will be noted. The interim medical history should include an
assessment for new medical conditions and symptoms suggestive of
an AE.
o
Physical examination:
o
A full physical examination will be performed at the screening
visit and Day 8, and a symptom-directed (targeted) physical
examination will be performed if indicated during other clinic
visits
▪
A full physical examination will include assessments of the
following organs and organ systems: skin, HEENT, neck,
lungs, heart, liver, spleen, abdomen, extremities, lymph
nodes (axillary and cervical), and nervous system.
▪
Height and weight will be measured, and BMI calculated,
at the screening visit only.
o
A symptom-directed (targeted) physical examination will
be performed if indicated during other scheduled clinical
site visits.

 
Page 33 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
▪ Targeted physical examinations will primarily focus on 
assessment of signs and symptoms suggestive of AEs. 
Interim or unscheduled physical examinations will be 
performed at the discretion of the participating clinical site 
PI or appropriate sub-investigator, if necessary, to evaluate 
AEs. 
o Subjects will be observed in the clinic for at least 30 
minutes post the first RD-X19 illumination. The 
oropharynx and surrounding tissues will be examined. 
Reactogenicity assessments will be performed on Days 1, 
2, 3, 5, and 8. An oropharyngeal examination will also be 
performed on Days 1 and 8 and during unscheduled visits 
and early termination visits and recorded on the 
appropriate source document prior to discharge from the 
clinic. Interim or unscheduled oropharyngeal examinations 
will be performed, if necessary, to evaluate AEs. 
o Vital signs:  
Vital sign measurements will include systolic and diastolic BP, 
HR, and oral temperature. Vital signs will be measured at 
timepoints specified in protocol section 4.2. Subjects must not eat 
or drink anything hot or cold within 10 minutes prior to taking 
their oral temperature or using the RD-X19 device. 
o 
Clinical laboratory evaluations: 
o Fasting is not required before collection of clinical laboratory evaluations. 
o Urine pregnancy test will be performed locally by the site 
laboratory at the screening visit and at the final study visit. Results 
must be confirmed as negative prior to randomization on Day 1 and 
allocation and use of the RD-X19 device. 
o Clinical laboratory evaluations CMP and CBC (diff) will be 
performed locally by the site selected laboratories.  
▪ Clinical safety laboratory evaluations will be performed 
locally by the  site laboratory.  
▪ Blood and urine will be collected at timepoints specified in 
the protocol section 4.2. 
 
Definition of Adverse Event (AE) 
AE means any untoward medical occurrence associated with the use of an intervention in humans, 
whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any 
unfavorable and unintended sign (including an abnormal clinical laboratory finding), symptom or 
disease temporally associated with the use of medicinal (investigational) product. 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the severity of any pre-existing medical condition 
increases, it should be recorded as an AE. 

 
Page 34 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
AEs can be further divided into solicited AEs and unsolicited AEs. Solicited AEs are those for 
which the study team will specifically query the subject whether they occurred. Unsolicited AEs 
are those events that the subject report occurring without being queried about the specific event. 
All AEs will be assessed for severity and relationship to study intervention. Reporting of all AEs, 
solicited and unsolicited, will occur during the period from study device administration on Day 1 
through Day 8 or until an early termination visit. 
All AEs, solicited and unsolicited, will be captured on the appropriate source documents and e-
CRFs. Information to be collected for AEs includes event description, date of onset, assessment of 
severity, relationship to study product and alternate etiology (assessed only by those with the 
training and authority to make a diagnosis as the participating clinical site PI or appropriate sub-
investigator), date of resolution, seriousness, and outcome. All AEs will be documented regardless 
of relationship. 
AEs will be followed to resolution or stabilization. 
 
Solicited Adverse Events - Reactogenicity 
Solicited AEs are anticipated AEs for which consistent collection of information is desired. Study 
clinicians will follow and collect resolution information for any reactogenicity symptoms that are 
not resolved during the active study period. 
Solicited AEs (i.e., reactogenicity) will be collected by direct questioning of study subjects and 
recorded on the appropriate source document and e-CRF during the entire course of the study. 
For this study, solicited AEs include: 
• 
Illumination site Pain 
• 
Illumination site Erythema 
• 
Illumination site Edema/Induration 
• 
Any other pain, redness, swelling or lesion of the oral mucosa 
 
Unsolicited Adverse Events 
All AEs spontaneously reported by the subject and/or in response to an open question from study 
staff or revealed by observation, physical examination or other diagnostic procedures must be 
recorded on the appropriate source document and e-CRF. 
Unsolicited AEs of all severities will be reported during the entire course of the study. 
 
Adverse Event Reporting 
Information on all AEs should be recorded on the appropriate source document and e-CRF. All 
clearly related signs, symptoms and results of diagnostic procedures performed because of an AE 
should be grouped together and recorded as a single diagnosis. If the AE is a clinical laboratory 
abnormality that is part of a clinical condition or syndrome, it should be recorded as the syndrome 
or diagnosis and be described in terms of duration (start and stop date). 

 
Page 35 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 
Definition of a Serious Adverse Event (SAE) 
An SAE is defined in 21 CFR 312.32 as follows: “An AE is considered serious if, in the view of 
either the participating clinical site PI or appropriate sub-investigator or the sponsor, it results in 
any of the following outcomes: 
• 
Death, 
• 
A life-threatening AE, 
• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, 
• 
Or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, are not immediately life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. An example of such a medical event would 
be an allergic bronchospasm requiring intensive treatment in an emergency room or at home to 
prevent the development of one of the definitions above. 
“Life-threatening” refers to an AE that at occurrence represents an immediate risk of death to a 
subject. An event that may cause death if it occurs in a more severe form is not considered life-
threatening. Similarly, a hospital admission for an elective procedure is not considered an SAE. 
All SAEs, as with any AE, will be assessed for severity and relationship to study intervention. All 
SAEs will be recorded on the appropriate SAE e-CRF. 
All SAEs will be followed through resolution or stabilization by a study clinician, licensed to 
make medical diagnoses and listed as the participating clinical site PI or appropriate sub-
investigator. 
All SAEs will be reviewed and evaluated by the Sponsor and will be reported to the IRB. This 
report will include severity, association with the study device, action(s) taken, and outcome. 
 
Serious Adverse Event Reporting 
Any AE that meets a protocol-defined criterion as an SAE must be submitted immediately (within 
24 hours of site awareness) on an SAE form to CRO/EmitBio Inc. Pharmacovigilance: 
EmitBio™ Pharmacovigilance  
SAE Hot Line: 1-843-540-3550 or 1-610-570-7425  
Text Immediate Report: 1-843-540-3550 
SAE Email: jmcneil@emitbio.com 
In addition to the SAE form, all SAE data must be entered into the SAE e-CRF. 
Other supporting documentation of the event may be requested by EmitBio™ Pharmacovigilance 
and should be provided as soon as possible. The Sponsor Medical Monitor will review and assess 

 
Page 36 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
the SAE for regulatory reporting and potential impact on study subject safety and protocol 
conduct. 
At any time after completion of the study, if the participating clinical site PI or appropriate sub-
investigator becomes aware of an SAE that is suspected to be related to study product, the 
participating clinical site PI or appropriate sub-investigator will report the event to the EmitBio™ 
Pharmacovigilance Group. 
 
Regulatory Reporting of Device-related SAEs 
Following notification from the participating clinical site PI or appropriate sub-investigator, 
EmitBio Inc., as the sponsor, will report to the FDA and will copy the External Monitoring 
Committee and clinical site investigators on all reports of potential serious risks from clinical 
studies of RD-X19, as soon as possible. EmitBio Inc. will report to the FDA any unexpected fatal 
or life-threatening suspected adverse reaction as soon as possible, but in no case later than 7 
calendar days after the sponsor’s initial receipt of the information. If the event is not fatal or life-
threatening, an SAE safety report will be submitted within 15 calendar days after the sponsor 
determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. 
Relevant follow-up information to the safety report will be submitted as soon as the information is 
available. Upon request from FDA, EmitBio™ will submit to the FDA any additional data or 
information that the agency deems necessary, as soon as possible, but in no case later than 15 
calendar days after receiving the request. 
SAEs that are not considered related to RD-X19 will not be reported to the FDA. 
 
Classification of an Adverse Event 
The determination of seriousness, and causality will be made by an on-site investigator who is 
qualified (licensed) to diagnose AE information, provide a medical evaluation of AEs and classify 
AEs based upon medical judgment. This includes, but is not limited to, physicians, physician 
assistants and nurse practitioners.  
 
Severity of Adverse Events 
All AEs or SAEs will be assessed for severity, according to the toxicity grading scales provided at 
Appendix 2. 
For AEs not included in the protocol-defined grading system, the following guidelines will be 
used to describe severity. 
• Mild (Grade 1): Events that are usually transient and may require only minimal or no 
treatment or therapeutic intervention and generally do not interfere with the subject’s usual 
activities of daily living. 
• Moderate (Grade 2): Events that are usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing discomfort 
but poses no significant or permanent risk of harm to the research subject. 
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. Severe events are usually 
incapacitating. 

Page 37 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
AEs characterized as intermittent require documentation of onset and duration of each episode. 
The start and stop date of each reported AE will be recorded on the appropriate e-CRF. Changes 
in the severity of an AE will be documented to allow an assessment of the duration of the event at 
each level of intensity. 
Relationship to Study Intervention 
For each reported adverse event, the participating clinical site PI or qualified designee must assess 
the relationship of the event to the study device using the following guidelines: 
•
Related – The AE is known to occur with the study intervention, there is a reasonable
possibility that the study intervention caused the AE, or there is a close temporal relationship
between the study intervention and event. Reasonable possibility means that there is evidence
to suggest a causal relationship between the study intervention and the AE.
•
Not Related – There is not a reasonable possibility that the administration of the study
intervention caused the event, there is no temporal relationship between the study intervention
and event onset, or an alternate etiology has been established.
Time Period and Frequency for Event Assessment and Follow-Up 
For this study: 
Solicited and Unsolicited AEs will be recorded by clinical trial staff for the entire duration of 
the study.  
Adverse Event Reporting to Study Subjects 
All device-attributed AEs and SAEs will be reported to participants in the study to better inform 
them of the potential risks vs. benefits of participation. 
Pregnancy Reporting 
All positive urine pregnancy tests will be reported during screening and at the end of the study. 
Women who screen positive for pregnancy will be encouraged to see their primary health care 
provider for a serological confirmatory test. 
9.3  Efficacy Assessments 
Efficacy comparisons will be made in the ITT Population with the intent of estimating the effect 
of the RD-X19 device relative to sham in several outcome measures.  Subjects will be instructed 
to fill out diary cards twice daily to assess their symptoms associated with disease progression and 
record the number of treatments completed.  Additionally, at Baseline and days 3, 5, and 8, 
subjects will provide two saliva specimens for virology endpoint assessments.  One saliva 
specimen will be collected, preserved, and shipped fresh to a central lab for assessment of SARS-
CoV-2 mRNA via RT-qPCR.  The second specimen will be collected in a separate collection tube, 
frozen, and stored at the site and shipped to a central lab at the end of each cohort.  
Efficacy assessments 
Various endpoints will explore the impact of RD-X19 treatment on the reduction in log10 SARS-
CoV-2 viral load and alleviation of symptoms associated with COVID-19.  Both the magnitude of 

Page 38 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
reduction as a function of dose as well as time to clearance will be assessed in support of the 
primary efficacy analysis. Subjects will be instructed to fill out a diary card or electronic 
equivalent to assess their signs and symptoms of disease twice daily.  Each of the eight symptoms 
will be rated on a scale from none (0) to severe (3). 
•
Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to
Day 8
•
Geometric mean viral load as measured in saliva on day 1, 3, 5, and 8 by RT-qPCR
•
Proportion of subjects demonstrating viral load reduction ≥95% by RT-qPCR (at each
visit)
•
Time to undetectable viral load in saliva by RT-qPCR.
•
Proportion of subjects demonstrating clearance of viral infection, defined as a negative
test via RT-qPCR on Day 8/ET.
•
Median time to alleviation of symptoms,
o
The time to alleviation of symptoms endpoint, is defined as the time when all
eight symptoms (cough, sore throat, nasal congestion, headache, chills/sweats,
muscle or joint pain, fatigue, and nausea) had been assessed by the subject as
none or mild.
•
Change in COVID-19 Severity Score from baseline
o
The COVID-19 Severity Score is defined as the sum of all the individual
symptom severity scores divided by the total number of symptoms assessed
(8).
•
Viral load by viral titer (at each visit)
10 STATISTICAL CONSIDERATIONS 
10.1 Statistical Hypotheses 
This is a randomized, ascending dose finding study.  The primary goal of the study is to evaluate 
the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with 
uncomplicated COVID-19.  
10.2 Power and Sample Size: 
This is a double-blind study and hypothesis generating in nature.  The sample size was selected 
for convenience. 
Subjects will be randomized to treatment arm within dose in a 2:1 ratio according to a fixed 
schedule using a permuted block design and stratified by clinical site.  The target number of 
subjects randomized per dose is 30 (20 subjects to the RD-X19 arm, 10 subjects to the sham arm.  
One interim analysis is planned at the end of Cohort 1. 
10.3 Populations for Analyses 
Three analysis populations are defined for this study. 

 
Page 39 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
• 
The Safety Population includes all randomized subjects who receive at least 1 study 
treatment.  This population will be used for all safety analyses.  Subjects will be 
analyzed based on actual treatment received. 
• 
The Intent-to-treat Population (ITT) includes all randomized subjects who received 
treatment and were not discontinued due to a significant abnormality from the baseline 
CMP and CBC tests.  This population will be used for all efficacy analyses as the 
primary population.  Subjects will be analyzed based on randomized treatment, 
regardless of the actual treatment received. 
• 
The Per Protocol (PP) Population includes all randomized subjects who complete the 
study and did not have a major protocol deviation (MPD).  The PP population will be 
used for supportive analysis of the efficacy endpoints.  MPDs are those that could have 
interfered with the administration of treatment or the precise evaluation of treatment 
efficacy (e.g. violation of inclusion/exclusion criteria, no Day 3 visit, etc.).  All MPDs 
will be identified before the database lock and study unblinding for analysis.     
10.4 Statistical Analyses 
For continuous variables, descriptive summaries will display number of subjects, arithmetic mean, 
geometric mean (as appropriate), standard deviation, median, minimum, and maximum by 
treatment group.  For categorical variables, counts and percentages will be displayed. 
In general, missing data will not be imputed with the exception that for the ITT analysis, missing 
viral load results will be imputed using the last-observation-carried-forward (LOCF) 
methodology.   
Additional details regarding statistical methods will be provided in the Statistical Analysis Plan. 
 Efficacy Analyses 
The primary efficacy endpoint is defined as time-weighted average (TWA) change in log10-
transformed viral load by RT-qPCR from baseline to Day 8, where TWA will be derived using the 
trapezoidal rule. At the final analysis, each dose of the RD-X19 device will be compared to sham 
using an Analysis of Covariance (ANCOVA) model with baseline viral load as a covariate and 
treatment group as an independent variable. Geometric means and their 95% CIs will be computed 
by exponentiating (base 10) the least squares means and 95% CIs of the log10-transformed viral 
load. 
Secondary efficacy endpoints include: 
• 
log10-transformed Viral load as measured in saliva by RT-qPCR at each visit 
• 
proportion of subjects with ≥95% reduction in SARS-CoV-2 viral load at each visit 
• 
time to undetectable viral load in saliva by RT-qPCR 
• 
proportion of subjects demonstrating clearance of viral infection, defined as a negative 
test via RT-qPCR at Day 8/ET visit 
• 
COVID-19 composite severity score at each visit 
• 
time to alleviation of COVID-19 symptoms, defined as the time when all eight 
symptoms had been assessed by the subject as none or mild.  

 
Page 40 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
Exploratory efficacy endpoint includes log10-transformed viral load at each visit as measured by 
TCID50 for replication competent virus. 
All secondary and exploratory efficacy endpoints will be summarized using descriptive statistics 
by visit (as appropriate) for each treatment group. For log10-transformed viral load data, 
geometric means will be computed by exponentiating (base 10) the group means of the log10-
transformed viral load. Time-to-event variables will be evaluated using the Kaplan-Meier method. 
 Safety Analyses 
Summaries will be presented by treatment arm on the Safety Population.  Adverse device effects 
will be coded using the latest version of the Medical Dictionary for Regulatory Activities 
(MedDRA).  Treatment-Emergent Adverse Events (TEAE), vital signs, and methemoglobin will 
be summarized using descriptive statistics.  Other safety data including prior and concomitant 
medications will be listed. 
TEAE is any event not present prior to the initiation of the treatments or any event already present 
that worsens in either intensity or frequency following exposure to the treatments.  Number and 
percent of subjects reporting TEAEs will be tabulated by treatment group.  Summaries will be 
presented by system organ class and preferred term, and further by severity and relationship to 
study treatment.  In the summaries of incidence rates (frequencies and percentages), severity and 
relationship to treatment, subjects who report more than one event that are mapped to the same 
preferred term will be counted only once under the strongest severity and relationship, 
accordingly.   
11 OPERATIONAL CONSIDERATIONS AND SUPPORTING DOCUMENTS 
11.1 Ethical Considerations 
This study will be conducted in conformity with the principles set forth in The Belmont Report: 
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (US National 
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; April 
18, 1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 
21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). 
An OHRP-registered IRB will review and approve this protocol, associated informed consent 
documents, recruitment material, and handouts or surveys intended for the subjects, prior to the 
recruitment, screening, and enrollment of subjects. The IRB review shall be in accordance with 45 
CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), 21 CFR 812 and other federal, state, and local 
regulations and policies, as applicable. 
Any amendments to the protocol or informed consent documents will be approved by the IRB 
before they are implemented. The participating clinical site PI will notify the Sponsor of 
deviations from the protocol and reportable SAEs, and, as applicable, to the IRB. 
EmitBio Inc must receive the documentation that verifies IRB approval for this protocol, informed 
consent documents, and associated documents prior to the recruitment, screening, and enrollment 
of subjects and the provision of adequate numbers of RD-X19 devices to conduct the protocol. 

Page 41 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Informed Consent Process 
Informed consent is a process that is initiated prior to an individual agreeing to participate in a 
trial and continuing throughout the individual’s trial participation. Investigators or designated 
research staff will obtain a subject’s informed consent in accordance with the requirements of 45 
CFR 46, 21 CFR 50 and 21 CFR 56, state and local regulations and policy, and ICH E6 GCP 
before any study procedures or data collection are performed. The participating clinical site PI or 
other study staff may obtain oral or written information for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without the informed consent of the prospective 
subject if the process is approved by the IRB. 
At the screening or first study visit, informed consent will be obtained and documented before any 
study procedures are performed. Subjects will receive a concise and focused presentation of key 
information about the clinical trial, verbally and with a written consent form. The key information 
about the purpose of the study, the procedures and experimental aspects of the study, study device, 
potential risks, benefits and discomforts, the expected duration of the subject’s participation in the 
trial, and alternative treatments and procedures that may be available to the subject. The 
explanation will be organized and presented in lay terminology and language that facilitates 
understanding why one might or might not want to participate. 
Subjects will receive an explanation that they will be compensated for their participation on a per 
visit basis, and medical treatments are available if device-related injury occurs, and, if so, what 
that treatment is, or where further information may be obtained. Subjects will be informed of the 
anticipated financial expenses, if any, to the subject for participating in the trial, as well as any 
anticipated prorated payments, if any, to the subject for participating in the trial. They will be 
informed of whom to contact (e.g., the participating clinical site PI and the Sponsor) for answers 
to any questions relating to the research project. Information will also include the foreseeable 
circumstances and/or reasons under which the subject’s participation in the trial may be 
terminated. The subjects will be informed that participation is voluntary and that they are free to 
withdraw from the study for any reason at any time without penalty or loss of benefits to which 
the subject is otherwise entitled.  
Subjects will be informed that records identifying the subject will be kept confidential, and, to the 
extent permitted by the applicable laws and/or regulations, will not be made publicly available. If 
the results of the trial are published, the subject’s identity will remain confidential. Subjects will 
be informed, even if identifiers are removed, that information collected from this research and/or 
specimens may be used for secondary research, including the sharing of deidentified data.  
Subjects will be informed that the monitor(s), auditors(s), IRB, and Sponsor will be granted direct 
access to the subject’s original medical records for verification of clinical trial procedures and/or 
data without violating the confidentiality of the subject, to the extent permitted by the applicable 
laws and regulations, and that, by signing a written ICF, the subject is authorizing such access. 
ICFs will be IRB-approved, and subjects will be asked to read and review the consent form. 
Subjects must sign the ICF prior to starting any study procedures being done specifically for this 
trial. Once signed, a copy of the ICF will be given to the subject for their records. 
New information will be communicated by the participating clinical site PI to subjects who 
consent to participate in this trial in accordance with IRB requirements. The informed consent 
document will be updated, and subjects will be re-consented per IRB requirements, if necessary. 

 
Page 42 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 Confidentiality and Privacy 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover clinical information relating 
to subjects, test results of biological specimens and all other information generated during 
participation in the study. No identifiable information concerning subjects in the study will be 
released to any unauthorized third party. Subject confidentiality will be maintained when study 
results are published or discussed in conferences. 
The study monitor, other authorized representatives of the sponsor and representatives of the IRB 
may inspect all documents and records required to be maintained by the participating clinical site 
PI, including, but not limited to, screening, medical and laboratory results for the subjects in this 
study. The participating clinical site will permit access to such records. 
All source records, including electronic data, will be stored in secured systems in accordance with 
institutional policies and federal regulations. 
All study data and research specimens that leave the site (including any electronic transmission of 
data) will be identified only by a coded number that is linked to a subject through a code key 
maintained at the clinical site. Names or readily identifying information will not be released 
unless strictly required by law. 
 Clinical Monitoring 
Monitoring will be conducted during the conduct of the trial, and will include, but is not limited 
to, source document verification, review of regulatory files, device accountability records, e-
CRFs, ICFs, medical and laboratory reports, training records, and protocol and GCP compliance. 
The monitors will have access to all study related documents and will meet with appropriate 
clinical site staff to discuss any problems and outstanding issues. Visit findings and discussions 
will be documented.  Some monitoring visits may be conducted remotely. 
 Quality System 
To ensure the reliability of study data, the clinical sites must maintain an appropriate quality 
system for the purposes of measuring, documenting and reporting study conduct, protocol 
adherence, human subjects’ protections, and reliability of the protocol-driven data collected 
independent of sponsor site monitoring. 
 Data Collection and Management Responsibilities 
Data collection is the responsibility of the study staff at the participating clinical trial site under 
the supervision of the participating clinical site PI and the overall study PI. The participating 
clinical trial site PI must maintain complete and accurate source documentation. Clinical research 
data from source documentation, including, but not limited to, AEs/SAEs, concomitant 
medications, medical history, physical assessments, and clinical laboratory data, will be entered 
by the participating clinical site into eCRFs via a 21 CFR Part 11-compliant internet data entry 
system provided by the Sponsor’s delegated data coordinating and analysis clinical support 
organization. The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. AEs 
and concomitant medications will be coded according to the most current versions of MedDRA 
and WhoDrug, respectively. The data coordinating and analysis CRO will be responsible for data 

 
Page 43 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
management, quality review, analysis, and reporting of the study data for this study. The study 
sponsor is responsible for review of data collection tools and processes, and review of data and 
reports. 
AEs will be coded according to the MedDRA dictionary version 23.0 or higher. 
 Source Documents 
Source documents contain all information in original records (and certified copies of original 
records) of clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data should be attributable, legible, 
contemporaneous, original, accurate, and complete. Each participating clinical site will maintain 
appropriate medical and research records for this trial, in compliance with ICH GCP, regulatory, 
and institutional requirements. Data recorded in the e-CRF derived from source documents should 
be consistent with the data recorded on the source documents. 
Interview of subjects is sufficient for obtaining medical history. Solicitation of medical records 
from the subject’s primary care provider is not required. 
At the end of the study, a copy of all datasets, including annotated CRFs and data dictionary, will 
be provided to EmitBio Inc. 
 Study Record Retention 
Study-related records, including the regulatory file, study device accountability records, consent 
forms, subject source documents and electronic records, should be maintained for a period of 2 
years following the date a marketing application is approved for the investigational device for the 
indication for which it is being investigated; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and the Sponsor 
is notified. These documents should be retained for a longer period, however, if required by local 
policies or regulations. No records will be destroyed without the written consent of EmitBio™.  
 Protocol Deviations 
A protocol deviation is any non-compliance with the clinical trial protocol, any process that is 
noted in the protocol and refers to details in the protocol or GCP requirements, or any critical 
study procedures with specific instructions in ancillary documents referenced in the protocol. 
The non-compliance may be either on the part of the subject, the participating clinical site PI, or 
the study site staff. Following a deviation(s), corrective actions should be developed by the site 
and implemented promptly. All individual protocol deviations will be addressed in study 
volunteer study records. 
It is the responsibility of the participating clinical site PI and study staff to use continuous 
vigilance to identify and report deviations within five working days of identification of the 
protocol deviation, or within five working days of the scheduled protocol-required activity. All 
deviations must be promptly reported to EmitBio Inc’s Senior Clinical Program Manager. 
Protocol deviations must be sent to the IRB of record. The participating clinical site PI and study 
staff are responsible for knowing and adhering to the IRB requirements. A completed copy of an 
approved Protocol Deviation Form must be maintained in the Regulatory File, as well as in the 
subject’s chart if the deviation is subject specific. 

