A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"
Phase: NA
Conditions: SARS CoV-2
Sponsor: E25Bio, Inc.

Version Date 
April 19, 2020 
Version No. 
2 
Protocol Number 
E25001 
NCT 
TBD 
Protocol Title 
A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test 
“DART”  
 
Approvals: 
Site 
Sponsor 
 
 
______________________________________ 
PI Printed Name 
 
 
 
 ______________________________________________ 
Principal Investigator                         Date 
 
   
 
 
 
 
 
 
 
 _______________________________________  
Irene Bosch, PhD                                                     Date 
CTO 
E25BIO, Inc      
Address: 501 Massachusetts Ave. Cambridge, MA 
02139 
 
 
 

E25001  v2.0  19Apr 2020 
ii 
Confidential 
 
Summary of Changes from Previous Version: 
Version # 
Version Date 
Summary of Revisions Made 
1 
03Apr2020 
 
2 
19Apr2020 
 

  
E25001  v2.0  19Apr 2020 
ii 
Confidential 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................ 4 
1 
PROTOCOL SUMMARY .............................................................................................................................. 4 
1.1 
Synopsis .............................................................................................................................................. 4 
1.2 
Schema ................................................................................................................................................ 6 
2 
INTRODUCTION ........................................................................................................................................... 7 
2.1 
Study Rationale ................................................................................................................................... 7 
2.2 
Background ......................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment ................................................................................................................... 7 
2.3.1 
Known Potential Risks .................................................................................................... 7 
2.3.2 
Known Potential Benefits ............................................................................................... 8 
3 
OBJECTIVES AND ENDPOINTS ............................................................................................................... 8 
4 
STUDY DESIGN ............................................................................................................................................ 8 
4.1 
Overall Design ..................................................................................................................................... 8 
4.2 
Scientific Rationale for Study Design .............................................................................................. 8 
4.3 
End of Study Definition ...................................................................................................................... 9 
5 
STUDY POPULATION ................................................................................................................................. 9 
5.1 
Inclusion Criteria ................................................................................................................................. 9 
5.2 
Exclusion Criteria ................................................................................................................................ 9 
6 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ............................................................................. 9 
6.1 
Discontinuation of Study Sample evaluation .................................................................................. 9 
7 
STUDY ASSESSMENTS AND PROCEDURES .................................................................................... 10 
7.1 
Study procedures .............................................................................................................................. 10 
7.2 
Adverse Events and Serious Adverse Events .............................................................................. 10 
7.2.1 
Definition of Adverse Events (AE) .............................................................................. 10 
7.2.2 
Definition of Serious Adverse Events (SAE) ............................................................. 10 
7.2.3 
Classification of an Adverse Event ............................................................................. 11 
7.2.4 
Serious Adverse Event Reporting .............................................................................. 12 
7.3 
Unanticipated Problems ................................................................................................................... 12 
7.3.1 
Definition of Unanticipated Problems (UP) ................................................................ 12 
8 
STATISTICAL CONSIDERATIONS ......................................................................................................... 13 
8.1 
Statistical Hypotheses ...................................................................................................................... 13 
8.2 
Sample Size Determination ............................................................................................................. 14 
8.3 
Populations for Analyses ................................................................................................................. 14 
8.4 
Statistical Analyses .......................................................................................................................... 14 
8.4.1 
General Approach ......................................................................................................... 14 
8.4.2 
Safety Analyses ............................................................................................................. 15 
8.4.3 
Baseline Descriptive Statistics .................................................................................... 15 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................. 15 
9.1 
Regulatory, Ethical, and Study Oversight Considerations .......................................................... 15 
9.1.1 
Informed Consent Process .......................................................................................... 15 
9.1.2 
Study Discontinuation and Closure ............................................................................ 16 
9.1.3 
Confidentiality and Privacy .......................................................................................... 16 
9.1.4 
Future Use of Stored Specimens and Data .............................................................. 17 
9.1.5 
Clinical Monitoring ......................................................................................................... 17 
9.1.6 
Quality Assurance and Quality Control ...................................................................... 18 
9.1.7 
Data Handling and Record Keeping ........................................................................... 18 

  
E25001  v2.0  19Apr 2020 
iii 
Confidential 
9.1.8 
Protocol Deviations ....................................................................................................... 19 
9.1.9 
Publication and Data Sharing Policy .......................................................................... 19 
9.1.10 
Conflict of Interest Policy ............................................................................................. 20 
9.2 
Abbreviations ..................................................................................................................................... 21 
10 
REFERENCES ............................................................................................................................................ 23 
11 
Appendix A – Case report form ................................................................................................................. 24 
 

 
Protocol Number: E25001 (NEU2012) 
 
