A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19
Phase: PHASE2
Conditions: Covid19, SARS-CoV Infection
Sponsor: Partner Therapeutics, Inc.

A randomized Phase 2b trial evaluating clinical outcomes of inhaled 
sargramostim in high-risk patients with mild-moderate COVID-19 
Sargramostim use in COVID-19 to Recover Patient Health (SCOPE) 
Protocol Number: PTX-001-003 
Study Drug: sargramostim 
Version Number: 4.0 
Version Date: August 23, 2021 
IND Number: 149323 
Principal Investigator 
 MD 
Sponsor 
Partner Therapeutics, Inc. 
Sponsor address 
19 Muzzey Street, Lexington, MA 02421 
Medical Monitor 
 MD 
Partner Therapeutics, Inc. 
Protocol History 
Version number 
Version date 
V1.0 
December 23, 2020 
V2.0 
February 16, 2021 
V3.0 
May 04, 2021 
V4.0 
August 23, 2021 
Property of Partner Therapeutics, Inc. May not be used, divulged, published, or otherwise disclosed without the 
consent of Partner Therapeutics, Inc. 
Leukine is a registered trademark licensed to Partner Therapeutics Inc. PARTNER THERAPEUTICS and 
 are 
registered trademarks of Partner Therapeutics, Inc. © 2020 Partner Therapeutics Inc. All rights reserved. 
NCT04707664

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TABLE OF CONTENTS 
PROTOCOL APPROVAL SIGNATURE PAGE ........................................................................................................... 5 
INVESTIGATOR SIGNATURE PAGE ....................................................................................................................... 6 
 
1 
STUDY SYNOPSIS ....................................................................................................................................... 8 
2 
SCHEMATIC OF STUDY DESIGN ................................................................................................................. 14 
3 
ABBREVIATIONS ....................................................................................................................................... 15 
4 
BACKGROUND.......................................................................................................................................... 17 
4.1 
SARGRAMOSTIM ................................................................................................................................................ 17 
4.2 
ROLE OF GM-CSF IN LUNG FUNCTION AND DISEASE ................................................................................................ 17 
4.3 
USE OF SARGRAMOSTIM IN CONDITIONS THAT ARE SIMILAR TO COVID-19 ARDS .......................................................... 18 
4.4 
RECENT TRANSLATIONAL DATA IN COVID-19 ......................................................................................................... 19 
4.5 
CLINICAL EXPERIENCE OF INHALED SARGRAMOSTIM .................................................................................................. 20 
4.6 
USE OF SARGRAMOSTIM INHALATION IN COVID-19 ................................................................................................. 21 
5 
OBJECTIVES .............................................................................................................................................. 23 
5.1 
PRIMARY OBJECTIVE ........................................................................................................................................... 23 
5.2 
SECONDARY OBJECTIVES ...................................................................................................................................... 23 
5.3 
EXPLORATORY OBJECTIVE .................................................................................................................................... 23 
6 
STUDY DESIGN ......................................................................................................................................... 24 
6.1 
STUDY DESCRIPTION ........................................................................................................................................... 24 
6.2 
RANDOMIZATION ............................................................................................................................................... 24 
6.2.1 
Emergency Unblinding ......................................................................................................................... 24 
6.2.2 
Replacement of Ineligible Patients ....................................................................................................... 25 
7 
ELIGIBILITY CRITERIA ................................................................................................................................ 25 
7.1 
INCLUSION CRITERIA ........................................................................................................................................... 25 
7.2 
EXCLUSION CRITERIA ........................................................................................................................................... 26 
8 
DRUG INFORMATION ............................................................................................................................... 26 
8.1 
TREATMENT REGIMEN ......................................................................................................................................... 26 
8.1.1 
Dose Modifications .............................................................................................................................. 27 
8.2 
CONCOMITANT MEDICATIONS AND MEDICAL PROCEDURES ........................................................................................ 27 
8.2.1 
Permitted therapies ............................................................................................................................. 27 
8.2.2 
Prohibited therapies in the outpatient setting ..................................................................................... 27 
8.2.3 
COVID-19 Vaccination .......................................................................................................................... 27 
9 
STUDY EFFICACY AND SAFETY ASSESSMENTS AND PROCEDURES .............................................................. 28 
9.1 
STUDY VISITS ..................................................................................................................................................... 28 
9.2 
ORDINAL SCALE ................................................................................................................................................. 28 
9.3 
SYMPTOM QUESTIONNAIRE, PATIENT GLOBAL IMPRESSION, AND DAY 60 SYMPTOM EVALUATION .................................... 28 
9.4 
PHYSICAL EXAMINATIONS ..................................................................................................................................... 29 
9.5 
VITAL SIGNS AND PULSE OXIMETRY ....................................................................................................................... 29 
9.6 
CLINICAL LABORATORY ASSESSMENTS .................................................................................................................... 30 
9.7 
PREGNANCY TESTING .......................................................................................................................................... 30 

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9.8 
EMERGENCY ROOM VISIT, HOSPITALIZATIONS AND DEATHS ........................................................................................ 30 
9.9 
SARS-COV-2 VARIANT ASSESSMENT ..................................................................................................................... 31 
9.10 
EXPLORATORY BIOMARKER ASSESSMENTS .......................................................................................................... 31 
9.10.1 
SARS-CoV-2 Viral Load Assessment ................................................................................................. 31 
9.10.2 
Anti-SARS-CoV-2 Antibody Assessments ......................................................................................... 31 
9.10.3 
Immunophenotyping for Cellular Immunity .................................................................................... 31 
9.10.4 
Sargramostim Immunogenicity Assessment ................................................................................... 31 
10 
SAFETY MONITORING............................................................................................................................... 32 
10.1 
DEFINITIONS ................................................................................................................................................. 32 
10.1.1 
Adverse Event .................................................................................................................................. 32 
10.1.2 
Serious Adverse Events .................................................................................................................... 32 
10.2 
SAFETY REPORTING ........................................................................................................................................ 33 
10.2.1 
Adverse Event Reporting ................................................................................................................. 33 
10.2.2 
Attribution of the AE ....................................................................................................................... 33 
10.2.3 
Grading of Adverse Events .............................................................................................................. 33 
10.2.4 
Serious Adverse Event Reporting..................................................................................................... 34 
10.2.5 
Pregnancy ....................................................................................................................................... 35 
10.3 
EXPECTED AND UNEXPECTED TOXICITIES ............................................................................................................ 35 
11 
SCHEDULE OF EVENTS AND STUDY PARAMETERS ..................................................................................... 36 
12 
RISKS AND TOXICITIES .............................................................................................................................. 37 
12.1 
OVERDOSE ................................................................................................................................................... 37 
12.2 
PREGNANCY ................................................................................................................................................. 37 
12.3 
PREGNANCY RISK SUMMARY ............................................................................................................................ 37 
12.4 
CONTRACEPTIVE GUIDANCE ............................................................................................................................. 37 
13 
STUDY DURATION AND EARLY TERMINATION .......................................................................................... 38 
13.1 
TREATMENT DISCONTINUATION CRITERIA ........................................................................................................... 38 
13.2 
TREATMENT PERIOD (DAYS 1-5) ...................................................................................................................... 39 
13.3 
POST-TREATMENT PERIOD (DAYS 6-60) ............................................................................................................ 39 
13.4 
STUDY COMPLETION ...................................................................................................................................... 39 
14 
STATISTICAL PLAN .................................................................................................................................... 39 
14.1 
SAMPLE SIZE ................................................................................................................................................. 39 
14.2 
GENERAL STATISTICAL METHODS ...................................................................................................................... 40 
14.3 
ANALYSIS SETS .............................................................................................................................................. 40 
14.4 
EFFICACY ANALYSIS ........................................................................................................................................ 41 
14.4.1 
Description of Patient Population ................................................................................................... 41 
14.4.2 
Primary Endpoint ............................................................................................................................ 41 
14.4.3 
Secondary Endpoints ....................................................................................................................... 42 
14.4.4 
Subgroup Analysis and Adjustment for Covariates ......................................................................... 43 
14.5 
SAFETY ANALYSES .......................................................................................................................................... 44 
15 
DATA AND SAFETY MONITORING BOARD ................................................................................................. 44 
16 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ....................................................................................... 45 
17 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................................................... 45 
18 
ETHICS ..................................................................................................................................................... 46 
18.1 
INFORMED CONSENT ...................................................................................................................................... 46 

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19 
DATA HANDLING AND RECORD KEEPING .................................................................................................. 46 
20 
FINANCING AND INSURANCE .................................................................................................................... 47 
21 
PUBLICATION POLICY ............................................................................................................................... 47 
22 
REFERENCES ............................................................................................................................................. 48 
APPENDIX A: 
NIAID ORDINAL SCALE ............................................................................................................ 55 
APPENDIX B: 
SYMPTOM SCORE QUESTIONNAIRE ........................................................................................ 56 
APPENDIX C: 
PATIENT GLOBAL IMPRESSION ................................................................................................ 59 
APPENDIX D: 
DAY 60 COVID-19 SYMPTOM EVALUATION ............................................................................. 60 
LIST OF TABLES 
Table 1: 
Schedule of Events ............................................................................................. 36 
LIST OF FIGURES 
Figure 1: 
GM-CSF modulates immune response to influenza virus infection (45). ........... 18 

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PROTOCOL APPROVAL SIGNATURE PAGE 
Protocol Number: PTX-001-003 
A randomized Phase 2b trial evaluating clinical outcomes of inhaled 
sargramostim in high-risk patients with mild-moderate COVID-19 
SCOPE Study 
I acknowledge that this study protocol contains all necessary details for my staff and me to conduct the 
study as described. I will conduct this study in compliance with all applicable regulations and guidelines, 
as stated in the protocol and other information supplied to me. 
Partner Therapeutics Chief 
Medical Officer: 
Signature: 
Signature Date: 

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INVESTIGATOR SIGNATURE PAGE 
Protocol Number: PTX-001-003 
A randomized Phase 2b trial evaluating clinical outcomes of inhaled 
sargramostim in high-risk patients with mild-moderate COVID-19 
SCOPE Study 
I acknowledge that this study protocol contains all necessary details for my staff and me to conduct the 
study as described. I will conduct this study in compliance with all applicable regulations and guidelines, 
as stated in the protocol and other information supplied to me. 
Site Principal Investigator: 
Signature: 
Signature Date: 

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1 
STUDY SYNOPSIS 
Sponsor: 
Partner Therapeutics, Inc. 
Name of Medical Products: 
sargramostim 
Study Phase: 
Phase 2b 
Study Title 
A randomized Phase 2b trial evaluating clinical outcomes of inhaled sargramostim in high-risk patients with mild-
moderate COVID-19 
Study Center(s) 
Up to approximately 50 sites (US and outside US) 
Study Design 
This Phase 2b, multicenter, placebo-controlled, double-blind study will randomize approximately 500 adult 
patients who are symptomatic with mild or moderate COVID-19 (as defined in the Food and Drug Administration 
(FDA) Guidance Document: Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, May 
2020) who are at high risk for progression to more severe disease. Patients will be randomized in a 1:1 ratio to 
inhaled sargramostim plus standard of care (SOC) or placebo plus SOC. Enrollment of patients who have completed 
a COVID-19 vaccination regimen or participated in a COVID-19 vaccine clinical trial will be capped at approximately 
100 patients. 
All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo diluent. 
Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer. Additional blood 
samples will be collected for biomarker assays for approximately 100 randomized patients (approximately 50 from 
each treatment group). 
Patients will be followed for up to 60 days after start of treatment. 
An interim safety and benefit/risk review will be performed by a data safety monitoring board (DSMB) after a total 
of approximately 100 patients (total of both arms) complete through Day 28 (or withdraw from study prior to Day 
28). 
Primary Objective 
Primary Outcome Measure 
To evaluate if inhaled sargramostim can 
prevent progression to more severe disease 
in an outpatient setting in symptomatic 
patients with mild or moderate COVID-19 
who are at higher risk for progression to 
more severe disease 
Proportion of patients who experience any emergency room 
visit or hospitalization, or death by Day 28. 
Secondary Objectives 
Secondary Outcome Measures 
To evaluate the effect of inhaled sargramostim 
on clinical progression of COVID-19 
Proportion of patients with any progression of disease as 
determined by a ≥ 2-point increase from baseline in the NIAID 
ordinal scale up to Day 28, and Day 60 
Time to progression of disease as determined by a ≥ 2-point 

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increase in the NIAID ordinal scale up to Day 28, and Day 60 
Change from baseline in overall symptom score, and individual 
symptom scores, as measured by the Symptom Score 
Questionnaire up to Day 28. 
To 
evaluate 
the 
safety 
of 
inhaled 
sargramostim in patients with COVID-19 
Adverse events (AE) up to Day 60. 
 
