Intervention: Zidovudine
Trial phase: Phase 2
ATC code: J05AF01 | J05AR01 | J05AR04 | J05AR05
SMILES: Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 297
Group description: Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19

Sargramostim: All patients randomized to the sargramostim treatment arm will be treated with 250 mcg inhaled sargramostim administered via a vibrating mesh nebulizer once daily for 5 days.
Eligibility criteria:
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