Sargramostim Use in COVID-19 to Recover Patient Health

Inclusion Criteria

• 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.
• Have one or more of the following mild or moderate COVID-19 symptoms for ≤5 days prior to randomization:
• Fever or chills
• New onset or worsening cough
• Sore throat
• Malaise or fatigue
• Headache
• Muscle pain (myalgias) or body aches
• Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
• New onset or worsening shortness of breath or difficulty breathing
• Nasal congestion or runny nose
• 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.
• At higher risk for progression to more severe COVID-19
• Age ≥ 60 years
• 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
• 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
• Negative pregnancy test (if woman of childbearing potential)
• Females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to Day 28
• The patient (or legally authorized decision maker) must give informed consent

Exclusion Criteria

• Hospitalized patients
• Patients who have received or are receiving other 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
• Patients enrolled in interventional clinical trials for other experimental therapies
• Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions
• Patients with unstable comorbid conditions (e.g., decompensated congestive heart failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled asthma)
• Patients with severe pulmonary comorbid conditions, including systemic steroid-dependent asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung transplant, or cystic fibrosis
• 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
• Patients with known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product
• Patients who have previously experienced severe and unexplained side effects during aerosol delivery of any kind of medical product
• Pregnant or breastfeeding females
• 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