Exploratory Objective 
Exploratory Outcome Measures 
To explore the effect of inhaled sargramostim 
on biological responses to COVID-19.  
Proportion of patients requiring supplemental oxygen up to 
Day 28 
The effect of sargramostim on SARS-CoV-2 viral load in 
samples collected from nasopharyngeal swabs up to Day 14 
(biomarker cohort only) 
Proportion of patients with generation of SARS-CoV-2 
antibody up to Day 28 (biomarker cohort only) 
Proportion of patients with markers of cellular immunity, via 
immunophenotyping, up to Day 14 (biomarker cohort only) 
Levels of ferritin, c-reactive protein (CRP), d-Dimer up to Day 
28 
Immunogenicity to sargramostim up to Day 28 (biomarker 
cohort only) 
Presence or absence of COVID-19 symptoms at Day 60 
Inclusion Criteria 
Clinical significance of underlying medical conditions and judgements related to the best interests of the patient 
are determined by the investigator. Sponsor consultation with the medical monitor is encouraged where there is 
a concern. 
1. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or a molecular test ≤5 
days prior to randomization. The test should have been authorized by the relevant regulatory authority. 
2. Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 days prior to 
randomization: 
a) Fever or chills 
b) New onset or worsening cough 
c) Sore throat 
d) Malaise or fatigue 
e) Headache 
f) 
Muscle pain (myalgias) or body aches 
g) Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 

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h) New onset or worsening shortness of breath or difficulty breathing 
i) 
Nasal congestion or runny nose 
j) 
New loss of taste (ageusia) and/or smell (anosmia). Note: any of these symptoms (ageusia, anosmia) 
alone or in combination cannot be used as the SOLE qualifying symptoms for enrollment. 
3. At higher risk for progression to more severe COVID-19 
a) Age ≥ 60 years 
b) Age 18-59 years with a clinically stable medical history of at least 1 or more of the following 
conditions that could lead to severe COVID-19: 
 
Chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease 
(COPD), pulmonary fibrosis 
 
Obesity with BMI ≥ 30 kg/m2 
 
Cardiovascular disease 
 
Sickle cell disease or thalassemia 
 
Diabetes mellitus being managed with concomitant medications 
 
Hypertension being managed with concomitant medications 
 
Chronic kidney disease 
4. Oxygen saturation by pulse oximeter > 93% on room air. Note: at altitudes of >4000 feet above sea level, 
oxygen saturation by pulse oximeter > 91% on room air is permitted 
5. Negative pregnancy test (if woman of childbearing potential) 
6. Females of childbearing potential and males with female partners of childbearing potential must agree to 
use acceptable contraceptive methods (from screening to Day 28) 
7. The patient (or legally authorized decision maker) must give informed consent  
Exclusion Criteria 
1. Hospitalized patients 
2. Patients who have received or are receiving treatments that are not approved/authorized  by the 
relevant regulatory authority for the treatment of patients with mild or moderate COVID-19 in an 
outpatient setting 
3. Patients enrolled in interventional clinical trials for other experimental therapies 
4. Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 
5. Patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, COPD with 
exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, 
uncontrolled asthma) 
6. Patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, 
systemic steroid-dependent COPD, oxygen-dependent COPD, lung transplant, or cystic fibrosis 
7. Patients who have received highly immunosuppressive therapy (to include systemic corticosteroids) or 
anti-cancer combination chemotherapy within 24 hours prior to first dose of study drug 
8. Patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of 

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the product 
9. Patients who have previously experienced severe and unexplained side effects during aerosol delivery of 
any kind of medical product 
10. Pregnant or breastfeeding females 
11. Patients who, in the opinion of the Investigator, will not be able to comply with all the study procedures 
and visits as outlined in the schedule of events, including follow-up 
Patient population: 
Adult non-hospitalized patients with mild-moderate COVID-19 without hypoxemia and at higher risk for 
progression to severe COVID-19 due to advanced age or comorbidities. 
Rationale: 
COVID-19 is a disease caused by the recently discovered coronavirus designated SARS-CoV-2. COVID- 19 is highly 
contagious and generally causes fever and respiratory symptoms in symptomatic individuals. Additional 
symptoms are gastrointestinal, cardiac, taste and smell abnormalities, and neurological. The disease spectrum 
varies from asymptomatic infection through fatal pneumonia and multiorgan failure. Older adults and 
individuals with significant comorbidities, including cardiorespiratory diseases, diabetes, obesity, and 
hypertension, are most severely affected. 
Few medications are currently available to treat COVID-19. Remdesivir, dexamethasone, and intravenous 
antibody treatments have been authorized for critically ill, hospitalized COVID-19 patients, but an easily 
administered outpatient medication for treatment of COVID-19 is a major unmet medical need. 
Sargramostim (Leukine) is a formulation of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), 
which is a critical cytokine for healthy pulmonary function. Detailed studies have shown that GM-CSF is 
necessary for alveolar macrophage (AM) maturation and maintenance. Although GM-CSF was discovered as a 
myelopoietic growth factor, it has diverse additional effects that both promote differentiation of myeloid 
precursors into neutrophils, monocytes, and dendritic cells and control function of mature myeloid cells. GM-
CSF is also known to reverse immunoparalysis seen in sepsis, resulting in beneficial outcomes. In addition, GM-
CSF prevents bacteremia in post influenza bacterial pneumonia through locally mediated improved lung 
antibacterial resistance; and increased reactive oxygen species production by AMs. Pulmonary delivery of this 
GM-CSF has potential to reduce morbidity and mortality due to viral pneumonias, potentially including 
COVID-19. 
Safety and efficacy of inhaled sargramostim 125 mcg have been evaluated in several clinical studies. In one 
clinical study of six patients with moderate to severe community-acquired pneumonia or ventilator-associated 
pneumonia acute respiratory distress syndrome (ARDS), 125 mcg of sargramostim was administered by an 
Aeroneb Solo nebulizer device (Covidien, Neustadt, Germany) at an interval of 48 hours for 2 doses. At this dose, 
a significant improvement of oxygenation in response to sargramostim inhalation (p=0.0035), with no drug-
related toxicity, was observed. Inhaled sargramostim has been evaluated at doses higher than 125 mcg in 
patients with autoimmune pulmonary alveolar proteinosis (aPAP). 
Patients with aPAP have extremely high titers of anti-GM-CSF antibodies, which sequesters native GM-CSF leading 
to accumulation of surfactant in alveolar sacs with resultant hypoxia. To overcome high anti-GM-CSF antibody 
levels in aPAP patients, sargramostim has been administered at doses of up to 500 mcg total daily dose, although 
daily doses of 125 mcg and 250 mcg have been used and associated with improvement in clinical outcome. Given 
demonstrated efficacy of 125 and 250 mcg doses, 125 mcg is considered a minimally effective dose when treating 
viral-related diseases. In PTX-001-002 (NCT04411680), inhaled sargramostim at a dose of 125 mcg twice daily was 
administered for up to 5 days. In this study, a DSMB has conducted four safety reviews (as of January 2021), and 
no changes to the study have been required. 

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Number of Patients: 
Approximately 500 patients will partake in this study. Approximately 250 patients will receive sargramostim and 
approximately 250 patients will receive placebo. Enrollment of patients who have completed a COVID-19 
vaccination regimen or participated in a COVID-19 vaccine clinical trial will be capped at approximately 100 
patients 
Duration of Therapy 
All randomized patients receive sargramostim or placebo for the duration the treatment period (Day 1 - 5), unless 
the patient has unacceptable toxicity to study treatment; the patient, legally authorized decision maker or 
Investigator decides to discontinue; or the patient has rapid clinical deterioration not conducive to continued 
study treatment; pregnancy; or death. 
Day 1 is the day the patient receives their first dose of study treatment. 
All patients should continue to receive SOC for their underlying comorbidities during the study. All patients may 
receive supportive care for signs and symptoms of COVID-19, per their study site's institutional standards. The 
post-treatment period (Days 6-60) will continue until completion of all safety and efficacy assessments on Day 60 
(end of study). 
Patients who need to start a COVID-19 vaccination regimen, can do so only after Day 21 of the study. 
All patients, including those who discontinue treatment early, will be followed for outcome measures until Day 
60. 
Duration of Follow-Up 
Patient follow-up will cease upon completion of all safety and efficacy assessments on Day 60. 
Duration of Study 
Study completion is defined as the date when the last patient completes the Day 60 visit or an early termination 
visit. Alternatively, the study may be stopped earlier for reasons such as poor enrollment, or ethical or safety 
reasons. 
Test Product/Device, Dose, and Mode of Administration: 
All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo 
diluent.  Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer. Patients 
will be observed in the clinic for approximately 30 minutes after the completion of the drug administration. 
Safety Assessments 
Patients will be followed for clinical and laboratory AEs throughout the course of the study according to the 
schedule of events. All clinical laboratory assessments will be performed at a central laboratory, except for urine 
pregnancy test and initial diagnostic SARS-CoV-2 test used for study inclusion. 
• 
Hematology laboratory parameters will include complete blood count with differential, 
hemoglobin, hematocrit, and absolute counts for white blood cells, platelets, neutrophils, 
lymphocytes, eosinophils, and monocytes 
• 
Chemistry laboratory parameters will include albumin, blood urea nitrogen, creatinine, alanine 
aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, direct 

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and total bilirubin, glucose, total protein, sodium, potassium, chloride, bicarbonate, calcium, and uric 
acid 
• 
Additional laboratory parameters will include serum ferritin, d-Dimer, and CRP 
• 
Vital sign assessments will include body temperature, blood pressure, pulse rate, and  respiration rate  
• 
Pulse oximetry 
• 
Physical examination 
Efficacy Assessments 
Efficacy data will include the following: 
• 
Need for emergency room visit or hospitalization 
• 
The NIAID ordinal scale 
• 
Evaluation of symptoms using a symptom score, patient global impression, and Day 60 COVID-19 
symptom evaluation questionnaires 
 
Exploratory Assessments 
In approximately 100 patients (approximately 50 from each treatment group), the following will be performed: 
• 
Nasal swab for SARS-CoV-2 viral RNA level and viral clearance 
• 
Blood sample collection for biomarker assays including 
• 
Antibody production against SARS-CoV-2 
• 
Immunophenotyping for cellular immunity, 
• 
Sargramostim anti-drug antibodies 
Statistical Plan 
The primary efficacy endpoint, proportion of patients who experience any emergency room visit or 
hospitalization, or death will be compared using logistic regression stratified by the factors used to randomize 
patients (full analysis set). Additionally, the primary analysis will be repeated in the modified intention to treat 
population. 
Key secondary endpoints summarized using proportions will be tested using a logistic regression model. Time to 
event endpoints will be analyzed using the stratified log-rank test with Kaplan-Meier curves used to descriptively 
summarize the data (hazard ratio estimate from Cox Regression). Change from baseline in the overall symptom 
questionnaire score, and individual symptom scores from baseline to Day 28 and Day 60 will be analyzed using a 
mixed model repeated measures analysis with the missing at random assumption for handling missing data. All 
randomized patients will be included in the analysis of the key secondary endpoints. 
 As this is a Phase 2b study; no adjustments for multiple comparisons will be made.   
 
 
 

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2 
SCHEMATIC OF STUDY DESIGN 
 
 
 
Informed Consent 
and Screening
1:1 Randomization
Sargramostim Arm 
N=250
Days 1-5 
Sargramostim 
Treatment
Days 6-60 
Post-treatment 
Period
Placebo Arm
N=250
Day 1-5 
Placebo 
Treatment
Days 6-60
Post-treatment 
Period

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3 
ABBREVIATIONS 
ADL 
Activities of Daily Living 
AE 
Adverse Event 
AEC 
Alveolar Epithelial Cell 
AM 
Alveolar Macrophage 
aPAP 
Autoimmune Pulmonary Alveolar Proteinosis 
ARDS 
Acute Respiratory Distress Syndrome 
CD 
Cluster of Differentiation 
CFR 
Code of Federal Regulations 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF/eCRF 
Case Report Form/electronic Case Report Form 
CRP 
c-reactive Protein 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GM-CSF 
Granulocyte-Macrophage Colony-Stimulating Factor 
HHC 
Home Health Care 
HLA-DR 
Human Leukocyte Antigen – DR Isotype 
ICH 
International Council for Harmonization of Technical Requirements for Pharmaceuticals for 
Human Use 
IFN 
Interferons 
IL 
Interleukin-1 

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IRB 
Institutional Review Boards 
IV 
Intravenous 
mITT 
Modified Intention to Treat 
NK 
Natural Killer (cells) 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SARS-CoV 
Severe Acute Respiratory Syndrome (SARS)-associated Coronavirus 
SOC 
Standard of Care 
TM 
Telemedicine 
TNF-α 
Tumor Necrosis Factor alpha 
US 
United States 
WOCBP 
Women of Childbearing Potential 
 
 
 

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4 
BACKGROUND 
4.1 
Sargramostim 
Sargramostim (Leukine®), a recombinant human granulocyte-macrophage colony-stimulating factor 
(GM-CSF), was approved in 1991 (29). In addition to hematopoietic growth factor activity, GM-CSF has 
diverse effects on differentiation and function of myeloid cells, including capacities for phagocytosis and 
antigen presentation (70). Importantly, the Leukine® systemic safety profile is well characterized. Over 
500,000 recipient patients provide extensive clinical and post-marketing data across disease states in 
diverse groups, including neonates and the elderly. 
4.2 
Role of GM-CSF in Lung Function and Disease 
GM-CSF plays a vital role in healthy pulmonary function. Alveolar macrophage (AM) maturation from fetal 
monocytes and maintenance in adulthood both rely on GM-CSF (15, 20). GM-CSF released from alveolar 
epithelial cells (AECs) ensures effective viral and surfactant clearance by AMs fostering maintenance of 
optimal gas exchange. GM-CSF neutralization by specific antibodies leads to the rare lung disease 
pulmonary alveolar proteinosis in which alveolar surfactant accumulation results in hypoxia. 
AEC-expressed GM-CSF stimulates macrophages to generate healing effects on injured epithelium by 
orchestrating epithelial proliferation and barrier repair (54, 55). Additionally, GM-CSF signals B1a B cells 
to secrete polyreactive emergency immunoglobulin M and ensures effective early frontline defense 
against bacterial lung invasion (65). GM-CSF has been shown to be protective in models of acute lung 
injury (52). During oxidative stress, GM-CSF protects AECs against apoptosis resulting from mitochondrial 
injury via induction of anti-apoptotic Mcl-1 and activation of the Akt pathway. Finally, inhaled GM-CSF 
prevents systemic bacteremia in post influenza bacterial pneumonia, primarily via locally mediated lung 
infection resistance (51, 60), as well as by increased production of reactive oxygen species by AMs (54). 
GM-CSF has been shown to reverse immunoparalysis seen in sepsis by immune activation (32, 34). 
Animal model studies demonstrate GM-CSF activity against acute respiratory distress syndrome (ARDS) 
and infections. In vivo airway GM-CSF rescues mice from lethal influenza pneumonia and reduces 
inflammation-induced damage from influenza A (22). Similarly, GM-CSF–dependent crosstalk between 
influenza virus infected AECs and cluster of differentiation (CD)103+ dendritic cells promote viral 
clearance and recovery, suggesting GM-CSF utility for severe influenza virus pneumonia (61). GM-CSF 
conferred resistance to influenza in mice via AMs that became more resistant to influenza- induced 
apoptosis. Delivery of intranasal GM-CSF to wild-type mice also conferred resistance to influenza (27). 
In conclusion, GM-CSF confers resistance to influenza by enhancing innate immune mechanisms that 
depend on AMs for health and normal function. Pulmonary sargramostim delivery has potential to reduce 
morbidity and mortality due to viral pneumonia, as displayed in  Figure 1. 