Page 44 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
CONFIDENTIAL 
Publication and Data Sharing Policy 
All study data and reports of study data are the property of the study sponsor. The sponsor may 
grant the PI the right to publish the results of this research in a scientific journal, conditional upon 
the review and concurrence of the sponsor.  
 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have 
such conflicts managed in a way that is appropriate to their participation in the design and conduct 
of this trial. EmitBio Inc requires that all study team members disclose any conflict of interest. 
Clinical Study sites are required to maintain a mechanism for the management of all reported 
dualities of interest. 
 Research Related Injuries 
For any potential research related injury, the participating clinical site PI or designee will assess 
the subject. Study staff will try to reduce, control and treat any complications from this trial. 
Immediate medical treatment may be provided by the participating clinical site, such as giving 
emergency medications to stop immediate allergic reactions. As needed, referrals to appropriate 
health care facilities will be provided to the subject. The participating clinical site PI should then 
determine if an injury occurred as a direct result of procedures or the device used in this trial. 
If it is determined by the participating clinical site PI that an injury occurred to a subject as a 
direct result of the procedures or device used in this trial, then referrals to appropriate health care 
facilities will be provided to the subject. No financial compensation will be provided to the subject 
by EmitBio Inc. or the participating clinical site for any injury suffered due to participation in 
clinical research.

 
Page 45 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
 
12 APPENDIX 1:  RD-X19 USER INSTRUCTIONS 
 
Confidential 
 
 
 

 
Page 46 of 46 
EmitBio, Inc. 
Version:  1.0 
EB-P12-01 
28 October 2020 
 
CONFIDENTIAL 
13 APPENDIX 2:  TOXICITY GRADING SCALES 
 
 
Available upon request. 
 
 

Page 1 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
CLINICAL TRIAL PROTOCOL 
A Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and 
Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals 
with Uncomplicated COVID-19 
Protocol Number: EB-P12-01 Version 2.0 (Amendment 1) 
Amendment 1 Date of Issuance:  November 6, 2020 
Original Date of Issuance:  October 28, 2020 
Investigational Countermeasure: RD-X19 
Specific Indication: Treatment of Uncomplicated COVID-19 
Target Respiratory Disease Pathogen(s): SARS-CoV-2 
Phase: I/II 
Name and Address of Sponsor:           
Name and Address of CRO: 
EmitBio Inc.
 Symbio, LLC   
Suite 470, 4222 Emperor Blvd 
 21 Perry Street 
Durham, NC 27703 
Port Jefferson, NY 11777 
Tel: + 1 (843) 540-3569 
Tel: +1 (631) 403-5125 
GCP Statement: This trial will be performed in compliance with (c)GCP. 
The information in this document is confidential and is proprietary to EmitBio Inc and/or 
KnowBio LLC. It is understood that information in this document shall not be used other than 
for the direct purpose of executing this protocol without the expressed written permission of 
EmitBio Inc or KnowBio LLC. 

Page 2 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
1 
INSTITUTIONAL STATEMENT OF COMPLIANCE 
Each institution engaged in this research will hold a current Federal Wide Assurance (FWA) 
issued by the Office of Human Research Protection (OHRP), and/or will be guided by the 
review and deliberations of an Institutional Review Board (IRB)/Independent or Institutional 
Ethics Committee (IEC) that must be registered with OHRP as applicable to the research. 
The study will be carried out in accordance with the following as applicable: 
•
United States (US) Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of
Human Subjects
•
Food and Drug Administration (FDA) Regulations: 21 CFR Part 50 (Protection of
Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical Investigators), 21
CFR Part 56 (IRBs), 21 CFR Part 11, and 21 CFR 812 (Investigational Device
Exemptions)
•
The International Council for Harmonization (ICH) of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) E6(R2) Good Clinical Practice
(GCP), and the Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subjects of Research, Report of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research
•
Any additional applicable Federal, State, and Local Regulations and Guidance

 
Page 3 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
2 
INVESTIGATOR’S AGREEMENT 
This signature provides the necessary assurance that this study will be conducted according to all 
stipulations of the protocol, including statements regarding confidentiality, and according to local 
legal and regulatory requirements, US federal regulations, and ICH E6(R2) GCP guidelines. 
 
 
Principal Investigator Signature: 
 
 
Signed: _____________________________ Date: _________________                                   
 
 
 
 
 
 

Page 4 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
3 
TABLE OF CONTENTS 
1 
INSTITUTIONAL STATEMENT OF COMPLIANCE ..................................................... 2 
2 
INVESTIGATOR’S AGREEMENT .................................................................................... 3 
3 
TABLE OF CONTENTS ....................................................................................................... 4 
4 
PROTOCOL SUMMARY ..................................................................................................... 6 
4.1 
EXECUTIVE SUMMARY ........................................................................................................ 6 
Study Goals ................................................................................................................... 6 
Study Design ................................................................................................................. 7 
Objectives and Endpoints ............................................................................................. 9 
Inclusion and Exclusion Criteria ................................................................................. 10 
4.2 
STUDY SCHEDULE OF ACTIVITIES ...................................................................................... 13 
5 
INTRODUCTION ................................................................................................................ 14 
5.1 
BACKGROUND AND STUDY RATIONALE ............................................................................ 14 
EmitBio™ RD-X19 Device Characteristics ............................................................... 15 
5.2 
RISK/BENEFIT ASSESSMENT ............................................................................................. 15 
Known Potential Risks ............................................................................................... 15 
Known Potential Benefits ........................................................................................... 16 
6 
STUDY DESIGN ................................................................................................................... 17 
6.1 
OVERALL DESIGN .............................................................................................................. 17 
6.2 
OBJECTIVES AND ENDPOINTS ............................................................................................ 19 
6.3 
SCIENTIFIC RATIONALE FOR THE STUDY ........................................................................... 20 
Justification for Doses ................................................................................................ 20 
7 
STUDY POPULATION ....................................................................................................... 21 
7.1 
INCLUSION CRITERIA ......................................................................................................... 21 
7.2 
EXCLUSION CRITERIA ........................................................................................................ 23 
7.3 
STUDY VOLUNTEER SELECTION, RETENTION & COMPENSATION ...................................... 24 
Recruitment................................................................................................................. 24 
Retention ..................................................................................................................... 24 
Compensation Plan for Subjects ................................................................................. 24 
Costs ........................................................................................................................... 24 
8 
STUDY DEVICE................................................................................................................... 25 
8.1 
REGULATORY CONSIDERATIONS ....................................................................................... 25 
Preliminary Regulatory Pathway for EmitBio™ RD-X19 ......................................... 25 
Proposed Label Claim/Indication for Use: ................................................................. 25 
Medical Device Quality System: ................................................................................ 25 
8.2 
STUDY DEVICE AND USE ................................................................................................... 25 
Device Description ..................................................................................................... 25 
8.3 
USE / STORAGE & MAINTENANCE / ACCOUNTABILITY ...................................................... 28 
Acquisition and Accountability .................................................................................. 28 
Device Storage and Maintenance ............................................................................... 28 
Preparation for Use and Use ....................................................................................... 28 
8.4 
MEASURES TO MAXIMIZE STUDY SUBJECT COMPLIANCE ................................................. 28 
8.5 
DEVICE DISCONTINUATION ............................................................................................... 29 
Study Pausing Criteria ................................................................................................ 29 

 
Page 5 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 Subject elects to discontinue ....................................................................................... 29 
 Investigator Decision to Discontinue Subject Use of Device..................................... 29 
 Follow-up of Study Subjects Who Discontinue Device Use ...................................... 30 
9 
STUDY ASSESSMENTS AND PROCEDURES ............................................................... 30 
9.1 
SCREENING ASSESSMENTS ................................................................................................ 30 
 Screening Procedures.................................................................................................. 30 
 Procedures for Clinically Significant Laboratory Values or Findings .......................... 32 
9.2 
SAFETY AND OTHER ASSESSMENTS ................................................................................... 32 
 Definition of Adverse Event (AE) .............................................................................. 34 
 Solicited Adverse Events - Reactogenicity ................................................................. 34 
 Unsolicited Adverse Events ........................................................................................ 35 
 Adverse Event Reporting ............................................................................................ 35 
 Definition of a Serious Adverse Event (SAE) ............................................................ 35 
 Serious Adverse Event Reporting ............................................................................... 36 
 Regulatory Reporting of Device-related SAEs ........................................................... 36 
 Classification of an Adverse Event ............................................................................. 36 
 Severity of Adverse Events ........................................................................................ 37 
 Relationship to Study Intervention ............................................................................. 37 
 Time Period and Frequency for Event Assessment and Follow-Up ........................... 37 
 Adverse Event Reporting to Study Subjects ............................................................... 37 
 Pregnancy Reporting .................................................................................................. 38 
9.3 
EFFICACY ASSESSMENTS ................................................................................................... 38 
 Efficacy assessments .................................................................................................. 38 
10 STATISTICAL CONSIDERATIONS ................................................................................. 39 
10.1 STATISTICAL HYPOTHESES ................................................................................................ 39 
10.2 POWER AND SAMPLE SIZE: ................................................................................................ 39 
10.3 POPULATIONS FOR ANALYSES ........................................................................................... 39 
10.4 STATISTICAL ANALYSES .................................................................................................... 39 
 Efficacy Analyses ....................................................................................................... 40 
 Safety Analyses .......................................................................................................... 40 
11 OPERATIONAL CONSIDERATIONS AND SUPPORTING DOCUMENTS ............. 41 
11.1 ETHICAL CONSIDERATIONS ............................................................................................... 41 
 Informed Consent Process .......................................................................................... 41 
 Confidentiality and Privacy ........................................................................................ 42 
 Clinical Monitoring .................................................................................................... 43 
 Quality System............................................................................................................ 43 
 Data Collection and Management Responsibilities .................................................... 43 
 Source Documents ...................................................................................................... 43 
 Study Record Retention .............................................................................................. 44 
 Protocol Deviations .................................................................................................... 44 
 Publication and Data Sharing Policy .......................................................................... 44 
 Conflict of Interest Policy ......................................................................................... 44 
 Research Related Injuries .......................................................................................... 45 
12 APPENDIX 1 ......................................................................................................................... 46 
13 APPENDIX 2 ......................................................................................................................... 47 

 
Page 6 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
4 
PROTOCOL SUMMARY 
4.1 Executive Summary 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknow cause.  Coronavirus ribonucleic acid (RNA) was quickly identified in 
some of these patients. As of October 11, 2020 there were approximately 37 million confirmed 
cases wordwide (>7.7 million in the US) and over 1,075,000 deaths (~215,000 in the US). The 
only FDA approved intervention currently is Remdesivir for hospitalized subjects with COVID-
19.  Other interventions currently being used are through the Emergency Use Authorizations 
(EUA), against SARS-CoV-2 / COVID-19.    Social distancing and personal protective equipment 
constitute our only viable countermeasures to help reduce incidence of community acquisition and 
transmission of SARS-CoV-2. Vaccine candidates are being developed at an unprecedented 
speed, however their efficacy and safety is unknown and will not be fully defined for many 
months. Remdesivir, Convalescent Immune Plasma and SoluMedrol are all used to treat patients 
hospitalized with COVID-19, but none has received marketing approval as a therapeutic for 
uncomplicated COVID-19.  Therefore, there remains an urgent public health need for rapid 
development of novel measures for prevention and treatment of SARS-CoV-2 and COVID-19. 
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent 
 Study Goals 
This is a randomized, sham-controlled dose escalation and bioeffect study.  The primary goal of 
the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected individuals with 
outpatient COVID-19 at two dosing schedules, and to assess the reduction of SARS-CoV-2 viral 
load in each dose group compared to sham controls.  This is an efficacy hypothesis-generating 
study; sample size is based on convenience. However, there is adequate power to detect large 
differences in group SARS-CoV-2 reduction effects. The primary safety measure is absence of 
device-related serious adverse events or patterns of severity  ≥2 device-related adverse events. 
Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by 
review of potential adverse events (AEs) and targeted physical examination, as required. 
Volunteers will be encouraged to contact designated clinical trial staff for AEs of a medically-
urgent nature as soon as is practically possible and to seek immediate medical care, if needed. 
Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline 
and at Day 8 or early termination (and potentially during unscheduled) clinic visits. 
Methemoglobin assessments will be performed at baseline and Day 8. 

 
Page 7 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 Study Design 
Subjects will provide informed consent prior to initiating any screening procedures.  Subjects 
meeting all screening criteria will be eligible for enrollment and randomization into the study.  
This study plans to enroll into two treatment arms within two escalating dose cohorts:  
• 
Cohort 1: 128 J/cm2 total dose RD-X19, Sham 
(5 minutes per treatment, 2X/Day for a duration of 4 days) 
• 
Cohort 2: 224 J/cm2 total dose RD-X19, Sham  
(5 minutes treatment, 2X/Day for a duration of 7 days)  
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to 
the RD-X19 treatment arm or the sham treatment arm within each cohort.  Subjects will be 
randomized in a 2:1 ratio (20 RD-X19 : 10 sham) per dose cohort. The double-blind, sham-
controlled treatment period of four (4) days of dosing for Cohort 1 is shown in Figure 1 below; 
increased weekly doses of light with twice daily dosing will occur in Cohort 2 for a treatment 
duration of seven (7) days.  Light will be administered locally to the mouth and throat only, 
aiming to eliminate viral load in these targeted portions of the upper respiratory tract.  
Assessments of treatment response will occur on study days 3 and 5, with the final determination 
of efficacy made on day 8 (inclusive).   
Study Subject safety will be monitored throughout the study by the Investigator and supported by 
regular review by the Sponsor’s Chief Medical Officer.   
Upon completion of all subjects in Cohort 1, the results of an unblinded interim analysis will be 
reviewed by a safety monitoring team and a recommendation will be made to the sponsor on 
whether the committee recommends proceeding with enrollment for the next cohort at the next 
planned dose or whether enrollment should continue in the next cohort at a reduced dosing 
frequency (e.g. once daily). The study is designed to evaluate at least 2 dosing schedules, 
ascending, or descending based on safety of each previous cohort.    
 
 

 
Page 8 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 
Figure 1: Study Design  
 
 
The interim analysis at the conclusion of Cohort 1 will consist of the following evaluations: 
• A planned efficacy evaluation of the time weighted average change in SARS-CoV-2 
viral load from baseline will be conducted as an assessment of benefit to the 
subjects. 
• Safety evaluations, performed by a independent safety monitoring team as outlined 
in the committee charter, are to ensure that each dose level under evaluation is safe.  
Specific criteria for safety review will include: 
o Number of subjects experiencing laryngospasm, bronchospasm or anaphylaxis 
within 2 hours after use of the RD-X19 Device that is considered related to RD-
X19.  
o Number of subjects experiencing an allergic reaction such as generalized urticaria 
(defined as occurring at three or more body parts) within 72 hours after 
administration of light that is considered related to RD-X19.  
o Number of subjects experiencing an SAE or Grade 3 AE, in the same SOC 
grouping of Preferred Terms based on Medical Dictionary for Regulatory 
Activities (MedDRA) coding, considered to be related to RD-X19.  
 
 

 
Page 9 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 
Objectives and Endpoints 
Table 1: Objectives and Endpoints (Outcome Measures) 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Safety Assessments 
• AEs and SAEs* 
 
 
 
• Methemoglobin  
• The primary safety measure is absence of 
device-related serious adverse events or 
any patterns of severity ≥2 device-related 
adverse events.* 
 
• Mean change in methemoglobin from 
baseline to Day 8/ET. 
Efficacy Assessments 
• viral load  
 
 
 
 
 
 
 
 
 
• viral infection 
 
 
 
 
 
 
 
 
 
• symptoms 
 
• Time weighted average change in 
viral load from baseline by RT-
qPCR from Day 1 to Day 8 
 
• Geometric mean viral load as 
measured in saliva on day 1, 3, 5, 
and 8 by RT-qPCR* 
• Proportion of subjects 
demonstrating viral load reduction 
≥ 95% by RT-qPCR (at each 
visit)* 
• Time to clearance of viral 
infection in saliva, defined as a 
negative test (Ct value ≥32) via 
RT-qPCR. 
• Proportion of subjects 
demonstrating clearance of viral 
infection, defined as a negative 
test (Ct value ≥32) via RT-qPCR 
on Day 8/ET. 
 
• Median time to alleviation of symptoms 
as measured by the time when all eight 
symptoms (cough, sore throat, nasal 
congestion, 
headache, 
chills/sweats, 

 
Page 10 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
• COVID-19 composite severity 
score.   
muscle or joint pain, fatigue, and nausea)  
had been assessed by the subject as none 
(0) or mild (1). 
 
Exploratory Assessment(s) 
 
 
• viral load by viral titer (at each 
visit) 
 
 
• Geometric mean viral load as 
measured in saliva on day 1, 3, 5, 
and 8 by TCID50 for replication 
competent virus. 
 
• Geometric mean viral load as 
measured by oropharyngeal 
swab on day 1, 3, 5, and 8 by 
TCID50 for replication 
competent virus. 
 
*- indicates planned analysis for safety monitoring committee review between cohorts. 
 
Inclusion and Exclusion Criteria 
A subject must meet all the following criteria to be eligible for inclusion in this study: 
1. Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the 
screening visit as detected using an FDA authorized SARS-CoV-2 antigen test.  
2. Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3 
days and have either a) fever of at least 100 °F or b) at least two moderate or severe 
symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, 
fatigue, and nausea) at the time of screening. 
3. Provides written informed consent prior to initiation of any study procedures. 
4. Be able to understand and agrees to comply with planned study procedures and be available 
for all study visits. 
5. Agrees to the collection of nasopharyngeal swabs, oropharyngeal swabs, oral saliva 
specimen collection and venous blood specimens per protocol. 
6. Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or 
mouthwashes of any kind during the study.  
7. Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment. 
8. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and 
symptoms*. 

Page 11 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
9.
No physical or mental conditions or attributes at the time of screening, which in the opinion of
the PI, will prevent full adherence to, and completion of, the protocol.
*The following COVID-19 onset of signs and symptoms generally appear 2-7 days after exposure
to SARS-CoV-2:
•
Cough
•
Sore throat
•
Nasal Congestion
•
Headache
•
Chills/sweats
•
Muscle or joint pain
•
Fatigue
•
Nausea
Severity of each COVID-19 symptom will be assessed based on definitions used for graded 
adverse events: 
•
None (Grade 0): Not present
•
Mild (Grade 1): Events that are usually transient and may require only minimal or no
treatment or therapeutic intervention and generally do not interfere with the subject’s
usual activities of daily living.
•
Moderate (Grade 2): Events that are usually alleviated with additional specific
therapeutic intervention. The event interferes with usual activities of daily living
causing discomfort but poses no significant or permanent risk of harm to the research
subject.
•
Severe (Grade 3): Events interrupt usual activities of daily living, or significantly
affects clinical status, or may require intensive therapeutic intervention. Severe events
are usually incapacitating.
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1.
Positive urine pregnancy test at screening.
2.
Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or
appropriate sub-investigator, precludes study participation.
3.
Presence of self-reported or medically documented uncontrolled significant medical or
psychiatric condition(s) other than COVID-19.
4.
Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen,
hepatitis C virus antibody, or HIV-1 antibodies at screening.

 
Page 12 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
5. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 
month of Study Day 1. 
6. COVID-19 signs associated with acute respiratory distress or imminent serious medical 
outcomes.^^ 
7. BMI ≥36. 
8. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be 
enrolled.  
9. Has participated in another investigational study involving any intervention for SARS-CoV-
2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational 
product within 30 days of screening.  
10. Currently enrolled in or plans to participate in another clinical trial with an interventional 
investigational agent that will be received during the study period. 
11. History of hospitalization within the past 60 days. 
12. History of systemic antiviral therapies within the past 30 days. 
13. History of oral corticoid steroid use within the past 14 days or steroid injection within the past 
6 months. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are 
not exclusionary. 
14. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized 
urticaria, angioedema, other significant reaction) to nitrites, nitrates or sun exposure.  
15. Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the 
investigator would interfere with device use, or intra-oral metal body piercings that cannot be 
removed for the duration of the study. Metal orthodontia is permitted as braces will be 
covered by the device mouthpiece. 
 
^^Potential Study Subjects Presenting with any of the following should be referred for immediate 
medical care and are not eligible for the study 
• Fever > 104o F 
• Cough with sputum production 
• Rales and/or rhonchi 
• Difficulty breathing or respiratory distress defined by a respiratory rate ≥30 per 
minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 
<300. 
• Persistent pain or pressure in the chest 
• Confusion 
 
 

 
Page 13 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
4.2 Study Schedule of Activities 
 
Study Procedures 
Screening, 
Enrollment & 
Randomization 
Follow-up Period 
(Visit Window) 
Study Days 
1 
2 
3 
 
5 
(-1 to +1) 
 
8/ET 
(-1 to +1) 
Informed Consent 
X 
 
 
 
 
COVID19 Screening & SARS-CoV-2 Rapid Antigen Test*** 
X 
 
 
 
 
Medical History & Physical Examination 
X 
Changes since 
last visit only 
 Changes since 
last visit only 
Changes since 
last visit only 
X 
Oropharyngeal Assessment 
X* 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
X 
Urine Pregnancy Test 
X 
 
 
 
X 
Concomitant Medication History/New 
Baseline 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Comprehensive Metabolic Panel & CBC 
X 
 
 
 
X 
Vital Signs 
X 
 
 
 
X 
Methemoglobin 
X 
 
 
 
X 
Adverse Event Assessment / Reactogenicity  
Baseline 
X 
X 
X 
X 
Demographics, Inclusion / Exclusion Review 
X 
 
 
 
 
Diary Dispensation/Collection 
X 
 
 
 
X 
Treatment at Site 
X** 
X** 
X** 
 
 
Biospecimen collection for viral assays (3 specimens)**** 
X 
 
X 
X 
X 
COVID-19 Severity Score 
X 
 
 
 
X 
Collect RD-X19 Device 
NA 
 
 
Cohort 1 
Cohort 2 
*On Day 1 to be evaluated 30 minutes after first illumination at site.  
**Only one treatment will be done on site, other treatment will be done at home, i.e. if afternoon appointment, 
subject will complete morning treatment at home and afternoon treatment administered at the site.  For scheduling 
purposes, recommended interval between treatment is approximately 8 – 12 hours but not < 4 hours.  
***Subjects presenting at the time of screening that have tested positive via a SARS-CoV-2 rapid antigen test at or 
within the past 24 hours of the screening visit and can provide documentation confirming proper identification, 
the date of the test and testing location, positivity of the result, and name/identity of the assay used to generate 
the result, are also eligible for enrollment and the rapid antigen test does not have to be repeated at the site.  
**** At Baseline and days 3, 5, and 8, subjects will provide two saliva specimens and an oropharyngeal swab for 
virology endpoint assessments.  One saliva specimen will be collected, preserved, and shipped fresh to a central 
lab for assessment of SARS-CoV-2 mRNA via RT-qPCR.  The second specimen and the oropharyngeal swab will be 
collected in  separate collection tubes, frozen, and stored at the site and shipped to a central lab at the end of 
each cohort.  
 

