Clinical trial: Sargramostim Use in COVID-19 to Recover Patient Health (NCT04707664)

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

               2. New onset or worsening cough

               3. Sore throat

               4. Malaise or fatigue

               5. Headache

               6. Muscle pain (myalgias)

               7. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)

               8. New onset or worsening shortness of breath (dyspnea)

               9. 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

          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 must give informed consent

        Exclusion Criteria:

          1. Hospitalized patients

          2. Patients who have received or are receiving other approved/authorized treatments to
             prevent progression of COVID-19 disease severity, including but not limited to:

               1. Monoclonal antibodies e.g., bamlanivimab, casirivimab plus imdevimab

               2. Antiviral agents e.g., remdesivir

               3. Other COVID-19 therapies used as part of the standard of care, e.g., convalescent
                  plasma, dexamethasone, baricitinib

          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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment