Sargramostim Use in COVID-19 to Recover Patient Health
Condition: Covid19; SARS-CoV Infection
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: Sargramostim; Placebo
Intervention description: 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.; All patients in the control arm will receive an equivalent volume of inhaled placebo diluent administered via a vibrating mesh nebulizer once daily for 5 days.
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 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.
Masking: Double (Participant, Investigator)
Masking description: Double blind
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; SARS-CoV2; sargramostim; Leukine; (recombinant human) GM-CSF; immune modulator; SCOPE

Summary:

      The purpose of this research is to understand if the study drug, also called sargramostim or
      Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This
      study will also help researchers understand if inhaled sargramostim can help prevent visits
      to the emergency room or hospitalization, or death.
    

Eligibility criteria:

        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

        Exclusion Criteria:

          1. Hospitalized patients

          2. 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

          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 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