Page 14 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
5 
INTRODUCTION 
5.1 Background and Study Rationale 
In December 2019 the Wuhan Municipal Health Committee identified an outbreak of viral 
pneumonia cases of unknow cause.  Coronavirus ribonucleic acid (RNA) was quickly identified in 
some of these patients. As of October 11, 2020 there were approximately 37 million confirmed 
cases wordwide (>7.7 million in the US) and over 1,075,000 deaths (~215,000 in the US). The 
only FDA approved intervention currently is Remdesivir for hospitalized subjects with COVID-
19. Other interventions currently being used are through the Emergency Use Authorizations
(EUA), against SARS-CoV-2 / COVID-19.  Social distancing and personal protective equipment
constitute our only viable countermeasures to help reduce incidence of community acquisition and
transmission of SARS-CoV-2. Vaccine candidates are being developed at an unprecedented
speed, however their efficacy and safety is unknown and will not be fully defined for many
months. Remdesivir, Convalescent Immune Plasma and SoluMedrol are all used to treat patients
hospitalized with COVID-19, but none has received marketing approval as a therapeutic for
uncomplicated COVID-19. Therefore, there remains an urgent public health need for rapid
development of novel measures for prevention and treatment of SARS-CoV-2 and COVID-19.
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent. 

 
Page 15 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 
 
EmitBio™ RD-X19 Device Characteristics 
Table 2.  
Characteristic 
Target 
Route of Administration 
Oral Illumination 
Device Configuration 
Hand-held, rechargeable 
Blue Light Source 
Non-coherent, light emitting diode (LED) array 
UVA Content (315 nm – 400 nm) 
<1% 
UVB Content (280 nm - 315 nm) 
not detectable* 
UVC Content (100 nm - 280 nm) 
not detectable* 
Target Exposure Area 
Oropharynx and surrounding tissues 
Exposure Time 
5 min per treatment, 2X/day, ~8 hrs apart 
Total Daily Dose (@ 83 mm) 
16 J/cm2 (Joules = Watts x seconds) 
Depth of Tissue Penetration 
< 0.5 mm 
Temperature (IEC 60601-1) 
< 48 °C (for durations <10 min) 
*UVA/UVB not detectable in Labsphere 1M Integrating Sphere equipped with CDS-610 Mini CCD Array Spectrometer 
5.2 Risk/Benefit Assessment 
 
Known Potential Risks 
The potential risks of participating in this trial are those associated with having blood drawn and 
mild, transient, local reactions as measured in RD19-01-3Q20 , a Phase I Open Label, Acute 
Safety Study of the EmitBio™ RD-X19 Device.  
Drawing blood may cause transient discomfort and fainting. Fainting is usually transient and 
managed by having the subject lie down and elevate his/her legs. Bruising at the blood draw site 
may occur but can be prevented or lessened by applying pressure to the blood draw site for a few 
minutes after the blood is taken. 
Extensive evaluation of the RD-X19 and similar energy-based devices routinely used for oral and 
skin care purposes resulted in the Sponsor, after careful consideration, making the determination 
that RD-X19 was a “Not Significant Risk” (NSR) device per FDA guidelines.  
Eye exposure is to be avoided. Direct illumination of unprotected eyes can result in damage to 
the retina, and especially the macula. Other eye structures can also experience thermal injury. 
Study staff must ensure volunteers understand to never point the RD-X19 device toward their or 
anyone else's eyes. 
RD19-01-3Q20  Phase I Trial 
This was a first-in-man Phase I study that evaluated the acute safety and tolerability of the RD-
X19 device among 25 healthy volunteers between the ages of 18 and 45. A single dose (9 
joules/cm2) and schedule (3 minutes twice a day, separated by at least 4 hours, preferably 8 to 12 

 
Page 16 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
hours apart) was evaluated for 14 consecutive days. In total, subjects received a weekly dose of 
128 J/cm2 per week for a time weighted average of 750 mJ/cm2 h-1.   
No SAEs were observed during the study. No AEs based on laboratory findings were observed 
during the study. 
Twelve (12) study subjects reported a total of 3 distinct AE terms (local site reaction, headache, 
nausea) and 23 total AEs. Of the 23 total AEs, 22 were classified as mild (grade 1) with a single 
headache classified as moderate (grade 2). No AE required treatment or alteration to the study 
subject’s participation in the trial. No study subject withdrew from the trial because of an AE. 
All AEs were of short duration, with resolution typically reached the same day or within 24 hours. 
Since study subjects used the RD-X19 device approximately every 12 hours for 14 contiguous 
days, there was a continuous temporal association with RD-X19 device use and incident AEs 
during the course of RD19-01-3Q20. By definition, all local site reactions were attributed to the 
device; all were mild and transient and there was no pattern of increasing frequency with repeated, 
cumulative dosing.  
Population-based epidemiological data for headaches and nausea were considered when 
establishing device attribution. Approximately 40% of the general adult population have weekly 
headache and over 30% suffer from intermittent bouts of nausea of unknown origin.  Given the 
frequencies of headache and nausea reported in RD19-01-3Q20  are less than those reported in 
population-based epidemiological studies, the relationship with the RD-X19 device cannot be 
determined.  
In summary, the RD19-01-3Q20 Phase I trial demonstrated that EmitBio™ RD-X19 is a safe 
device, consistent with the sponsor’s and IRB’s original conclusion that RD-X19 is a NSR device. 
Risks to Privacy 
Subjects will be asked to provide personal health information (PHI). All attempts will be made to 
keep this PHI confidential within the limits of the law. However, there is a chance that 
unauthorized persons will see the subject’s PHI. All study records will be kept in a locked file 
cabinet or maintained in a locked room at the participating clinical trial site(s). Electronic files 
will be password protected. Only people who are involved in the conduct, oversight, monitoring, 
or auditing of this trial will be allowed access to the PHI that is collected. Any publications from 
this trial will not use information that will identify subjects by name. 
Organizations that may inspect and/or copy research records maintained at the participating 
clinical trial site(s) for quality assurance (QA) and data analysis include groups such as the IRB 
and the FDA. 
A description of this clinical trial will be posted on http://www.ClinicalTrials.gov. This web site 
does not include information that can identify subjects. 
There may be other risks, discomforts or side effects that are entirely unknown at this time. 
 
Known Potential Benefits 
There is no guaranteed benefit to study participants. Use of EmitBio™ RD-X19 is intended to 
reduce viral load of SARS-CoV-2 and alleviate the symptoms associated with uncomplicated 
COVID-19. There is also the potential for benefit to society resulting from insights gained from 

 
Page 17 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
participation in this study due to the widespread, and accelerating, threat of SARS-CoV-2 and 
COVID-19.  
6 
STUDY DESIGN 
6.1 Overall Design 
Volunteers will provide informed consent prior to initiating any screening procedures.  Those 
meeting all screening criteria will be eligible for enrollment and randomization into the study.  
Study subjects will be enrolled into treatment and control arms within two cohorts:  
• Cohort 1: 128 J/cm2 total dose RD-X19, Sham 
(5 minutes per treatment, 2X/Day for a duration of 4 days) 
• Cohort 2: 224 J/cm2 total dose RD-X19, Sham  
(5 minutes per treatment, 2X/Day for a duration of 7 days) 
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to 
the RD-X19 treatment arm or the sham treatment arm within each cohort.  Study subjects will be 
randomized in a 2:1 ratio (20 RD-X19 : 10 sham) per dose cohort. The double-blind, sham-
controlled period will last 8 days.  Assessments of study subjects will occur on study days 1, 2, 3, 
5 and the final assessment visit on Day 8. Since CMP and CBC results will not be available until 
study day 2, all volunteers who have significant abnormalities will be immediately contacted and 
advised of the abnormality, discontinued from active participation in the protocol and advised 
regarding appropriate medical follow-up outside the study. All such study subjects will be 
replaced with a new volunteer.  This is a randomized, adaptive, group sequential dose finding 
study.  The primary goal of the study is to evaluate the efficacy and safety of the RD-X19 device 
in SARS-CoV-2 infected individuals with outpatient COVID-19.  The primary efficacy outcome 
is the time weighted average change in SARS-CoV-2 viral load assessed via RT-qPCR. Safety 
assessment will include the incidence of device-related serious adverse events or patterns of 
severity ≥2 device-related adverse events. 
 
 
 

 
Page 18 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
Figure 1: Study Design  
 
 
The interim analysis at the conclusion of Cohort 1 will consist of the following evaluations: 
• A planned efficacy evaluation of the time weighted average change in SARS-CoV-2 
viral load from baseline will be conducted as an assessment of benefit to the 
subjects. 
• Safety evaluations, performed by a independent safety monitoring team as outlined 
in the committee charter, are to ensure that each dose level under evaluation is safe 
through 4 days of treatment.  Specific criteria for safety review will include: 
o Number of subjects experiencing laryngospasm, bronchospasm or anaphylaxis 
within 2 hours after use of the RD-X19 Device that is considered related to RD-
X19.  
o Number of subjects experiencing an allergic reaction such as generalized urticaria 
(defined as occurring at three or more body parts) within 72 hours after 
administration of light that is considered related to RD-X19.  
o Number of subjects experiencing an SAE or Grade 3 AE, in the same SOC 
grouping of Preferred Terms based on Medical Dictionary for Regulatory 
Activities (MedDRA) coding, considered to be related to RD-X19.  
Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by review of 
potential adverse events (AEs) and targeted physical examination, as required. Volunteers will be 
encouraged to contact designated clinical trial staff for AEs of a medically-urgent nature as soon as is 
practically possible and to seek immediate medical care, if needed. 
Metabolic, liver, kidney and hematological laboratory evaluations will be performed at screening and 
at Day 8 or early termination (and potentially during unscheduled) clinic visits.  
Study Subject safety will be monitored throughout the study by the Investigator and supported by 
regular review by the Medical Monitor and an external Data Monitoring Committee.    

Page 19 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
6.2 Objectives and Endpoints 
Table 1: Objectives and Endpoints (Outcome Measures) 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
Safety Assessments
•
AEs and SAEs*
•
Methemoglobin
•
The primary safety measure is absence of
device-related serious adverse events or
any patterns of severity >2 device-related
adverse events.*
•
Mean change in methemoglobin from
baseline to Day 8/ET.
Efficacy Assessments 
•
Viral load
•
Viral infection
•
Symptoms
• Time weighted average change in
viral load from baseline by RT-
qPCR from Day 1 to Day 8 
• Geometric mean viral load as
measured in saliva on day 1, 3, 5,
and 8 by RT-qPCR* 
• Proportion of subjects
demonstrating viral load reduction
≥ 95% by RT-qPCR (at each 
visit)* 
• Time to clearance of viral
infection in saliva, defined as a
negative test (Ct value ≥32) via 
RT-qPCR. 
• Proportion of subjects
demonstrating clearance of viral
infection, defined as a negative 
test (Ct value ≥32) via RT-qPCR 
on Day 8/ET. 
•
Median time to alleviation of symptoms
as measured by the time when all eight
symptoms (cough, sore throat, nasal
congestion, 
headache, 
chills/sweats,

 
Page 20 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
OBJECTIVES 
ENDPOINTS 
(OUTCOME MEASURES) 
• COVID-19 composite severity 
score.   
muscle or joint pain, fatigue, and nausea) 
had been assessed by the subject as none 
(0) or mild (1). 
 
Exploratory Assessment(s) 
 
 
• Viral load by viral titer (at each 
visit) 
 
 
• Geometric mean viral load as 
measured in saliva on day 1, 3, 5, 
and 8 by TCID50 for replication 
competent virus. 
 
• Geometric mean viral load as 
measured via oropharyngeal 
swab on day 1, 3, 5 and 8 by 
TCID50 for replication 
competent virus. 
 
*- indicates planned analysis for safety monitoring committee review between cohorts. 
6.3 Scientific Rationale for the Study 
RD-X19 through both direct and intermediate mechanisms, kills cell-free virus by as much as 
99.99% and inhibits cell-associated replication of SARS-CoV-2 by 99.9% when measured at 24 
hours after a single 5 minute treatment. Putative key virucidal mechanisms include upregulation of 
nitric oxide in epithelial tissue through increase of nitric oxide synthases (NOSs) and stimulation 
of the instantaneous release of the body’s bound store of nitric oxide. Nitric oxide produced 
physiologically in epithelial tissues also induces and attracts effector cells of the innate immune 
system, including natural killer (NK) cells, neutrophils and macrophages to phagocytize virus-
infected cells at the site of primary infection. The technology utilized by RD-X19 has been 
repeatedly demonstrated to provide high-level viral control in multiple, consistent, expert-
laboratory in vitro studies. The mechanism of action, utilizing augmented innate immunity, 
presents an unprecedented opportunity for protection that is not specific antigen-directed or 
dependent. 
 
Justification for Doses 
In repeated experiments, including experiments conducted by third party external laboratories, it 
has been determined that the light emitted by the EmitBio™ RD-X19 device provides for potent 
antiviral activity against SARS-CoV-2.  Reduction in cell-free virus of ≥1000 fold and inhibition 
of viral replication of ≥99% have been observed in repeated experiments conducted by the 
sponsor and external expert laboratories.  Dose dependent effects are observed ranging from as 
little as a single 7.5 J/cm2 exposure up to complete antiviral activity at 30 J/cm2 measured 24 

Page 21 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
hours after exposure.  Multiple cell types including human respiratory epithelial cells and 3D 
epithelial tissue in culture show high viability at single doses of visible blue light up to 120 
Joules/cm2. These repeated experiments, conducted in multiple labs with multiple cell types, along 
with years of medical use of licensed devices with comparable wavelengths and energy, support 
the doses proposed in this protocol for dose finding to achieve optimal efficacy and safety.  
As in the Phase I study of RD-X19, a schedule of two treatments per day, separated by a 
recommended 8-12 hours will be evaluated.  The Phase I study evaluated a dosing schedule of 9.2 
J/cm2, 3 minutes twice daily for a total duration of 14 days (257 J/cm2 total).  A total weekly 
exposure of 128 J/cm2 was found to be well tolerated with minor application site adverse events. 
In light of these data, the current study will begin with the total energy exposure capped at 128 
J/cm2 which has been shown to be safe in the Phase I trial, and explore the delivery of 16 J/cm2 
BID for a duration of 4 days (Cohort 1 – 128 J/cm2 total dose).  Pending review of safety and local 
application site reactogenicity, a second Cohort of and 16 J/cm2 BID for a duration of 7 days (224 
J/cm2 total dose) will be evaluated.  The dosing schedule and duration has been selected to 
provide a reduction in viral load and symptomatic relief as rapidly as possible in COVID-19 
patients while still maintaining an acceptable safety margin for each individual treatment session. 
If patterns of ≥ grade 2 device-related adverse events are observed, dosing will be reduced to one 
exposure/day for the remainder of treatment time. If serious or severe device-related adverse 
events are observed, further treatments at that dose will be terminated. 
Strict safety oversight will provide rapid detection of significant device/dose-related adverse 
events warranting pausing or halting the trial. 
7 
STUDY POPULATION 
The study population is individuals infected with SARS-CoV-2 who have symptoms associated 
with COVID-19 that is either not under active medical treatment or is being treated as an 
outpatient. Study subjects must be symptomatic for 3 days or less and have a positive COVID-19 
antigen test using an FDA authorized SARS-CoV-2 antigen diagnostic test at or within the 
past 24 hours of screening.  Study subjects will be randomized to treatment arm within dose in a 
2:1 ratio according to a fixed schedule using a permuted block design.  The targeted number of 
subjects randomized per dose is 30 (20 volunteers to the RD-X19 arm, 10 subjects to the sham 
arm). This is a sample size of convenience as this is a hypothesis generating study.   
The target population should reflect the subject population with uncomplicated  COVID-19 in the 
community at large.  
Subject Inclusion and Exclusion Criteria must be confirmed by a study clinician, licensed to make 
medical diagnoses.  
7.1 Inclusion Criteria 
A subject must meet all the following criteria to be eligible to participate in this study: 
1. Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the
screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
2. Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3
days* and have either a) a fever of at least 100 °F or b) at least two moderate or severe

Page 22 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint 
pain, fatigue, and nausea) at the time of screening. 
3. Provides written informed consent prior to initiation of any study procedures.
4. Be able to understand and agrees to comply with planned study procedures and be available
for all study visits.
5. Agrees to the collection of nasopharyngeal swabs, oropharyngeal swabs, oral saliva specimen
collection and venous blood specimens per protocol.
6. Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or
mouthwashes of any kind during the study.
7. Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
8. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and
symptoms*.
9. No physical or mental conditions or attributes at the time of screening, which in the opinion of
the PI, will prevent full adherence to, and completion of, the protocol.
*The following COVID-19 onset of signs and symptoms generally appear 2-7 days after exposure to
SARS-CoV-2:
• Cough
• Sore Throat
• Nasal Congestion
• Headache
• Chills/sweats
• Muscle or joint pain
• Fatigue
• Nausea
Severity of COVID-19 symptoms will be assessed based on definitions used for graded adverse 
events: 
• None (Grade 0): Not present
• Mild (Grade 1): Events that are usually transient and may require only minimal or no treatment
or therapeutic intervention and generally do not interfere with the subject’s usual activities of
daily living.
• Moderate (Grade 2): Events that are usually alleviated with additional specific therapeutic
intervention. The event interferes with usual activities of daily living causing discomfort but
poses no significant or permanent risk of harm to the research subject.
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects
clinical status, or may require intensive therapeutic intervention. Severe events are usually
incapacitating.

Page 23 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
7.2 Exclusion Criteria 
A subject who meets any of the following criteria will be excluded from participation in this 
study: 
1. Positive urine pregnancy test at screening.
2. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or
appropriate sub-investigator, precludes study participation.
3. Presence of self-reported or medically documented uncontrolled significant medical or
psychiatric condition(s) other than COVID-19.
4. Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen,
hepatitis C virus antibody, or HIV-1 antibodies at screening.
5. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1
month of Study Day 1.
6. COVID-19 signs associated with acute respiratory distress or imminent serious medical
outcomes. ^^
7. BMI ≥36
8. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household
cannot be enrolled.
9. Has participated in another investigational study involving any intervention for
SARS-CoV-2/COVID- 19 within the past 6 months or any clinical trial with
interventional investigational product within 30 days of screening.
10. Currently enrolled in or plans to participate in another clinical trial with an
interventional investigational agent that will be received during the study period.
11. History of hospitalization within the past 60 days.
12. History of systemic antiviral therapies within the past 30 days.
13. History of oral corticoid steroid use within the past 14 days or steroid injection
within the past 6 months. Active use of nasal or inhalable steroids is also exclusionary.
Topical steroids are not exclusionary.
14. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,
generalized urticaria, angioedema, other significant reaction) to nitrites, nitrates or sun
exposure.
15. Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of
the investigator would interfere with device use, or intra-oral metal body piercings
that cannot be removed for the duration of the study. Metal orthodontia is permitted as
braces will be covered by the device mouthpiece.

 
Page 24 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
^^Potential Study Subjects Presenting with any of the following should be referred for immediate 
medical care and are not eligible for the study: 
• Fever > 104o F 
• Cough with sputum production 
• Rales and/or rhonchi 
• Difficulty breathing or respiratory distress defined by a respiratory rate ≥30 per minute, heart 
rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 <300. 
• Persistent pain or pressure in the chest 
•  Confusion 
7.3  Study Volunteer Selection, Retention & Compensation 
 
Recruitment 
Potential subjects will learn about the study via IRB-approved recruitment strategies, including 
direct mailing, recruitment from an IRB-approved trial registry, digital advertisements and local 
advertisements/flyers. Pre-screening may begin with a brief IRB-approved telephone call from 
study staff. Information about the study will be presented to potential subjects and questions about 
their health and ability to comply with the study visit schedule will be asked of potential subjects 
to presumptively determine eligibility. Appointments will be made at the clinical trial unit for 
potential subjects who are interested in the study for further screening procedures and additional 
protocol-specific information. 
 
Retention 
Study retention strategies will include education and explanation of the study schedule and 
procedures during screening and enrollment visits and restriction of enrollment to persons who 
can attend all study visits. Participating subjects will be reminded of subsequent visits during each 
visit, and study staff will contact subjects prior to appointments. Study staff will contact subjects 
who miss appointments to encourage them to return for completion of safety evaluations. 
 
Compensation Plan for Subjects 
Subjects will be compensated for their participation in this trial. Compensation will take into 
consideration both the urgency and importance of developing new treatments for this COVID-19 
pandemic and local IRB guidelines, and will be ultimately subject to local IRB approval. 
Reimbursements will be disbursed at specific timepoints during the study with the total amount 
contingent on completing study procedures. 
 
Costs 
There is no cost to subjects for the research tests, procedures/evaluations or study device while 
taking part in this trial. Procedures and treatment for clinical care may be billed to the subject, 
subject's insurance or third party. 

Page 25 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
8 
STUDY DEVICE 
8.1 Regulatory Considerations 
Preliminary Regulatory Pathway for EmitBio™ RD-X19 
The Food and Drug Administration (FDA) plays a critical role in protecting the United States 
from threats such as emerging infectious diseases, including the COVID-19 pandemic. To date, 
the agency has utilized various mechanisms to expand access for drugs, grant emergency use 
authorization (EUA) for certain diagnostic and treatment approaches and has issued policies for 
medical devices without premarket notification during the COVID-19 public health emergency. 
Risk management activities have been completed according to EmitBio’s SOP for Risk 
Management and a Risk Management Plan was developed, which are compliant with the 
applicable 21 CFR part 820 regulations, ANSI AAMI ISO 14971, and ISO TR 24971.  A Hazard 
Analysis, including a Failure Effects Mode Analysis, of the device characteristics and use was 
performed based on ANSI AAMI ISO 14971.   
The risks identified, mitigation measures and control strategies, in combination with a review of 
all available nonclinical and clinical safety information, has led the company to conclude that the 
RD-X19 operating at the proposed fluence levels is a Nonsignificant Risk Device.   
Per the FDA guidance document titled “Significant Risk and Nonsignificant Risk Medical Device 
Studies,” NSR device studies do not have to have an Investigational Device Exemption (IDE) 
application approved by FDA prior to initiation.  
EmitBio™ conducted RD19-01-3Q20 under 21 CFR 812 as a Non-Significant Risk (NSR), 
Minimal Risk protocol. The Institutional Review Board agreed with EmitBio™ based on the 
protocol and supporting documentation submitted with the protocol and granted final approval to 
conduct the study on September 1, 2020. 
Proposed Label Claim/Indication for Use: 
The RD-X19 device is intended for use as a treatment to reduce viral load in the upper respiratory 
tract in subjects ages 12 to 65 who have tested positive for SARS-CoV-2 and who have symptoms 
consistent with uncomplicated COVID-19 for no more than 3 days. 
Medical Device Quality System: 
EmitBio™ will operate under an established Quality Management System, with a commitment for 
continuous improvement and effectiveness, in accordance with the requirements of the customers 
and applicable international standards. Specifically, the EmitBio™ Quality Management System 
is compliant with the requirements of the FDA Quality Systems Regulations (QSR). 
8.2 Study Device and Use 
 
Device Description 
The RD-X19 device emits safe, visible blue light to eliminate invading pathogens and stimulate 
host defenses in the oropharynx and surrounding tissues. The RD-X19 device does this without 
additional photosensitizers or chemical reagents that are typically employed with traditional 

 
Page 26 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
photodynamic therapeutics. Specifically, selected wavelengths of light have been evaluated across 
the visible spectrum, and it was discovered that safe, visible blue light emitted from non-coherent 
LED sources could perform the following functions: 
 
• 
kill cell-free virus by several orders of magnitude, 
• 
inhibit viral replication post infection,  
• 
stimulate host immune response through the instantaneous release of the body’s 
bound stores of nitric oxide as well as upregulate nitric oxide production in 
epithelial tissue. 
The device consists of three components: (1) Aluminum housing, (2) Light Engine, and (3) Light 
Delivery Assembly.  Each of those components are described briefly below.  Each of the building 
blocks described are designed to allow the assembled device to meet specific criteria based on 
targeted safety and efficacy. 
 