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Figure 1: 
GM-CSF modulates immune response to influenza virus infection (45).  
After pulmonary influenza virus infection GM-CSF is released from AEC II, mediated through HGF/c-
Met and TGF-α/EGFR signaling. In an autocrine manner, it stimulates epithelial repair, including 
epithelial proliferation and barrier restoration. Via PU.1, GM-CSF improves AM resistance, 
maturation, ROS production, and phagocytosis capacity, e.g., by the FcγR-mediated 
opsonophagocytosis. GM-CSF stimulates activation and proliferation of DC, especially CD103+ DC, 
and T cells and enhances antigen priming and influenza virus-specific CD8+ T cell recruitment. 
Innate and adaptive immunity are activated, resulting in accelerated viral clearance. Altogether 
AECs GM-CSF leads to increased survival and reduced lung injury. 
[AEC alveolar epithelial cells, AM alveolar macrophage, c-Met hepatocyte growth factor receptor, 
DC dendritic cells, EGFR epithelial growth factor receptor, FcγR Fcɣ receptor, GM-CSF granulocyte-
macrophage colony-stimulating factor, HGF hepatocyte growth factor, PU.1 transcription factor 
PU.1, ROS reactive oxygen species, TGF-α transforming growth factor α]. 
4.3 
Use of sargramostim in conditions that are similar to COVID-19 ARDS 
A double-blind randomized placebo-controlled trial (N=18) of low-dose (3 mcg/kg daily for 5 days) 
intravenous (IV) GM-CSF in adults with sepsis and respiratory dysfunction showed that GM-CSF treatment 
led to improved gas exchange (40). A Phase II randomized placebo-controlled trial (N=130) in patients 
with sepsis and respiratory dysfunction studied IV sargramostim (250 mcg/m2 daily for 14 days). Improved 
28-day mortality on sargramostim was observed but did not reach statistical significance (36). In a clinical 
study of six patients with moderate to severe community- acquired pneumonia or ventilator-associated 
pneumonia ARDS, 125 mcg of sargramostim was administered by an Aeroneb Solo nebulizer device 
(Covidien, Neustadt, Germany) at an interval of 48 hours for 2 doses (25). At this dose, a significant 
improvement of oxygenation in response to sargramostim inhalation (p=0.0035), with no drug-related 
toxicity, was observed. There was improvement in morbidity using standard scoring systems, and four of 
six patients recovered and were discharged from the hospital. 
Six additional trials evaluated sargramostim given by IV, subcutaneous, or inhaled routes in critically ill 
patients. These trials monitored systemic cytokines, markers of inflammation, and safety (21, 25, 34, 36, 

S C O P E P R O T O C OL | P art n er T h er a p e utics, I nc . 
 
V 4 . 0 
Pr o p erty of P art n er T h er a p e utics, I nc.  
Versi o n D at e: 2 3 A u g ust  2 0 2 1  
Strictl y C o nfi d e nti al  
1 9  of 6 1  
3 8, 4 4) . N o n e of t h es e st u di es s h o w e d a n i ncr e as e i n s yst e mic c yt o ki n es, i ncl u di n g i nt erl e u ki n (IL)-6, IL -8, 
IL-1 β, IL -1 0, t u m or n ecr osis f act or ( T N F) α, G M -C S F, a n d IL -1 2 -p 7 0, tr e at m e nt -r el at e d or g a n t oxicity, or 
i ncr e as e d r at es of tr e at m e nt-r el at e d s eri o us a d v ers e e v e nts ( S A E). I n st u di es m o nit ori n g IL-6, a k e y dri v er 
of  c yt o k i n e  st or m,  n o  c h a n g es  i n  s yst e mic  IL-6  l e v els  w er e  o bs er v e d.  T h es e  d at a  s u p p ort  t h at  
s ar gr a m osti m  d o es  n ot  i ncr e as e  t h e  ris k  of  c yt o ki n e  st or m  i n  critic all y  ill  p ati e nts.  Evi d e nc e  of  
s ar gr a m osti m cli nic al acti vit y w as o bs er v e d. 
4. 4  
R ec e nt Tr a nsl ati o n al D at a i n  C O VI D -1 9  
S e v er e ac ut e r es pir at or y s y n dr o m e ( S A R S) -ass oci at e d C or o n a vir us ( S A R S -C o V) -2 r e plic ati o n g e n er at e d 
li mit e d a nti vir al r es p o ns es i n b ot h a h u m a n l u n g al v e ol ar c arci n o m a c ell li n e a n d i n vi v o i n f err ets ( 4). Als o, 
h u m a n ex vi v o l u n g tiss u e ex pl a nts c h all e n g e d b y S A R S -C o V -2 or S A R S -C o V r e v e al e d hi g h er a m o u nts of 
vir us  wit h  l o w er  i nt erf er o ns  (I F Ns)  a n d  pr o - i nfl a m m at or y  c yt o ki n es/c h e m o ki n es  o n  S A R S-C o V -2 
c h all e n g e, s u g g esti n g a v oi d a nc e of i n n at e i m m u n e d et ecti o n (1 3 ). E arl y p h as e i m m u n e e v asi o n m a y all o w 
u nc h ec k e d S A R S -C o V -2 r e plic ati o n i n t h e r es pir at or y tr act, l e a di n g t o hi g h vir al l o a d a n d as y m pt o m atic 
p ers o n -t o-p ers o n tr a ns missi o n ( 6 6). M ost, b ut n ot all h os pit aliz e d p ati e nts s e e m t o m o u nt b ot h C D 8 + a n d 
C D 4 + T c ell r es p o ns es. H o w e v er, s u b o pti m al, exc essi v e, or ot h er wis e i n a p pr o pri at e T c ell r es p o ns es h a v e 
b e e n ass oci at e d wit h s e v er e dis e as e ( 8). Al o n g wit h i ncr e as e d s yst e mic c yt o ki n es, a d ecr e as e i n bl o o d 
i m m u n e c ell p o p ul ati o ns s uc h as C D 4, C D 8 a n d n at ur al kill er ( N K) c ells w er e i d e ntifi e d as ris k f act ors f or 
c yt o ki n e st or m i n C O VI D-1 9 -i nf ect e d p n e u m o ni a p ati e nts ( 9, 4 6, 6 4). A d diti o n all y, N K c ells a n d c yt ot oxic 
l y m p h oc yt es a p p e ar e d t o b e ex h a ust e d wit h r e d uc e d a bilit y t o pr o d uc e C D 1 0 7 a, I F N-γ, IL -2, gr a n z y m e B, 
a n d  T N F -α ( 7 1).  T  c ells  fr o m  C O VI D-1 9  p ati e nts  als o  d e m o nstr at e  hi g h er  ex h a usti o n  m ar k er  P D -1 
ex pr essi o n, r el ati v e t o h e alt h y c o ntr ols ( 7 1). T c ell P D-1 a n d Ti m -3 ex pr essi o n i ncr e as e d as C O VI D -1 9 
i nf ecti o ns pr o gr ess e d fr o m mil dl y s y m pt o m atic t o s e v er e, als o s u g g esti v e of T c ell ex h a usti o n (1 2, 1 4 , 4 9, 
6 2) . 
L u n g d a m a g e d u e t o u nc h ec k e d vir al r e plic ati o n l e a ds t o e pit h eli al b arri er br e a k d o w n wit h diff us e al v e ol ar 
d a m a g e a n d i ncr e as e d micr o v asc ul ar p er m e a bilit y. L e a k a g e of i nfl a m m at or y c yt o ki n es IL -6 a n d IL -1 i nt o 
s yst e mic circ ul ati o n r ecr uits n e utr o p hils a n d pr o-i nfl a m m at or y m o n oc yt es i nt o t h e l u n g. T his ‘c yt o ki n e 
st or m’ c a n o v er w h el m h o m e ost atic p ul m o n ar y tiss u e r e p air, l e a di n g t o A M d e pl eti o n a n d irr e v ersi bl e 
tiss u e d a m a g e ( 2 6, 6 8). D uri n g t his pr oc ess acti v at e d fi br o bl asts d e p osit exc ess c oll a g e n, i m p airi n g g as 
exc h a n g e ( 3 3). E pit h eli al c ell d e at h m a y als o ex p os e t h e b as e m e nt m e m br a n e t o s ec o n d ar y micr o bi al 
p at h o g e ns, off eri n g t h e m acc ess t o t h e s yst e mic circ ul ati o n ( 3 9). A Ms ar e i n n at e i m m u n e s e nti n els a g ai nst 
r es pir at or y p at h o g e ns t h at r el e as e ox y g e n m et a b olit es a n d a nti-micr o bi al pr ot e as es, as w ell as r ecr uit 
n e utr o p hils i nt o al v e ol ar s p ac es. T h e y als o ai d i n r es ol vi n g i nfl a m m ati o n b y p h a g oc yt osi n g a p o pt otic 
n e utr o p hils a n d pr o d uci n g a nti -i nfl a m m at or y c yt o ki n es, s uc h as tr a nsf or mi n g gr o wt h f act or- a n d IL -1 0 
( 2 3, 2 8). T h us, A M l oss m a y c o ntri b ut e t o f ail e d l u n g f u ncti o n i n C O VI D-1 9 p ati e nts. I m p ort a ntl y, w hil e 
A Ms ar e t h e pri nci p al l u n g m acr o p h a g es i n h e at h y c o ntr ols a n d mil dl y i nf ect e d C O VI D -1 9 p ati e nts, t h e y 
w er e al m ost c o m pl et el y l ost i n s e v er el y i nf ect e d l u n gs ( 3 0). 
Vir al, b act eri al, a n d f u n g al p ul m o n ar y i nf ecti o ns c a n all c a us e a c yt o ki n e st or m s y n dr o m e. A c o m pl ex 
c yt o ki n e r es p o ns e t h at b uil ds i n i nf ecti o n is c h ar act eriz e d b y a s eri es of o v erl a p pi n g n et w or ks  t h at m a y 
s h o w si mil ariti es acr oss i n dic ati o ns p at h o g e ns a n d ar e c h all e n gi n g t o diff er e nti at e cli nic all y. C yt o ki n e 
r el e as e s y n dr o m e is a n ac ut e s yst e mic i nfl a m m at or y s y n dr o m e c h ar act eriz e d b y f e v er a n d m ulti pl e or g a n 
d ysf u ncti o n t h at is ass oci at e d wit h c hi m eric a nti g e n r ec e pt or T c ell t h er a p y, t h er a p e utic a nti b o di es, a n d 
h a pl oi d e ntic al  all o g e n eic  tr a ns pl a nt ati o n.  L e v els  of  i nfl a m m at or y  m ar k ers  a n d  c yt o ki n es  m a y  diff er  
dr a m atic all y a m o n g c yt o ki n e st or m v ari a nts ( 6 3). T h e C O VI D-1 9 h y p eri nfl a m m at or y r es p o ns e h as b e e n 