STATEMENT OF COMPLIANCE 
 
The trial will be conducted in compliance with the protocol, International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable state, local and federal regulatory requirements (United States (US) Code of Federal 
Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or 21 CFR Part 812). 
Each engaged institution must have a current Federal-Wide Assurance (FWA) issued by the Office for Human Research 
Protections (OHRP) and must provide this protocol and the associated informed consent documents and recruitment 
materials for review and approval by an appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered 
with OHRP. Any amendments to the protocol or consent materials must also be approved before implementation. The 
protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled.  Any amendment to the protocol will require review and approval by the IRB 
before the changes are implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form. 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test 
“DART” 
Study Description: 
A rapid point of care bioassay for the detection of virus particles will be 
compared to the hospital validated RT-PCR detection standard. 
Nasopharyngeal and saliva samples will be collected along with hospital 
standard of care collection.   
Intended Use 
The SARS-CoV-2 DART is a bioassay intended for rapid point-of-care 
detection of the SARS-CoV-2 virus 
Objective 
 
Primary: To validate the performance of SARS-COV-2 DART in a clinical 
setting 
 
Endpoints: 
Primary: Compared to Gold Standard PCR, DART with nasopharyngeal 
swab will provide agreement with respect to PCR 
  

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 5 of 43 
Study Population: 
Samples will be collected in an Emergency Room setting from up to 200 
subjects who entered the hospital over concerns about SARS-CoV-2. The 
goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects 
and N=30 confirmed Covid-19 negative subjects of comparable ages, 
genders and races. 
Phase: 
N/A 
Description of 
Sites/Facilities Enrolling 
Participants: 
Beth Israel Deaconess Medical Center 
Study Duration: 
The trial is expected to take 1 month 
Participant Duration: 
Individual participation only includes sample collection 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 6 of 43 
 
1.2 
SCHEMA 
 
 
 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
Time Point  
 
 
 
 
 
 
 
• 
Perform nasopharyngeal swabs 
• 
One swab will be used for PCR according to hospital protocol 
• 
The second swab will be used for DART antigen test 
• 
Place sample in DART tube in the E25Bio transport media  
• 
Add dipstick  
• 
Collect saliva and serum for future use 
Final Assessments 
Collect readings after 15 and after 30 
minutes
Covid (+/-) 
   Clinical criteria 
Enrollment 
Total up to N=200:  Obtain informed consent. Screen potential participants by inclusion 
and exclusion criteria; document relevant medical history 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 7 of 43 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
The current standard of care for diagnosis of SARS-CoV-2 infection involves sample collection to be prepared and 
measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the 
level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take 
hours to several days.  A rapid assay that does not require the sophisticated laboratory equipment and techniques could 
provide a significant advantage to the way practitioners screen and ultimately treat patients. 
 
2.2 
BACKGROUND  
The SARS-CoV-2 Direct Antigen Rapid Test (“DART”) is an immunoassay for point-of-care, qualitative detection of 
SARS-CoV-2 viral particles/secreted protein in nasopharyngeal swabs  from  suspected patients  with  COVID-19  
infection.  Dipsticks are printed with a monoclonal antibody that binds the signature SARS-CoV-2 viral 
particles/protein (Test line) and a control antibody (Control line) for quality control. A second monoclonal antibody is 
attached to gold nanoparticles (conjugate) and quencher buffer, and mixed with the patient samples, though in the 
near future the final format will contain the dry conjugate. The SARS-CoV-2 viral particles/Spike protein attach to 
both antibodies resulting in a visual line on the test strip within 15 minutes. Prior experience for detection virus and 
viral proteins via antibody binding using lateral flow are E25Bio portfolio platform for dengue, Zika and Chikungunya 
viruses among others. 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
• 
Potential risk of False Positive results leading to unnecessary clinical care which may include medications and 
additional diagnostic tests. 
• 
Potential risk of False Negatives which may delay potential therapeutic care, and in severe cases may delay 
critical lifesaving care  
• 
Negative results cannot be proven negative 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 8 of 43 
In both cases, the risks are mitigated by the Inclusion/Exclusion requirement that subjects test positive or negative for 
Covid-19 via the standard RT-PCR diagnostics. 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
No potential benefits to the subject are expected as a result of participation in this trial. The benefits to future patients 
may include a more rapid point-of-care diagnostic test than currently available.  
 
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
The primary objective is to confirm 
performance and validation of the 
SARS-CoV-2 DART bioassay for 
rapid detection of infection when 
using nasopharyngeal swab 
 
 
Agreement with respect to PCR 
 
Commonly accepted 
thresholds for antigen 
lateral flow bioassays 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This trial is a clinical performance validation comparing DART to RT-PCR. The endpoints will be agreement with PCR. We 
know that the sensitivity of PCR will not reach 100%, but we will use PCR to define positive samples. In addition, routine 
pathogen screen will be in place for Influenza A and B, Adenovirus, RSV for the Hospital Clia Lab protocols. 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Alternatives to genome detection are critical for front line point of care medical specialists when battling an active 
epidemic. Lateral flow bioassays are relatively inexpensive to manufacture, easy to store, and easy for front line medical 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 9 of 43 
technicians to use. A test that is comparable and reproducible when compared to Gold Standard RT-PCR will meet these 
critical needs.  
 
 
4.3 
END OF STUDY DEFINITION 
 
Study Subjects are not expected to participate beyond consent and collection of the nasopharyngeal and saliva samples. 
 