Figure 3. Fully assembled RD-X19 device. 
 
1. Aluminum Housing - The aluminum housing measures approximately 16 cm x 3.5 cm x 
3.5 cm.  It has been engineered for function and ease of manufacturing and designed for 
ergonomics.  With regard to functionality, the aluminum housing provides durable support 
for the light engine, the light delivery system, and the battery to provide for long-lifetime 
operation and effective heat dissipation.  With respect to ergonomics, the housing 
incorporates a right angle, providing a comfortable transition from the light engine to the 
light delivery assembly as well as for single-handed use. 

 
Page 27 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
2. Light Engine - Completely located inside of the aluminum housing, the light engine 
consists of five major sub-components:  
• Battery - The 3500 mAh lithium ion rechargeable battery can be quickly and 
routinely charged via a micro USB charging cable for everyday use.   
• Treatment actuator - The actuator is a high reliability (300,000 cycle rating) 
instantaneous contactor that both starts the auto-timed treatment and provides a 
user-controlled method to stop the treatment before completion if needed.  In 
addition, the treatment actuator contains LED indicators to inform the user of 
device state (e.g. charging, fully-charged, treatment in progress, device 
malfunction).   
• Treatment control board - The treatment control board governs the electronic 
operation of the device to both measure charge state of the battery and provide for 
battery charging, both while isolating the user from the AC power source.  It also 
provides the LED array with a calibrated amount of electrical power which the 
LEDs convert into the targeted optical power.  Finally, at the heart of the treatment 
board is a microprocessor that monitors parameters such as battery health and time 
between treatments while also automatically stopping the optical treatment after a 
specified duration.   
• LED Array - The LED array incorporates a series of safe, visible blue LEDs 
soldered on a metal core circuit board.   The quantity and characteristics (e.g. 
optical power and wavelength) of the individual LEDs in the LED array have been 
chosen to promote for maximum therapeutic index against viral pathogens and for 
photobiomodulation of nitric oxide.  At the use conditions contemplated, the LED 
useful lifetime is expected to be greater than 100,000 treatments. 
• Optical Lens - After emission from the LEDs, the light passes through the optical 
grade, glass lens.  The diameter, focal length, and thickness of the lens have been 
chosen to homogenize the emission from the LED array while optimizing 
transmission of the light. 
3. Light Delivery Assembly - The light delivery assembly shapes the light while transferring 
the optical energy from the LED array to the host tissue and is the only component that 
comes into contact with the oral cavity.  It measures approximately 8 cm x 6.5 cm x 4.0 
cm and consists of two primary sub-components, the light guide (LG) and the light guide 
positioner (LGP). 
• Light Guide (LG) - After passing through the lens, the pre-shaped beam enters the 
LG.  The LG further shapes the beam for final delivery to the host tissue while also 
shielding the user from any edge high intensity light.  While the oropharynx can be 
sufficiently exposed through proper head positioning, the LG also incorporates a 
shaped element to assist the tongue in staying out of the light path.  When the 
device is in use, the LG is anchored securely to the aluminum housing via spring 
clips.  The clips not only allow for secure anchoring, but they also provide for easy 
removal and cleaning of the LG. 
• Light Guide Positioner (LGP) - Through its relationship to the LG and the oral 
cavity – specifically to both the upper and lower teeth – the LGP ensures that the 

 
Page 28 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
light emitting from the LED array and shaped by the lens and LG is directed 
toward the oropharynx.   As an important consideration, since both the LG and the 
LGP are in contact with the oral cavity, both have been shown to be both safe for 
daily repeat dosing 2 weeks in duration and the fabricated sub-components been 
made with materials that have been previously evaluated under ISO 10993. 
There are two primary accessories required for use of the device.  The first accessory, the AC 
adapter, is used to for recharging the device.  The AC adapter is plugged into wall voltage and 
then connected to the device via a micro USB cable between device uses.  The user is prompted, 
via indicator lights, when recharging is necessary, in progress, and complete.  The second 
accessory, the stand, is used for storing the device between uses.  The stand is portable, and the 
device is held in an upright position when placed in the stand. 
8.3 Use / Storage & Maintenance / Accountability 
 Acquisition and Accountability 
The sponsor will provide clinical sites with RD-X19 devices packaged in appropriately labelled 
containers containing all components as well as instructions for use by study participants.  Each 
RD-X19 device will be stamped on its power unit with a serial number.  Study staff will ensure 
that each device’s serial number is assigned to a specific study subject and the link between device 
serial number and study subject study number will be maintained on an accountability log.  
Subjects will be requested to bring their device to the clinic for each scheduled visit.  Upon 
termination of a subject’s participation in the trial, all RD-X19 devices and components must be 
returned to the study site and then to the study sponsor. 
 Device Storage and Maintenance 
All RD-X19 devices will be stored in a locked device storage room at the clinical trial site until 
needed for assignment to an enrolled study volunteer.  Upon acquisition by the study subject, 
devices should be stored in a dry climate-controlled environment in the original container in 
which it was provided.   
The device should be stored securely out of the reach of children who may mistakenly misuse the 
device, especially illumination of eyes – which is always to be avoided. The mouthpiece of the 
device is removable for rinsing with mild soap and warm water.  The device tongue depressor and 
power housing may be cleaned with a soft cloth that has been dampened in mild dish detergent 
diluted in water; pieces should then be dried with a soft cloth.  The optic device can be wiped 
gently with a dry cloth suitable for cleaning optical glasses. 
 Preparation for Use and Use 
[Refer to Appendix 1: RD-X19 User Instructions]  
8.4 Measures to Maximize Study Subject Compliance 
Randomization between active treatment and sham control devices has been set at 2:1 to provide 
higher probability of the subjects being randomized to the investigational treatment during the 
study duration. 

 
Page 29 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
Subjects will receive appropriate compensation for the disruption to normal daily activities created 
by this protocol that also considers the frequency with which they are requesting to travel to the 
site, the twice daily journaling and treatment regimen, and the number of biospecimens scheduled 
to be collected for virology assessments.   
Additionally, the subjects will be educated on the role of their individual contribution in clinical 
research as it relates to developing a solution for the COVID-19 pandemic on a global scale. 
8.5 Device Discontinuation 
 
Study Pausing Criteria 
EB-P12-01 enrollment will be paused if any of the following events occur: 
• Any subject experiences an SAE after use of the RD-X19 Device that is considered 
related to RD-X19. 
• Any subject experiences laryngospasm, bronchospasm or anaphylaxis within 2 hours 
after use of the RD-X19 Device that is considered related to RD-X19. 
• Two (2) or more subjects experience an allergic reaction such as generalized 
urticaria (defined as occurring at three or more body parts) within 72 hours after 
administration of light that is considered related to RD-X19. 
• Three (3) or more subjects experience a Grade 3 AE (systemic and/or clinical 
laboratory abnormality), in the same SOC grouping of Preferred Terms based on the 
Medical Dictionary for Regulatory Activities (MedDRA) coding, considered to be 
related to RD-X19. 
Enrollment may resume only after external safety review of the SAE/AEs that caused the pause to 
the study.  Given the frequency of visits and the duration of the protocol, study device use may 
continue after assessing the safety and AEs for individual subjects at either regulatory scheduled 
or an unscheduled site visits. 
 
Subject elects to discontinue 
A study volunteer may elect to discontinue participation in the trial at any time. Investigative staff 
will ask the volunteer to return for an early termination evaluation, but they are under no 
obligation to do so. All study subjects must return the RD-X19 device at study termination and 
study staff must verify that the device serial number matches the study subject to whom it was 
assigned. 
 
Investigator Decision to Discontinue Subject Use of Device 
A subject may be removed from the study for the following reasons post initial device use; 
however, whenever possible the subject should be followed for safety evaluations per protocol: 
• 
Study non-compliance to protocol requirements that in the opinion of the participating 
clinical site PI or appropriate sub-investigator poses an increased risk (e.g., missing safety 
labs) or compromises the validity of the data. 
• 
Lost to follow-up. (A subject will be considered lost to follow-up if he or she fails to 
appear for a follow-up assessment. Extensive effort (i.e., generally three documented 
contact attempts via telephone calls, e-mail, etc., made on separate occasions) will be 

 
Page 30 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
made to locate or recall the subject, or at least to determine the subject’s health status. 
These efforts will be documented in the subject’s study file.) 
• 
Medical disease or condition, or new clinical finding(s) for which continued 
participation, in the opinion of the participating clinical site PI or appropriate sub- 
investigator, might compromise the safety of the subject, interfere with the subject’s 
successful completion of this study, or interfere with the evaluation of safety. 
• 
If any AE, clinical laboratory abnormality or situation occurs such that continued 
participation in the study would not be in the best interest of the subject. 
• 
The occurrence of a SAE. 
• 
 If the subject is using the device in any manner inconsistent with instructions and 
protocol directives and procedures. 
 
If the subject agrees, every attempt will be made to follow all AEs through resolution or 
stabilization. 
Subjects who withdraw or are lost to follow-up after signing the informed consent form (ICF) and 
use of the RD-X19 device will not be replaced. Subjects who withdraw or are withdrawn from this 
study after signing the ICF but before use of the device may be replaced. 
The reason for subject discontinuation or withdrawal from the study will be recorded on the 
appropriate e-CRF. 
 
Follow-up of Study Subjects Who Discontinue Device Use 
Discontinuation of study device use does not constitute discontinuation from the study, and the 
study procedures for early termination should be completed as indicated by the Study Schedule of 
Activities. If a clinically significant finding is identified, including, but not limited to, changes 
from baseline, after enrollment, the participating clinical trial site PI or qualified designee will 
determine if any change in subject management is needed. Any new clinically relevant finding 
will be reported as an AE. 
9 
STUDY ASSESSMENTS AND  PROCEDURES 
9.1 Screening Assessments 
 
Screening Procedures 
At the screening visit, and prior to any other study-related activities, the participating clinical site 
PI or appropriate sub-investigator will provide the subject with detailed study information and will 
obtain written informed consent (see section 11.1.1 for more details). 
 Subject numbers will be assigned with the three-digit numerical site number beginning with 
numbers greater than one hundred (e.g. 101) followed by an alphanumeric cohort identifier (e.g. 
C1) and finally a two digit unique numerical identifier assigned with each new subject (e.g. 01). 
Example Subject Number: 101-C1-01 
 

 
Page 31 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
COVID-19 Screening 
Eligible subjects presenting with uncomplicated COVID-19 must have an oral temperature of at 
least 100 ˚F or have at least two moderate or severe symptoms (cough, nasal congestion, or sore 
throat, headache, chills/sweats, muscle or joint pain, fatigue, or nausea) and consent to be 
randomized within 3 days of first symptom onset. The subjects will self-assess their COVID-19 
symptoms as none (0), mild (1), moderate (2), or severe (3) during screening.  
Additionally, subjects who identify with symptomatology associated with COVID-19 will be 
screened by taking a nasal culture and analyzed for the presence of SARS-CoV-2 by an FDA 
authorized SARS-CoV-2 antigen test (e.g. BD Veritor™ Plus System, AccessBio Carestart).  
These systems allow for rapid detection of SARS-CoV-2 via immunoassay for the direct and 
qualitative detection of SARS-CoV-2 antigens.  Subjects presenting at the time of screening 
that have tested positive via a SARS-CoV-2 rapid antigen test within the past 24 hours and 
can provide documentation confirming proper identification, the date of the test and testing 
location, positivity of the result, and name/identity of the assay used to generate the result, 
are also eligible for enrollment.   
There is a small amount of risk to subjects who report mild-to-moderate symptomatology 
consistent with COVID-19 may have an unknown health problem or co-morbidity at the time of 
screening that can lead to worsening of condition or hospitalization during study. 
General Screening 
Some or all of the following assessments are performed during the screening visit to determine 
eligibility requirements as specified in the inclusion and exclusion criteria: 
o Obtain medical history focusing on conditions per protocol exclusion criteria. 
o Review all pre-study medications, vitamins, supplements, and 
therapies up to 14 days prior to the start of screening that could impact 
the use of, or response to, the device and record on the appropriate e-
CRF.  Subjects are allowed to use over-the-counter medications and 
remedies to alleviate symptoms (e.g. acetaminophen, ibuprofen, 
cough drops, etc. and should be recorded.) 
o Measure vital signs (HR, BP, RR, and oral temperature) 
and height and weight for determination of BMI. 
o Perform full physical examination which will include assessments of 
the following organs and organ systems: skin, head, ears, eyes, nose, 
and throat (HEENT), neck, lungs, heart, liver, spleen, abdomen, 
extremities, lymph nodes (axillary and cervical), and nervous system. 
o Obtain blood and urine for clinical screening laboratory evaluations: 
▪ Comprehensive Metabolic Panel (fasting or non-fasting) 
▪ CBC with differential 
▪ Urine pregnancy test (in women of childbearing potential) 
o Review inclusion and exclusion criteria. 

 
Page 32 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
The overall eligibility of the subject to participate in the study will be assessed once all screening 
values are available. The screening process can be suspended prior to complete assessment at any 
time if exclusions are identified by the study team. 
Study subjects who qualify for inclusion will be immediately randomized for their day 1 visit. 
If a physiologic parameter, e.g., vital signs, is outside of the protocol-specified range, then the 
measurement may be repeated once if, in the judgment of the participating clinical site PI or 
appropriate sub-investigator, the abnormality is the result of an acute, short-term, rapidly 
reversible condition (e.g., stress, anxiety or “white coat syndrome”) or other source of error. A 
physiologic parameter may also be repeated if there is a technical problem with the measurement 
caused by malfunctioning, or an inappropriate measuring device (i.e., inappropriate-sized BP 
cuff). 
A subject may be re-screened if there is a transient disease status (e.g., absent signs and symptoms 
associated with mild COVID-19), or if a protocol eligibility criterion that is not met at the initial 
time of screening, will be met by rescreening of all assessments within the next 2 days using the 
same subject number. 
No subjects may be screened more than twice due to a screening failure result as defined above. 
Subjects will be provided the results of abnormal clinical laboratory test values or abnormal 
clinical findings necessitating follow-up with their primary care provider. 
 
Procedures for Abnormal Clinically Significant Laboratory Values or 
Findings 
If in the judgement of the PI the finding poses a previously unknown risk to the subject or leads to 
a diagnosis of a disease or condition that would have been disqualified the subject for enrollment, 
the subject will be withdrawn from the study immediately.   
All clinically significant findings that occur post randomization and after the first use of the RD-
X19 device will be considered AEs.  Clinically significant lab findings based on Visit 1 lab 
draws are considered Medical History and not Adverse Events. 
 
9.2 Safety and Other Assessments 
Study procedures are specified in protocol section 4.2. A study clinician, licensed to make medical 
diagnoses as the participating clinical site PI or appropriate sub-investigator, will be responsible 
for all study-related medical decisions. 
o Medical history: 
o A complete medical history will be obtained by interview of 
subjects at the screening visit. Subjects will be queried regarding a 
history of significant medical disorders of the head, ears, eyes, 
nose, throat, mouth, cardiovascular system, lungs, gastrointestinal 
tract, liver, pancreas, kidney, urologic system, nervous system, 
blood, lymph nodes, endocrine system, musculoskeletal system, 
skin, and genital/reproductive tract. A history of any allergies, 
cancer, immunodeficiency, psychiatric illness, substance abuse, and 
autoimmune disease will be solicited. 

 
Page 33 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
o At all subsequent visits an interim medical history will be obtained 
by interview of subjects and any changes since the previous clinic 
visit will be noted. The interim medical history should include an 
assessment for new medical conditions and symptoms suggestive of 
an AE. 
o Physical examination: 
o A full physical examination will be performed at the screening 
visit and Day 8, and a symptom-directed (targeted) physical 
examination will be performed if indicated during other clinic 
visits 
▪ A full physical examination will include assessments of the 
following organs and organ systems: skin, HEENT, neck, 
lungs, heart, liver, spleen, abdomen, extremities, lymph 
nodes (axillary and cervical), and nervous system. 
▪ Height and weight will be measured, and BMI calculated, 
at the screening visit only. 
o A symptom-directed (targeted) physical examination will 
be performed if indicated during other scheduled clinical 
site visits. 
▪ Targeted physical examinations will primarily focus on 
assessment of signs and symptoms suggestive of AEs. 
Interim or unscheduled physical examinations will be 
performed at the discretion of the participating clinical site 
PI or appropriate sub-investigator, if necessary, to evaluate 
AEs. 
o Subjects will be observed in the clinic for at least 30 
minutes post the first RD-X19 illumination. The 
oropharynx and surrounding tissues will be examined. 
Reactogenicity assessments will be performed on Days 1, 
2, 3, 5, and 8. An oropharyngeal examination will also be 
performed on Days 1 and 8 and during unscheduled visits 
and early termination visits and recorded on the 
appropriate source document prior to discharge from the 
clinic. Interim or unscheduled oropharyngeal examinations 
will be performed, if necessary, to evaluate AEs. 
o Vital signs:  
Vital sign measurements will include systolic and diastolic BP, 
HR, RR, and oral temperature. Vital signs will be measured at 
timepoints specified in protocol section 4.2. Subjects must not eat 
or drink anything hot or cold within 10 minutes prior to taking 
their oral temperature or using the RD-X19 device. 
o 
Clinical laboratory evaluations: 
o Fasting is not required before collection of clinical laboratory evaluations. 

 
Page 34 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
o Urine pregnancy test will be performed locally by the site 
laboratory at the screening visit and at the final study visit. Results 
must be confirmed as negative prior to randomization on Day 1 and 
allocation and use of the RD-X19 device. 
o Clinical laboratory evaluations CMP and CBC (diff) will be 
performed locally by the site selected laboratories.  
▪ Clinical safety laboratory evaluations will be performed 
locally by the  site laboratory.  
▪ Blood and urine will be collected at timepoints specified in 
the protocol section 4.2. 
 
Definition of Adverse Event (AE) 
AE means any untoward medical occurrence associated with the use of an intervention in humans, 
whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any 
unfavorable and unintended sign (including an abnormal clinical laboratory finding), symptom or 
disease temporally associated with the use of medicinal (investigational) product. 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the severity of any pre-existing medical condition 
increases, it should be recorded as an AE. 
AEs can be further divided into solicited AEs and unsolicited AEs. Solicited AEs are those for 
which the study team will specifically query the subject whether they occurred. Unsolicited AEs 
are those events that the subject report occurring without being queried about the specific event. 
All AEs will be assessed for severity and relationship to study intervention. Reporting of all AEs, 
solicited and unsolicited, will occur during the period from study device administration on Day 1 
through Day 8 or until an early termination visit. 
All AEs, solicited and unsolicited, will be captured on the appropriate source documents and e-
CRFs. Information to be collected for AEs includes event description, date of onset, assessment of 
severity, relationship to study product and alternate etiology (assessed only by those with the 
training and authority to make a diagnosis as the participating clinical site PI or appropriate sub-
investigator), date of resolution, seriousness, and outcome. All AEs will be documented regardless 
of relationship. 
AEs will be followed to resolution or stabilization. 
 
Solicited Adverse Events - Reactogenicity 
Solicited AEs are anticipated AEs for which consistent collection of information is desired. Study 
clinicians will follow and collect resolution information for any reactogenicity symptoms that are 
not resolved during the active study period. 
Solicited AEs (i.e., reactogenicity) will be collected by direct questioning of study subjects and 
recorded on the appropriate source document and e-CRF during the entire course of the study. 
For this study, solicited AEs include: 
• 
Illumination site Pain 

 
Page 35 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
• 
Illumination site Erythema 
• 
Illumination site Edema/Induration 
• 
Any other pain, redness, swelling or lesion of the oral mucosa 
 
Unsolicited Adverse Events 
All AEs spontaneously reported by the subject and/or in response to an open question from study 
staff or revealed by observation, physical examination or other diagnostic procedures must be 
recorded on the appropriate source document and e-CRF. 
Unsolicited AEs of all severities will be reported during the entire course of the study. 
 
Adverse Event Reporting 
Information on all AEs should be recorded on the appropriate source document and e-CRF. All 
clearly related signs, symptoms and results of diagnostic procedures performed because of an AE 
should be grouped together and recorded as a single diagnosis. If the AE is a clinical laboratory 
abnormality that is part of a clinical condition or syndrome, it should be recorded as the syndrome 
or diagnosis and be described in terms of duration (start and stop date). 
 
Definition of a Serious Adverse Event (SAE) 
An SAE is defined in 21 CFR 312.32 as follows: “An AE is considered serious if, in the view of 
either the participating clinical site PI or appropriate sub-investigator or the sponsor, it results in 
any of the following outcomes: 
• 
Death, 
• 
A life-threatening AE, 
• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, 
• 
Or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, are not immediately life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. An example of such a medical event would 
be an allergic bronchospasm requiring intensive treatment in an emergency room or at home to 
prevent the development of one of the definitions above. 
“Life-threatening” refers to an AE that at occurrence represents an immediate risk of death to a 
subject. An event that may cause death if it occurs in a more severe form is not considered life-
threatening. Similarly, a hospital admission for an elective procedure is not considered an SAE. 
All SAEs, as with any AE, will be assessed for severity and relationship to study intervention. All 
SAEs will be recorded on the appropriate SAE e-CRF. 

 
Page 36 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
All SAEs will be followed through resolution or stabilization by a study clinician, licensed to 
make medical diagnoses and listed as the participating clinical site PI or appropriate sub-
investigator. 
All SAEs will be reviewed and evaluated by the Sponsor and will be reported to the IRB. This 
report will include severity, association with the study device, action(s) taken, and outcome. 
 
Serious Adverse Event Reporting 
Any AE that meets a protocol-defined criterion as an SAE must be submitted immediately (within 
24 hours of site awareness) on an SAE form to CRO/EmitBio Inc. Pharmacovigilance: 
EmitBio™ Pharmacovigilance  
SAE Hot Line: 1-843-540-3550 or 1-610-570-7425  
Text Immediate Report: 1-843-540-3550 
SAE Email: jmcneil@emitbio.com 
In addition to the SAE form, all SAE data must be entered into the SAE e-CRF. 
Other supporting documentation of the event may be requested by EmitBio™ Pharmacovigilance 
and should be provided as soon as possible. The Sponsor Medical Monitor will review and assess 
the SAE for regulatory reporting and potential impact on study subject safety and protocol 
conduct. 
At any time after completion of the study, if the participating clinical site PI or appropriate sub-
investigator becomes aware of an SAE that is suspected to be related to study product, the 
participating clinical site PI or appropriate sub-investigator will report the event to the EmitBio™ 
Pharmacovigilance Group. 
 
Regulatory Reporting of Device-related SAEs 
Following notification from the participating clinical site PI or appropriate sub-investigator, 
EmitBio Inc., as the sponsor, will report to the FDA and will copy the External Monitoring 
Committee and clinical site investigators on all reports of potential serious risks from clinical 
studies of RD-X19, as soon as possible. EmitBio Inc. will report to the FDA any unexpected fatal 
or life-threatening suspected adverse reaction as soon as possible, but in no case later than 7 
calendar days after the sponsor’s initial receipt of the information. If the event is not fatal or life-
threatening, an SAE safety report will be submitted within 15 calendar days after the sponsor 
determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. 
Relevant follow-up information to the safety report will be submitted as soon as the information is 
available. Upon request from FDA, EmitBio™ will submit to the FDA any additional data or 
information that the agency deems necessary, as soon as possible, but in no case later than 15 
calendar days after receiving the request. 
SAEs that are not considered related to RD-X19 will not be reported to the FDA. 
 
