Sargramostim Use in COVID-19 to Recover Patient Health

Inclusion Criteria

• •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:
• •1. Fever or chills
• •2. New onset or worsening cough
• •3. Sore throat
• •4. Malaise or fatigue
• •5. Headache
• •6. Muscle pain (myalgias) or body aches
• •7. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
• •8. New onset or worsening shortness of breath or difficulty breathing
• •9. Nasal congestion or runny nose
• •10. 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
• •1. Age ≥ 60 years
• •2. 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