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likened to conditions including classical ARDS, macrophage activation syndrome, or hemophagocytic 
lymphohistiocytosis, or simply “cytokine storm.” COVID-19 patients display diverse inflammatory effects 
and pathophysiology with some biomarkers showing a strong correlation to worse disease or mortality (9, 
11, 43). The COVID-19 hyperinflammatory response is accompanied by a simultaneous anti-inflammatory 
response that associates with poor outcomes and may increase risk of secondary bacterial infections. 
Peripheral immune responses in severe COVID-19 patients demonstrate reconfiguration of immune cell 
composition and phenotype (67). SARS-CoV-2 infection also induces profound alterations of the myeloid 
compartment (47). While mild COVID-19 was marked by presence of inflammatory Human Leukocyte 
Antigen – DR Isotype (HLA-DR)hiCD11chi CD14+ monocytes, an increase in dysfunctional HLA-
DRloCD163hi and HLA- DRloS100Ahi CD14+ monocytes was observed as patients transitioned to 
moderate/severe disease (47). 
Functional immunoparalysis and disruption of immune homeostasis in moderate/severe cases has been 
further confirmed in translational data reported in COVID-19 patients, warranting exploration of precision 
based immunomodulatory therapy against SARS CoV-2 (24, 50, 53). 
A long-term strategy to ameliorate the COVID-19 pandemic has been to develop an effective vaccine that 
can prevent new infections and stop disease transmission. While vaccines targeting SARS-CoV-2 are now 
authorized for emergency use, limited quantities will be available. Also, geographic differences affecting 
availability are likely. Although data supporting preventive vaccines is encouraging, longer- term efficacy 
and safety remain to be seen. Additionally, certain patient populations may not respond adequately to a 
vaccine. Other therapeutic options, such as pathogen-targeted antibodies and antivirals, are also being 
explored. Yet their efficacy and safety in patients with mild or moderate COVID- 19 at risk for progression 
to severe disease is not well elucidated. Therefore, it is important to investigate treatment options that 
may relieve disease immunopathology, such as inhaled sargramostim in patients with mild or moderate 
COVID-19. In addition, evaluation of inhaled sargramostim in patients with COVID-19 may extend its 
applicability for therapeutic use in patients with other viral respiratory infections. 
4.5 
Clinical Experience of Inhaled Sargramostim 
Safety of inhaled sargramostim follows from studies in autoimmune pulmonary alveolar proteinosis 
(aPAP). In this disease, surfactant accumulates in alveolar sacs, resulting in hypoxia. Tazawa and 
colleagues conducted a Phase II study of inhaled sargramostim in patients with unremitting or progressive 
aPAP with hypoxia and symptoms (57). Patients received 250 mcg daily by inhalation for 7 days, repeated 
every other week for six cycles (total 12 weeks). Treatment was well tolerated with no serious adverse 
events. Adverse events (AE) were reported in 7 of 39 patients receiving sargramostim; all these events 
were transient. Treatment led to improved oxygenation, radiological changes, and symptoms. Thirty-five 
such patients were followed for a 30-month observation period, and sargramostim was shown to sustain 
remission in over half (56). A study in 6 aPAP patients evaluated inhaled sargramostim 250 mcg once daily 
in a 4 days-on, 4 days-off schedule, as long as needed (37). Upon remission, sargramostim dose was 
reduced. All patients achieved remission, and 3 patients maintained remission when dose was reduced. 
No significant AEs were noted (37). 
A larger randomized Phase 3 study was conducted by Japanese investigators in 12 centers. Sixty-four 
patients with mild to moderate aPAP and hypoxia were randomized to receive placebo or sargramostim 
(33 patients) at a dose of 125 mcg twice a day for 7 days, followed by a week of no treatment. This two- 
week cycle was repeated 12 times over a period of 24 weeks. Treatment was well tolerated with no 
significant differences in AEs between groups. Sargramostim treated patients had a significantly improved 

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alveolar-arterial oxygen gradient, as well as lung field density by computed tomography (58). Additionally, 
interim results from a study (6) in 18 patients with aPAP suggested that inhaled sargramostim could 
increase relapse-free time after whole lung lavage. 
Inhaled sargramostim has been studied in other diseases, including cancers, ARDS, cystic fibrosis, and 
Sezary syndrome (1-3, 5, 25, 31, 35, 37, 41, 42, 48, 59, 69). In total, 259 patients received inhaled 
sargramostim at doses of up to 2000 mcg BID and durations up to about 1.5 years. In these studies, inhaled 
sargramostim was well-tolerated. Clinical experience with sargramostim in viral pneumonia and aPAP 
suggests salutary effects. In addition, these studies establish safety of inhaled sargramostim and provide 
evidence for activity of inhaled sargramostim. 
4.6 
Use of Sargramostim Inhalation in COVID-19 
An investigator-sponsored study in Belgium [NCT04326920], “Prospective, Randomized, Open-label, 
Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and 
Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients Acute Hypoxic Respiratory 
Failure” was initiated on March 26, 2020. Approximately 80 patients were randomized to receive either 
inhaled sargramostim 125 mcg twice daily via a vibrating mesh nebulizer for 5 days (active group) together 
with institutional standard of care (SOC), or SOC alone (control group). SOC included: administration of 
antibiotics, anti-viral therapy, other COVID-19 therapy, and use of supplemental oxygen and noninvasive 
or invasive ventilation. A data and safety monitoring board (DSMB) oversaw the study. After the first 20 
and 40 patients were enrolled and treated with 5 days of sargramostim, the DSMB reviewed safety data. 
The study continued as planned with no changes needed due to safety findings. At these interim 
assessments, levels of c-reactive protein (CRP) and ferritin were lower and declining during sargramostim 
treatment, compared to control patients whose CRP levels remained higher and ferritin levels increased 
during the same time period. Furthermore, during treatment, patients who received sargramostim had 
greater improvements in eosinophils and lymphocyte counts than control patients, showing improvement 
in immune function (personal communication by Prof Bart Lambrecht, Principal Investigator [PI]). 
Preliminary results from this study in patients with COVID-19 indicate that cytokine storm is not occurring 
with sargramostim use in this patient population. 
An additional investigator-sponsored study in Singapore (NCT04400929), “Using GM-CSF as a Host 
Directed Therapeutic Against COVID-19” was initiated in June 2020. This randomized placebo-controlled 
trial is actively recruiting and is evaluating sargramostim by IV administration in approximately 30 patients 
with COVID-19. 
The ongoing Partner Therapeutics study, iLeukPulm (PTX-001-002, NCT04411680) is a Phase 2 trial 
evaluating sargramostim in hospitalized patients with COVID-19 associated acute hypoxemia. This study 
will randomize approximately 120 patients with COVID-19; 80 will receive sargramostim plus the SOC, and 
40 patients will receive SOC alone. All patients on the sargramostim arm will be treated with 125 mcg 
inhaled sargramostim twice for 5 days delivered via a vibrating mesh nebulizer, in addition to institutional 
SOC. A DSMB is overseeing this study. After the first 9 and 22 patients were enrolled and treated with 5 
days of sargramostim, the DSMB reviewed safety data. Additional safety reviews were performed after 
approximately 60 and 80 patients (total across both arms) were randomized. The study continued as 
planned with no changes needed based on safety findings. 
In COVID-19 studies described above, about 120 patients have received inhaled sargramostim for 
treatment of COVID-19. However, these studies are in patients who were hospitalized with more severe 

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disease. Observed safety in these studies informs potential benefits and risks for evaluating inhaled 
sargramostim in patients with mild to moderate COVID-19 who are at high-risk for progression to more 
severe disease. 
GM-CSF is vital to maintain and restore lung function and immune homeostasis, clinical data in critically 
ill patients and patients with COVID-19 support safety of inhalational sargramostim. Hence, this 
randomized double-blind placebo-controlled study will evaluate whether once-daily inhaled 
sargramostim for 5-days can prevent progression to more severe disease in an outpatient setting in 
symptomatic patients with mild or moderate COVID-19 who are at high risk for progression to more severe 
disease.  
Furthermore, available pharmacokinetic data in healthy volunteers, suggests that a single inhaled 
sargramostim dose (125 mcg, 250 mcg or 500 mcg) supports dose proportional exposure (35). Based on 
the totality of available data, including with approximately 120 hospitalized patients treated with inhaled 
sargramostim 125 mcg twice daily for COVID-19, a once daily dose of 250 mcg of inhaled sargramostim 
has been chosen for this outpatient study.  Also, the study drug will be prepared and administered at the 
investigational site, therefore, a single daily dose enables both patient convenience and treatment 
compliance. A single daily dose also minimizes exposure to an infectious agent for the health care staff. 
Since early 2021, the number of individuals in the US vaccinated against COVID-19 continues to increase. 
As of August 9, 2021, more than 166 million people in USA have been fully vaccinated. While many 
vaccinated individuals who get COVID-19 may be asymptomatic or have mild symptoms, over 8000 fully 
vaccinated patients have been reported to have a breakthrough COVID-19 infection and been hospitalized 
or died (7).  While these numbers are likely undercounted, hospitalizations and deaths are much less likely 
to occur among fully vaccinated individuals compared to unvaccinated or partially vaccinated individuals. 
Although the great majority of SARS-CoV-2 infected individuals presenting for health care are 
unvaccinated, the large number of vaccinated individuals raises the possibility that a significant number 
of screened subjects might have been vaccinated.  Therefore, the number of subjects who have been 
vaccinated will be capped at approximately 100 in order to ensure adequate power to determine the 
efficacy of sargramostim. 
 
 

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5 
OBJECTIVES 
5.1 
Primary Objective 
Primary Objective  
Primary Outcome Measure 
To evaluate if inhaled sargramostim can prevent 
progression to more severe disease in an outpatient 
setting in symptomatic patients with mild or moderate 
COVID-19 who are at higher risk for progression to more 
severe disease 
Proportion of patients who experience any emergency 
room visit or hospitalization, or death by Day 28. 
5.2 
Secondary Objectives 
Secondary Objectives 
Secondary Outcome Measures 
To evaluate the effect of inhaled sargramostim on 
clinical progression of COVID-19 
 
Proportion of patients with any progression of disease 
as determined by a ≥ 2-point increase from baseline in 
the NIAID ordinal scale up to Day 28, and Day 60. 
Time to progression of disease as determined by a ≥ 2-
point increase in the NIAID ordinal scale up to Day 28, 
and Day 60 
 Change from baseline in overall symptom score, and 
individual symptom scores, as measured by the 
symptom questionnaire up to Day 28. 
To evaluate the safety of inhaled sargramostim in 
patients with COVID-19 
AEs up to Day 60. 
5.3 
Exploratory Objective 
Exploratory Objective 
Exploratory Outcome Measures 
To explore the effect of inhaled sargramostim on 
biological responses to COVID-19.  
Proportion of patients requiring supplemental oxygen 
up to Day 28 
The effect of sargramostim on SARS-CoV-2 viral load 
in samples collected from nasopharyngeal swabs up to 
Day 14 (biomarker cohort only) 
Proportion of patients with generation of SARS-CoV-2 
antibody up to Day 28 (biomarker cohort only) 
Proportion of patients with markers of cellular 
immunity, via immunophenotyping, up to Day 14 
(biomarker cohort only) 
Levels of ferritin, CRP, d-Dimer up to Day 28 
Immunogenicity to sargramostim up to Day 28 
(biomarker cohort only) 
Presence or absence of COVID-19 symptoms at Day 60 
 
 

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6 
STUDY DESIGN 
This study is a randomized placebo-controlled double-blind study.  
Neither patients, nor investigators, nor the sponsor study team will be aware of treatment assignments 
prior to the final data base lock at the conclusion of the study. 
6.1 
Study Description 
This Phase 2b study will randomize approximately 500 patients who are symptomatic with mild or 
moderate COVID-19 (as defined in the Food and Drug Administration (FDA) Guidance Document: COVID-
19: Developing Drugs and Biological Products for Treatment or Prevention, May 2020) who are at high risk 
for progression to more severe disease. Patients will be randomized in a 1:1 ratio to inhaled sargramostim 
plus SOC or placebo plus SOC. Enrollment of patients who have completed a COVID-19 vaccination 
regimen or participated in a COVID-19 vaccine clinical trial will be capped at approximately 100 patients. 
All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo 
diluent.  Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer. 
Additional blood samples will be collected for biomarker assays for approximately 100 randomized 
patients (approximately 50 from each treatment group). 
Patients will be followed for up to 60 days after start of treatment. 
6.2 
Randomization 
Each eligible patient will be randomized to either the treatment (inhaled sargramostim) or placebo groups 
using a 1:1 randomization ratio with stratification based on 
• 
geographic region (US, outside the US), and 
• 
completion of a COVID-19 vaccination regimen or participation in a COVID-19 vaccine clinical 
trial (yes, no). 
Patients will be randomized using a centralized, automated randomization system, which will be used to 
assign a blinded treatment assignment to each patient. 
6.2.1 
Emergency Unblinding 
Emergency unblinding may be required for medical management of patients: 
• 
Patient safety must always be the first consideration in making such a determination. 
• 
In case of an emergency, the investigator has the sole responsibility for determining if 
unblinding of a patient’s treatment assignment is warranted. 
• 
The investigator should make all attempts to contact the Medical Monitor in advance of 
unblinding. 
• 
If a patient’s treatment assignment is unblinded, the sponsor must be notified immediately 
after breaking the blind even if consultation occurred in advance. 

