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

Lickteig et al., NCT04969991, STAIRS, NCT04969991, Nov 2022

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https://c19early.org/lickteig.html

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. Low-cost treatments were excluded, reducing the probability of treatment—especially early—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).

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).

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.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

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.

This Paper Varespladib All

Late treatment
is less effective

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