The end of the study is defined as completion of the last procedure shown in the SoA in the trial globally. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
 Up to 200 subjects will be screened, consented, and enrolled to obtain 60 eligible candidates. In order to be eligible to 
participate in this study, an individual must meet all of the following criteria: 
1. Provision of verbal informed consent form 
2. Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden 
onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) 
AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact 
with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms. 
3. Subject is an appropriate candidate for Nasopharyngeal sample collection 
4. Subject is willing to provide nasopharyngeal swab and saliva samples 
 
5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Individuals who present to ER with 10 or greater days of COVID-19 Related Symptoms,  (Fever, Cough, Fatigue, 
Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence  
 
6 
CONVALESCENCE.PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
6.1 
DISCONTINUATION OF STUDY SAMPLE EVALUATION 
 
Subjects may withdraw consent at any time and request that their samples not be processed. 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 10 of 43 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 
STUDY PROCEDURES 
 
All reagents and DART viral transport media will be provided by the sponsor and shipped together. The dipsticks should 
be kept at Room Temperature until use.  
1. Subjects will be approached by research staff to determine if they would be interested in participating in a study 
that requires an additional sample collection. If willing, then a qualified study team member will conduct the 
informed consent process with the subject, obtain verbal agreement by subject, document verbal consent of the 
participant, and provide a copy of the informed consent form information sheet to the participant. 
2. Study staff will complete the necessary source document elements and case report forms collecting relevant 
subject demographic information, eligibility criteria, and medical history. Medical personnel will collect 
nasopharyngeal swabs (2X samples each), saliva, and serum.  
3. One of the swabs will be utilized to conduct the traditional PCR method at the Hospital 
4. The second nasopharyngeal swab collected in the 0.4ml viral E25Bio transport media 
5. Mix vigorously and let stand until use within the next minutes 
6. In a tube provided, apply the 100μl viral transport media  
7. Insert dipstick for DART test into the tube. 
8. The liquid should be moving up into the tests strip for minimum of 15 min and maximum of 30 minutes.  
9. Visually read and interpret the final result as indicated below, two lines= positive. One line=negative and record 
on form. 
10. A second DART swab may be administered if the results of the first swab are not interpretable. 
11. Medical staff will collect saliva sample from participant for future use.  
 
7.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
7.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
Adverse event means any untoward medical occurrence associated with the use of an intervention in humans, whether 
or not considered intervention-related. 
 
7.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 11 of 43 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, 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, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
 
7.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.2.3.1 SEVERITY OF EVENT 
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate 
events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other 
treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, the term “severe” 
does not necessarily equate to “serious”. 
 
7.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
• 
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 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. 
 
7.2.3.3 EXPECTEDNESS  
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 12 of 43 
Nasopharyngeal swabs are taken on routine basis by trained medical staff. There are no known expected reactions 
beyond mild discomfort. 
 
7.2.4 SERIOUS ADVERSE EVENT REPORTING  
 
There is minimal to absent adverse events (AEs) for the current protocol as it constitutes a protocol for an external in 
vitro diagnostic device. The AE are not associated with the diagnostic device itself but are associated with the 
performance of the nasopharyngeal swab procedure. 
 
Serious AEs occurring after a subject is consented through 30 minutes following sample retrieval must be reported as 
SAEs on the Innovations SAE Report Form and followed until resolution (with autopsy report if applicable).  The 
Innovations Safety Department must be notified of all SAEs, regardless of causality, within 24 hours of the first 
knowledge of the event by the treating physician or research personnel. 
 
To report an SAE, the SAE Report Form should be completed with the necessary information. 
The SAE Report Form should be sent to the Innovations Safety Department via fax or e-mail using the following contact 
information (during both business and non-business hours): 
 
Sarah Cannon Innovations Safety Department 
 
Safety Dept. Fax #:      1-866-807-4325 
 
Safety Dept. Email:     CANN.SAE@SCRI-Innovations.com 
 
Transmission of the SAE report should be confirmed by the site personnel submitting the report. 
 
Reporting UADEs: 
The study investigator shall complete an Unanticipated Adverse Device Effect (UADE) Form and submit to the study 
sponsor and to the reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 working 
days after the investigator first learns of the effect.  The study sponsor is responsible for conducting an evaluation of an 
unanticipated adverse device effect and shall report the results of such evaluation to the Food and Drug Administration 
(FDA) and to all reviewing IRBs and participating investigators within 10 working days after the sponsor first receives 
notice of the effect. Thereafter, the sponsor shall submit such additional reports concerning the effect as FDA requests. 
 
 
7.3 
UNANTICIPATED PROBLEMS 
 
7.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 13 of 43 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in 
the protocol-related documents, such as the Institutional Review Board (IRB)-approved research protocol and 
informed consent document; and (b) the characteristics of the participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in the 
research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
An investigator shall submit to the sponsor and to the reviewing Institutional Review Board (IRB) a report of any 
unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)), A sponsor who conducts an 
evaluation of an unanticipated adverse device effect under 812.46(b) shall report the results of such evaluation to the 
Food and Drug Administration (FDA) and to all reviewing IRB's and participating investigators within 10 working days 
after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports 
concerning the effect as FDA requests (21 CFR 812.150(b)(1)).    
 