Classification of an Adverse Event 
The determination of seriousness, and causality will be made by an on-site investigator who is 
qualified (licensed) to diagnose AE information, provide a medical evaluation of AEs and classify 

 
Page 37 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
AEs based upon medical judgment. This includes, but is not limited to, physicians, physician 
assistants and nurse practitioners.  
 
Severity of Adverse Events 
All AEs or SAEs will be assessed for severity, according to the toxicity grading scales provided at 
Appendix 2. 
For AEs not included in the protocol-defined grading system, the following guidelines will be 
used to describe severity. 
• Mild (Grade 1): Events that are usually transient and may require only minimal or no 
treatment or therapeutic intervention and generally do not interfere with the subject’s usual 
activities of daily living. 
• Moderate (Grade 2): Events that are usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing discomfort 
but poses no significant or permanent risk of harm to the research subject. 
• Severe (Grade 3): Events interrupt usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. Severe events are usually 
incapacitating. 
AEs characterized as intermittent require documentation of onset and duration of each episode. 
The start and stop date of each reported AE will be recorded on the appropriate e-CRF. Changes 
in the severity of an AE will be documented to allow an assessment of the duration of the event at 
each level of intensity. 
 Relationship to Study Intervention 
For each reported adverse event, the participating clinical site PI or qualified designee must assess 
the relationship of the event to the study device using the following guidelines: 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable 
possibility that the study intervention caused the AE, or there is a close temporal relationship 
between the study intervention and event. Reasonable possibility means that there is evidence 
to suggest a causal relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 Time Period and Frequency for Event Assessment and Follow-Up 
For this study: 
Solicited and Unsolicited AEs will be recorded by clinical trial staff for the entire duration of 
the study.  
 Adverse Event Reporting to Study Subjects 
All device-attributed AEs and SAEs will be reported to participants in the study to better inform 
them of the potential risks vs. benefits of participation. 

 
Page 38 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 Pregnancy Reporting 
All positive urine pregnancy tests will be reported during screening and at the end of the study. 
Women who screen positive for pregnancy will be encouraged to see their primary health care 
provider for a serological confirmatory test. 
9.3  Efficacy Assessments 
Efficacy comparisons will be made in the ITT Population with the intent of estimating the effect 
of the RD-X19 device relative to sham in several outcome measures.  Subjects will be instructed 
to fill out diary cards twice daily to assess their symptoms associated with disease progression and 
record the number of treatments completed.  Additionally, at Baseline and days 3, 5, and 8, 
subjects will provide two saliva specimens and an oropharyngeal swab for virology endpoint 
assessments.  One saliva specimen will be collected, preserved, and shipped fresh to a central lab 
for assessment of SARS-CoV-2 mRNA via RT-qPCR.  The second specimen and the 
oropharyngeal swab will be collected in  separate collection tubes, frozen, and stored at the site 
and shipped to a central lab at the end of each cohort.  
 
Efficacy assessments 
Various endpoints will explore the impact of RD-X19 treatment on the reduction in log10 SARS-
CoV-2 viral load and alleviation of symptoms associated with COVID-19.  Both the magnitude of 
reduction as a function of dose as well as time to clearance will be assessed in support of the 
primary efficacy analysis. Subjects will be instructed to fill out a diary card or electronic 
equivalent to assess their signs and symptoms of disease twice daily.  Each of the eight symptoms 
will be rated on a scale from none (0) to severe (3). 
• Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to 
Day 8  
• Geometric mean viral load as measured in saliva on day 1, 3, 5, and 8 by RT-qPCR  
• Proportion of subjects demonstrating viral load reduction ≥95% by RT-qPCR (at each 
visit)  
• Time to undetectable viral load in saliva by RT-qPCR. 
• Proportion of subjects demonstrating clearance of viral infection, defined as a negative 
test via RT-qPCR on Day 8/ET. 
• Median time to alleviation of symptoms,  
o The time to alleviation of symptoms endpoint, is defined as the time when all 
eight symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, 
muscle or joint pain, fatigue, and nausea) had been assessed by the subject as 
none or mild. 
• Change in COVID-19 Severity Score from baseline 
o The COVID-19 Severity Score is defined as the sum of all the individual 
symptom severity scores divided by the total number of symptoms assessed 
(8). 
• Viral load by viral titer (at each visit) 

 
Page 39 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
o The paired oropharyngeal swab and saliva sample from each subject at each 
visit allows for independent analysis via two different live virus sampling 
methodologies and also a direct paired sample comparison of the viral load 
present in the back of the throat versus saliva. 
10 STATISTICAL CONSIDERATIONS 
10.1 Statistical Hypotheses 
This is a randomized, ascending dose finding study.  The primary goal of the study is to evaluate 
the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with 
uncomplicated COVID-19.  
10.2 Power and Sample Size: 
This is a double-blind study and hypothesis generating in nature.  The sample size was selected 
for convenience. 
Subjects will be randomized to treatment arm within dose in a 2:1 ratio according to a fixed 
schedule using a permuted block design and stratified by clinical site.  The target number of 
subjects randomized per dose is 30 (20 subjects to the RD-X19 arm, 10 subjects to the sham arm.   
One interim analysis is planned at the end of Cohort 1. 
10.3 Populations for Analyses 
Three analysis populations are defined for this study. 
• 
The Safety Population includes all randomized subjects who receive at least 1 study 
treatment.  This population will be used for all safety analyses.  Subjects will be 
analyzed based on actual treatment received. 
• 
The Intent-to-treat Population (ITT) includes all randomized subjects who received 
treatment and were not discontinued due to a significant abnormality from the baseline 
CMP and CBC tests.  This population will be used for all efficacy analyses as the 
primary population.  Subjects will be analyzed based on randomized treatment, 
regardless of the actual treatment received. 
• 
The Per Protocol (PP) Population includes all randomized subjects who complete the 
study and did not have a major protocol deviation (MPD).  The PP population will be 
used for supportive analysis of the efficacy endpoints.  MPDs are those that could have 
interfered with the administration of treatment or the precise evaluation of treatment 
efficacy (e.g. violation of inclusion/exclusion criteria, no Day 3 visit, etc.).  All MPDs 
will be identified before the database lock and study unblinding for analysis.     
10.4 Statistical Analyses 
For continuous variables, descriptive summaries will display number of subjects, arithmetic mean, 
geometric mean (as appropriate), standard deviation, median, minimum, and maximum by 
treatment group.  For categorical variables, counts and percentages will be displayed. 

 
Page 40 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
In general, missing data will not be imputed with the exception that for the ITT analysis, missing 
viral load results will be imputed using the last-observation-carried-forward (LOCF) 
methodology.   
Additional details regarding statistical methods will be provided in the Statistical Analysis Plan. 
 Efficacy Analyses 
The primary efficacy endpoint is defined as time-weighted average (TWA) change in log10-
transformed viral load by RT-qPCR from baseline to Day 8, where TWA will be derived using the 
trapezoidal rule. At the final analysis, each dose of the RD-X19 device will be compared to sham 
using an Analysis of Covariance (ANCOVA) model with baseline viral load as a covariate and 
treatment group as an independent variable. Geometric means and their 95% CIs will be computed 
by exponentiating (base 10) the least squares means and 95% CIs of the log10-transformed viral 
load. 
Secondary efficacy endpoints include: 
• 
log10-transformed Viral load as measured in saliva by RT-qPCR at each visit 
• 
proportion of subjects with ≥95% reduction in SARS-CoV-2 viral load at each visit 
• 
time to undetectable viral load in saliva by RT-qPCR 
• 
proportion of subjects demonstrating clearance of viral infection, defined as a negative 
test via RT-qPCR at Day 8/ET visit 
• 
COVID-19 composite severity score at each visit 
• 
time to alleviation of COVID-19 symptoms, defined as the time when all eight 
symptoms had been assessed by the subject as none or mild.  
Exploratory efficacy endpoints includes log10-transformed viral load at each visit as measured by 
TCID50 for replication competent virus via both expelled saliva specimen and oropharyngeal 
swab collection methodologies. 
All secondary and exploratory efficacy endpoints will be summarized using descriptive statistics 
by visit (as appropriate) for each treatment group. For log10-transformed viral load data, 
geometric means will be computed by exponentiating (base 10) the group means of the log10-
transformed viral load. Time-to-event variables will be evaluated using the Kaplan-Meier method. 
 Safety Analyses 
Summaries will be presented by treatment arm on the Safety Population.  Adverse device effects 
will be coded using the latest version of the Medical Dictionary for Regulatory Activities 
(MedDRA).  Treatment-Emergent Adverse Events (TEAE), vital signs, and methemoglobin will 
be summarized using descriptive statistics.  Other safety data including prior and concomitant 
medications will be listed. 
TEAE is any event not present prior to the initiation of the treatments or any event already present 
that worsens in either intensity or frequency following exposure to the treatments.  Number and 
percent of subjects reporting TEAEs will be tabulated by treatment group.  Summaries will be 
presented by system organ class and preferred term, and further by severity and relationship to 
study treatment.  In the summaries of incidence rates (frequencies and percentages), severity and 
relationship to treatment, subjects who report more than one event that are mapped to the same 

 
Page 41 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
preferred term will be counted only once under the strongest severity and relationship, 
accordingly.   
11 OPERATIONAL CONSIDERATIONS AND SUPPORTING DOCUMENTS 
11.1 Ethical Considerations 
This study will be conducted in conformity with the principles set forth in The Belmont Report: 
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (US National 
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; April 
18, 1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 
21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). 
An OHRP-registered IRB will review and approve this protocol, associated informed consent 
documents, recruitment material, and handouts or surveys intended for the subjects, prior to the 
recruitment, screening, and enrollment of subjects. The IRB review shall be in accordance with 45 
CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), 21 CFR 812 and other federal, state, and local 
regulations and policies, as applicable. 
Any amendments to the protocol or informed consent documents will be approved by the IRB 
before they are implemented. The participating clinical site PI will notify the Sponsor of 
deviations from the protocol and reportable SAEs, and, as applicable, to the IRB. 
EmitBio Inc must receive the documentation that verifies IRB approval for this protocol, informed 
consent documents, and associated documents prior to the recruitment, screening, and enrollment 
of subjects and the provision of adequate numbers of RD-X19 devices to conduct the protocol. 
 Informed Consent Process 
Informed consent is a process that is initiated prior to an individual agreeing to participate in a 
trial and continuing throughout the individual’s trial participation. Investigators or designated 
research staff will obtain a subject’s informed consent in accordance with the requirements of 45 
CFR 46, 21 CFR 50 and 21 CFR 56, state and local regulations and policy, and ICH E6 GCP 
before any study procedures or data collection are performed. The participating clinical site PI or 
other study staff may obtain oral or written information for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without the informed consent of the prospective 
subject if the process is approved by the IRB. 
At the screening or first study visit, informed consent will be obtained and documented before any 
study procedures are performed. Subjects will receive a concise and focused presentation of key 
information about the clinical trial, verbally and with a written consent form. The key information 
about the purpose of the study, the procedures and experimental aspects of the study, study device, 
potential risks, benefits and discomforts, the expected duration of the subject’s participation in the 
trial, and alternative treatments and procedures that may be available to the subject. The 
explanation will be organized and presented in lay terminology and language that facilitates 
understanding why one might or might not want to participate. 
Subjects will receive an explanation that they will be compensated for their participation on a per 
visit basis, and medical treatments are available if device-related injury occurs, and, if so, what 
that treatment is, or where further information may be obtained. Subjects will be informed of the 
anticipated financial expenses, if any, to the subject for participating in the trial, as well as any 

 
Page 42 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
anticipated prorated payments, if any, to the subject for participating in the trial. They will be 
informed of whom to contact (e.g., the participating clinical site PI and the Sponsor) for answers 
to any questions relating to the research project. Information will also include the foreseeable 
circumstances and/or reasons under which the subject’s participation in the trial may be 
terminated. The subjects will be informed that participation is voluntary and that they are free to 
withdraw from the study for any reason at any time without penalty or loss of benefits to which 
the subject is otherwise entitled.  
Subjects will be informed that records identifying the subject will be kept confidential, and, to the 
extent permitted by the applicable laws and/or regulations, will not be made publicly available. If 
the results of the trial are published, the subject’s identity will remain confidential. Subjects will 
be informed, even if identifiers are removed, that information collected from this research and/or 
specimens may be used for secondary research, including the sharing of deidentified data.  
Subjects will be informed that the monitor(s), auditors(s), IRB, and Sponsor will be granted direct 
access to the subject’s original medical records for verification of clinical trial procedures and/or 
data without violating the confidentiality of the subject, to the extent permitted by the applicable 
laws and regulations, and that, by signing a written ICF, the subject is authorizing such access. 
ICFs will be IRB-approved, and subjects will be asked to read and review the consent form. 
Subjects must sign the ICF prior to starting any study procedures being done specifically for this 
trial. Once signed, a copy of the ICF will be given to the subject for their records. 
New information will be communicated by the participating clinical site PI to subjects who 
consent to participate in this trial in accordance with IRB requirements. The informed consent 
document will be updated, and subjects will be re-consented per IRB requirements, if necessary. 
 Confidentiality and Privacy 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover clinical information relating 
to subjects, test results of biological specimens and all other information generated during 
participation in the study. No identifiable information concerning subjects in the study will be 
released to any unauthorized third party. Subject confidentiality will be maintained when study 
results are published or discussed in conferences. 
The study monitor, other authorized representatives of the sponsor and representatives of the IRB 
may inspect all documents and records required to be maintained by the participating clinical site 
PI, including, but not limited to, screening, medical and laboratory results for the subjects in this 
study. The participating clinical site will permit access to such records. 
All source records, including electronic data, will be stored in secured systems in accordance with 
institutional policies and federal regulations. 
All study data and research specimens that leave the site (including any electronic transmission of 
data) will be identified only by a coded number that is linked to a subject through a code key 
maintained at the clinical site. Names or readily identifying information will not be released 
unless strictly required by law. 

Page 43 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
Clinical Monitoring 
Monitoring will be conducted during the conduct of the trial, and will include, but is not limited 
to, source document verification, review of regulatory files, device accountability records, e-
CRFs, ICFs, medical and laboratory reports, training records, and protocol and GCP compliance. 
The monitors will have access to all study related documents and will meet with appropriate 
clinical site staff to discuss any problems and outstanding issues. Visit findings and discussions 
will be documented.  Some monitoring visits may be conducted remotely. 
Quality System 
To ensure the reliability of study data, the clinical sites must maintain an appropriate quality 
system for the purposes of measuring, documenting and reporting study conduct, protocol 
adherence, human subjects’ protections, and reliability of the protocol-driven data collected 
independent of sponsor site monitoring. 
Data Collection and Management Responsibilities 
Data collection is the responsibility of the study staff at the participating clinical trial site under 
the supervision of the participating clinical site PI and the overall study PI. The participating 
clinical trial site PI must maintain complete and accurate source documentation. Clinical research 
data from source documentation, including, but not limited to, AEs/SAEs, concomitant 
medications, medical history, physical assessments, and clinical laboratory data, will be entered 
by the participating clinical site into eCRFs via a 21 CFR Part 11-compliant internet data entry 
system provided by the Sponsor’s delegated data coordinating and analysis clinical support 
organization. The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. AEs 
and concomitant medications will be coded according to the most current versions of MedDRA 
and WhoDrug, respectively. The data coordinating and analysis CRO will be responsible for data 
management, quality review, analysis, and reporting of the study data for this study. The study 
sponsor is responsible for review of data collection tools and processes, and review of data and 
reports. 
AEs will be coded according to the MedDRA dictionary version 23.0 or higher. 
Source Documents 
Source documents contain all information in original records (and certified copies of original 
records) of clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data should be attributable, legible, 
contemporaneous, original, accurate, and complete. Each participating clinical site will maintain 
appropriate medical and research records for this trial, in compliance with ICH GCP, regulatory, 
and institutional requirements. Data recorded in the e-CRF derived from source documents should 
be consistent with the data recorded on the source documents. 
Interview of subjects is sufficient for obtaining medical history. Solicitation of medical records 
from the subject’s primary care provider is not required. 
At the end of the study, a copy of all datasets, including annotated CRFs and data dictionary, will 
be provided to EmitBio Inc. 

Page 44 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
Study Record Retention 
Study-related records, including the regulatory file, study device accountability records, consent 
forms, subject source documents and electronic records, should be maintained for a period of 2 
years following the date a marketing application is approved for the investigational device for the 
indication for which it is being investigated; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and the Sponsor 
is notified. These documents should be retained for a longer period, however, if required by local 
policies or regulations. No records will be destroyed without the written consent of EmitBio™. 
Protocol Deviations 
A protocol deviation is any non-compliance with the clinical trial protocol, any process that is 
noted in the protocol and refers to details in the protocol or GCP requirements, or any critical 
study procedures with specific instructions in ancillary documents referenced in the protocol. 
The non-compliance may be either on the part of the subject, the participating clinical site PI, or 
the study site staff. Following a deviation(s), corrective actions should be developed by the site 
and implemented promptly. All individual protocol deviations will be addressed in study 
volunteer study records. 
It is the responsibility of the participating clinical site PI and study staff to use continuous 
vigilance to identify and report deviations within five working days of identification of the 
protocol deviation, or within five working days of the scheduled protocol-required activity. All 
deviations must be promptly reported to EmitBio Inc’s Senior Clinical Program Manager. 
Protocol deviations must be sent to the IRB of record. The participating clinical site PI and study 
staff are responsible for knowing and adhering to the IRB requirements. A completed copy of an 
approved Protocol Deviation Form must be maintained in the Regulatory File, as well as in the 
subject’s chart if the deviation is subject specific. 
Publication and Data Sharing Policy 
All study data and reports of study data are the property of the study sponsor. The sponsor may 
grant the PI the right to publish the results of this research in a scientific journal, conditional upon 
the review and concurrence of the sponsor.  
 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have 
such conflicts managed in a way that is appropriate to their participation in the design and conduct 
of this trial. EmitBio Inc requires that all study team members disclose any conflict of interest. 
Clinical Study sites are required to maintain a mechanism for the management of all reported 
dualities of interest.  

 
Page 45 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 Research Related Injuries 
For any potential research related injury, the participating clinical site PI or designee will assess 
the subject. Study staff will try to reduce, control and treat any complications from this trial. 
Immediate medical treatment may be provided by the participating clinical site, such as giving 
emergency medications to stop immediate allergic reactions. As needed, referrals to appropriate 
health care facilities will be provided to the subject. The participating clinical site PI should then 
determine if an injury occurred as a direct result of procedures or the device used in this trial. 
If it is determined by the participating clinical site PI that an injury occurred to a subject as a 
direct result of the procedures or device used in this trial, then referrals to appropriate health care 
facilities will be provided to the subject. No financial compensation will be provided to the subject 
by EmitBio Inc. or the participating clinical site for any injury suffered due to participation in 
clinical research. 
 
 

 
Page 46 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
 
CONFIDENTIAL 
 
12 APPENDIX 1:  RD-X19 USER INSTRUCTIONS 
 
 
Confidential. 
 
 
 

Page 47 of 47 
EmitBio, Inc. 
Version:  2.0 
EB-P12-01 
6 November 2020 
CONFIDENTIAL 
13 APPENDIX 2:  TOXICITY GRADING SCALES 
Available upon request. 

 
 
 
 
Clarification Memorandum #1 for: 
EB-P12-01 
 
A Phase I/II Randomized, Dose Escalation Study to 
Evaluate the Safety and Antiviral Activity of the RD- 
X19 Device in SARS-CoV-2 Infected Individuals 
with Uncomplicated COVID-19 
 
DATE: 
TO: 
 
FROM: 
SUBJECT: 
November 23, 2020 
 
 
  Beth Landis 
 
  Senior Clinical Project Manager 
 
  SymBio Inc. 
 
  Sponsor’s Chief Medical Officer (Dr. John G. McNeil, MD MPH PHD)  
 
  Clarification Memo# 1 to Protocol EB-P12-01, Version 
2.0 , 11/6/20 entitled, "A Phase I/II Randomized, Dose Escalation 
Study to Evaluate the Safety and Antiviral Activity of the RD-X19 
Device in SARS-CoV-2 Infected Individuals with Uncomplicated 
COVID-19" 
 
 
This clarification outlines the procedure for documenting emergent signs and symptoms 
of COVID-19 on Diary Cards vs Adverse Event source documents. 
 
1. Study subjects meeting enrollment criteria related to COVID-19 signs and symptoms 
are still in a phase of disease pathogenesis where additional COVID-19 signs and 
symptoms not present at screening may emerge. A timeframe of up to and including 
study day three will document new COVID-related signs and symptoms as 
associated with COVID-19 and documented as COVID-19 signs and symptoms with 
participant-assessed severity scores on diary cards. 
 
2. New signs and symptoms consistent with COVID-19 that first occur on or after 
study day 4 will be assessed and severity graded and documented as adverse 
events by site investigators on adverse event source documents. The assessing 
investigator will be responsible for using their best clinical judgment in assigning 
attribution of the adverse event. 
 
3. Kindly forward this Clarification Memorandum to Investigators, CRAs and other 
appropriate staff at the clinical sites. Sites should also forward a copy to their IRBs 
and maintain a copy with protocol documentation. 

Clarification Memorandum #2 for: 
EB-P12-01 
A Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety 
and Antiviral Activity of the RD- X19 Device in SARS-CoV-2 Infected 
Individuals with Uncomplicated COVID-19 
DATE: 
TO: 
FROM: 
SUBJECT: 
December 1, 2020 
EB-P12-01 Sites 
Sponsor’s Chief Scientific Officer (Nathan Stasko, PHD) 
Clarification Memo# 2 to Protocol EB-P12-01, Version 
2.0 , 11/6/20 entitled, "A Phase I/II Randomized, Dose Escalation 
Study to Evaluate the Safety and Antiviral Activity of the RD-X19 
Device in SARS-CoV-2 Infected Individuals with Uncomplicated 
COVID-19" 
This clarification outlines the sponsors decision to allow enrollment for up to a 20% 
overage of the proposed number of subjects.    
1. Up to 36 total subjects meeting enrollment criteria related to COVID-19 signs and
symptoms may be enrolled per each dose Cohort. This clarification is intended to
allow for enrollment of Hispanic subjects for at least 7 days post translation of all
study documents into Spanish that was approved and available on November 25th,
2020 for Cohort 1.