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6.2.2 
Replacement of Ineligible Patients 
Ineligible patients will not be replaced after enrollment. 
7 
ELIGIBILITY CRITERIA 
Clinical significance of underlying medical conditions and judgements related to the best interests of the 
patient are determined by the investigator. Sponsor consultation with the medical monitor is encouraged 
where there is a concern. 
7.1 
Inclusion Criteria 
1) Patients with a positive laboratory diagnosis of SAR-CoV-2 infection by an antigen or a molecular 
test ≤5 days prior to randomization. The test should have been authorized by the relevant 
regulatory authority. 
2) Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 
days prior to randomization: 
a. Fever or chills 
b. New onset or worsening cough 
c. Sore throat 
d. Malaise or fatigue 
e. Headache 
f. Muscle pain (myalgias) or body aches 
g. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 
h. New onset or worsening shortness of breath or difficulty breathing 
i. 
Nasal congestion or runny nose 
j. 
New loss of taste (ageusia) and/or smell (anosmia). Note: any of these symptoms 
(ageusia, anosmia) alone or in combination cannot be used as the SOLE qualifying 
symptoms for enrollment. 
3) At higher risk for progression to more severe COVID-19 
a. Age ≥ 60 years 
b. Age 18-59 years with a clinically stable medical history of at least 1or more of the 
following conditions that could lead to severe COVID-19  
i. 
Chronic respiratory conditions such as asthma, chronic obstructive pulmonary 
disease (COPD), pulmonary fibrosis 
ii. 
Obesity with BMI ≥ 30 kg/m2 
iii. Cardiovascular disease 
iv. Sickle cell disease or thalassemia 
v. Diabetes mellitus being managed with concomitant medications 

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vi. Hypertension being managed by concomitant medications 
vii. Chronic kidney disease 
4) Oxygen saturation by pulse oximeter > 93% on room air. Note: at altitudes of >4000 feet above 
sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted 
5) Negative pregnancy test (if woman of childbearing potential) 
6) Females of childbearing potential and males with female partners of childbearing potential must 
agree to use acceptable contraceptive methods from screening to Day 28 (see Section 12.4 for 
Contraceptive Guidance) 
7) The patient (or legally authorized decision maker) must give informed consent 
7.2 
Exclusion Criteria 
1) Hospitalized patients 
2) Patients who have received or are receiving treatments that are not approved/authorized by the 
relevant regulatory authority for the treatment of patients with mild or moderate COVID-19 in 
an outpatient setting 
3) Patients enrolled in interventional clinical trials for other experimental therapies 
4) Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions 
5) Patients with unstable comorbid conditions (e.g., decompensated congested heart failure, COPD 
with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled 
hypertension, uncontrolled asthma) 
6) Patients with severe pulmonary comorbid conditions, including systemic steroid- dependent 
asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung transplant, or cystic 
fibrosis 
7) Patients who have received highly immunosuppressive therapy (to include systemic 
corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to first dose of 
study drug 
8) Patients with known or suspected intolerance or hypersensitivity to sargramostim, or any 
component of the product 
9) Patients who have previously experienced severe and unexplained side effects during aerosol 
delivery of any kind of medical product 
10) Pregnant or breastfeeding females 
11) Patients who, in the opinion of the Investigator, will not be able to comply with all the study 
procedures and visits as outlined in the schedule of events, including follow-up 
8 
DRUG INFORMATION 
8.1 
Treatment Regimen 
All patients will be randomized to receive either 250 mcg of sargramostim or equivalent volume of placebo 
diluent.  Treatment will be administered once daily for 5 days delivered via a vibrating mesh nebulizer. 

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Patients will be observed in the clinic for approximately 30 minutes after the completion of the drug 
administration. 
Refer to the Pharmacy Manual for full details on study drug supply, preparation, and accountability. 
8.1.1 
Dose Modifications 
Patients with documented white blood cell count > 50,000/mm3 should stop study treatment. 
8.2 
Concomitant Medications and Medical Procedures 
All concomitant medications administered during the patient’s participation in the study until Day 60 must 
be recorded in the source documents and eCRF. 
8.2.1 
Permitted therapies 
8.2.1.1 
Outpatient setting 
• 
Medications such as antipyretics, antiemetics, antidiarrheals, analgesics, and other medications 
intended to treat signs and symptoms of COVID-19.   
• 
Antibiotics can be used to treat suspected bacterial respiratory infections secondary to COVID-19. 
• 
Oxygen supplementation, as needed, including low-flow oxygen, high-flow oxygen, or any other 
form of respiratory support per the Investigator discretion  
• 
Medications to treat underlying or newly diagnosed medical conditions 
• 
Approved/authorized (by the relevant regulatory authority) treatments (including monoclonal 
antibodies) for patients with mild or moderate COVID-19 in an outpatient setting. 
8.2.1.2 
Inpatient setting 
If a patient is hospitalized, patients should receive SOC for COVID-19 per the institutional standards 
without any exceptions. If a patient is hospitalized, prior to completing the 5 days of study treatment, the 
study treatment should be discontinued. Patients who discontinue study treatment will continue to be 
evaluated for efficacy and safety endpoints. 
8.2.2 
Prohibited therapies in the outpatient setting 
• 
Use of GM-CSF for any purpose other than study treatment. 
• 
Any investigational drugs or non-approved/authorized (by the relevant regulatory authority) 
treatments for patients with mild or moderate COVID-19 in an outpatient setting during the 
period of study participation. 
8.2.3 
COVID-19 Vaccination 
Patients who are at least 2 weeks post completion of a COVID-19 vaccination regimen (either 2 dose or 1 

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dose regimen as applicable) can be included in the study. 
Patients who need to start a COVID-19 vaccination regimen, can do so only after Day 21 of the study. 
Patients who participated in and completed a COVID-19 vaccine clinical study can be included. 
9 
STUDY EFFICACY AND SAFETY ASSESSMENTS AND PROCEDURES 
Study procedures and their timing are summarized in the Schedule of Events (Table 1). Adherence to the 
study procedures and their timing is essential for study conduct. All screening evaluations should be done 
after signing of the informed consent document. They must be completed and reviewed to confirm that 
potential patients meet all eligibility criteria.  
9.1 
Study Visits 
The screening visit, Day 1 through Day 5, Day 14, and Day 28 visits should take place at the investigational 
site. If the patient is unable to come to the investigational site, the procedures may be done via home 
health care (HHC) visit. 
Telemedicine (TM) or HHC visits will be conducted daily during Days 6-13 and every other day during Days 
15-27, and at Day 60.  A TM visit is defined as a member of the study staff contacting the patient via a 
video or telephone call to check on the patient’s well-being. If the study site research staff detects a 
decline in a patient’s condition (e.g., pulse ox ≤ 93%), in consultation with the site clinical staff the patient 
should get a HHC visit or be directed to return to the clinic or go to the Emergency Room or hospital 
affiliated with the investigational site.   
HHC visits are defined as a health care provider visiting the patient at their home setting to facilitate vital 
signs collection (body temperature, blood pressure, pulse rate) and pulse oximetry and/or to assess the 
patient’s condition. 
Baseline is considered to be either the screening or Day 1 assessment that occurs closest to and prior to 
the first dose of study treatment. 
9.2 
Ordinal Scale 
A patient’s status will be assessed by study staff per the Schedule of Events using the NIAID Ordinal Scale 
(Appendix A). 
9.3 
Symptom Questionnaire, Patient Global Impression, and Day 60 Symptom Evaluation 
Patients in the outpatient setting, will rate their severity of symptoms associated with COVID-19 by a daily 
questionnaire (Appendix B).  
The questionnaire contains assessment of these symptoms: 
• 
Nasal congestion/rhinorrhea 
• 
Sore throat 
• 
Shortness of breath 

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• 
Cough 
• 
Fatigue 
• 
Body aches and pain 
• 
Headache 
• 
Chills 
• 
Feeling feverish 
• 
Nausea 
• 
Vomiting  
• 
Diarrhea 
• 
Sense of smell 
• 
Sense of taste 
Patient-reported global impression will be assessed daily by the patient reflecting their impression on 
their return to usual health, ability to perform usual activities in the past 24 hours, rated as Yes or No.  In 
addition, patients will rate the severity of their overall COVID-19 symptoms, as none, mild, moderate, or 
severe.  Patient global impression is shown in Appendix C. 
The symptom questionnaire and patient global impression will be completed electronically, by the patient, 
at approximately the same time every day.  An alternative format will be available for patients who cannot 
complete these questionnaires electronically. The symptom questionnaire should be completed first, then 
followed by the patient global impression.  On the study drug dosing days this will be done prior to 
administration of the study drug. On other days, this will be done before any other study related 
procedure or assessment is performed. 
Translations of these questionnaires will be available for patients.  If a patient cannot read or does not 
have access to any translations in his/her language, a close contact of the patient can help the patient 
complete the assessments.  Investigator or clinic staff should not help the patients complete these 
assessments.  
At Day 60, patients will be asked for presence or absence of COVID-19 symptoms in the 7 days prior to 
the visit (see Appendix D). 
9.4 
Physical Examinations 
A complete physical examination will be performed at screening. This examination will not include pelvic, 
rectal, and breast examinations unless clinically indicated. A targeted (symptom- directed) physical 
examination will be performed at other visits, as specified in the Schedule of Events, and as clinically 
indicated. A targeted physical examination can occur at the HHC visit or the clinic visit. 
9.5 
Vital Signs and Pulse Oximetry 
Vital signs and pulse oximetry will be measured as specified in the Schedule of Events and as clinically 
indicated. Vital signs include body temperature, blood pressure, pulse rate, and respiration rate. 
Vital signs and pulse oximetry at additional times may be measured during the study if warranted, as 
determined by the Investigator. 

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Vital signs and pulse oximetry in the home setting will be obtained by the patient using devices provided 
by the sponsor. In home vital signs and pulse oximetry will be performed at approximately the same time 
of day. The site staff will obtain the vital sign and pulse oximetry data from the patient for recording on 
the eCRF. 
9.6 
Clinical Laboratory Assessments 
All clinical laboratory assessments will be performed at a central laboratory, except for urine pregnancy 
test and initial diagnostic SARS-CoV-2 test used for study inclusion. See Schedule of Events for the timing 
and frequency. See laboratory manual for sample collection details. 
Hematology laboratory parameters will include complete blood count with differential, hemoglobin, 
hematocrit, and absolute counts for white blood cells, platelets, neutrophils, lymphocytes, eosinophils, 
and monocytes. 
Chemistry laboratory parameters will include albumin, blood urea nitrogen, creatinine, alanine 
aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, direct and 
total bilirubin, glucose, total protein, sodium, potassium, chloride, bicarbonate, calcium, and uric acid. 
Additional laboratory parameters will include serum ferritin, d-Dimer, and CRP. 
Clinically significant abnormal laboratory findings are those which are not associated with COVID-19, 
unless judged by the Investigator to be more severe than expected for the patient’s condition. These 
laboratory findings will be deemed clinically significant if needing intervention (e.g., discontinuation of 
study drug, need for additional procedures, need for concomitant medications) and/or associated with an 
SAE or an AE. 
The Investigator must review the laboratory report, document this review, and record any clinically 
significant abnormal findings occurring during the study in the AE section of the Case Report Form (CRF). 
If a clinical laboratory assessment performed at the Investigators local laboratory leads to a change in 
patient management or is considered clinically significant by the Investigator (e.g., SAE or AE or dose 
modification), it will be reported in the AE section of the CRF. 
9.7 
Pregnancy Testing 
Women of childbearing potential (WOCBP) must undergo urine pregnancy testing at the investigative site 
according to the Schedule of Events.  
9.8 
Emergency Room Visit, Hospitalizations and Deaths 
Hospitalization will be defined as ≥24 hours of acute care. 
If a patient treated in the outpatient setting is subsequently hospitalized, study treatment should be 
discontinued.  Patients should continue on study for the efficacy and safety evaluations.  

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Every effort should be made to collect the following data from the emergency room visit or hospitalization 
• 
NIAID ordinal scale information 
• 
Whether the visit was related to COVID-19 
• 
Death 
Record on the CRF if the following events occur: 
• 
Emergency room visits 
• 
Hospitalization and discharge 
• 
ICU admittance and discharge 
• 
Extended care facility admittance and discharge 
 
9.9 
SARS-CoV-2 Variant Assessment 
The presence of SARS-CoV-2 variants on Day 1 will be evaluated by nasopharyngeal swabs collected in all 
patients per the Schedule of Events (Table 1). See laboratory manual for sample collection details. 
9.10 
Exploratory Biomarker Assessments 
Approximately 100 patients (approximately 50 from each treatment group) enrolled into the study at 
selected sites, will have the samples collected for biomarker assessments as detailed below. These 
samples may also be used for additional exploratory analysis of biomarkers to further understand 
pathways 
associated 
with 
COVID-19 
disease, 
and 
sargramostim 
pharmacokinetics 
and 
pharmacodynamics. 
9.10.1 
SARS-CoV-2 Viral Load Assessment 
The SARS-CoV-2 viral RNA level and viral clearance will be evaluated by nasopharyngeal swabs collected 
per the Schedule of Events (Table 1). See laboratory manual for sample collection details. 
9.10.2 
Anti-SARS-CoV-2 Antibody Assessments 
Blood samples will be collected per the Schedule of Events to assess the generation and level of antibody 
production against SARS-CoV-2. See laboratory manual for sample collection details. 
9.10.3 
Immunophenotyping for Cellular Immunity 
Blood samples will be collected per the Schedule of Events for immunophenotyping to assess changes in 
cellular immunity. See laboratory manual for sample collection details. 
9.10.4 
Sargramostim Immunogenicity Assessment 
Blood samples will be collected per the Schedule of Events to assess sargramostim anti-drug antibodies. 
See laboratory manual for sample collection details. 

