A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients

Sagent Pharmaceuticals, NCT04583592, NCT04583592

Mar 2021

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RCT 295 outpatients in the USA, showing no significant differences with camostat.

Standard of Care (SOC): 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, 152.1% higher, RR 2.52, p = 1.00, treatment 1 of 194 (0.5%), control 0 of 101 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 28.

ER, hospitalization, death, 13.2% lower, RR 0.87, p = 0.79, treatment 10 of 194 (5.2%), control 6 of 101 (5.9%), NNT 127.

risk of no viral clearance, 16.1% lower, RR 0.84, p = 0.36, treatment 58 of 194 (29.9%), control 36 of 101 (35.6%), NNT 17, day 15.

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.

Sagent Pharmaceuticals et al., 31 Mar 2021, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04583592 (history). Contact: ctinkoff@sagentpharma.com.

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