8 
STATISTICAL CONSIDERATIONS  
Details of the statistical analysis are described in the FDA Guidance, 'Statistical Guidance on Reporting Results from 
Studies Evaluating Diagnostic Tests'.  
8.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Efficacy Endpoint(s): The DART antigen test will be compared to Gold Standard RT-PCR for the detection 
of SARS-Cov-2. We will be reporting the agreement between these two techniques. 
• 
From the laboratory at BEI (NIH) we obtained performances reaching 100 % sensitivity and 100% specificity from 
validated laboratory viral samples.  
• 
Percent Positive Agreement =  A/(A + C) or True Positives/(True Positives + False Negatives) 
• 
Negative Percent Agreement = D/(B + D) or True Negatives/(True Negatives + False positives) 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 14 of 43 
8.2 
SAMPLE SIZE DETERMINATION 
 
The sample size was based upon FDA guidance regarding EUA clinical validation procedures following EUA approval. N= 
30 positive samples and N=30 negative samples should provide sufficient confidence that the DART bioassay is sensitive 
and specific for detection of SARS-Cov-2 early infection. 
 
8.3 
POPULATIONS FOR ANALYSES 
 
Subjects testing positive or negative by PCR and having DART assessments 
 
8.4 
STATISTICAL ANALYSES 
 
8.4.1 GENERAL APPROACH 
 
The 2X2 binary method is industry standard when testing a new clinical diagnostic with the gold standard. 
The positive and negative percent agreement between the candidate device results generated separately for each 
claimed matrix comparator method using 2 x 2 tables as follows: 
 
  
Clinical comparator method/Clinical truth (RT-PCR) 
E25Bio Test 
  
Positive 
Negative 
Positive 
A 
B 
Negative 
C 
D 
 
 
Percent Positive Agreement =  A/(A + C) or True Positives/(True Positives + False Negatives) 
 
Negative Percent Agreement = D/(B + D) or True Negatives/(True Negatives + False positives) 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 15 of 43 
 
 
8.4.2 SAFETY ANALYSES 
 
Adverse events will be recorded and categorized according to toxicity and relationship to procedure.  
 
Adverse events will be analyzed by a very common summary of AEs is by SOC (System Organ Class), Preferred Term, and 
Grade). 
 
8.4.3 BASELINE DESCRIPTIVE STATISTICS 
 
Descriptive statistics will be used to describe age, race, and gender of the sample population. 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
 
 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the participant and 
written documentation of informed consent is required prior to starting intervention/administering study intervention.  
The human samples will be anonymized if consented for future investigations. 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and continues 
throughout the individual’s study participation. Consent forms will be Institutional Review Board (IRB)-approved and the 
participant will be asked to read and review the document. The investigator and/or appropriate delegated medical 
personnel will explain the research study to the participant and answer any questions that may arise. A verbal 
explanation will be provided in terms suited to the participant’s comprehension of the purposes, procedures, and 
potential risks of the study and of their rights as research participants.  Participants will have the opportunity to carefully 
review the written consent form and ask questions prior to signing. The participants should have the opportunity to 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 16 of 43 
discuss the study with their family or surrogates or think about it prior to agreeing to participate. Participants must be 
informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice. 
Once the participant provides verbal consent, the PI or delegated team member will sign the informed consent 
document. A copy of the informed consent document will be given to the participants for their records. The informed 
consent process will be conducted and documented in the source document (including the date), and the form signed, 
before the participant undergoes any study-specific procedures. The rights and welfare of the participants will be 
protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to 
participate in this study. 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause.  If the study 
is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study participants, the 
Institutional Review Board (IRB), and sponsor and will provide the reason(s) for the termination or suspension.  Study 
participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and satisfy the 
sponsor, IRB and/or Food and Drug Administration (FDA).] 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their interventions. This confidentiality is extended to cover testing of biological samples and genetic 
tests in addition to the clinical information relating to participants. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the study or the data 
will be released to any unauthorized third party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 17 of 43 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional Review Board 
(IRB), regulatory agencies or pharmaceutical company supplying study product may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) 
and pharmacy records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use during the study. 
At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated by the 
reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted 
to and stored at the <specify name of Data Coordinating Center>. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by clinical sites and by sponsor 
research staff will be secured and password protected. At the end of the study, all study databases will be de-identified 
and archived at the sponsor facilities. 
 
9.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data collected for this study will be analyzed and stored at participating hospitals, central lab,  or sponsor labs for up to 
3 years. After the study is completed, the de-identified, archived data will be transmitted to and stored at the sponsor 
facilities, for use by other researchers including those outside of the study.  
 
With the participant’s approval and as approved by local Institutional Review Boards (IRBs), de-identified biological 
samples will be stored at the Hospital/Central facility and/or sponsor laboratories with the same goal as the sharing of 
data. These samples could be used to research the causes of COVID-19 and spread of SARS-CoV-2, its complications and 
other conditions for which individuals with SARS-CoV-2 infection are at increased risk, and to improve treatment.  
 