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10 
SAFETY MONITORING 
All AEs will be managed and reported in compliance with all applicable regulations and included in the 
final clinical study report. 
10.1 
Definitions 
10.1.1 
Adverse Event 
An AE is any untoward medical occurrence in a patient administered study treatment and which does not 
necessarily have to have a causal relationship with this treatment. 
This includes the following: 
• 
AEs not previously observed in the patient that emerge during the reporting period, that were 
not present prior to the AE reporting period 
• 
Preexisting medical conditions judged by the Investigator to have worsened in severity or 
frequency or changed in character during the reporting period 
The following clinical events associated with COVID-19 are exempt from AE reporting unless 
deemed by the Investigator to be related to the administration of study drug: 
• 
Hypoxemia/respiratory failure due to COVID-19 requiring supplemental oxygen, high flow 
oxygen devices, non-invasive ventilation, invasive ventilation, or extracorporeal membrane 
oxygenation. 
The following clinical events associated with COVID-19 are exempt from AE reporting unless 
deemed by the Investigator to be related to the administration of study drug and/or judged by 
the Investigator to be more severe than expected for the patient’s condition: 
• 
Any clinically significant abnormal laboratory findings or other abnormal safety assessments 
• 
Expected progression, signs, or symptoms of COVID-19 
 
All hospitalizations, emergency room visits, and deaths are part of the efficacy evaluation of this study, 
whether they are considered AEs/SAEs or not.  Hence, they are required to be reported on the appropriate 
pages of the Case Report Form.  See Section 9.8. 
10.1.2 
Serious Adverse Events 
An SAE is any untoward medical occurrence regardless of causality that results in any of the following: 
• 
Death 
• 
A life-threatening AE 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
Persistent or significant disability/incapacity 
• 
Congenital anomaly/birth defect 

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• 
An important medical event that may not be immediately life-threatening or result in death 
or hospitalization but may jeopardize the patient or may require intervention to prevent one 
of the other outcomes listed in the definition above 
If an event is not an AE as defined above (Section 10.1.1), then it cannot be an SAE even if conditions for 
seriousness are met (e.g., hospitalization for signs/symptoms of COVID-19, death due to progression of 
COVID-19). 
10.2 
Safety Reporting 
10.2.1 
Adverse Event Reporting 
All AEs (as defined in section 10.1.1) regardless of seriousness, starting from informed consent (i.e., 
occurring during the baseline period even in the absence of any administration of study treatment), until 
participation in the study has ended (Day 60) are to be recorded on the CRF. 
Whenever possible, diagnosis or single syndrome should be reported instead of symptoms. The 
Investigator should specify the date of onset, severity, action taken with respect to study drug, corrective 
treatment/therapy given, additional investigations performed, outcome, and his/her opinion as to 
whether there is a reasonable possibility that the AE was caused by the study drug.  
AE should be followed until the event has resolved, stabilized, has decreased in severity to the same or 
less than baseline (pre-treatment), or patient has completed the follow-up period. 
Vital signs abnormalities are to be recorded as AEs only if they are symptomatic and/or requiring 
corrective treatment and/or leading to treatment discontinuation and/or modification of dosing and/or 
fulfilling a seriousness criterion. 
Laboratory abnormalities are to be recorded as AEs only if they lead to treatment discontinuation, 
modification of dosing, fulfill a seriousness criterion, additional concomitant therapy, and/ or additional 
medical procedures. 
Treatment-emergent AEs are AE that begin or worsen after the start of treatment. 
10.2.2 
Attribution of the AE 
The relationship or attribution of an AE to study treatment is defined as follows: 
- 
Definite - The AE is clearly related to the study treatment 
- 
Probable - The AE is likely related to the study treatment 
- 
Possible - The AE may be related to the study treatment 
- 
Unlikely - The AE is doubtfully related to the study treatment 
- 
Unrelated - The AE is clearly NOT related to the study treatment 
10.2.3 
Grading of Adverse Events 
All AE will be graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 or 
later. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical 
descriptions of severity for each AE based on this general guideline: 

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Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age- 
appropriate instrumental activities of daily living (ADL), i.e., preparing meals, shopping for 
groceries or clothes, using the telephone, managing money, etc. 
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL, i.e., bathing, dressing, 
and undressing, feeding self, using the toilet, taking medications, and not bedridden. 
Grade 4: Life-threatening consequences; urgent intervention indicated 
Grade 5: Death related to AE 
CTCAE resources: 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm  
Quick reference guide: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Referenc 
e_5x7.pdf 
10.2.4 
Serious Adverse Event Reporting 
In the case of a SAE, a pregnancy report, or an overdose, the Investigator must immediately: 
• 
REPORT (within 24 hours of becoming aware of an SAE by fax or e-mail) information related 
to the SAE, pregnancy, or overdose to Partner Therapeutics as noted below: 
 
 
ENTER SAE information on SAE Report Form and complete the AE CRF. Include a photocopy 
of all examinations done and dates on which these examinations were performed. Care 
should be taken to ensure that patient identity is protected (and redacted), and patient trial 
identifiers are present on copies of source documents provided to the Partner Therapeutics. 
For laboratory results, include laboratory normal ranges. 
o All further data updates should be recorded in the SAE reporting form and AE CRF, as 
appropriate. Further documentation with additional laboratory data, concomitant 
medication, and patient status should be reported to Partner Therapeutics as above 
within 24 hours of knowledge. Fatal or life-threatening SAEs should be updated within 
the week (7 days) following initial notification. 
e-mail: projects.partnertx@symogen.com  and ScopeSAEs@partnertx.com, 
or 
fax number: +44 (0) 1628 460018 

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o An SAE occurring at a different time interval or otherwise considered unrelated to a 
previously reported one should be reported separately as a new event. 
10.2.5 
Pregnancy 
Patients who become pregnant will be discontinued from the study treatment and should continue to be 
followed for efficacy and safety evaluations. If a pregnancy is reported, the Investigator should inform 
Partner Therapeutics within 24 hours of learning of the pregnancy. 
The patient will be followed to determine the outcome of the pregnancy. The Investigator will collect 
follow-up information on the patient and the newborn, and the information will be forwarded to Partner 
Therapeutics. Generally, follow-up will not be required for longer than 6 to 8 weeks beyond the estimated 
delivery date. Any termination of pregnancy will be reported, including fetal status (presence or absence 
of anomalies) or indication for the procedure. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or elective 
termination of a pregnancy for medical reasons will be reported as an AE or SAE. 
A spontaneous abortion (occurring at <20 weeks gestational age) or still birth (occurring at >20 weeks 
gestational age) is always considered to be an SAE and will be reported as such. 
Additionally, congenital anomalies in the neonate and ectopic pregnancy are considered SAEs. 
10.3 
Expected and Unexpected Toxicities 
Refer to the Investigator Brochure for any expected or unexpected toxicities. These will be collected and 
reported to the competent authorities and relevant ethics committees in accordance with Directive 
2001/20/EC or as per national regulatory requirements in participating countries. 
 
 

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11 
SCHEDULE OF EVENTS AND STUDY PARAMETERS 
Table 1: 
Schedule of Events 
 
Screen 
Treatment Period 
Post-treatment Period 
Day  
(-5)-0 a 
1 
2 
3 
4 
5 
6-13 b 
14 ± 2 
15-27 c 
28 ± 2 
60 ± 7 
Visit Location 
C 
C 
C 
C 
C 
C 
TM or 
HHC 
C 
TM or 
HHC 
C 
TM or 
HHC 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
Review 
X 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 Test 
X 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test  d 
X 
 
 
 
 
 
 
 
 
 
 
Randomization  
 
X 
 
 
 
 
 
 
 
 
 
Patient Reported Outcomes: 
     Symptom Score Questionnaire  
 
X f 
X f 
X f 
X f 
X f 
X 
X 
daily 
X 
 
     Patient Global Impression  
 
X f 
X f 
X f 
X f 
X f 
X 
X 
daily 
X 
 
     Day 60 COVID-19 Symptom 
Evaluation 
 
 
 
 
 
 
 
 
 
 
X 
NIAID Ordinal Scale 
 
X f 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ER/Hospitalization and associated 
Events i 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination e 
X 
X f 
X f 
X f 
X f 
X f 
 
X 
 
X 
 
Vital Signs and Pulse oximetry g 
X 
X f 
X f 
X f 
X f 
X f 
X 
X 
X 
X 
 
Hematology with Differential 
 
X f 
 
 
 
 
 
X 
 
X 
 
Blood Chemistry 
 
X f 
 
 
 
 
 
X 
 
X 
 
CRP/Ferritin/d-Dimer 
 
X f 
 
 
 
X 
 
X 
 
X 
 
Nasopharyngeal Swab  
 
X f 
 
 
 
 
 
 
 
 
 
Blood samples for biomarker 
cohort 
Anti-SARS-CoV-2 antibody h 
 
X f 
 
 
 
X f 
 
X 
 
X 
 
Immunogenicity h 
 
X f 
 
 
 
X f 
 
X 
 
X 
 
Immunophenotyping h 
 
X f 
 
 
 
X f 
 
X 
 
 
 
Nasopharyngeal Swab (biomarker 
cohort only) h 
 
 
 
 
 
X f 
 
X 
 
 
 
Study Drug Administration 
 
X 
X 
X 
X 
X 
 
 
 
 
 
AE Monitoring 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Oxygen supplementation 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Survival status 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: C = Clinic; TM = Telemedicine; HHC = Home Health Care 
a. 
Day 0 and Day 1 procedures can be done on the same day. 
b. 
Telemedicine/HHC visits will be conducted daily by video call or telephone call 
c. 
Telemedicine/HHC visits will be conducted every other day by video or telephone call  
d. 
Urine pregnancy test for women of child-bearing potential 
e. 
A complete physical examination will be conducted at screening. A targeted (symptom-directed) physical examination may be 
conducted at other clinic visits. 
f. 
Must be collected/done prior to study treatment administration 
g. 
Vital signs include body temperature, blood pressure, pulse rate, respiration rate (clinic/HHC visits only)  
h. 
After Day 1, no sample collection needed if patient is hospitalized. 
i. 
Record if the following events occur: Emergency room visits, hospitalized, ICU admittance, Extended care facility admittance, and 
discharge 
 

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12 
RISKS AND TOXICITIES 
12.1 
Overdose 
There is no clinical experience with overdose of sargramostim, and no specific antidote or detoxification 
measures can be recommended to date. If accidental overdose is suspected, the patient should be treated 
symptomatically. 
12.2 
Pregnancy 
There are limited data in pregnant and breastfeeding women. There is potential for increased risk of 
spontaneous abortion based on rabbit studies. Investigators should counsel patients of the risk to the 
fetus. 
Note: this information is based on systemic administration of sargramostim. There are no data available 
for inhaled sargramostim. 
12.3 
Pregnancy Risk Summary 
Limited available data on sargramostim use in pregnant women are insufficient to inform drug- associated 
risk of adverse developmental outcomes. Based on animal studies sargramostim may cause embryofetal 
harm. In animal reproduction studies, administration of sargramostim to pregnant rabbits during 
organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at 
systemic exposures ≥1.3 times the human exposure expected at the recommended human dose. Advise 
pregnant women of the potential risk to a fetus. 
The estimated background risk of major birth defects and miscarriage for the indicated population is 
unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the 
U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically 
recognized pregnancies are 2%-4% and 15%-20%, respectively. 
12.4 
Contraceptive Guidance 
A woman is of childbearing potential following menarche and until becoming post-menopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and 
bilateral oophorectomy. 
A postmenopausal state is defined as no menses for 12 consecutive months without an alternative 
medical cause. 
A man is considered fertile after puberty unless sterile by bilateral orchidectomy or vasectomy. 
Acceptable effective methods of contraception for WOCBP to be used from time of screening through Day 
28 include: 
• 
combined (estrogen and progestogen containing) hormonal contraception associated with 

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inhibition of ovulation: oral, intravaginal, transdermal 
• 
progestogen-only hormonal contraception associated with inhibition of ovulation: oral, 
injectable, implantable 
• 
intrauterine device (IUD) 
• 
intrauterine hormone-releasing system (IUS) 
• 
progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mode of action 
• 
male or female condom with or without spermicide 
• 
cap, diaphragm, or sponge with spermicide 
• 
combination of male condom with either cap, diaphragm, or sponge with spermicide (double 
barrier methods) 
• 
bilateral tubal occlusion 
• 
vasectomized partner 
• 
sexual abstinence – continuous abstinence during the study period 
Male patients with pregnant or non-pregnant WOCBP partner should use condoms from time of screening 
through Day 28. Additionally, they should not donate sperm during this period. 
13 
STUDY DURATION AND EARLY TERMINATION 
13.1 
Treatment Discontinuation Criteria 
Patients will receive sargramostim or placebo, in addition to the SOC, unless: 
• 
patient withdraws consent or decision by the patient (or his/her legally authorized decision 
maker), or Investigator/attending physician decides to stop treatment 
• 
unacceptable toxicity to study drug 
• 
rapid deterioration requiring other advanced treatments or medical care not conducive to 
continued treatment with study drug  
• 
pregnancy 
• 
death 
Patients who discontinue treatment early, should remain on study and continue follow-up per the 
schedule of events (unless consent is withdrawn from study participation).   
Only patients that have withdrawn their consent to participate in the trial are excluded from further 
follow-up after their consent has been withdrawn. Any available data up to the date of withdrawal of 
consent will be used for the purpose of this study. 
All efforts should be made to follow a patient for survival through Day 60. For patients who are lost to 
follow-up, or contact cannot be made (despite repeated attempts), Investigators are strongly encouraged 
to contact the patient’s next of kin or legally authorized representative, and/or to search publicly available 
records (as permitted by local laws) to determine patient survival status. 

