Kintor Pharma's Proxalutamide Demonstrated Reduction in Hospitalization/Mortality for Patients with Mild to Moderate COVID-19 in Phase III MRCT Study

Kintor, Press Release, NCT04870606, Apr 2022

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https://c19early.org/kintorpx3x.html

RCT 733 outpatients, 99% in the USA, showing lower hospitalization/death, and significantly reduced viral load with proxalutamide treatment. The viral clearance result is from Ma et al.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments2. 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, 66.7% lower, RR 0.33, p = 1.00, treatment 0 of 365 (0.0%), control 1 of 365 (0.3%), NNT 365, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 1+ days of treatment, group sizes approximated.

risk of hospitalization, 50.0% lower, RR 0.50, p = 0.38, treatment 4 of 365 (1.1%), control 8 of 365 (2.2%), NNT 91, 1+ days of treatment, group sizes approximated.

risk of death, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 360 (0.0%), control 1 of 361 (0.3%), NNT 361, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), >1 day of treatment, group sizes approximated.

risk of hospitalization, 71.3% lower, RR 0.29, p = 0.18, treatment 2 of 360 (0.6%), control 7 of 361 (1.9%), NNT 72, >1 day of treatment, group sizes approximated.

risk of death, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 346 (0.0%), control 1 of 347 (0.3%), NNT 347, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), >7 days of treatment, group sizes approximated.

risk of hospitalization, 92.3% lower, RR 0.08, p = 0.03, treatment 0 of 346 (0.0%), control 6 of 347 (1.7%), NNT 58, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), >7 days of treatment, group sizes approximated.

risk of no viral clearance, 73.9% lower, RR 0.26, p < 0.001, treatment 365, control 365, group sizes approximated, day 7.

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1. Ma et al., Mechanisms of action (MOA) for proxalutamide, an androgen receptor (AR) antagonist, for the treatment of mild, moderate and severe COVID-19 patients, AACR Annual Meeting 2022, www.abstractsonline.com/pp8/#!/10517/presentation/18533abstractsonline.com.

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

Kintor et al., 5 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, study period 5 March, 2021 - 1 April, 2022, trial NCT04870606 (history).

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