During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens 
stored for future research. However, withdrawal of consent with regard to biosample storage may not be possible after 
the study is completed.  
 
When the study is completed, access to study data and/or samples will be provided through the sponsor. 
 
9.1.5 CLINICAL MONITORING 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 18 of 43 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are protected, that the 
reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the 
currently approved protocol/amendment(s), with International Conference on Harmonisation Good Clinical Practice (ICH 
GCP), and with applicable regulatory requirement(s).  
 
9.1.6 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Each clinical site will perform internal quality management of study conduct, data and biological specimen collection, 
documentation and completion.  An individualized quality management plan will be developed to describe a site’s 
quality management. 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will 
be run on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for 
clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is conducted and 
data are generated and biological specimens are collected, documented (recorded), and reported in compliance with 
the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).  
 
The investigational site will provide direct access to all trial related sites, source data/documents, and reports for the 
purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
 
9.1.7 DATA HANDLING AND RECORD KEEPING  
 
9.1.7.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site investigator. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for recording data for 
each participant enrolled in the study.  Data recorded in the hospital electronic medical records, should be consistent 
with the data recorded on the source documents. A 21 CFR Part 11 compliant medical record will be electronically 
transferred to the sponsor per agreed upon terms and standards. 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 19 of 43 
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into the approved databasea 21 CFR Part 11-compliant data capture system provided by 
the CRO. The data system includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source 
documents. 
 
9.1.7.2 STUDY RECORDS RETENTION  
 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing application in an 
International Conference on Harminosation (ICH) region and until there are no pending or contemplated marketing 
applications in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the study intervention. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to be retained. 
 
9.1.8 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on Harmonisation 
Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The noncompliance may be either on 
the part of the participant, the investigator, or the study site staff. As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report deviations.  All deviations 
must be addressed in study source documents and reported to the sponsor.  Protocol deviations must be sent to the 
reviewing Institutional Review Board (IRB) per their policies. The site investigator is responsible for knowing and 
adhering to the reviewing IRB requirements.  
 
9.1.9 PUBLICATION AND DATA SHARING POLICY 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 20 of 43 
It is expected that publications will result from these studies, and investigators/institutions are encouraged to generate 
manuscripts. 
 
a. The results of the present study, in the event that they form part of a multi -center trial, may not be 
published until the overall results have been published. 
 
b. The Sponsor shall not cite the investigators’ names without their authorization, except in the case of 
references to works already published. 
 
c. Any publication and/or disclosure in any form of the results of medical investigations carried out with the 
Sponsor’s products must be agreed with the Sponsor prior to its publication and/or disclosure. 
 
d. The sponsor allows the publication, with the mentions that are legally provided for, of the data obtained 
in this Trial in journals of recognised scientific prestige and its disclosure in seminars and conferences 
within the medical professional field, providing that the provisions established in sections a) and c) of this 
clause are respected. 
 
e. Section c) above is understood to be applicable to information obtained in Trials that have not been 
completed or have been suspended before completion. 
 
f. The research team shall not disclose the results of the investigation to third parties, with the exception of 
the procedure foreseen in this clause. 
The publication of the clinical study will include key personnel, scientific personnel and medical key contributors. The 
source of funding will be stated, proper statement of commercial interest will be disclosed. The confidentiality agreement 
will include the details regarding data sharing policy.  
 