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 1 of 56 
STATISTICAL ANALYSIS PLAN 
 Protocol EB-P12-01 
Version 2.0 
January 25, 2021 
A Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and 
Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals 
with Uncomplicated COVID-19 
EmitBio Inc. 
Suite 470, 4222 Emperor Blvd 
Durham, NC 27703 
Approved By:    
______________________________ 
____________________ 
Ye Wang, PhD
Date 
Director of Statistics  
Symbio LLC  
______________________________ 
____________________ 
John McNeil, MD, MPH, PhD 
Date 
Chief Medical Officer  
EmitBio Inc. 
______________________________ 
____________________ 
Nathan Stasko, PhD  
Date 
Chief Scientific Officer  
EmitBio Inc. 
CONFIDENTIAL 
/s/ Ye Wang
01/25/2021
/s/ John McNeil
01/25/2021
/s/ Nathan Stasko
01/25/2021

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                          
SAP Version: 2.0 
Page 2 of 56 
 
Table of Contents 
1 
Purpose of Statistical Analysis Plan .......................................................................................... 3 
2 
Study Objectives ......................................................................................................................... 3 
3 
Study Design and Sample Size Determination ......................................................................... 3 
3.1 
Study Design ..................................................................................................................................................... 3 
3.2 
Sample Size Determination ............................................................................................................................... 4 
4 
Populations To Be Analyzed ...................................................................................................... 4 
5 
Planned Analyses ........................................................................................................................ 5 
5.1 
Methodological Considerations ........................................................................................................................ 5 
5.2 
Handling of Missing Data ................................................................................................................................. 5 
5.2.1 
Missing Efficacy Endpoints..................................................................................................................... 5 
5.2.2 
Missing or Incomplete Dates for Adverse Events and Concomitant Medications .................................. 5 
5.3 
Demographics and Baseline Characteristics ..................................................................................................... 6 
5.4 
Subject Accountability ...................................................................................................................................... 6 
5.5 
Efficacy Variables and Analyses ...................................................................................................................... 6 
5.5.1 
Analysis of Primary Efficacy Endpoint ................................................................................................... 7 
5.5.2 
Analysis of Secondary Efficacy Endpoints ............................................................................................. 7 
5.5.3 
Analysis of Exploratory Efficacy Endpoint ............................................................................................. 8 
5.6 
Safety and Tolerability Variables and Analyses ............................................................................................... 8 
5.6.1 
Adverse Events ........................................................................................................................................ 8 
5.6.2 
Vital Signs ............................................................................................................................................... 9 
5.6.3 
Methemoglobin ....................................................................................................................................... 9 
5.6.4 
Other Assessments .................................................................................................................................. 9 
6 
Tables and Listings ................................................................................................................... 10 
7 
Appendices ................................................................................................................................. 10 
7.1 
Study Schedule of Activities ........................................................................................................................... 10 
7.2 
List of Summary Tables, Data Listings and Figures ....................................................................................... 12 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                          
SAP Version: 2.0 
Page 3 of 56 
 
Statistical Analysis Plan 
1 
Purpose of Statistical Analysis Plan 
The purpose of the statistical analysis plan is to describe in detail all the data, statistical methods, 
and summary tables required to implement the statistical analysis of Clinical Study Protocol EB-
P12-01 (Section 10 in the study protocol version 2.0 (Amendment 1), dated November 06, 2020).  
2 
Study Objectives 
To assess the efficacy and safety of the RD-X19 device in SARS-CoV-2 infected individuals with 
outpatient COVID-19. 
3 
Study Design and Sample Size Determination 
3.1 
Study Design  
For the purpose of exploring the above objectives, the study will be conducted as a randomized, 
double-blind, sham-controlled dose escalation study in SARS-CoV-2 infected individuals with 
outpatient COVID-19 at two dosing schedules.  
 
This study plans to enroll into two treatment arms within two escalating dose cohorts:  
• Cohort 1: 128 J/cm2 total dose RD-X19, Sham  
(5 minutes per treatment, 2X/Day for a duration of 4 days)  
• Cohort 2: 224 J/cm2 total dose RD-X19, Sham  
(5 minutes treatment, 2X/Day for a duration of 7 days)  
  
 
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized 
to the RD-X19 treatment arm or the sham treatment arm within each cohort in a 2:1 ratio (20 
RD-X19 : 10 sham), according to a fixed schedule via a permuted block design and stratified by 
clinical site. Light will be administered twice daily locally to the mouth and throat only for four 
days for Cohort 1 and for seven days for Cohort 2.  
 
The clinic visits will occur at: 
- 
Visit 1 / Screening, Enrollment & Randomization 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                          
SAP Version: 2.0 
Page 4 of 56 
 
- 
Visit 2 / Day 2  
- 
Visit 3 / Day 3 
- 
Visit 4 / Day 5 (± 1 day) 
- 
Visit 5 / Day 8 (± 1 day) / Early Termination (ET) 
 
Assessments of treatment response will occur on study days 3 and 5, with a final determination 
of efficacy made on day 8 (inclusive). 
 
Efficacy will be evaluated through evaluation of viral load through quantitation of SARS-CoV-
2 mRNA by RT-qPCR and via quantitation of replication competent virus by viral titer. Severity 
of the symptoms of disease will also be aggregated to produce a composite COVID-19 severity 
score. Safety and tolerability assessments will include solicited and unsolicited adverse events 
(AEs), physical examinations, vital signs, and clinical laboratory tests. 
 
One unblinded interim analysis is planned upon completion of all subjects in Cohort 1. The 
results of the interim analysis will be reviewed by a safety monitoring team and a 
recommendation will be made to the sponsor on whether enrollment should proceed for the next 
cohort at the next planned dose or at a reduced dosing frequency (e.g. once daily). The study is 
designed to evaluate at least 2 dosing schedules, ascending, or descending based on safety of 
each previous cohort.  
3.2 
Sample Size Determination 
The study is hypothesis generating in nature. Hence, the sample size was selected for 
convenience.  
 
The target number of subjects randomized is 60 in total, and 30 per cohort (20 subjects to RD-
X19 and 10 subjects to sham).  
4 
Populations To Be Analyzed 
Three subject populations are defined as follows:  
(1) Safety: This population will include all subjects who receive at least 1 study treatment. 
The Safety Population will be used for analysis of safety and tolerability data. Subjects 
will be analyzed based on actual treatment received. 
(2) Intent-to-Treat (ITT): This population will include all randomized subjects who receive 
treatment and were not discontinued due to a significant abnormality from the baseline 
CMP and CBC tests.  This population will be used for all efficacy analyses as the primary 
population.  Subjects will be analyzed based on randomized treatment, regardless of the 
actual treatment received. 
(3) Per-Protocol Population (PP): This population will include subjects who complete the 
study and did not have a major protocol deviation (MPD).  The PP population will be used 
for supportive analysis of the efficacy endpoints.  MPDs are those that could have 
interfered with the administration of treatment or the precise evaluation of treatment 
efficacy.   
MPDs may include but will not be limited to the following:  
• 
Violation of inclusion/exclusion criteria;  
• 
Use of prohibited concomitant medications during the treatment period;  
• 
No Day 3 Visit;  

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 5 of 56 
•
Returned for Day 8 Visit outside the designated visit window;
•
Was not compliant with the dosing regimen.
All MPDs will be identified before the database lock and study unblinding for analysis. 
5 
Planned Analyses  
5.1 
Methodological Considerations 
General Conventions 
SAS software (version 9.4 or higher) will be used for all data analyses and tabulations. 
The study is not powered for hypothesis testing. P-values will be considered descriptive and will 
not be adjusted for multiplicity. 
Data for all investigational centers will be pooled for analysis. 
Unless specified elsewhere, baseline is defined as the last available measurement prior to 
administration of study drug. Change from baseline will be calculated as the post-baseline value 
minus the baseline value. 
Summary tables will include the data based upon the protocol scheduled time points. For 
subjects who are early discontinued from the study, all efficacy assessments captured at the ET 
visit will be assigned to the nearest protocol scheduled time point.  
Visit of Treatment Period 
Range* 
Target Day 
Visit 1 / Baseline (Day 1) 
Study Day = 1 
Day 1 
Visit 2 / Day 2 
Study Day = 2 
Day 2 
Visit 3 / Day 3 
Study Day = 3 
Day 3 
Visit 4 / Day 5 (± 1 day) 
Study Day 4 to 6 
Day 5 
Visit 5 / Day 8 (± 1 day) 
Study Day 7 to 9 
Day 8 
*Study day = date of visit - date of first treatment + 1
Descriptive statistics of continuous variables will include n, mean, standard deviation (SD), 
median, minimum and maximum. Generally, the minimum and maximum values will be 
presented to the same decimal precision as the raw values, the mean and median values to one 
more, and the SD, to two more decimal places than the raw values. Summaries for categorical 
data will include frequencies and percentages. Percentages will be presented to one decimal 
place. 
5.2 
Handling of Missing Data 
5.2.1 Missing Efficacy Endpoints 
Missing data will be replaced for the efficacy endpoint in the ITT analyses using the Last 
observation carried forward (LOCF) method. 
5.2.2 Missing or Incomplete Dates for Adverse Events and Concomitant Medications 
Adverse Events 
Handling of partial dates is only considered for the start date. An adverse event with a partial 
start date is considered treatment emergent if: 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 6 of 56 
- only the day is missing and the start month/year is the same or after the month/year of the
first treatment
- the day and month are missing and the start year is the same or greater than the year of the
first treatment date
- the start date is completely missing
Concomitant Medications 
Handling of partial dates is only considered for the stop date. A medication with a partial stop 
date is considered concomitant if: 
- only the day is missing and the stop month/year is the same or after the month/year of the first
treatment
- the day and month are missing and the stop year is the same or greater than the year of the
first treatment date
- the stop date is completely missing or the medication is ongoing.
5.3 
Demographics and Baseline Characteristics 
Demographics and baseline characteristics will be summarized descriptively for the Safety 
population.  
5.4 
Subject Accountability 
A summary of subject disposition will be provided for all subjects descriptively, including 
reason for discontinuation and analysis populations. 
5.5 
Efficacy Variables and Analyses 
All efficacy analyses will be performed for both the ITT and PP populations with results in ITT 
as primary and PP as supportive.  
Viral load (log base 10 copies/mL) and cycle threshold (Ct) data that are continuous in nature 
but may be reported as “undetermined” or “inconclusive” or “<LOQ”. All virology data will be 
included in the efficacy analysis except the samples with “Inconclusive” viral load quantitation 
and the samples with an “Undetermined” RNase P (RP) internal control Ct value.   
For analysis-qualified samples, results of “undetermined” and “<LOQ” will be handled as 
follows for data summary purpose: 
•
For viral load reported as “Undetermined”, value 1 will be used to calculate descriptive
statistics. This will support the need for logarithm transformation.
•
For viral load reported as “<LOQ”, value 5x101 will be used to calculate descriptive
statistics.
In conjuncture with above handling of the viral data scenarios, for purposes of this protocol, 
clearance of viral infection is defined as achievement of: [1] RP Ct ≥0, AND [2] Average N1 Ct 
≥32 or Average N1 Ct = “Undetermined”. 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                          
SAP Version: 2.0 
Page 7 of 56 
 
5.5.1 Analysis of Primary Efficacy Endpoint 
The primary efficacy endpoint is defined as time-weighted average (TWA) change in log10-
transformed viral load by RT-qPCR from baseline to Day 8, where TWA will be derived using 
the trapezoidal rule: 
 
Yi is the change from baseline in in log10-transformed viral load by RT-qPCR at Visit i, t is the 
actual study day at the specified timepoint, a is the baseline visit at Day 1, and b is the Day 8 
visit. 
At the final analysis, each dose of the RD-X19 device will be compared to sham using an 
Analysis of Covariance (ANCOVA) model with baseline viral load on log10 scale as a covariate 
and treatment group as an independent variable.  
An example of SAS code for the analysis is as follows: 
proc glm data=datain;  
  class trt;  
 model aval = trt base /ss3;  
  estimate '4x RD-X19 vs Sham' trt 1 0 -1; 
  estimate '7x RD-X19 vs Sham' trt 0 1 -1; 
  lsmeans trt /pdiff stderr cl; 
run;  
where AVAL denotes the variable to be analyzed, BASE denotes the covariate baseline value, 
and TRT denotes treatment group with values 1 for 4 Days RD-X19, 2 for 7 Days RD-X19, and 
3 for Sham. 
5.5.2 Analysis of Secondary Efficacy Endpoints 
The following 6 secondary efficacy endpoints will be summarized using descriptive statistics by 
visit, as appropriate: 
• 
log10-transformed Viral load as measured in saliva by RT-qPCR at each visit by 
RT-qPCR 
• 
proportion of subjects with ≥95% reduction in SARS-CoV-2 viral load by RT-
qPCR at each visit 
• 
time to clearance of viral infection in saliva via RT-qPCR 
• 
proportion of subjects demonstrating clearance of viral infection via RT-qPCR at 
Day 8/ET visit 
• 
COVID-19 composite severity score at each visit 
• 
time to alleviation of COVID-19 symptoms, defined as the number of hours from 
the first dose to the first time when all eight symptoms had been assessed by the 
subject as none (0) or mild (1) 
• 
time to sustained alleviation of COVID-19 symptoms, defined the number of 
hours from the first dose to the time when all eight symptoms had been assessed 
by the subject as none (0) or mild (1) and no single symptom reoccurs later at a 
level above mild (1).  

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 8 of 56 
Both time to alleviation of COVID-19 symptoms and time to sustained alleviation of COVID-
19 symptoms will be derived from self-assessment by study subjects and recorded on the 
subjects’ diary cards.  
For log10-transformed viral load data, geometric means will be computed by exponentiating 
(base 10) the group means of the log10-transformed viral load. Time-to-event variables will be 
evaluated using the Kaplan-Meier method and p-values for treatment comparison will be 
provided via log rank test. 
5.5.3 Analysis of Exploratory Efficacy Endpoint 
Exploratory efficacy endpoint includes log10-transformed viral load at each visit as measured 
by TCID50 for replication competent virus via both expelled saliva specimen and oropharyngeal 
swab collection methodologies. The sponsor will analyze the data collected for each biospecimen 
after the study is unblinded and provide details on the R&D test method and geometric means 
for inclusion in the complete study report. 
5.6 
Safety and Tolerability Variables and Analyses 
Safety and tolerability analyses will be performed for the Safety Population. All safety listings 
and tables will be stratified by treatment assignment. 
5.6.1 Adverse Events 
All adverse events (AEs) occurring during the study will be recorded and coded in the Medical 
Dictionary for Regulatory Activities (MedDRA), version 22.1 or higher. TEAEs are defined as 
AEs recorded after first application of the study treatment.   
Frequency and percent of subjects reporting TEAEs will be tabulated for each treatment by 
system organ class (SOC) and preferred terms (PT) for the following:  
-
all TEAEs
-
all TEAEs by severity
-
all TEAEs by relationship to study treatment
In the summaries of incidence (frequencies and percentages) of all TEAEs, subjects who report 
more than one event that are mapped to the same PT will be counted only once. In the summaries 
of incidence of TEAEs by severity and by relationship to study treatment, subjects who report 
more than one event that are mapped to the same PT will be counted only once under the 
strongest severity and relationship, accordingly. The composite of study subjects captured in this 
analysis will then be tabulated by what study day the ‘most severe’ observation was made. 
Tabulations will be generated for solicited AEs (reactogenicity) separate from unsolicited AEs. 
Numbers and percentages of illumination site reactions, as well as unsolicited AEs, will be 
tabulated for each study day 1 through 8 so daily AE point prevalence may be determined. 
Likewise, tabulate oropharyngeal assessment overall and for each study visit. 
Treatment-Emergent Serious Adverse Events (TESAEs) will be discussed within the clinical 
study report. TEAEs, TESAEs and TEAEs that led to treatment interruption or discontinuation 
will be presented in data listing. 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 9 of 56 
5.6.2 Vital Signs 
For each vital sign (systolic and diastolic blood pressure, heart rate, and oral temperature), actual 
values and change from baseline values will be summarized using descriptive statistics for each 
treatment group by visit. 
5.6.3 Methemoglobin 
Actual values of methemoglobin at baseline and Day 8/ET as well as change from baseline 
values will be summarized using descriptive statistics for each treatment group. 
5.6.4 Other Assessments 
Following assessment results will be presented in subject data listing: medical history, physical 
examination, clinical laboratory evaluations, concomitant medications. 
Interim Analysis 
Upon completion of all subjects in Cohort 1, an unblinded interim analysis will be conducted 
focusing on the following evaluations:  
•
Efficacy:
o
Geometric mean viral load as measured in saliva on day 1, 3, 5 and 8 by RT-
qPCR
o
Proportion of subjects demonstrating viral load reduction ≥95% on day 3, 5 and 8
by RT-qPCR.
o
Time to alleviation of COVID-19 signs and symptoms
o
Time to sustained alleviation of COVID-19 signs and symptoms
•
Safety:
o
All safety tabulations as listed in section 5.6.1 will be assessed as part of the interim
analysis.
o
Summary or Treatment Emergent Adverse Events including a review of listings to
monitor:
o
Number of study subjects experiencing any Serious Adverse Reaction (SAE).
o
Number of study subject experiencing treatment site reactions, including pain,
induration or erythema of the oropharyx or oral mucosa, including the uvula
and tongue.
o
Number of study subjects with any laboratory result that is out-of-range using
the testing laboratory’s institutional standards, including blood, urine and
methemoglobin measured by pulse oxymetry.
o
Number of subjects experiencing laryngospasm, bronchospasm or anaphylaxis
within 2 hours after use of the RD-X19 Device that is considered related to
RD-X19.
o
Number of subjects experiencing an allergic reaction such as generalized
urticaria (defined as occurring at three or more body parts) within 72 hours
after use of study treatment that is considered related to RD-X19.
o
Number of subjects experiencing Grade 3 TEAE, in the same SOC grouping
of PT, considered to be related to RD-X19.

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                          
SAP Version: 2.0 
Page 10 of 56 
 
As study subjects in cohort 1 are essentially a separate study, there is no prohibition to sponsor 
being unblinded for the interim analysis.  Cohort 1 subjects are not tied to cohort 2 in any way 
and unblinding data from cohort 1 has no operational or statistical implications for cohort 2 
assessment by sponsor.  Study site personnel may not be unblinded to cohort 1 as there is a 
reasonable possibility that this information could be the basis for bias in the assessment of cohort 
2. 
 
To meet above review interest, the following summary tables (treatment groups: 4 Days RD-
X19 vs. Sham) and by-subject data listings will be prepared for the interim analysis:  
 
Tables / Listing 
Description 
Population 
Efficacy 
 
 
Table 14.1.3 
Demographic and Baseline Characteristics 
Safety Population 
Cohort 1 
Table 14.2.1.1 
Time-Weighted Average Change in Log10-Transformed Viral 
Load by RT-qPCR from Baseline to Day 8 
ITT Population of 
Cohort 1 
Table 14.2.2.1 
Log10-Transformed Viral Load via RT-qPCR by Visit 
ITT Population of 
Cohort 1 
Table 14.2.2.3 
Proportion of Subjects with At Least 95% Reduction by Visit in 
SARS-Cov-2 Viral Load via RT-qPCR  
ITT Population of 
Cohort 1 
Table 14.2.5.1  
Time to Alleviation of COVID-19 Symptoms 
ITT Population of 
Cohort 1 
Table 14.2.5.2  
Time to Sustained Alleviation of COVID-19 Symptoms 
ITT Population of 
Cohort 1 
Safety 
 
 
Table 14.3.1.1 
Treatment-Emergent Adverse Events by System Organ Class and 
Preferred Term 
Safety Population 
of Cohort 1 
Table 14.3.1.2 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Severity 
Safety Population 
of Cohort 1 
Table 14.3.1.3 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Causality to Study Device 
Safety Population 
of Cohort 1 
Table 14.3.2 
Reactogenicity by Visit  
Safety Population 
of Cohort 1 
Table 14.3.3 
Oropharyngeal assessment by Visit  
Safety Population 
of Cohort 1 
Listing 16.2.7 
Adverse Events 
Cohort 1 subjects 
Listing 16.2.8.1  
Out-of-Range Results of Clinical Laboratory Tests 
Cohort 1 subjects 
Listing 16.2.9.1 
Reactogenecity Assessment 
Cohort 1 subjects 
Listing 16.2.9.2 
Oropharyngeal Assessment 
Cohort 1 subjects 
Listing 16.2.9.6  
Methemoglobin Measurement 
Cohort 1 subjects 
6 
Tables and Listings 
The following is an example of tables, listings and figures that will be included in the clinical study 
report. They may be modified as needed during the data analyses. 
7 
Appendices 
7.1 
Study Schedule of Activities 
The schedule of visits and procedures to be conducted at each visit are summarized in the Study 
Schedule of Activities. 
 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 11 of 56 
Study Procedures 
Screening, 
Enrollment & 
Randomization 
Follow-up Period 
(Visit Window) 
Study Days 
1 
2 
3 
5 
(-1 to +1) 
8/ET 
(-1 to +1) 
Informed Consent 
X 
COVID19 Screening & SARS-CoV-2 
Rapid Antigen Test*** 
X 
Medical History & Physical Examination 
X 
Changes since 
last visit only 
 Changes since 
last visit only 
Changes since 
last visit only 
X 
Oropharyngeal Assessment 
X* 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
X 
Urine Pregnancy Test 
X 
X 
Concomitant Medication History/New 
Baseline 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Changes since 
last visit only 
Comprehensive Metabolic Panel & CBC 
X 
X 
Vital Signs 
X 
X 
Methemoglobin 
X 
X 
Adverse Event Assessment / Reactogenicity 
Baseline 
X 
X 
X 
X 
Demographics, Inclusion / Exclusion 
Review 
X 
Diary Dispensation/Collection 
X 
X 
Treatment at Site 
X** 
X** 
X** 
Biospecimen collection for viral assays (3 
specimens)**** 
X 
X 
X 
X 
COVID-19 Severity Score 
X 
X 
Collect RD-X19 Device 
NA 
Cohort 1 
Cohort 2 
*On Day 1 to be evaluated 30 minutes after first illumination at site.
**Only one treatment will be done on site, other treatment will be done at home, i.e. if afternoon 
appointment, subject will complete morning treatment at home and afternoon treatment administered at the 
site.  For scheduling purposes, recommended interval between treatment is approximately 8 – 12 hours but 
not < 4 hours.  
***Subjects presenting at the time of screening that have tested positive via a SARS-CoV-2 rapid 
antigen test at or within the past 24 hours of the screening visit and can provide documentation 
confirming proper identification, the date of the test and testing location, positivity of the result, and 
name/identity of the assay used to generate the result, are also eligible for enrollment and the rapid 
antigen test does not have to be repeated at the site.  
**** At Baseline and days 3, 5, and 8, subjects will provide two saliva specimens and an 
oropharyngeal swab for virology endpoint assessments.  One saliva specimen will be collected, 
preserved, and shipped fresh to a central lab for assessment of SARS-CoV-2 mRNA via RT-qPCR.  
The second specimen and the oropharyngeal swab will be collected in  separate collection tubes, 
frozen, and stored at the site and shipped to a central lab at the end of each cohort.  

