Summary of COVID-19 sargramostim studies

1. Paine et al., 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)

122 patient sargramostim late treatment RCT: 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.
Dec 2022, Military Medicine, https://academic.oup.com/milmed/article/188/7-8/e2629/6865122, https://c19p.org/paine

2. Joshi et al., 279. 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

600 patient sargramostim late treatment RCT: 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 endpoint between groups. The sargramostim group had a different antibody response, with lower IgM titers at day 28 in vaccinated patients and higher IgG4 titers associated with isotype switching. Inflammatory cytokine levels did not increase with treatment.
Nov 2023, Open Forum Infectious Diseases, https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofad500.351/7447762, https://c19p.org/joshi

3. Bosteels et al., Early treatment with inhaled GM-CSF improves oxygenation and anti-viral immunity in COVID-19 induced lung injury – a randomized clinical trial

81 patient sargramostim late treatment RCT: 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 least 25% improvement in oxygenation. Sargramostim treatment also increased circulating class-switched B cells and effector SARS-CoV-2 specific CD8 T cells. There were no significant differences in mortality or clinical scores.
Oct 2021, Research Square, https://www.researchsquare.com/article/rs-959220/v1, https://c19p.org/bosteels

4. Shimasaki et al., 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

70 patient sargramostim late treatment RCT: 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. In a post-hoc analysis of patients who received ≤500mg prednisolone-equivalent corticosteroids over 5 days, sargramostim improved oxygenation and clinical status compared to placebo. Higher corticosteroid doses were associated with delayed recovery. Authors hypothesize that high-dose corticosteroids may impair differentiation of monocytes into mature alveolar macrophages.
Sep 2023, Infectious Diseases, https://www.tandfonline.com/doi/full/10.1080/23744235.2023.2254380, https://c19p.org/shimasaki

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