 
9.1.10 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.  The study leadership has established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all reported dualities of interest. 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 21 of 43 
9.2 
ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 22 of 43 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 23 of 43 
10 REFERENCES         
1. Kim JY, Ko JH, Kim Y, et al. Viral Load Kinetics of SARS-CoV-2 Infection in First Two Patients in Korea. J Korean Med Sci. 
2020;35(7):e86. Published 2020 Feb 24. doi:10.3346/jkms.2020.35.e86 
2. Bosch I, de Puig H, Hiley M, Carré-Camps M, Perdomo-Celis F, Narváez CF, Salgado DM, Senthoor D, O’Grady M, Phillips E, 
Durbin A, Fandos D, Miyazaki H, Yen C-W, Gélvez-Ramírez M, Warke RV, Ribeiro LS, Teixeira MM, Almeida RP, Muñóz-
Medina JE, Ludert JE, Nogueira ML, Colombo TE, Terzian ACB, Bozza PT, Calheiros AS, Vieira YR, Barbosa-Lima G, Vizzoni A, 
Cerbino-Neto J, Bozza FA, Souza TML, Trugilho MRO, de Filippis AMB, de Sequeira PC, Marques ETA, Magalhaes T, Díaz FJ, 
Restrepo BN, Marín K, Mattar S, Olson D, Asturias EJ, Lucera M, Singla M, Medigeshi GR, de Bosch N, Tam J, Gómez-
Márquez J, Clavet C, Villar L, Hamad-Schifferli K, Gehrke L. Rapid antigen tests for dengue virus serotypes and Zika virus in 
patient serum. Sci Transl Med [Internet]. 2017 Sep 27;9(409). Available from: 
http://dx.doi.org/10.1126/scitranslmed.aan1589 PMID: 28954927 
3. de Puig H, Bosch I, Gehrke L, Hamad-Schifferli K. Challenges of the Nano-Bio Interface in Lateral Flow and Dipstick 
Immunoassays. Trends Biotechnol [Internet]. 2017 Dec;35(12):1169–1180. Available from: 
http://dx.doi.org/10.1016/j.tibtech.2017.09.001 PMCID: PMC5696013 
4. Myhrvold C, Freije CA, Gootenberg JS, Abudayyeh OO, Metsky HC, Durbin AF, Kellner MJ, Tan AL, Paul LM, Parham LA, 
Garcia KF, Barnes KG, Chak B, Mondini A, Nogueira ML, Isern S, Michael SF, Lorenzana I, Yozwiak NL, MacInnis BL, Bosch I, 
Gehrke L, Zhang F, Sabeti PC. Field-deployable viral diagnostics using CRISPR-Cas13. Science [Internet]. 2018 Apr 
27;360(6387):444–448. Available from: http://dx.doi.org/10.1126/science.aas8836 PMID: 29700266 
5. Tam JO, de Puig H, Yen C-W, Bosch I, Gómez-Márquez J, Clavet C, Hamad-Schifferli K, Gehrke L. A comparison of 
nanoparticle-antibody conjugation strategies in sandwich immunoassays. J Immunoassay Immunochem [Internet]. 
2017;38(4):355–377. Available from: http://dx.doi.org/10.1080/15321819.2016.1269338 PMID: 27982728 
6. Pardee K, Green AA, Takahashi MK, Braff D, Lambert G, Lee JW, Ferrante T, Ma D, Donghia N, Fan M, Daringer NM, Bosch I, 
Dudley DM, O’Connor DH, Gehrke L, Collins JJ. Rapid, Low-Cost Detection of Zika Virus Using Programmable Biomolecular 
Components. Cell [Internet]. 2016 May 19;165(5):1255–1266. Available from: http://dx.doi.org/10.1016/j.cell.2016.04.059 
PMID: 27160350 
7. Yen CW, de Puig H, Tam JO, Gomez-Marquez J, Bosch I, Hamad-Schifferli K, Gehrke L. Multicolored silver nanoparticles for 
multiplexed disease diagnostics: distinguishing dengue, yellow fever, and Ebola viruses. Lab Chip [Internet]. 2015;15:1638–
1641. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25672590 PMID: 25672590 
8. Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 
2020;12(1):9. Published 2020 Mar 3. doi:10.1038/s41368-020-0075-9 
9. Wang WK, Chen SY, Liu IJ, et al. Detection of SARS-associated coronavirus in throat wash and saliva in early 
diagnosis. Emerg Infect Dis. 2004;10(7):1213–1219. doi:10.3201/eid1007.031113 
10. Tong TR. SARS-CoV sampling from 3 portals. Emerg Infect Dis. 2005;11(1):167. doi:10.3201/eid1101.040645 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 24 of 43 
 
11 APPENDIX A – CASE REPORT FORM  
. 
 
 
Case Report Form (CRF)  
E25001 
 
FINAL_ Version 0.8, 19/APR/2020 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 25 of 43 
Table of Contents 
 
ADMINISTRATIVE ................................................................................................................................................... 26 
VISIT 
26 
PATIENT INFORMATION .................................................................................................................................. 27 
SCREENING ............................................................................................................................................................ 28 
ELIGIBILITY .......................................................................................................................................................... 28 
DEMOGRAPHICS ............................................................................................................................................... 29 
COVID-19 RELATED SYMPTOMS ................................................................................................................... 30 
MEDICAL HISTORY ............................................................................................................................................ 32 
ASSESSMENTS ...................................................................................................................................................... 35 
SAMPLE COLLECTION ...................................................................................................................................... 35 
DART DIPSTICK VISUAL ASSESSMENT ....................................................................................................... 37 
PCR RESULT ....................................................................................................................................................... 39 
ADVERSE EVENTS ................................................................................................................................................ 40 
ADVERSE EVENTS ............................................................................................................................................ 40 
SUBJECT STATUS ................................................................................................................................................... 1 
END OF STUDY ..................................................................................................................................................... 1 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 26 of 43 
12 ADMINISTRATIVE 
 
Template: VISIT-01 Version 12/3/2013 
 
12.1 VISIT 
 
Visit Name: 
____________________ 
Visit Date (DD/MON/YYYY): 
/
/
 
 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 27 of 43 
 
Template: SUB-02 Version 7/19/2013 
 
12.2 PATIENT INFORMATION 
 
Patient Number 
 
Patient Caption 
 
 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 28 of 43 
13 SCREENING 
Template: IE-01 Version  
13.1 ELIGIBILITY 
 
What was the date of informed consent? (DD/MON/YYYY): 
/
/
 
Protocol version used to confirm eligibility:  
 Protocol Version 1 (Original) 
 Protocol Version 2 (Amendment 1) 
 Protocol Version 3 (Amendment 2) 
Did the patient have symptoms consistent with a clinical assessment of COVID-19?    
 Yes  
 No 
Did the patient meet all eligibility criteria?
Yes
No
If No, specify critera not met: 
 
Type of Criterion Failed 
Failed Criterion Number 
 Inclusion 
 Exclusion 
 
Did the patient enroll? 
 Yes 
 No 
If No, specify reason: ____________________ 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 29 of 43 
Template: DM-01 Version 2/4/2015 
General Note: Race option is check all that apply. 
 
