Sargramostim Use in COVID-19 to Recover Patient Health

Completed · Phase 2 · Has a placebo group

Conditions studied: Covid19, SARS-CoV Infection

In brief

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.

Key facts

Study ID

NCT04707664

Run by

Partner Therapeutics, Inc.

People needed

600

Starts

2021-04-27

Expected to finish

2022-01-31

Last updated by the study team

2023-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Valley Research Clinic, LLC — Phoenix, Arizona, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Hope Clinical Research — Canoga Park, California, United States
• Benchmark Research — Colton, California, United States
• Synergy Healthcare — Bradenton, Florida, United States
• Invesclinic US, LLC. — Fort Lauderdale, Florida, United States
• Indago Research & Health Center, Inc. (Subject Visits Only) — Hialeah, Florida, United States
• Encore Medical Research — Hollywood, Florida, United States
• IMIC Inc. — Palmetto Bay, Florida, United States
• Encore Medical Research of Weston — Weston, Florida, United States
• Gwinnett Research Institute, LLC — Buford, Georgia, United States
• Paramount Research Solutions — College Park, Georgia, United States
• TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States
• Revive Research Institute, Inc. — Farmington Hills, Michigan, United States
• Revival Research Institute, LLC. — Sterling Heights, Michigan, United States
• Olive Branch Family Medical Center — Olive Branch, Mississippi, United States
• Great Plains Health — North Platte, Nebraska, United States
• Excel Clinical Research — Las Vegas, Nevada, United States
• Richmond University Medical Center — Staten Island, New York, United States
• Monroe Biomedical Research — Monroe, North Carolina, United States
• Hometown Urgent Care and Research — Cincinnati, Ohio, United States
• Hometown Urgent Care and Research — Columbus, Ohio, United States
• Urgent Care Specialists, LLC DBA Hometown Urgent Care and Research — Dayton, Ohio, United States
• TruCare Internal Medicine and Infectious Disease — DuBois, Pennsylvania, United States
• Urgent Care Clinical Trials @ AFC Urgent Care - Easley — Easley, South Carolina, United States

Full record on ClinicalTrials.gov

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