Sargramostim for COVID-19: real-time analysis of 4 studies

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c19early.org

Sargramostim for COVID-19

4 studies with >800 patients

Serious outcome risk

Sargramostim

Control

Significantly lower risk for viral clearance.

2 studies from 2 independent teams (both from the same country) show significant benefit.

COVID-19 Sargramostim studies · October 2026

Outcome (studies)

Improvement

Relative risk · 95% CI

All studies (4)−13%

Mortality (2)19%

Hospitalization (1)−3%

Viral clearance (1)27%

RCTs (4)−13%

RCT mortality (2)19%

Late (4)−13%

00.511.5+

← Sargramostim
reduces riskIncreased
risk →

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	Covid Analysis	Sargramostim for COVID-19: real-time meta-analysis of 4 studies
	Meta-analysis using the most serious outcome reported shows 13% [-31‑85%] higher risk, without reaching statistical significance. Currently all studies are RCTs. Currently there is limited data, with only 870 patients and only ..
Nov 27 2023	Joshi et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad500.351	Inhaled Sargramostim (rhu GM-CSF) Leads to Enhanced SARS-CoV-2 Virus-Specific Immune Response and Viral Clearance: Results of the Biomarker Cohort of a Randomized, Double-Blind, Placebo-Controlled Phase 2b Trial in Non-Hospitalized Patients with COVID-19
	30% higher progression (p=0.5) and 27% improved viral clearance (p=0.005). RCT 600 non-hospitalized COVID-19 patients at high risk for progression showing enhanced SARS-CoV-2 viral clearance by day 14 with inhaled sargramostim (rhu GM-CSF) compared to placebo. There was no significant difference in the primary e..
Sep 20 2023	Shimasaki et al., Infectious Diseases, doi:10.1080/23744235.2023.2254380	Short-term inhalation of sargramostim with concomitant high-dose steroids does not hasten recovery in moderate COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial
	12% slower improvement (p=0.1) and 10% longer hospitalization. RCT 70 hospitalized COVID-19 patients with moderate pneumonia in Japan showing no significant difference in time to clinical improvement with inhaled sargramostim (GM-CSF) vs. placebo. Concomitant corticosteroid dose was not standardized...
Dec 2 2022	Paine et al., Military Medicine, doi:10.1093/milmed/usac362	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)
	23% lower mortality (p=0.58), 27% lower ventilation (p=0.58), 56% lower need for oxygen therapy (p=0.04), and 3% longer hospitalization (p=0.86). RCT 122 hospitalized COVID-19 patients showing improved oxygenation with inhaled sargramostim (GM-CSF) treatment. There was no significant difference in intubation rate, mortality, or adverse events.
Oct 13 2021	Bosteels et al., Research Square, doi:10.21203/rs.3.rs-959220/v1	Early treatment with inhaled GM-CSF improves oxygenation and anti-viral immunity in COVID-19 induced lung injury – a randomized clinical trial
	20% higher ventilation (p=0.77), 10% worse results (p=0.77), and 43% lower need for oxygen therapy (p=0.13). RCT 81 non-ventilated COVID-19 patients with hypoxemic respiratory failure showing improved oxygenation after 5 days of inhaled sargramostim (rhu-GM-CSF) compared to standard of care. More patients in the sargramostim group experienced at..