13.2 DEMOGRAPHICS 
 
Date of Birth (DD/MON/YYYY): 
/
/
 
Sex:  
 
 Female 
Ethnicity: 
 
  Hispanic or Latino 
  Not Hispanic or Latino 
U k
 Race:  
 
 American Indian or Alaskan Native 
 
 Asian 
 
 Black or African American 
 
 Native Hawaiian or Other Pacific Islander 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 30 of 43 
Template: CUSTOM 
 
13.3 COVID-19 RELATED SYMPTOMS 
 
Has the patient experienced any past and/or concomitant diseases related to COVID19? 
 Yes  
 No 
 
MH Number 
Medical History Term 
Number of Days Since Onset of 
Symptoms 
Ongoing 
1 
Fever 
 
 Yes 
 No 
2 
Cough 
 
 Yes 
 No 
3 
Fatigue 
 
 Yes 
 No 
4 
Decreased appetite 
 
 Yes 
 No 
5 
Shortness of breath 
 
 Yes 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 31 of 43 
 No 
6 
Chills 
 
 Yes 
 No 
7 
Muscle Aches 
 
 Yes 
 No 
8 
Sore Throat 
 
 Yes 
 No 
9 
Loss of smell 
 
 Yes 
 No 
10 
Loss of taste 
 
 Yes 
 No 
11 
Nausea 
 
 Yes 
 No 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
 
Template: CUSTOM 
 
13.4 MEDICAL HISTORY 
 
Did the patient provide additional medical history information? 
 Yes  
 No 
 
MH Number 
Medical History Term 
Check all that apply 
Ongoing 
1 
Addiction 
 
 Yes 
 No 
2 
Anemia 
 
 Yes 
 No 
3 
Anxiety 
 
 Yes 
 No 
4 
Arthritis 
 
 Yes 
 No 
5 
Asthma 
 
 Yes 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 33 of 43 
 No 
6 
Bipolar disorder 
 
 Yes 
 No 
7 
Congestive Heart Failure 
 
 Yes 
 No 
8 
COPD 
 
 Yes 
 No 
9 
Dementia 
 
 Yes 
 No 
10 
Depression 
 
 Yes 
 No 
11 
Diabetes Mellitus 
 
 Yes 
 No 
12 
GERD 
 
 Yes 
 No 
13 
Hepatitis 
 
 Yes 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 34 of 43 
 No 
14 
Hyperlipdemia 
 
 Yes 
 No 
15 
Hypertension 
 
 Yes 
 No 
16 
Irritable Bowel Syndrome 
 
 Yes 
 No 
17 
Migraine 
 
 Yes 
 No 
18 
Osteoporosis 
 
 Yes 
 No 
19 
Pulmonary Embolism 
 
 Yes 
 No 
20 
Seizures 
 
 Yes 
 No 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 35 of 43 
14 ASSESSMENTS 
Template: PC-01  
 
14.1 SAMPLE COLLECTION 
 
Were any samples collected? 
 Yes 
 No 
 
Check if 
Not 
Done 
Sample 
Collection Date 
(DD/MON/YYYY) 
Collection Time 
(HH:MM) 
If Not Done, indicate reason 
 
PCR 
Nasopharyngeal 
Swab. Sent to 
Laboratory 
/
/
 
:
 
 Informed consent withdrawn 
 Adverse Event 
 Other _____________________ 
 
DART 
Nasopharyngeal 
Swab  
/
/
 
:
 
 Informed consent withdrawn 
 Adverse Event 
 Other _____________________ 
 
Saliva. Sent to 
Laboratory 
/
/
 
:
 
 Informed consent withdrawn 
 Adverse Event 
 Other _____________________ 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 36 of 43 
 
Serum. Sent to 
Laboratory 
/
/
 
:
 
 Informed consent withdrawn 
 Adverse Event 
 Other _____________________ 
 
 
 
General Note: Per page 2 of protocol version 1, saliva is to be collected. 
 

 
Protocol Number: E25001 (NEU2012) 
 
Template: Custom 
 
14.2 DART DIPSTICK VISUAL ASSESSMENT 
Date of Dipstick Assessment (DD/MON/YYYY): 
/
/
 
 
Check if 
not done 
Protocol 
Timepoint 
Time of 
Dipstick 
Assessment 
(HH:MM): 
Result 
If the assessment was 
not done, what was the 
reason? 
 