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 12 of 56 
7.2 
List of Summary Tables, Data Listings and Figures 
List of Summary Tables 
Number 
Description 
Analysis Set 
Source Listing(s) 
14.1 
Demographic and Baseline Data 
Summaries 
14.1.1 
Subject Final Study Disposition 
All Randomized 
Subjects 
16.2.1 
14.1.2 
Subject Analysis Population 
All Randomized 
Subjects 
16.2.1, 16.2.2.1 
14.1.3 
Demographic and Baseline Characteristics 
Safety Population 
16.2.4.1, 16.2.9.3 
14.2 
Efficacy Data Summary Tables 
14.2.1.1 
Time-Weighted Average Change in Log10-
Transformed Viral Load by RT-qPCR from 
Baseline to Day 8 
ITT Population 
16.2.6.4 
14.2.1.2 
Time-Weighted Average Change in Log10-
Transformed Viral Load by RT-qPCR from 
Baseline to Day 8 
PP Population 
16.2.6.4 
14.2.2.1 
Log10-Transformed Viral Load via RT-
qPCR by Visit 
ITT Population 
16.2.6.4 
14.2.2.2 
Log10-Transformed Viral Load via RT-
qPCR by Visit 
PP Population 
16.2.6.4 
14.2.2.3 
Proportion of Subjects with At Least 
95% Reduction by Visit in SARS-Cov-2 
Viral Load via RT-qPCR  
ITT & PP 
Populations 
16.2.6.3 
14.2.3 
Clearance of Viral Infection in Saliva 
via RT-qPCR 
ITT & PP 
Populations 
16.2.6.4 
14.2.4 
COVID-19 Composite Severity Score by Visit 
ITT & PP 
Populations 
16.2.6.1 
14.2.5.1 
Time to Alleviation of COVID-19 Symptoms 
ITT & PP 
Populations 
16.2.6.1.2, 
16.2.5.3 
14.2.5.2 
Time to Sustained Alleviation of COVID-19 
Symptoms 
ITT & PP 
Populations 
16.2.6.1.2, 
16.2.5.3 
14.3 
Safety Data Summaries 
14.3.1.1 
Treatment-Emergent Adverse Events by 
System Organ Class and Preferred Term 
Safety Population 
16.2.7 
14.3.1.2 
Treatment-Emergent Adverse Events by 
System Organ Class, Preferred Term and 
Severity 
Safety Population 
16.2.7 
14.3.1.3 
Treatment-Emergent Adverse Events by 
System Organ Class, Preferred Term and 
Causality to Study Device 
Safety Population 
16.2.7 
14.3.1.4 
Treatment-Emergent Adverse Events by 
System Organ Class, Preferred Term and 
Study Day of Most Severe Observation 
Safety Population 
16.2.7 
14.3.2 
Reactogenicity by Visit 
Safety Population 
16.2.9.1 
14.3.3 
Oropharyngeal Assessment by Visit 
Safety Population 
16.2.9.2 
14.3.4 
Vital Signs by Visit 
Safety Population 
16.2.9.3 
14.3.5 
Methemoglobin by Visit 
Safety Population 
16.2.9.6 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 13 of 56 
List of Data Listings 
Number 
Description 
16.2.1 
Subject Disposition 
16.2.2.1 
Protocol Deviations 
16.2.2.2 
Informed Consent and Eligibility Criteria 
16.2.2.3 
General Comments 
16.2.4.1 
Demographics 
16.2.4.2 
Medical/Surgical History 
16.2.5.1 
Subject Randomization, Dosing Diary and Study Device Dispensing at Visit 1/Day 1, 
and Illumination Treatment at Site 
16.2.5.2 
Treatment Record and Subject Diary Collection at End of Study 
16.2.5.3 
Treatment Application Log 
16.2.6.1.1 
COVID-19 Symptom Assessment and Severity Score 
16.2.6.1.2 
COVID-19 Symptom Assessment and Severity Score from Subject Diary 
16.2.6.2 
Clearance of COVID-19 Symptoms 
16.2.6.3 
Viral Load via Saliva Specimen and Oropharyngeal Swab Collection 
16.2.6.4 
Derived Clearance of Viral Infection and Time-Weighted Average Change from Baseline 
in Log10-Transformed Viral Load via RT-qPCR 
16.2.7 
Adverse Events 
16.2.8.1 
Out-of-Range Results of Clinical Laboratory Tests 
16.2.8.2 
Pregnancy Test (Female Subjects Only) 
16.2.9.1 
Reactogenicity Assessment 
16.2.9.2 
Oropharyngeal Assessment 
16.2.9.3 
Vital Signs 
16.2.9.4 
Physical Examination 
16.2.9.5 
Prior and Concomitant Medications 
16.2.9.6 
Methemoglobin Measurement 
List of Figures 
Number 
Description 
Analysis Set 
15.1.1 
Kaplan-Meier Plot of Time to Clearance of Viral Infection 
ITT Population 
15.1.2 
Kaplan-Meier Plot of Time to Clearance of Viral Infection 
PP Population 
15.2.1 
Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms 
ITT Population 
15.2.2 
Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms 
PP Population 
15.3.1 
Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 
Symptoms 
ITT Population 
15.3.2 
Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 
Symptoms 
PP Population 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
 
Page 14 of 56 
 
 
Summary Tables

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 15 of 56 
Table 14.1.1 – Subject Final Study Disposition 
Treatment Group 
Total 
 n (%) 
4 Days RD-X19 
n (%)     
7 Days RD-X19 
n (%)     
Sham 
n (%) 
Subjects Randomized 
XX 
XX 
XX 
XX 
Subjects Completed Study 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Subjects Discontinued 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Reason for Discontinuations: 
Withdrawal by Subject 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Adverse Event 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Medication Code Unblinded 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Lost to Follow-Up 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Pregnancy 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Physician Decision 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Failure to Meet Entry Criteria 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Other 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Source: Listing 16.2.1 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year. 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 16 of 56 
Table 14.1.2 – Subject Population 
Treatment Group 
Total 
 n (%) 
4 Days RD-X19 
n (%)     
7 Days RD-X19 
n (%)     
Sham 
n (%) 
Randomized 
XX 
XX 
XX 
XX 
Safety population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Exclusion from Safety population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
      Reason for exclusion from Safety: 
         No record of first dose 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Intent-to-Treat (ITT) population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Exclusion from ITT population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
      Reason for exclusion from ITT: 
No record of first dose 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Discontinued due to a significant abnormality from the baseline CMP and CBC 
tests 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Per-Protocol (PP) population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Exclusion from PP population 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
      Reason for exclusion from PP 
No record of first dose 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Discontinued due to a significant abnormality from the baseline CMP and CBC 
tests 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Inclusion/exclusion criteria violation 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
… 
Subjects with multiple exclusion reasons are presented under each category of Reason for Exclusion as appropriate.  
Source: Listing 16.2.1, 16.2.2.1 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year. 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 17 of 56 
 
Table 14.1.3 – Demographic and Baseline Characteristics for Safety Population 
 
 
Category 
Treatment Group 
Total 
4 Days RD-X19      
7 Days RD-X19      
Sham               
Age (Years) 
N  
XX 
XX 
XX 
XX 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
Median 
XX.X 
XX.X 
XX.X 
XX.X 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
Gender n (%) 
Male 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Female 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
Ethnicity n (%) 
Hispanic or Latino 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Not Hispanic or Latino 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Not Willing to Provide 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Race n (%) 
American-Indian or Alaska Native 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Asian 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Black or African-American 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Native Hawaiian or Other Pacific Islander 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
White or Caucasian 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
 
Other 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 XX (XX.X) 
Body Mass Index (kg/m2) 
N  
XX 
XX 
XX 
XX 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
Median 
XX.X 
XX.X 
XX.X 
XX.X 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
XX, XX 
Source: Listing 16.2.4.1, 16.2.9.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 18 of 56 
 
Table 14.2.1.1 – Time-Weighted Average Change in Log10-Transformed Viral Load by RT-qPCR from Baseline to Day 8 for Intent-to-Treat Population 
 
 
Statistics 
4 Days RD-X19        
7 Days RD-X19        
Sham 
TWA Change in Log10-Transformed Viral Load 
N  
XX 
XX 
XX 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
Median 
XX.X 
XX.X 
XX.X 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
 
LSM (SE) 
XX (XX.X) 
  XX (XX.X) 
 XX (XX.X) 
 
95% CI for LSM 
(XX.X, XX.X) 
  (XX.X, XX.X) 
  (XX.X, XX.X) 
 
RD-X19 vs. Sham 
 
 
 
 
    LSMD (SE) 
XX (XX.X) 
  XX (XX.X) 
 
 
    95% CI for LSMD 
(XX.X, XX.X) 
  (XX.X, XX.X) 
 
 
    P-value 
0.XXX 
  0.XXX 
  
Abbreviation: CI = Confidence Interval; GTM = Geometric Mean; LSM = Least Square Mean; LSMD = Least Square Mean Difference; SE = Standard Error 
Note 1: Missing data will be replaced for the efficacy endpoint in the ITT analyses using the Last observation carried forward (LOCF) method. 
Note 2: LSM, LSMD, 95% CI for LSMD, and p-values are based on an Analysis of Covariance (ANCOVA) model with baseline viral load on log10 scale as a 
covariate and treatment group as an independent variable.  
Source: Listing 16.2.6.4 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
Repeat Table 14.2.1.1 for the following: 
 
Table 14.2.1.2 – Time-Weighted Average Change in Log10-Transformed Viral Load by RT-qPCR from Baseline to Day 8 for Per-Protocol Population 
 (with Note 1 removed) 
 
 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 19 of 56 
Table 14.2.2.1 – Log10-Transformed Viral Load via RT-qPCR by Visit for Intent-to-Treat Population
Study Visit 
Statistics 
4 Days RD-X19 
(N=XX)         
7 Days RD-X19 
(N=XX)         
Sham 
(N=XX) 
Visit 1 /Day 1 
N 
XX 
XX 
XX 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Geometric Mean on Original Scale 
XX.X
XX.X
XX.X
Visit 3 /Day 3 
N 
XX
XX
XX
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Geometric Mean on Original Scale 
XX.X
XX.X
XX.X
Visit 4 /Day 5 
Visit 5 /Day 8 
Missing data will be replaced for the efficacy endpoint in the ITT analyses using the Last observation carried forward (LOCF) method. 
Note: Geometric Means are computed by exponentiating (base 10) the Means of the log10-transformed viral load. 
Source: Listing 16.2.6.4 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year. 
Repeat Table 14.2.2.1 for the following: 
Table 14.2.2.2 – Log10-Transformed Viral Load via RT-qPCR by Visit for Per-Protocol Population
(with footnote 1 removed) 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 20 of 56 
 
Table 14.2.2.3 – Proportion of Subjects with At Least 95% Reduction by Visit in SARS-Cov-2 Viral Load via RT-qPCR  
 
Population 
Study Visit 
Statistics 
4 Days RD-X19      
7 Days RD-X19      
Sham 
Intent-to-Treat 
Visit 3 /Day 3  
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Visit 4 /Day 5 
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Visit 5 /Day 8 
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
 
 
 
 
Per-Protocol 
Visit 3 /Day 3  
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Visit 4 /Day 5 
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Visit 5 /Day 8 
N  
XX 
XX 
XX 
 
 
n (%) Subjects with >=95% Reduction 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
Note: Missing data will be replaced for the efficacy endpoint in the ITT analyses using the Last observation carried forward (LOCF) method. 
Source: Listing 16.2.6.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 21 of 56 
 
Table 14.2.3 – Clearance of Viral Infection in Saliva via RT-qPCR 
 
Population 
Endpoint 
Statistics 
4 Days RD-X19      
7 Days RD-X19      
Sham 
Intent-to-Treat 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
P-value RX-X19 vs. Sham 
n (%)  
0.XXX 
XX (XX.X) 
0.XXX 
XX (XX.X) 
 
XX (XX.X) 
 
Per-Protocol 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
P-value RX-X19 vs. Shamn 
(%)  
0.XXX 
XX (XX.X) 
0.XXX 
XX (XX.X) 
 
XX (XX.X) 
Abbreviation: CI = Confidence Interval 
Subjects with clearance of viral infection at baseline are excluded from the analysis of time-to-clearance of viral infection. 
Note 1: Clearance of viral infection in saliva is defined as a negative test (Ct value ≥32) via RT-qPCR, i.e. achievement of [1] RP Ct =0, AND [2] Average N1 Ct =32 
or Average N1 Ct ='Undetermined'. Subjects who did not achieve clearance at the last assessment of the study are considered censored at the time of the last 
assessment.  
Note 2: Subjects who did not achieve clearance at the exit of study are considered censored. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.4, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
Figure 15.1.1 - Kaplan-Meier Plot of Time to Clearance of Viral Infection for Intent-to-Treat Population 
Figure 15.1.2 - Kaplan-Meier Plot of Time to Clearance of Viral Infection for Per-Protocol Population 
 
 

EmitBio Inc.      
Protocol: EB-P12-01     
SAP Version: 2.0 
Page 22 of 56 
Table 14.2.4 – COVID-19 Composite Severity Score by Visit 
Population 
Study Visit 
Category 
Statistics 
4 Days RD-X19      
7 Days RD-X19      
Sham 
Intent-to-Treat 
Visit 1 /Day 1 (Baseline) 
Actual Value 
N 
XX 
XX 
XX 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Visit 5 /Day 8 
Actual Value 
N 
XX 
XX 
XX 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Change from Baseline 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Per-Protocol 
Visit 1 /Day 1 (Baseline) 
Actual Value 
N 
XX 
XX 
XX 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Visit 5 /Day 8 
Actual Value 
N 
XX 
XX 
XX 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Change from Baseline 
Mean ± SD 
XX.X ± XX.X
XX.X ± XX.X
XX.X ± XX.X
Median 
XX.X
XX.X
XX.X
Min, Max 
XX, XX
XX, XX
XX, XX
Note: Missing data will be replaced for the efficacy endpoint in the ITT analyses using the Last observation carried forward (LOCF) method. 
Source: Listing 16.2.6.1 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 23 of 56 
 
Table 14.2.5.1 – Time to Alleviation of COVID-19 Symptoms 
 
Population 
Statistics 
4 Days RD-X19             
7 Days RD-X19  
Sham 
Intent-to-Treat 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
 
Per-Protocol 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Abbreviation: CI = Confidence Interval 
Note 1: Alleviation of COVID-19 symptoms is defined as all eight symptoms assessed by the subject as none (0) or mild (1).  
Note 2: Time to alleviation is calculated as the number of hours from the first dose to the time of the first occurrence of symptoms alleviation. Subjects who did not 
achieve alleviation at the last assessment of study are considered censored at the time of the last assessment. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.1.2, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
Figure 15.2.1 - Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms for Intent-to-Treat Population 
Figure 15.2.2 - Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms for Per-Protocol Population 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 24 of 56 
 
 
Table 14.2.5.2 – Time to Sustained Alleviation of COVID-19 Symptoms 
 
Population 
Statistics 
4 Days RD-X19             
7 Days RD-X19             
Sham 
Intent-to-Treat 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Per-Protocol 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Abbreviation: CI = Confidence Interval 
Note 1: Sustained alleviation of COVID-19 symptoms is defined as all eight symptoms assessed by the subject as none (0) or mild (1) AND no single symptom reoccurs 
later at a level above mild (1). 
Note 2: Time to sustained alleviation is calculated as the number of hours from the first dose to the time of the occurrence of sustained symptoms alleviation. Subjects 
who did not 
achieve sustained alleviation at the last assessment of the study are considered censored at the time of the last assessment. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.1.2, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
Figure 15.3.1 - Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 Symptoms for Intent-to-Treat Population 
Figure 15.3.2 - Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 Symptoms for Per-Protocol Population 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 25 of 56 
 
Table 14.3.1.1 - Treatment-Emergent Adverse Events by System Organ Class and Preferred Term for Safety Population 
 
System Organ Class  
  Preferred Term 
4 Days RD-X19  
(N=XX)     
n (%)                 
7 Days RD-X19  
(N=XX)      
n (%)                 
Sham 
(N=XX) 
n (%) 
Subjects Reporting at Least One Adverse Event 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
System Organ Class #1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
 
 
 
 
 
 
System Organ Class #2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
 
 
 
 
 
 
Counts reflect numbers of subjects reporting one or more TEAE that map to the MedDRA system organ class/preferred term. At each level of summarization 
(system organ class or preferred term), subjects reporting more than one TEAE are counted only once. 
Source: Listing 16.2.7 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
  
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 26 of 56 
 
Table 14.3.1.2 - Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Severity for Safety Population 
 
System Organ Class  
  Preferred Term 
Severity 
4 Days RD-X19  
(N=XX)     
n (%)               
7 Days RD-X19  
(N=XX)      
n (%)               
Sham 
(N=XX) 
n (%) 
Subjects Reporting at Least One Adverse Event 
Mild 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Moderate 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Severe 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
System Organ Class #1 
Mild 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Moderate 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Severe 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #1 
Mild 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Moderate 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
Severe 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
 
 
… 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
Counts reflect numbers of subjects reporting one or more TEAE that map to the MedDRA system organ class/preferred term. At each level of summarization 
(system organ class or preferred term), subjects reporting more than one TEAE are counted only once (under the greatest reported severity). 
Source: Listing 16.2.7 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 27 of 56 
 
Table 14.3.1.3 - Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Causality to Study Device for Safety Population 
 
System Organ Class  
  Preferred Term 
Causality 
4 Days RD-X19  
(N=XX)     
n (%)               
7 Days RD-X19  
(N=XX)      
n (%)               
Sham 
(N=XX) 
n (%) 
Subjects Reporting at Least One Adverse Event 
Not Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
System Organ Class #1 
Not Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Preferred Term #1 
Not Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Related 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
Counts reflect numbers of subjects reporting one or more TEAE that map to the MedDRA system organ class/preferred term. At each level of summarization 
(system organ class or preferred term), subjects reporting more than one TEAE are counted only once (under the greatest reported causality). 
Source: Listing 16.2.7 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 28 of 56 
 
Table 14.3.1.4 –Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Study Day of Most Severe Observation for Safety Population 
 
System Organ Class  
  Preferred Term 
Study Day* 
4 Days RD-X19  
(N=XX)     
n (%)               
7 Days RD-X19  
(N=XX)      
n (%)               
Sham 
(N=XX) 
n (%) 
Subjects Reporting at Least One Adverse Event 
Day 1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Day 2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
 
 
 
 
 
 
System Organ Class #1 
Day 1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Day 2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
… 
 
 
 
 
 
 
 
Preferred Term #1 
Day 1 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Day 2 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
… 
… 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
*Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. For the summary, Study Day is the day number when the most severe 
observation was made of an event. 
Counts reflect numbers of subjects reporting one or more TEAE that map to the MedDRA system organ class/preferred term. At each level of summarization 
(system organ class or preferred term), subjects reporting more than one TEAE are counted only once under the earliest Study Day when the event of greatest 
severity was reported. 
Source: Listing 16.2.7 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 29 of 56 
 
Table 14.3.2 – Reactogenicity by Visit for Safety Population 
 
Study Visit 
Category 
4 Days RD-X19  
n (%)            
7 Days RD-X19  
n (%)            
Sham 
n (%) 
Visit 1 /Day 1  
N 
XX  
  XX  
XX  
n (%) subject with illumination site pain 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with illumination site erythema 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with illumination site Edema/Induration 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with other pain, redness, swelling, or lesion of the oral mucosa 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Visit 2 /Day 2 
N 
XX  
  XX  
XX  
n (%) subject with illumination site pain 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with illumination site erythema 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with illumination site Edema/Induration 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
n (%) subject with other pain, redness, swelling, or lesion of the oral mucosa 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Visit 3 /Day 3 
… 
 
 
 
 
 
 
Visit 4 /Day 5 
… 
 
 
 
 
 
 
Visit 5 /Day 8/ET 
… 
 
 
 
 
 
 
 
 
 
Source: Listing 16.2.9.1 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 30 of 56 
 
Table 14.3.3 – Oropharyngeal Assessment by Visit for Safety Population 
 
Study Visit 
Category 
4 Days RD-X19  
n (%)                  
7 Days RD-X19  
n (%)                  
Sham 
n (%) 
Overall* 
N 
XX 
  XX  
XX  
Normal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Abnormal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Visit 1 /Day 1 
N 
XX 
  XX  
XX  
Normal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Abnormal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Visit 2 /Day 2 
N 
XX 
  XX  
XX  
Normal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
 
Abnormal 
XX (XX.X) 
  XX (XX.X) 
XX (XX.X) 
Visit 3 /Day 3 
… 
 
 
 
 
 
 
 
Visit 4 /Day 5 
… 
 
 
 
 
 
 
 
Visit 5 /Day 8/ET 
… 
 
 
 
 
 
 
 
 
 
*For Overall, Normal category includes subjects with a normal result for all visits; Abnormal category includes subjects with an abnormal result at any visit. 
Source: Listing 16.2.9.2 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 31 of 56 
 
Table 14.3.4 – Vital Signs by Visit for Safety Population 
 
Vital Sign 
Study Visit 
Category 
Statistics 
4 Days RD-X19  
(N=XX)          
7 Days RD-X19  
(N=XX)          
Sham 
(N=XX) 
 Systolic Blood Pressure 
(mmHg) 
Visit 1 /Day 1 (Baseline)  Actual Value 
N  
XX 
XX 
XX 
 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
 
Visit 5 /Day 8/ET  
Actual Value 
N  
XX 
XX 
XX 
 
 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
 
 
Change from Baseline 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
Diastolic Blood Pressure 
(mmHg) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heart Rate (beats/min) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Temperature (F) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Respiratory (breaths/min) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing 16.2.9.3  
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 32 of 56 
 
Table 14.3.5 – Methemolgobin by Visit for Safety Population 
 
Study Visit 
Category 
Statistics 
4 Days RD-X19  
(N=XX)            
7 Days RD-X19  
(N=XX)            
Sham 
(N=XX) 
Visit 1 /Day 1 (Baseline)  
Actual Value 
N  
XX 
XX 
XX 
 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
Visit 5 /Day 8/ET  
Actual Value 
N  
XX 
XX 
XX 
 
 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
 
Change from Baseline 
Mean ± SD 
XX.X ± XX.X 
XX.X ± XX.X 
XX.X ± XX.X 
 
 
Median 
XX.X 
XX.X 
XX.X 
 
 
Min, Max 
XX, XX 
XX, XX 
XX, XX 
Source: Listing 16.2.9.6  
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 33 of 56 
 
 
Data Listings 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 34 of 56 
 
Listing 16.2.1 - Subject Disposition 
 
Subject 
Cohort 
Safety 
Population 
ITT  
Population 
PP  
Population 
Date of  
First Treatment 
Study Exit Date 
(Study Day) 
 
Completed 
Study? 
Primary Reason for Study Discontinuation 
Treatment:  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
Abbreviations: ITT, Intent-to-Treat; PP, Per-Protocol 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 35 of 56 
 
Listing 16.2.2.1 - Protocol Deviations 
 
Subject 
Cohort 
Major (Significant) Protocol Deviation? 
Description of Deviation 
 
 
Treatment:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Major (Significant) protocol deviations are those that exclude subjects from the per-protocol analysis. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 36 of 56 
 
Listing 16.2.2.2 - Informed Consent and Eligibility Criteria 
 
Subject 
Cohort 
Date of Informed 
Consent 
SARS-CoV-2 Rapid Antigen Test 
 
Baseline/Randomization 
Nasal swab collected 
and analyzed? 
Result of Antigen Test 
Subject met all 
Entry Criteria? 
If No, Criterion Not Met 
Treatment:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 37 of 56 
 
Listing 16.2.2.3 - General Comments 
 
Subject  
 
Cohort 
Date of Comment 
eCRF Form/Module 
Comment 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 38 of 56 
 
Listing 16.2.4.1 - Demographics 
 
Subject 
Cohort 
Date of Birth 
Age 
Sex 
 
Ethnicity 
Race 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is calculated relative to date of informed consent. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 39 of 56 
 
Listing 16.2.4.2 - Medical/Surgical History 
 
Subject 
Cohort 
Subject had medical or 
surgical history? 
Condition or Procedure 
Onset Date 
Stop Date 
Concomitant 
medications? 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 40 of 56 
 
Listing 16.2.5.1 - Subject Randomization, Dosing Diary and Study Device Dispensing at Visit 1/Day 1, and Illumination Treatment at Site 
 
Subject 
Cohort 
Randomization  
Number 
Date of 
Randomization 
Dosing instructions reviewed and 
dosing diary dispensed? 
Investigational device 
dispensed to the subject? 
Initials of 
Dispenser 
Illumination treatment performed on site 
under supervision? 
Visit 1  
/Day 1 
Visit 2  
/Day 2 
Visit 3 
/Day 3 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 41 of 56 
 
Listing 16.2.5.2 – Treatment Record and Subject Diary Collection at End of Study 
 
Subject 
Cohort 
Subject applied at least one 
treatment? 
Total Illumination  
Treatments 
Total Treatments 
Missed 
Subject diary 
collected? 
Investigational device 
collected? 
Initials of 
Collector 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 42 of 56 
 
Listing 16.2.5.3 – Treatment Application Log 
 
Subject 
Cohort 
Dose Number 
Date of Dose 
Time of Dose 
Missed Dose 
Dose Not Applicable 
Unknown 
Treatment:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 43 of 56 
 
Listing 16.2.6.1.1 – COVID-19 Symptom Assessment and Severity Score 
 
Subject 
Cohort 
Visit 
Assessment  
Cough 
Sore  
Throat 
Nasal 
Congestion Headache 
Chills/ 
Sweats 
Muscle or 
Joint pain 
Fatigue 
Nausea 
Fever 
(F) 
COVID-19  
Severity Score 
Study 
Day 
Date:Time  
Treatment:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COVID-19 Symptom: 0=None, 1=Mild, 2=Moderate, 3=Severe. Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
Note: Assessment at a visit was based on symptoms the subject reports as occurring within the past 3 days of that visit. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 44 of 56 
 
Listing 16.2.6.1.2- COVID-19 Symptom Assessment and Severity Score from Subject Diary 
 
 
Assessment 
 
Site-Subject Cohort 
Not 
Done Day 
Study 
Day 
Date:Time 
Cough 
Sore 
Throat 
Nasal 
Congestion Headache 
Chills/ 
Sweats 
Muscle or 
Joint pain Fatigue Nausea 
Fever 
(F) 
COVID-19 
Severity 
Score 
Treatment:  
xxxx 
x 
 
Day 1-
Assessment 1 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 1-
Assessment 2 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 2-
Assessment 1 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COVID-19 Symptom: 0=None, 1=Mild, 2=Moderate, 3=Severe. Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
Note: Assessment at a visit was based on symptoms the subject reports as occurring within the past 3 days of that visit. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 45 of 56 
 
Listing 16.2.6.2 – Clearance of COVID-19 Symptoms 
 
Subject 
Cohort 
Has there been a timepoint/day that ALL of the subject's Covid-19 
symptom assessment scores reached 0 and/or 1? 
Date (Study Day) 
Time 
Treatment:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 46 of 56 
 
Listing 16.2.6.3 – Viral Load via Saliva Specimen and Oropharyngeal Swab Collection 
 
Subject  
Cohort 
Type of 
Biospecimen 
Visit 
Sample Received 
Test Date 
(Study Day) 
Test Result  
Average  
N1 Ct 
RP Ct 
Viral Load Quantitation 
(copies/mL) 
Date 
(Study Day) 
Time 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 47 of 56 
 
Listing 16.2.6.4 – Derived Clearance of Viral Infection and Time-Weighted Average Change from Baseline in Log10-Transformed Viral Load via RT-qPCR 
 
Subject Cohort 
Analysis 
Clearance of Viral Infection (Study Day) 
 
Change from Baseline in Log10-Transformed Vital 
Load (Study Day) 
TWA Change from  
Day 1 to Day 8 
Visit 2 /Day 2 
Visit 3 /Day 3  
Visit 4 /Day 5 
Visit 5 /Day 8 
 Visit 3 /Day 3  
Visit 4 /Day 5 
Visit 5 /Day 8 
Treatment: 
 
 
 
 
 
 
 
 
ITT 
No (2) 
No (3) 
No (5) 
No (9) 
 
xx.x (3) 
xx.x (5) 
xx.x (9) 
xx.x 
 
PP 
No (2) 
No (3) 
 
No (9) 
xx.x (3) 
 
xx.x (9) 
xx.x 
 
 
 
 
Abbreviation: ITT = Intent-to-Treat, PP = Per-Protocol, TWA = Time-Weighted Average, LOCF = Last observation carried forward 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
For the ITT analysis, missing viral load will be imputed using the LOCF method. 
Note 1: Clearance of viral infection is defined, based on viral load via RT-qPCR, as achievement of: [1] RP Ct ≥0, AND [2] Average N1 Ct ≥32 or Average N1 Ct = “Undetermined”. 
Note 2: TWA Change from Day 1 to Day 8 is calculated using the trapezoidal rule.  
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 48 of 56 
 
Listing 16.2.7 - Adverse Events 
 
Subject 
 
Cohort 
AE  
No. 
System Organ Class / 
Preferred Term / 
Event Name 
Occurred prior 
to first dose? 
 