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If a patient is discontinuing study prior to Day 60, all Day 60 evaluations should be completed at 
discontinuation. 
13.2 
Treatment Period (Days 1-5) 
All randomized patients will receive study drug for 5 days (unless hospitalized on/before Day 5 when study 
drug should be discontinued). Patients who are hospitalized should continue on study for the efficacy and 
safety evaluations.  Day 1 is the day the patient receives the first dose of the study treatment. 
If at any time the constraints of this protocol are detrimental to the patient's health, the study drug should 
be discontinued. This includes any clinical AE, laboratory abnormality or intercurrent illness which, in the 
opinion of the Investigator, indicates that continued treatment with study therapy is not in the best 
interest of the patient. 
13.3 
Post-Treatment Period (Days 6-60) 
Following the treatment period (Days 1-5), patients should continue to receive SOC (see Section 8.2) as 
appropriate per the Investigator. The patients will undergo study assessments per the Schedule of Events. 
All patients, including those who discontinue treatment early, should be followed for the duration of the 
study. 
13.4 
Study Completion 
Study completion will be defined as the date when the last patient completes the Day 60 visit or an early 
termination visit. The study may be stopped earlier for reasons such as poor enrollment, ethical or safety 
reasons. 
14 
STATISTICAL PLAN 
14.1 
Sample Size 
A total of approximately 500 patients will be randomized using a 1:1 assignment ratio. The sample size is 
selected to achieve at least 80% power to detect a difference at the 0.05 level of significance (2-sided) in 
the proportion of patients who experience any emergency room visit or hospitalization, or death over 28 
days.  
This sample size is based upon an assumed 3% rate for the sargramostim arm and a 10% rate for the 
placebo arm (risk ratio of 0.30) in unvaccinated patients (similar to that observed for bamlanivimab BLAZE-
1 study (10, 18, 19). As discussed in Section 4.6, the rate of any emergency room visit or hospitalization, 
or death over 28 days is expected to be very low, or near zero for vaccinated patients.  
It is also assumed that the proportion of vaccinated patients will be approximately 20-25% of the study 
population, with enrollment of patients who have completed a COVID-19 vaccination regimen or 
participated in a COVID-19 vaccine clinical trial capped at approximately 100 patients; no events are 
expected to occur in these patients for either treatment arm.  Therefore, the overall event rate (for 

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unvaccinated and vaccinated patients combined) for the primary endpoint is expected to be 2.4% for 
sargramostim and 8.0% for placebo (risk ratio of 0.30) and maintains at least 80% power. As discussed in 
Section 6.2, one of the randomization stratification factors is completion of a COVID-19 vaccination 
regimen or participation in a COVID-19 vaccine clinical trial (yes, no). 
The Sponsor (or designee) will monitor (in a blinded manner and pooled across both treatment arms) the 
usage rate of authorized/approved therapies (such as monoclonal antibodies) for patients with mild or 
moderate COVID-19 in an outpatient setting.  If there is a notable rate of these therapies, which could 
further impact the assumed event rates for the primary endpoint, a re-evaluation of sample size and 
power may be required.  In this scenario, no adjustment to Type 1 error is required.   Further details will 
be provided in the Statistical Analysis Plan. 
14.2 
General Statistical Methods 
As this is a Phase 2b study; no adjustments for multiple comparisons will be made.  Derivation of two-
sided 95% confidence intervals and p-values will be generated where applicable. 
Continuous endpoints will be summarized by n, means, medians, minimum, maximum, and 25th and 75th 
percentiles.   
Alternative statistical methods will be employed if underlying assumptions and/or distributions for a given 
statistical method are not satisfied.  If there are insufficient numbers of patients or events for any 
randomization stratification factor (such as COVID-19 vaccination) to permit valid stratified analyses, then 
factor(s) may be dropped from analyses. 
Missing data may be imputed using last-observation-carried forward, or other advanced statistical 
imputation methods (such as linear interpolation or multiple imputations), depending on the endpoint.  
Methods for handling missing data will be specified in the Statistical Analysis Plan. 
Additional exploratory analyses may be performed to evaluate the robustness and sensitivity of the study 
results, including but not limited to the analysis populations, subgroup analyses, treatment interactions, 
adjusted or stratified analyses, and/or alternative statistical methods. 
A Statistical Analysis Plan will contain further details of the planned statistical analyses for efficacy and 
safety endpoints. Unblinding details will be specified in the unblinding plan section of the Statistical 
Analysis Plan or in a separate unblinding plan document. 
Any change to the data analysis methods described in the protocol will require an amendment only if it 
changes a principal feature of the protocol. Any other change to the data analysis methods described in 
the protocol, and the justification for making the change, will be described in the Statistical Analysis Plan 
prior to unblinding. 
14.3 
Analysis Sets 
Full Analysis Set: All randomized patients and analyzed according to the treatment as randomized. This 
population is analogous to an intent-to-treat population. 

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Modified Intent-To-Treat (mITT): All randomized patients who meet eligibility criteria and receive at least 
1 dose of any study treatment. Patients will be excluded from the mITT Population, if they fail to meet 
eligibility criteria or if they do not receive any study treatment. This population will be used for the 
purposes of sensitivity analyses, and analyses will be performed according to the treatment as 
randomized. 
Safety Set: All randomized patients receiving 1 or more doses of either study treatment, analyzed 
according to the treatment as received on Day 1. 
14.4 
Efficacy Analysis 
Unless otherwise specified, the efficacy analysis will be performed on the full analysis set. 
The efficacy analyses will consider all data, regardless of any intercurrent events, such as early 
discontinuation of therapy, any protocol deviations, or any additional treatments for COVID-19; i.e., the 
treatment policy strategy. 
14.4.1 
Description of Patient Population 
Patient disposition, demographics, baseline SARS-CoV-2 test, SARS-CoV-2 variant, and any concomitant 
procedures/surgeries, will be summarized. A summary of each analysis population will be tabulated, 
including any reasons for exclusion from a given analysis population. 
Baseline medical history (including preexisting conditions) will be coded using the latest version of the 
Medical Dictionary for Regulatory Activities.  Medical history will be summarized by system organ class 
and preferred term; a patient will only be counted once per system organ class and once per preferred 
term within a treatment group.  
Concomitant medications will be coded using the most current WHO Drug Dictionary and summarized by 
drug class and medication term with results presented by treatment group.  
Intercurrent events such as early discontinuation of treatment, any treatment crossover, any major 
protocol deviations, and any other approved or authorized treatments to prevent progression of COVID-
19 disease severity or to treat COVID-19 (such as monoclonal antibodies, antivirals such as remdesivir, 
etc.) will be tabulated. 
14.4.2 
Primary Endpoint 
The primary endpoint is the proportion of patients who experience any emergency room visit or 
hospitalization, or death by Day 28. Any occurrence of any of the 3 types of events will be considered as 
an event.   
Statistical hypothesis testing for the primary endpoint will be conducted using a logistic regression model 
with a Firth penalized likelihood (16) at the two-sided 0.05 significance level.  The model will include 
treatment as the independent variable.  Event rates within strata will be evaluated to determine whether 
it is appropriate to conduct a sensitivity analysis that which includes, stratification by the randomization 
stratification factors for geographic region (US vs outside US) and completion of a COVID-19 vaccination 
regimen or participation in a COVID-19 vaccine clinical trial (yes, no).  

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The primary estimand of treatment effect will be the treatment risk difference between arms, the 
corresponding 95% confidence interval (CI), and p-value.  Additionally, the odds ratio, corresponding 95% 
CI, and p-value will be generated. 
The proportion of patients who have any emergency room visit or hospitalization, or death by Days 7, 14 
and Day 28 will be tabulated.  A Chi-square or Fisher’s exact test will compare treatment arms at each 
timepoint of interest. 
A sensitivity analyses of the primary endpoint will be the analysis of COVID-19-related emergency room 
visits, COVID-19-related hospitalizations, or deaths (any cause).  The analysis methods will mirror the 
primary endpoint as specified above. 
A sensitivity analysis of the primary analysis will use the modified Intent-to-Treat population. The analysis 
methods will mirror the primary endpoint as specified above. 
14.4.3 
Secondary Endpoints 
14.4.3.1 
Proportion of patients with any progression of disease as determined by a ≥ 2-point 
increase in the NIAID ordinal scale up to Day 28 and Day 60 
The proportion of patients with any progression of disease as determined by a ≥ 2-point increase in the 
NIAID ordinal scale up to Day 28 and Day 60 (e.g., a change from 2 to 4, or a change from 2 to 5).  The 
analysis will be performed using a logistic regression model as specified above for the primary endpoint 
and will have the same estimands.  
The proportion of patients with any progression of disease as determined by a ≥ 2-point increase in the 
NIAID ordinal scale by Days 7, 14, 28 and 60 will be tabulated.  A Chi-square or Fisher’s exact test will 
compare treatment arms at each timepoint of interest. 
In the event of missing NIAID assessments, hospitalization records, supplemental oxygen use, or death, 
provided the data are known, can be used to impute the NIAID ordinal score. 
14.4.3.2 
Time to progression of disease as determined by a ≥ 2-point increase in the NIAID 
ordinal scale up to Day 28 and Day 60 
The time to progression is defined as the time from randomization to the first occurrence of a ≥ 2-point 
increase in the NIAID ordinal scale up to Day 60.  Patients who do not have a ≥ 2-point increase in the 
NIAID ordinal scale up to Day 60 will be censored at the date of last non-missing NIAID assessment up to 
Day 60.  If the event of missing NIAID assessments, hospitalization records, supplemental oxygen use, or 
death, provided the data are known, can be used to impute the NIAID ordinal score. 
Kaplan Meier methods will be used for time to event endpoint analyses. A stratified logrank test (stratified 
by the 2 randomization factors) will compare the two treatment arms.  Timepoints estimates (7, 14, 28 
and 60 days) and median point estimates will be derived from the Kaplan Meier analysis.  The primary 
estimands of treatment effect will be the hazard ratio and 95% CI, derived from a Cox proportional 
hazards, stratified by the 2 randomization factors, along with comparisons of the timepoint estimates at 
Day 28 and Day 60. 

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14.4.3.3 
Change from baseline in overall symptom score, and individual symptom scores, as 
measured by the symptom questionnaire up to Day 28 
The overall symptom score will be calculated as a sum of the individual scores from the 14 questions on 
the symptom score questionnaire (Appendix B). Each response will be scored according to the FDA’s 
Guidance on “Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in 
Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment” (17). The scores 
correspond to the responses:  
Questions 1-10: None = 0, Mild = 1, Moderate = 2, Severe = 3;  
Questions 11-12: Not at all = 0, 1-2 times = 1, 3-4 times = 2, 5 or more times = 3;  
Questions 13-14: Same as usual = 0, Less than usual = 1, No sense = 2. 
 
Change from baseline in the overall symptom questionnaire score, and individual symptom scores from 
baseline to 28 will be analyzed using a mixed model repeated measures analysis with the missing at 
random assumption for handling missing data. The model will contain baseline as a covariate, treatment, 
day, and treatment-by-day interaction as fixed effects, along with strata for the 2 randomization factors. 
The primary estimand of treatment effect will be the treatment differences and corresponding 95% CIs, 
with p-values. Estimates at days 7 and 14 will also be generated.  All available data will be used in the 
analysis. 
A graphical approach for the overall symptom questionnaire score and each individual symptom will plot 
the means (and 95% confidence intervals) of the patient’s daily symptom scores from baseline through 
Day 28, by treatment arm (e.g., linear plot over time). 
14.4.4 
Subgroup Analysis and Adjustment for Covariates 
This study is not powered for subgroup analyses; therefore, all subgroup analyses will be treated as 
exploratory. Subgroup analyses will be conducted for the primary endpoint, and if warranted, on other 
efficacy endpoints.  Subgroup by treatment interactions will be included to assess differential treatment 
effects. 
Prior to performing the analyses, a blinded review of the baseline characteristics will be performed, to 
evaluate whether there are enough patients in each category.  If there are insufficient numbers of patients 
in each category, some categories may be combined. Conversely, if there are more patients than expected 
in each category, additional categories may be considered. 
Baseline characteristics will be considered for subgroup analyses and covariate adjustment in statistical 
models.  As the science evolves, additional baseline factors may be considered for these analyses.  
• 
Region (US, outside US) 
• 
Completion of a COVID-19 vaccination regimen or participation in a COVID-19 vaccine clinical 
trial (yes, no). 
• 
Age group (18-59, ≥ 60 years).  For regulatory purposes, an additional analysis may be 
performed using age groups defined as 18-64, and ≥ 65 years.  If there are enough patients ≥ 
75 years or ≥ 85 years, these categories may be included. 