15 
Minutes 
:
 
 Positive for COVID-19 (Two lines on dipstick) 
 Negative for COVID-19 (One line on dipstick) 
 Inconclusive 
 No result assessment done 
____________________ 
 
30 
Minutes 
:
 
 Positive for COVID-19 (Two lines on dipstick) 
 Negative for COVID-19 (One line on dipstick) 
 Inconclusive 
 No result assessment done 
____________________ 
 
If the assessment was inconclusive, was another sample collected? 
 Yes 
 No 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 38 of 43 
Check if 
not done 
Protocol 
Timepoint 
Time of 
Dipstick 
Assessment 
(HH:MM): 
Result 
If the assessment was 
not done, what was the 
reason? 
 
15 
Minutes 
:
 
 Positive for COVID-19 (Two lines on dipstick) 
 Negative for COVID-19 (One line on dipstick) 
 Inconclusive 
 No result assessment done 
____________________ 
 
30 
Minutes 
:
 
 Positive for COVID-19 (Two lines on dipstick) 
 Negative for COVID-19 (One line on dipstick) 
 Inconclusive 
 No result assessment done 
____________________
____ 
 
 
 
CP Note: This form will not be displayed if the Sample Collection CRF indicates that no DART Nasopharyngeal Swab was collected. 
 
 
 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 39 of 43 
Template: Custom 
 
14.3 PCR RESULT 
Date of PCR Result (DD/MON/YYYY): 
/
/
Time of PCR Result (HH:MM): 
:
 
Which PCR Platform was used for analysis? 
 Abbott m2000 System 
 Other, Specify: _______________________________________________________________________ 
What was the PCR test result? 
 Positive for COVID-19 
 Presumptive Positive for COVID-19 
 Negative for COVID-19 
 Invalid 
 Other, Specify: _______________________________________________________________________ 
 
Ct Value: 
 
 
If the assessment was not done, what was the reason?  _____________________________________________________ 
 
 
CP Note: This form will not be displayed if the Sample Collection CRF indicates that no PCR Nasopharyngeal Swab was collected. 

 
Protocol Number: E25001 (NEU2012) 
 
15 ADVERSE EVENTS 
Template: AE-02  
15.1 ADVERSE EVENTS 
 
Were any adverse events experienced between informed consent and 30 minutes post sample collection? 
 Yes  
 No 
 
 
AE Number: 
 
 
Adverse Event 
____________________ 
 
Start Date (DD/MON/YYYY) 
Start Time 
(HH:MM) 
Outcome Post Swab 
Toxicity Grade 
Relationship to 
Study Intervention 
Action Taken with Sample 
Collection 
Serious 
If SAE, 
criteria met 
for IRB 
submission? 
/
/
 
:
 
 Fatal 
 Not Recovered or Not Resolved 
 Recovered or Resolved 
 Recovered or Resolved with Sequelae 
 Recovering or Resolving 
 Unknown 
 Grade 1 
 Grade 2 
 Grade 3 
 Grade 4 
 Grade 5 
 Related 
 Possibly Related 
 Not Related 
 No Action 
 Collection Interrupted 
 Collection Discontinued 
 Yes 
 No 
 Yes 
 No 

 
Protocol Number: E25001 (NEU2012) 
black font = CDASH standard, red font = SCRI Standard 
Page 41 of 43 
/
/
 
:
 
 Fatal 
 Not Recovered or Not Resolved 
 Recovered or Resolved 
 Recovered or Resolved with Sequelae 
 Recovering or Resolving 
 Unknown 
 Grade 1 
 Grade 2 
 Grade 3 
 Grade 4 
 Grade 5 
 Related 
 Possibly Related 
 Not Related 
 No Action 
 Collection Interrupted 
 Collection Discontinued 
 Yes 
 No 
 Yes 
 No 
/
/
 
:
 
 Fatal 
 Not Recovered or Not Resolved 
 Recovered or Resolved 
 Recovered or Resolved with Sequelae 
 Recovering or Resolving 
 Unknown 
 Grade 1 
 Grade 2 
 Grade 3 
 Grade 4 
 Grade 5 
 Related 
 Possibly Related 
 Not Related 
 No Action 
 Collection Interrupted 
 Collection Discontinued 
 Yes 
 No 
 Yes 
 No 
/
/
 
:
 
 Fatal 
 Not Recovered or Not Resolved 
 Recovered or Resolved 
 Recovered or Resolved with Sequelae 
 Recovering or Resolving 
 Unknown 
 Grade 1 
 Grade 2 
 Grade 3 
 Grade 4 
 Grade 5 
 Related 
 Possibly Related 
 Not Related 
 No Action 
 Collection Interrupted 
 Collection Discontinued 
 Yes 
 No 
 Yes 
 No 
 
General Notes: 
One CRF page should be used per unique (contiguous) AE 
One row should be added each time the grade or seriousness changes 
Only Adverse Events that occur between informed consent and 30 mins post sample collection will will be collected. 

A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test “DART” 
Version 2 
Protocol E25001 
19Apr2020 
 
Confidential 
 
1 
 
16 SUBJECT STATUS 
Template: EOS-01  
16.1 END OF STUDY  
 
What was the date of study discontinuation (DD/MON/YYYY)? 
/
/
 
 
What was the patient’s reason for study discontinuation? 
 
 Completed 
 Study Terminated by Sponsor 
 Informed Consent Withdrawn 
 Other, Specify:____________________