Study of Sargramostim in Patients With COVID-19
Completed · Phase 2
Conditions studied: COVID-19, SARS-CoV-2
In brief
The purpose of this research is to find out if a drug (sargramostim) also known as Leukine® could help patient recover faster from COVID-19. Sargramostim may help the lungs recover from the effects of COVID-19, and this research study will help to find this out.
Key facts
- Study ID
- NCT04411680
- Run by
- Partner Therapeutics, Inc.
- People needed
- 123
- Starts
- 2020-08-18
- Expected to finish
- 2021-05-19
- Last updated by the study team
- 2023-08-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged ≥ 18 years
- Patients (or legally authorized decision maker) must provide informed consent
- Test positive for SARS-CoV-2 virus by PCR
- Admitted to hospital
- Presence of acute hypoxemia defined as (either or both)
- saturation below 93% on ≥ 2 L/min oxygen supplementation
- PaO2/FiO2 below 350
You may not qualify if…
- Patients requiring invasive (mechanical ventilation) or non-invasive (CPAP, BiPAP for hypoxemia) ventilation or ECMO (Note: oxygen supplementation using high flow oxygen systems or low flow oxygen systems would not exclude patients from this study)
- Intractable metabolic acidosis
- Cardiogenic pulmonary edema
- Hypotension requiring use of vasopressors
- Hyperferritinemia (serum ferritin ≥2,000 mcg/L)
- White blood cell count > 50,000/mm3
- Participation in another interventional clinical trial for COVID-19 therapy
- Highly immunosuppressive therapy or anti-cancer combination chemotherapy within 24 hours prior to first dose of sargramostim
- Known or suspected intolerance or hypersensitivity to sargramostim, or any component of the product
- Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medical product
- Presence of any preexisting illness that, in the opinion of the Investigator, would place the patient at an unreasonably increased risk through participation in this study
- Pregnant or breastfeeding females
- Severe or uncontrolled pulmonary comorbid conditions, including systemic steroid dependent asthma, systemic steroid dependent COPD, oxygen dependent COPD, lung transplant, known interstitial lung disease, or cystic fibrosis
Where it is running
- St. Jude Medical Center — Fullerton, California, United States
- St. Joseph Hospital of Orange — Orange, California, United States
- California Pacific Medical Center - Van Ness Campus — San Francisco, California, United States
- TidalHealth Peninsula Regional, Inc — Salisbury, Maryland, United States
- University of Missouri Health Care — Columbia, Missouri, United States
- Great Plains Health — North Platte, Nebraska, United States
- Richmond University Medical Center — Staten Island, New York, United States
- Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States
- University of Toledo Medical Center — Toledo, Ohio, United States
- Memorial Hermann Hospital Affiliated with the University of Texas Health Science Center at Houston, McGovern Medical School — Houston, Texas, United States
- University of Utah Health — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.