Study of Sargramostim in Patients With COVID-19

• Status: Completed
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

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 COVID-19, and this research study will help to find this out.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Partner Therapeutics, Inc.
• Collaborator: United States Department of Defense
• Treatments: Sargramostim

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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