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A Proof of Concept, Randomized, Double-blind, Placebo-controlled Trial of Orally Administered Belnacasan Tablets for the Treatment of Mild to Moderate COVID-19

Wortmann et al., NCT05164120, NCT05164120, Oct 2022
https://c19early.org/wortmann.html
Recovery time -34% Improvement Relative Risk Recovery time, WHO 0 -43% Recovery time, WHO 1 -31% Belnacasan  Wortmann et al.  EARLY TREATMENT  DB RCT Is early treatment with belnacasan beneficial for COVID-19? Double-blind RCT 40 patients in the USA Slower recovery with belnacasan (not stat. sig., p=0.29) c19early.org Wortmann et al., NCT05164120, October 2022 Favorsbelnacasan Favorscontrol 0 0.5 1 1.5 2+
RCT 40 outpatients in the USA, showing no significant difference in recovery with belnacasan 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.
recovery time, 33.8% higher, relative time 1.34, p = 0.29, treatment mean 20.6 (±18.1) n=14, control mean 15.4 (±7.8) n=17, time to sustained recovery or resolution of common COVID-19 symptoms.
recovery time, 43.2% higher, relative time 1.43, p = 0.05, treatment mean 27.2 (±14.3) n=17, control mean 19.0 (±8.9) n=17, time to WHO scale 0.
recovery time, 31.0% higher, relative time 1.31, p = 0.39, treatment mean 9.3 (±6.1) n=15, control mean 7.1 (±5.0) n=8, time to WHO scale 1.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Wortmann et al., 11 Oct 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT05164120 (history). Contact: Alexander.Kroemer@gunet.georgetown.edu, Khalid.M.Khan@gunet.georgetown.edu.
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