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• 
Number of pre-existing medical conditions which put patients at higher risk of progression to 
severe COVID-19 (0-1, 2 or more), based on inclusion criteria 3b.  Note: age will be considered 
separately as denoted above. If there are enough patients for any pre-existing condition in 
Inclusion Criteria 3b, a subgroup analysis may be performed. 
• 
Duration of any COVID-19 symptoms (0-2, 3-5 days) 
• 
Baseline NIAID ordinal score (1, 2)  
• 
Gender (male, female) 
• 
Race (White, Black, or African American, Asian, all others) 
• 
Ethnicity (Hispanic or Latino, Not Hispanic or Latino) 
• 
Body mass index (<18.5 kg/m2, 18.5 to <25 kg/m2, ≥25 to <30 kg/m2, ≥30 kg/m2)  
• 
Baseline SARS-CoV-2 variant (groupings to be determined based on prevalence) 
• 
Use of approved/authorized COVID-19 therapies (including monoclonal antibodies) prior to 
randomization (if there are enough patients) 
To evaluate the precision of the estimates of the primary endpoint, covariate adjustment using baseline 
factors will be performed, in an exploratory manner.  Covariate adjustment may be performed on the 
secondary efficacy endpoints.  
• 
First, each baseline factor will be assessed for potential impact on the outcome of interest in a 
model containing treatment arm (and randomization stratification factors as appropriate).  
Baseline factors will be assessed based on a p-value < 0.05. 
• 
Baseline factors with a p-value < 0.05, will be added to a multivariate model containing treatment 
arm (and randomization stratification factors as appropriate).  A stepwise approach will be used 
to determine the final covariate-adjusted model for each outcome of interest. 
14.5 
Safety Analyses 
The Safety Set will be used in the safety analysis.  
Treatment administration and compliance will be summarized. 
AEs will be coded using the latest version of the Medical Dictionary for Regulatory Activities. 
Treatment-emergent AEs and SAEs will be summarized by system organ class and preferred term; a 
patient will only be counted once per system organ class and once per preferred term within a treatment. 
Clinical laboratory and other continuous parameter results (such as vital signs) at each time point and 
change from baseline will be displayed using summary statistics (n, mean, standard deviation [SD], 
median, minimum, and maximum values) by treatment group.  
15 
DATA AND SAFETY MONITORING BOARD 
The DSMB will comprise of independent external experts to review the safety data and benefit/risk 

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evaluation from Day 1 - 28 (or study discontinuation) in approximately 100 randomized patients (total 
across both arms). Enrollment will not be paused during the DSMB process. 
This safety and risk/benefit review will use the available safety and efficacy data to formulate a 
benefit/risk evaluation. The available data will be accepted as is, and the data may not have gone through 
data cleaning processes. 
No formal interim efficacy analysis will be performed for the purpose of stopping the study.  Based on the 
totality of data, if the DSMB perceives an unfavorable benefit/risk or overall lack of efficacy, the DSMB 
may recommend Partner Therapeutics take appropriate actions, including an enrollment pause, modifying 
or stopping the study, and/or requesting an additional DSMB data review and meeting. 
Additional details will be provided in the DSMB charter. 
16 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The PI and/or designee, will prepare and maintain adequate and accurate patient case histories with 
observations and data pertinent to the study. Study specific CRFs will document safety and treatment 
outcomes for safety monitoring and data analysis. All study data will be entered into standardized CRFs in 
accordance with the overall study schedule. 
The information collected on CRFs shall be identical to that appearing in original source documents. 
Source documents will be found in the patient’s medical records maintained by study site personnel. All 
original source documentation must be maintained at the study site. 
In accordance with Good Clinical Practices (GCP) and all applicable regulatory requirements, the 
Investigator is responsible for the accuracy and authenticity of all clinical and laboratory data entered 
onto CRFs. The PI will approve all completed CRFs to attest that the information contained on the CRFs is 
true and accurate. 
In signing this protocol, the Investigator understands and agrees to give access to the necessary source 
documentation and files to enable study monitoring by employees or representatives of Partner 
Therapeutics. 
Monitoring of the study will be performed in compliance with GCP and all applicable regulatory 
requirements. Alternative methods of monitoring may need to be employed in light of the COVID-19 
pandemic, and in accordance with FDA guidance: Conduct of Clinical Trials of Medical Products During the 
COVID-19 Public Health Emergency, and/or applicable guidance from other regulatory authorities. 
17 
QUALITY CONTROL AND QUALITY ASSURANCE 
To ensure compliance with GCP and applicable regulatory requirements, a quality assurance audit may be 
conducted. Regulatory agencies may also conduct a regulatory inspection of this study. Such 
audits/inspections can occur at any time during or after study completion. If an audit or inspection occurs, 
the Investigator and institution agree to allow the auditor/inspector direct access to all relevant 
documents and to allocate his/her time and time of his/her staff to the auditor/inspector to discuss 
findings and any relevant issues. In the case of an audit or inspection, the Investigator or a designee will 
alert Partner Therapeutics as soon as he/she becomes aware of the audit or inspection. 

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The Investigator is responsible for maintaining a comprehensive and accurate filing system of all study-
related documentation that will be suitable for inspection at any time by Partner Therapeutics and its 
designees, and/or regulatory agencies. 
18 
ETHICS 
This study will be conducted in compliance with Institutional Review Board (IRB)/Ethics Committee (EC) 
and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human 
Use (ICH) GCP Guidelines; United States (US) Code of Federal Regulations (CFR) dealing with clinical 
studies (21 CFR § 50, 56, 312); the Declaration of Helsinki, and with applicable ICH guidelines regarding 
scientific integrity. This study will also adhere to all FDA and local regulatory requirements, and 
requirements for data protection. 
18.1 
Informed consent 
Investigators must follow local IRB/EC approved institutional practice for obtaining either written or 
verbal informed consent which should be obtained after adequate, thorough, and clear explanation of the 
study objectives, procedures, as well as the potential hazards of the study. The Investigator must use the 
most current IRB/EC-approved consent form. In cases where the patient is incapable of providing consent 
and the patients legally authorized decision maker is providing consent, the patient should be informed 
about the study to the extent possible given his/her understanding. 
19 
DATA HANDLING AND RECORD KEEPING 
Data collection is the responsibility of investigational site study staff under the oversight of the PI. The PI 
must maintain complete and accurate source documentation. 
Clinical research data from source documentation will be entered by the site into CRFs via a 21CRF Part 
11 compliant electronic data collection system (EDC). The EDC system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appears inconsistent, 
incomplete, or inaccurate. AEs and concomitant medications will be coded according to the most current 
versions of WHODrug and MedDRA dictionaries. 
Collection and processing of personal data from patients enrolled in this study will be limited to data 
necessary to fulfill study objectives. These data must be collected and processed with adequate 
precautions to ensure confidentiality and compliance with applicable data privacy protection laws and 
regulations. Records related to the study will be retained for a period of fifteen (15) years after study 
completion or discontinuation, unless otherwise notified by the Sponsor. 
Appropriate technical and organizational measures to protect personal data against unauthorized 
disclosures or access, accidental or unlawful destruction, or accidental loss or alteration must be put in 
place. Sponsor and site personnel whose responsibilities require access to personal data agree to keep 
patient identity confidential. 
Patient informed consent includes explicit consent for processing personal data and for 
Investigator/institution access to original medical records (source data/documents) for study-related 
monitoring, audit, Ethics Committee review and regulatory inspection, as well as for research purposes 
unrelated to this study. This consent also addresses data transfer to other entities, if applicable. 

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20 
FINANCING AND INSURANCE 
Before study initiation, each Investigator must provide a protocol signature page and a fully executed and 
signed Form FDA 1572 (for US sites) to Partner Therapeutics. For sites in countries other than US, 
Investigators will provide a Statement of Investigator Form which includes commitment to compliance to 
GCP (21 CFR 312.120). 
Financial Disclosure Forms must be completed by all Investigators and Sub Investigators who will be 
directly involved in the treatment or evaluation of research patients in this study. The Investigator(s) are 
required to disclose any financial arrangement whereby the value of the compensation for conducting the 
study could be influenced by the outcome of the study following information; any significant payments of 
other sorts from Partner Therapeutics, such as a grant to fund ongoing research, compensation in the 
form of equipment, retainer for ongoing consultation, or honoraria; any proprietary interest in 
sargramostim; any significant equity interest in Partner Therapeutics as defined in the US Code of Federal 
Regulations (21 CFR 54 2(b)). 
21 
PUBLICATION POLICY 
In accordance with Partner Therapeutics’ publication policy, this study’s results will be submitted for 
publication by a peer-reviewed journal if results are of significant medical importance. 
 
 

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22 
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APPENDIX A: NIAID ORDINAL SCALE 
Measure 
Ordinal Score 
Death 
8 
Hospitalized, receiving invasive mechanical ventilation or 
extracorporeal membrane oxygenation (ECMO) 
7 
Hospitalized, requiring non-invasive ventilation or use of high flow 
oxygen devices 
6 
Hospitalized, requiring supplemental oxygen 
5 
Hospitalized, not requiring supplemental oxygen - requiring ongoing 
medical care (related to COVID-19 or to other medical conditions) 
4 
Hospitalized, not requiring supplemental oxygen and no longer 
requires ongoing medical care (used if hospitalization was extended 
for infection-control or other nonmedical reasons) 
3 
Not hospitalized, with limitation of activities, home oxygen requirement, 
or both 
2 
Not hospitalized, no limitations on activities 
1 
 
 
 

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APPENDIX B: SYMPTOM SCORE QUESTIONNAIRE 
This Symptom Score Questionnaire is based on the FDA Guidance document Assessing COVID-19-
Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological 
Products for COVID-19 Prevention or Treatment (17). 
Instructions 
As a participant taking part in our research study, you are being asked to complete this 
questionnaire. This questionnaire asks about the impact of COVID-19 on your health. 
Your answers should reflect the severity of the symptoms at their worst over the last 24 
hours. Please respond to the questions below to the best of your ability and ask the research 
study staff if you have any questions. 
1) What was the severity of your STUFFY OR RUNNY NOSE at its worst over the last 24 hours?  
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
2) What was the severity of your SORE THROAT at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
3) What the was the severity of your SHORTNESS OF BREATH (difficulty breathing) at its worst 
over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
 
 

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4) What was the severity of your COUGH at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
5) What was the severity of your LOW ENERGY OR TIREDNESS at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
6) What was the severity of your MUSCLE OR BODY ACHES at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
7) What was the severity of your HEADACHES at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
8) What was the severity of your CHILLS OR SHIVERING at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
 
 

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9) What was the severity of FEELING HOT OR FEVERISH at its worst over the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
10) What was the severity of your NAUSEA (feeling like you wanted to throw up) at its worst over 
the last 24 hours? 
⃝  None 
⃝ Mild 
⃝ Moderate 
⃝ Severe 
11) How many times did you VOMIT (throw up) in the last 24 hours?  
⃝ I did not vomit at all 
⃝ 1-2 times 
⃝ 3-4 times 
⃝ 5 or more times 
12) How many times did you have DIARRHEA (loose or watery stools) in the last 24 hours?  
⃝  I did not have diarrhea at all 
⃝ 1-2 times 
⃝ 3-4 times 
⃝ 5 or more times 
13) Rate your SENSE OF SMELL in the last 24 hours: 
⃝  My sense of smell is THE SAME AS usual 
⃝ My sense of smell is LESS THAN usual 
⃝ I have NO sense of smell 
14) Rate your SENSE OF TASTE in the last 24 hours: 
⃝  My sense of taste is THE SAME AS usual 
⃝ My sense of taste is LESS THAN usual 
⃝ I have NO sense of taste 

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APPENDIX C: PATIENT GLOBAL IMPRESSION 
Instructions 
As a participant taking part in our research study, you are being asked to complete this 
questionnaire. This questionnaire asks about the impact of COVID-19 on your health. 
Complete this questionnaire after completing the symptom questionnaire. 
1. In the past 24 hours, have you returned to your usual health (before your COVID-19 
illness)? 
⃝ 
Yes 
⃝ 
No  
2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 
illness)? 
⃝ 
Yes 
⃝ 
No  
3. In the past 24 hours, what was the severity of your overall COVID-19-related symptoms 
at their worst? 
⃝ 
None 
⃝ 
Mild 
⃝ 
Moderate 
⃝ 
Severe 
 
 
 
 

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APPENDIX D: DAY 60 COVID-19 SYMPTOM EVALUATION 
This Symptom Evaluation includes the same symptoms as in the FDA Guidance document 
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical 
Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (FDA, 2020).  The 
purpose of this Day 60 symptom evaluation is to evaluate whether patients have COVID-19 
symptoms. 
Instructions 
On Day 60, as the patient completes the study, the investigator site staff should ask the patient 
whether they have had any symptoms of COVID-19 over the last 7 days.  
1) 
Have you had any STUFFY OR RUNNY NOSE over the last 7 days?  
⃝ 
Yes 
⃝ 
No 
2) 
Have you had a SORE THROAT over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
3) 
Have you had any SHORTNESS OF BREATH (difficulty breathing) over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
4) 
Have you had any COUGH over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
5) 
Have you had any LOW ENERGY OR TIREDNESS over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
6) 
Have you had any MUSCLE OR BODY ACHES over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
 
 

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7) 
Have you had any HEADACHES over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
8) 
Have you had any CHILLS OR SHIVERING over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
9) 
Have you had any FEELING HOT OR FEVERISH the last 7 days? 
⃝ 
Yes 
⃝ 
No 
10) Have you had any NAUSEA (feeling like you wanted to throw up) over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
11) Have you VOMITED (thrown up) over the last 7 days?  
⃝ 
Yes 
⃝ 
No 
12) Have you had DIARRHEA (loose or watery stools) over the last 7 days?  
⃝ 
Yes 
⃝ 
No 
13) Has your SENSE OF SMELL been the same as usual over the last 7 days? 
⃝ 
Yes 
⃝ 
No 
14) Has your SENSE OF TASTE been the same as usual over the last 7 days? 
⃝ 
Yes 
⃝ 
No