Status:
COMPLETED
Study of Sargramostim in Patients With COVID-19
Lead Sponsor:
Partner Therapeutics, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This Phase 2 study is designed as a proof of concept study and will randomize 2:1 approximately 120 patients with COVID-19 associated acute hypoxemia: of which 80 patients will receive sargramostim pl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT04411680
Start Date
August 18 2020
End Date
May 19 2021
Last Update
August 23 2023
Active Locations (11)
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1
St. Jude Medical Center
Fullerton, California, United States, 92835
2
St. Joseph Hospital of Orange
Orange, California, United States, 92868
3
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States, 94109
4
TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, United States, 21801