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Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

Kane et al., NCT04590547, NCT04590547, Apr 2025
Late treatmentRCT · NCT04590547 · 132 patients · multinational
Zenuzolac for COVID-19
Kane et al. NCT04590547 · April 2025
Higher mortality with zenuzolac
Not statistically significant · p = 0.34
RCT 132 hospitalized COVID-19 patients showing no significant difference in outcomes with zenuzolac (GLS-1027) treatment.
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OutcomeImprovementEffect · pTreatmentControl
risk of death 200.2% higher · RR 3.00 · p = 0.34 200.2% higherRR 3.00p = 0.34 46 44 treatment 46, control 44
risk of death 195.7% higher · RR 2.96 · p = 1.00 195.7% higherRR 2.96p = 1.00 1 of 46 (2.2%) 0 of 44 (0.0%) treatment 1 of 46 (2.2%), control 0 of 44 (0.0%)continuity correction due to zero events360mg
risk of death 204.8% higher · RR 3.05 · p = 0.49 204.8% higherRR 3.05p = 0.49 1 of 42 (2.4%) 0 of 44 (0.0%) treatment 1 of 42 (2.4%), control 0 of 44 (0.0%)continuity correction due to zero events120mg
risk of no recovery 0.7% higher · RR 1.01 · p = 0.99 0.7% higherRR 1.01p = 0.99 46 44 treatment 46, control 44
risk of no recovery 43.5% higher · RR 1.43 · p = 1.00 43.5% higherRR 1.43p = 1.00 3 of 46 (6.5%) 2 of 44 (4.5%) treatment 3 of 46 (6.5%), control 2 of 44 (4.5%)360mg
risk of no recovery 47.6% lower · RR 0.52 · p = 1.00 47.6% lowerRR 0.52p = 1.00 1 of 42 (2.4%) 2 of 44 (4.5%) treatment 1 of 42 (2.4%), control 2 of 44 (4.5%)NNT 46120mg
hospitalization time 1.1% lower · relative time 0.99 · p = 0.87 1.1% lowerrelative time 0.99p = 0.87 46 44 treatment 46, control 44
hospitalization time 1.1% lower · relative time 0.99 · p = 0.90 1.1% lowerrelative time 0.99p = 0.90 mean 9.3 (±3.65) n=46 mean 9.4 (±4.1) n=44 mean 9.3 (±3.65) n=46, mean 9.4 (±4.1) n=44360mg
hospitalization time 1.1% lower · relative time 0.99 · p = 0.91 1.1% lowerrelative time 0.99p = 0.91 mean 9.3 (±4.2) n=42 mean 9.4 (±4.1) n=44 mean 9.3 (±4.2) n=42, mean 9.4 (±4.1) n=44120mg

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Kane et al., 11 Apr 2025, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 1 author, trial NCT04590547 (history). Contact: dkane@genels.us.
Zenuzolac (GLS-1027) is an oral, small molecule isoxazole immunomodulator that down-regulates NF-κB/p38-mediated pro-inflammatory cytokine production and Th17 responses.
Late treatment
is less effective