A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Varespladib in Patients Hospitalized With Severe COVID 19 Caused by SARS-CoV-2
et al., NCT04969991, STAIRS, NCT04969991, Nov 2022
Very small early terminated RCT showing no significant differences with varespladib treatment.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments1.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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risk of death, 120.0% higher, RR 2.20, p = 1.00, treatment 1 of 15 (6.7%), control 0 of 3 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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risk of mechanical ventilation, 240.0% higher, RR 3.40, p = 1.00, treatment 2 of 15 (13.3%), control 0 of 3 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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risk of progression, 240.0% higher, RR 3.40, p = 1.00, treatment 2 of 15 (13.3%), control 0 of 3 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), respiratory failure or death.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Lickteig et al., 22 Nov 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04969991 (history) (STAIRS).
Contact: tim@ophirex.com.
Late treatment
is less effective
is less effective
