Study of Sargramostim in Patients With COVID-19

Phase 2 Completed 123 enrolled Partner Therapeutics, Inc. United States Department of Defense · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-08-18
Primary completion: 2021-03-02
Completion: 2021-05-19

Outcome

Met primary endpoint

release “In both the SARPAC and iLeukPulm clinical studies, inhaled Leukine significantly improved P(A-a)O 2 gradient indicating improved oxygenation and diffusion.” partnertx.com ↗

release “Department of Defense (DOD) Sponsored U.S. Study Met Primary Endpoint for Improvement in Oxygenation and Demonstrated Treatment with Inhaled Leukine Was Safe and Well Tolerated” partnertx.com ↗

Publications

Results Paine R, Chasse R, Halstead ES, Nfonoyim J, Park DJ, Byun T, Patel B, Molina-Pallete G, Harris ES, Garner F, Simms L, Ahuja S, McManus JL, Roychowdhury DF. Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm). Mil Med. 2023 Jul 22;188(7-8):e2629-e2638. doi: 10.1093/milmed/usac362.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sargramostim	Protein / enzyme biologic	125 ug	Inhaled
Subject	sargramostim	Protein / enzyme biologic	125 ug/m2	Inhaled