Status:
COMPLETED
Sargramostim Use in COVID-19 to Recover Patient Health
Lead Sponsor:
Partner Therapeutics, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 h...
Detailed 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 Do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04707664
Start Date
April 27 2021
End Date
January 31 2022
Last Update
February 6 2023
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
West Valley Research Clinic, LLC
Phoenix, Arizona, United States, 85031
2
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
3
Hope Clinical Research
Canoga Park, California, United States, 91303
4
Benchmark Research
Colton, California, United States, 92324