A Proof of Concept, Randomized, Double-blind, Placebo-controlled Trial of Orally Administered Belnacasan Tablets for the Treatment of Mild to Moderate COVID-19
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 treatments
1.
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.
|
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.