Start Date 
(Study Day) 
 
Stop Date 
(Study Day) 
 
 
Serious 
AE? 
Intensity 
Causality  
to Study Device 
Action  
Taken  
Outcome 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Adverse events coded in MedDRA, version xx.x  
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment while Day -1 is the day prior to first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 49 of 56 
 
Listing 16.2.8.1 – Out-of-Range Results of Clinical Laboratory Tests 
 
Subject 
Cohort 
 
Visit 
Lab Panel 
Test Name 
Result 
Flag 
Out of Range: NCS or CS 
Treatment: 
 
Abbreviation: CS = clinically significant, NCS = not clinically significant 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 50 of 56 
 
Listing 16.2.8.2 - Pregnancy Test (Female Subjects Only) 
 
Subject 
Cohort 
 
Visit 
Pregnancy 
Test Done? 
If not done, subject is not of 
childbearing potential due to 
Date of Test  
(Study Day) 
 
Result 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 51 of 56 
 
Listing 16.2.9.1 - Reactogenicity Assessment 
 
Subject 
Cohort 
Visit 
Illumination Site Pain? 
Illumination Site Erythema?  
Illumination Site Edema/ 
Induration? 
Other pain, redness, swelling, or 
lesion of the oral mucosa? 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 52 of 56 
 
Listing 16.2.9.2 - Oropharyngeal Assessment 
 
Subject 
 
Cohort 
Visit 
Oropharyngeal Assessment 
performed? 
Any changes 
since previous visit?  
Assessment Result  
Description of Abnormality 
Treatment: 
 
 
 
 
 
 
 
 
                                                                                       
    
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 53 of 56 
 
Listing 16.2.9.3 - Vital Signs 
 
Subject Cohort 
Visit 
Height 
(in) 
Weight 
(lb) 
Body Mass Index 
(kg/m2) 
Systolic Blood Pressure  
(mmHg) 
Diastolic Blood Pressure 
(mmHg) 
Heart Rate 
(beats/min) 
Respiratory Rate 
(breaths/min) 
Temperature 
(F) 
Treatment: 
 
 
 
 
 
 
 
XX /NCS 
 
XXX /NCS 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
For out-of-range results, CS = clinically significant, NCS = not clinically significant. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 54 of 56 
 
Listing 16.2.9.4 - Physical Examination 
 
Subject Cohort 
Visit 
PE  
Performed? 
Subject requires a 
targeted PE? 
Test Name 
Description of Abnormality 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 55 of 56 
 
Listing 16.2.9.5 - Prior and Concomitant Medications 
 
Subject 
Cohort 
WHO Class / 
WHO Drug Name / 
Medication Name 
 
Start Date 
(Study Day) 
 
End Date 
(Study Day) 
Dose 
Unit 
Route 
Frequency Indication 
Treatment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ATC = anatomic therapeutic chemical; WHODDE, World Health Organization Drug Dictionary Enhanced 
Medications are coded to ATC class and drug names using the WHODDE, version xxxxx. 
Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment while Day -1 is the day prior to first treatment. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
Programming Note:  
• 
If specifications for indications are reported as an AE or MH #, merge with AE/MH data to present the actual reported event as the specification. 
• 
When creating WHO Class, utilize ATC level 4 drug class; utilize level 3 term if level 4 is missing and level 2 if both level 3 and level 4 are missing in the dataset 
 
 
  
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Version: 2.0 
Page 56 of 56 
 
Listing 16.2.9.6 - Methemoglobin Measurement 
 
Subject 
Cohort 
Visit 
Methemoglobin measured? 
Methemoglobin Result (Percent) 
Treatment: 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                
SAP Amendment #1 
 
Page 1 of 11 
 
Statistical Analysis Plan Amendment #1  
 
 
Protocol No.:   
 
EB-P12-01 
 
Title:  
A Phase I/II Randomized, Dose Escalation Study to 
Evaluate the Safety and Antiviral Activity of the RD-
X19 Device in SARS-CoV-2 Infected Individuals with 
Uncomplicated COVID-19 
Previous SAP (v1.0) Date:  
December 17, 2020 
 
Amendment 01 Date:  
January 25, 2021 
 
Sponsor:  
 
 
EmitBio Inc.  
Suite 470, 4222 Emperor Blvd 
Durham, NC 27703 
 
Amendments:  
 
Per sponsor request, diary of COVID-19 symptom assessments have been added 
to the database. Time to alleviation of COVID-19 symptoms should be derived 
based on the diary entries. Time to sustained alleviation is added to the list of 
secondary efficacy endpoints. For all time-to-event variables, Kaplan-Meier plots 
and log rank p-values for treatment comparisons will be provided. Content of 
interim analysis is adjusted. 
 
1. Original Text and Location 
5.5.2 Analysis of Secondary Efficacy Endpoints  
The following 6 secondary efficacy endpoints will be summarized using 
descriptive statistics by visit, as appropriate: 
• 
log10-transformed Viral load as measured in saliva by RT-qPCR at each 
visit by RT-qPCR 
• 
proportion of subjects with ≥95% reduction in SARS-CoV-2 viral load by 
RT-qPCR at each visit 
• 
time to clearance of viral infection in saliva via RT-qPCR 
• 
proportion of subjects demonstrating clearance of viral infection via RT-
qPCR at Day 8/ET visit 
• 
COVID-19 composite severity score at each visit 
• 
time to alleviation of COVID-19 symptoms, defined as the time when all 
eight symptoms had been assessed by the subject as none (0) or mild (1).  
For log10-transformed viral load data, geometric means will be computed by 
exponentiating (base 10) the group means of the log10-transformed viral load. 
Time-to-event variables will be evaluated using the Kaplan-Meier method. 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                
SAP Amendment #1 
 
Page 2 of 11 
Revised Text and Location 
5.5.2 Analysis of Secondary Efficacy Endpoints  
The following 7 secondary efficacy endpoints will be summarized using 
descriptive statistics by visit, as appropriate: 
• 
log10-transformed Viral load as measured in saliva by RT-qPCR at each 
visit by RT-qPCR 
• 
proportion of subjects with ≥95% reduction in SARS-CoV-2 viral load by 
RT-qPCR at each visit 
• 
time to clearance of viral infection in saliva via RT-qPCR 
• 
proportion of subjects demonstrating clearance of viral infection via RT-
qPCR at Day 8/ET visit 
• 
COVID-19 composite severity score at each visit 
• 
time to alleviation of COVID-19 symptoms, defined as the number of 
hours from the first dose to the first time when all eight symptoms had 
been assessed by the subject as none (0) or mild (1) 
• 
time to sustained alleviation of COVID-19 symptoms, defined the number 
of hours from the first dose to the time when all eight symptoms had been 
assessed by the subject as none (0) or mild (1) and no single symptom 
reoccurs later at a level above mild (1).  
 
Both time to alleviation of COVID-19 symptoms and time to sustained alleviation 
of COVID-19 symptoms will be derived from self-assessment by study subjects 
and recorded on the subjects’ diary cards.  
 
For log10-transformed viral load data, geometric means will be computed by 
exponentiating (base 10) the group means of the log10-transformed viral load.  
Time-to-event variables will be evaluated using the Kaplan-Meier method and p-
values for treatment comparison will be provided via log rank test. 
 
2. Original Text and Location 
 
Interim Analysis 
Upon completion of all subjects in Cohort 1, an unblinded interim analysis will be 
conducted focusing on the following evaluations:  
 
• Efficacy:  
o Geometric mean viral load as measured in saliva on day 1, 3, 5 and 8 
by RT-qPCR  
o Proportion of subjects demonstrating viral load reduction ≥95% on day 
3, 5 and 8 by RT-qPCR.  
  
• Safety:  
o All safety tabulations as listed in section 5.6.1 will be assessed as part of 
the interim analysis. 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                
SAP Amendment #1 
 
Page 3 of 11 
o Summary or Treatment Emergent Adverse Events including a review of 
listings to monitor: 
o Number of subjects experiencing laryngospasm, bronchospasm or 
anaphylaxis within 2 hours after use of the RD-X19 Device that is 
considered related to RD-X19.  
o Number of subjects experiencing an allergic reaction such as 
generalized urticaria (defined as occurring at three or more body 
parts) within 72 hours after use of study treatment that is 
considered related to RD-X19.  
o Number of subjects experiencing SAE or Grade 3 AE, in the same 
SOC grouping of PT, considered to be related to RD-X19.  
 
As study subjects in cohort 1 are essentially a separate study, there is no prohibition 
to sponsor being unblinded for the interim analysis.  Cohort 1 subjects are not tied 
to cohort 2 in any way and unblinding data from cohort 1 has no operational or 
statistical implications for cohort 2 assessment by sponsor.  Study site personnel 
may not be unblinded to cohort 1 as there is a reasonable possibility that this 
information could be the basis for bias in the assessment of cohort 2. 
 
To meet above review interest, the following summary tables (treatment groups: 4 
Days RD-X19 vs. Sham) and by-subject data listings will be prepared for the 
interim analysis:  
 
Tables / Listing 
Description 
Population 
Efficacy 
 
 
Table 14.2.2.1 
Log10-Transformed Viral Load via RT-qPCR by Visit 
ITT Population of 
Cohort 1 
Table 14.2.2.3 
Proportion of Subjects with At Least 95% Reduction by Visit in 
SARS-Cov-2 Viral Load via RT-qPCR  
ITT Population of 
Cohort 1 
Safety 
 
 
Table 14.3.1.1 
Treatment-Emergent Adverse Events by System Organ Class and 
Preferred Term 
Safety Population 
of Cohort 1 
Table 14.3.1.2 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Severity 
Safety Population 
of Cohort 1 
Table 14.3.1.3 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Causality to Study Device 
Safety Population 
of Cohort 1 
Table 14.3.2 
Reactogenicity by Visit  
Safety Population 
of Cohort 1 
Table 14.3.3 
Oropharyngeal assessment by Visit  
Safety Population 
of Cohort 1 
Listing 16.2.7 
Adverse Events 
Cohort 1 subjects 
Listing 16.2.9.1 
Reactogenecity Assessment 
Cohort 1 subjects 
Listing 16.2.9.2 
Oropharyngeal Assessment 
Cohort 1 subjects 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                
SAP Amendment #1 
 
Page 4 of 11 
Revised Text and Location 
 
Interim Analysis 
Upon completion of all subjects in Cohort 1, an unblinded interim analysis will be 
conducted focusing on the following evaluations:  
 
• Efficacy:  
o Geometric mean viral load as measured in saliva on day 1, 3, 5 and 8 
by RT-qPCR  
o Proportion of subjects demonstrating viral load reduction ≥95% on day 
3, 5 and 8 by RT-qPCR.  
o Time to alleviation of COVID-19 signs and symptoms  
o Time to sustained alleviation of COVID-19 signs and symptoms 
 
• Safety:  
o All safety tabulations as listed in section 5.6.1 will be assessed as part of 
the interim analysis. 
o Summary or Treatment Emergent Adverse Events including a review of 
listings to monitor: 
o Number of study subjects experiencing any Serious Adverse 
Reaction (SAE). 
o Number of study subject experiencing treatment site reactions, 
including pain, induration or erythema of the oropharyx or oral 
mucosa, including the uvula and tongue. 
o Number of study subjects with any laboratory result that is out-of-
range using the testing laboratory’s institutional standards, 
including blood, urine and methemoglobin measured by pulse 
oxymetry. 
o Number of subjects experiencing laryngospasm, bronchospasm or 
anaphylaxis within 2 hours after use of the RD-X19 Device that is 
considered related to RD-X19.  
o Number of subjects experiencing an allergic reaction such as 
generalized urticaria (defined as occurring at three or more body 
parts) within 72 hours after use of study treatment that is 
considered related to RD-X19.  
o Number of subjects experiencing Grade 3 TEAE, in the same SOC 
grouping of PT, considered to be related to RD-X19.  
 
As study subjects in cohort 1 are essentially a separate study, there is no prohibition 
to sponsor being unblinded for the interim analysis.  Cohort 1 subjects are not tied 
to cohort 2 in any way and unblinding data from cohort 1 has no operational or 
statistical implications for cohort 2 assessment by sponsor.  Study site personnel 
may not be unblinded to cohort 1 as there is a reasonable possibility that this 
information could be the basis for bias in the assessment of cohort 2. 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                
SAP Amendment #1 
 
Page 5 of 11 
To meet above review interest, the following summary tables (treatment groups: 4 
Days RD-X19 vs. Sham) and by-subject data listings will be prepared for the 
interim analysis:  
 
Tables / Listing 
Description 
Population 
Efficacy 
 
 
Table 14.1.3 
Demographic and Baseline Characteristics 
Safety Population 
Cohort 1 
Table 14.2.1.1 
Time-Weighted Average Change in Log10-Transformed Viral 
Load by RT-qPCR from Baseline to Day 8 
ITT Population of 
Cohort 1 
Table 14.2.2.1 
Log10-Transformed Viral Load via RT-qPCR by Visit 
ITT Population of 
Cohort 1 
Table 14.2.2.3 
Proportion of Subjects with At Least 95% Reduction by Visit in 
SARS-Cov-2 Viral Load via RT-qPCR  
ITT Population of 
Cohort 1 
Table 14.2.5.1  
Time to Alleviation of COVID-19 Symptoms 
ITT Population of 
Cohort 1 
Table 14.2.5.2  
Time to Sustained Alleviation of COVID-19 Symptoms 
ITT Population of 
Cohort 1 
Safety 
 
 
Table 14.3.1.1 
Treatment-Emergent Adverse Events by System Organ Class and 
Preferred Term 
Safety Population 
of Cohort 1 
Table 14.3.1.2 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Severity 
Safety Population 
of Cohort 1 
Table 14.3.1.3 
Treatment-Emergent Adverse Events by System Organ Class, 
Preferred Term and Causality to Study Device 
Safety Population 
of Cohort 1 
Table 14.3.2 
Reactogenicity by Visit  
Safety Population 
of Cohort 1 
Table 14.3.3 
Oropharyngeal assessment by Visit  
Safety Population 
of Cohort 1 
Listing 16.2.7 
Adverse Events 
Cohort 1 subjects 
Listing 16.2.8.1  
Out-of-Range Results of Clinical Laboratory Tests 
Cohort 1 subjects 
Listing 16.2.9.1 
Reactogenecity Assessment 
Cohort 1 subjects 
Listing 16.2.9.2 
Oropharyngeal Assessment 
Cohort 1 subjects 
Listing 16.2.9.6  
Methemoglobin Measurement 
Cohort 1 subjects 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 6 of 11 
3. Original Summary Table 14.2.3 
 
Table 14.2.3 – Clearance of Viral Infection in Saliva via RT-qPCR 
 
Population 
Endpoint 
Statistics 
4 Days RD-X19      
7 Days RD-X19      
Sham 
Intent-to-Treat 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
 
n (%)  
 
XX (XX.X) 
 
XX (XX.X) 
 
XX (XX.X) 
 
Per-Protocol 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
 
n (%)  
 
XX (XX.X) 
 
XX (XX.X) 
 
XX (XX.X) 
Abbreviation: CI = Confidence Interval 
Note 1: Clearance of viral infection in saliva is defined as a negative test (Ct value ≥32) via RT-qPCR.  
Note 2: Subjects who did not achieve clearance at the exit of study are considered censored. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. 
Source: Listing 16.2.6.4 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 7 of 11 
Revised Summary Table and Added Figures 
 
 
Table 14.2.3 – Clearance of Viral Infection in Saliva via RT-qPCR 
 
Population 
Endpoint 
Statistics 
4 Days RD-X19      
7 Days RD-X19      
Sham 
Intent-to-Treat 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
P-value RX-X19 vs. Sham 
n (%)  
0.XXX 
XX (XX.X) 
0.XXX 
XX (XX.X) 
 
XX (XX.X) 
 
Per-Protocol 
Time to Clearance of Viral Infection 
N  
XX 
XX 
XX 
 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
Subjects Demonstrating Clearance of Viral 
Infection at Day 8/ET Visit 
P-value RX-X19 vs. Sham 
n (%)  
0.XXX 
XX (XX.X) 
0.XXX 
XX (XX.X) 
 
XX (XX.X) 
Abbreviation: CI = Confidence Interval 
Subjects with clearance of viral infection at baseline are excluded from the analysis of time-to-clearance of viral infection. 
Note 1: Clearance of viral infection in saliva is defined as a negative test via RT-qPCR, i.e. achievement of [1] RP Ct =0, AND [2] Average N1 Ct =32 or 
Average N1 Ct ='Undetermined'. Subjects who did not achieve clearance at the last assessment of the study are considered censored at the time of the last 
assessment. 
Note 2: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.4, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
Figure 15.1.1 - Kaplan-Meier Plot of Time to Clearance of Viral Infection for Intent-to-Treat Population 
Figure 15.1.2 - Kaplan-Meier Plot of Time to Clearance of Viral Infection for Per-Protocol Population 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 8 of 11 
4. Original Summary Table 14.2.5 
 
Table 14.2.5 – Time to Alleviation of COVID-19 Symptoms 
 
Population 
Statistics 
4 Days RD-X19             
7 Days RD-X19  
Sham 
Intent-to-Treat 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
Per-Protocol 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
Abbreviation: CI = Confidence Interval 
Note 1: Alleviation of COVID-19 symptoms is defined as all eight symptoms assessed by the subject as none (0) or mild (1).  
Note 2: Subjects who did not achieve alleviation at the exit of study are considered censored. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. 
Source: Listing 16.2.6.1, 16.2.6.2 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 9 of 11 
Revised Summary Table and Added Figures 
 
 
Table 14.2.5.1 – Time to Alleviation of COVID-19 Symptoms 
 
Population 
Statistics 
4 Days RD-X19             
7 Days RD-X19             
Sham 
Intent-to-Treat 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Per-Protocol 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Abbreviation: CI = Confidence Interval 
Note 1: Alleviation of COVID-19 symptoms is defined as all eight symptoms assessed by the subject as none (0) or mild (1).  
Note 2: Time to alleviation is calculated as the number of hours from the first dose to the time of the first occurrence of symptoms alleviation. Subjects who did 
not achieve alleviation at the last assessment of study are considered censored at the time of the last assessment. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.1.2, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
Figure 15.2.1 - Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms for Intent-to-Treat Population 
Figure 15.2.2 - Kaplan-Meier Plot of Time to Alleviation of COVID-19 Symptoms for Per-Protocol Population 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 10 of 11 
 
5. New Summary Table and Figures 
 
Table 14.2.5.2 – Time to Sustained Alleviation of COVID-19 Symptoms 
 
Population 
Statistics 
4 Days RD-X19             
7 Days RD-X19             
Sham 
Intent-to-Treat 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Per-Protocol 
N  
XX 
XX 
XX 
 
n (%) Censored 
XX (XX.X) 
XX (XX.X) 
XX (XX.X) 
 
Median of Time 
XX.X 
XX.X 
XX.X 
 
25th, 75th Percentiles 
XX.X, XX.X 
XX.X, XX.X 
XX.X, XX.X 
 
95% CI of Median  
(XX.X, XX.X) 
(XX.X, XX.X) 
(XX.X, XX.X) 
 
P-value RX-X19 vs. Sham  
0.XXX 
0.XXX 
 
Abbreviation: CI = Confidence Interval 
Note 1: Sustained alleviation of COVID-19 symptoms is defined as all eight symptoms assessed by the subject as none (0) or mild (1) AND no single symptom 
reoccurs later at a level above mild (1). 
Note 2: Time to sustained alleviation is calculated as the number of hours from the first dose to the time of the occurrence of sustained symptoms alleviation. 
Subjects who did not 
achieve sustained alleviation at the last assessment of the study are considered censored at the time of the last assessment. 
Note 3: Percentiles and 95% CI of median are derived using the Kaplan-Meier method. P-values for treatment comparison are from Log Rank Test. 
Source: Listing 16.2.6.1.2, 16.2.5.3 
O:\Studies\EmitBio\EB-P12-01\Biometrics\Programs\Tables\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year.  
 
 
Figure 15.3.1 - Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 Symptoms for Intent-to-Treat Population 
Figure 15.3.2 - Kaplan-Meier Plot of Time to Sustained Alleviation of COVID-19 Symptoms for Per-Protocol Population 
 
 

EmitBio Inc.                                                                                             
 
 
  
Protocol: EB-P12-01                                                                                                                                                                                                                               
SAP Amendment #1 
 
Page 11 of 11 
6. New Subject Data Listing 
 
Listing 16.2.6.1.2- COVID-19 Symptom Assessment and Severity Score from Subject Diary 
 
 
Assessment 
 
Site-Subject Cohort 
Not 
Done Day 
Study 
Day 
Date:Time 
Cough 
Sore 
Throat 
Nasal 
Congestion Headache 
Chills/ 
Sweats 
Muscle or 
Joint pain Fatigue Nausea 
Fever 
(F) 
COVID-19 
Severity 
Score 
Treatment:  
xxxx 
x 
 
Day 1-
Assessment 1 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 1-
Assessment 2 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 2-
Assessment 1 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COVID-19 Symptom: 0=None, 1=Mild, 2=Moderate, 3=Severe. Study Day is calculated relative to date of first treatment. Day 1 is the day of first treatment. 
Note: Assessment at a visit was based on symptoms the subject reports as occurring within the past 3 days of that visit. 
O:\Studies\ EmitBio\EB-P12-01\Biometrics\Programs\Listings\xxx.sas ran on Month Day, Year at hh:mm on data from Month Day, Year  
 
 
 
 
Note: The original Listing 16.2.6.1 is changed to Listing 16.2.6.1.1.