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0 0.5 1 1.5 2+ Mortality 67% Improvement Relative Risk Hospitalization 50% Mortality (b) 67% Hospitalization (b) 71% Mortality (c) 67% Hospitalization (c) 92% Viral clearance 74% c19early.org/aa Kintor et al. NCT04870606 Proxalutamide RCT EARLY Is early treatment with antiandrogens beneficial for COVID-19? Double-blind RCT 730 patients in the USA Improved viral clearance with antiandrogens (p=0.0001) Kintor News Release Favors proxalutamide Favors control
Kintor Pharma's Proxalutamide Demonstrated Reduction in Hospitalization/Mortality for Patients with Mild to Moderate COVID-19 in Phase III MRCT Study
Kintor News Release (News), NCT04870606 (history)
Kintor, Kintor Pharma's Proxalutamide Demonstrated Reduction in Hospitalization/Mortality for Patients with Mild to.., News Release (News), NCT04870606
Apr 2022   Source   PDF  
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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].
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 size 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 size 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 size 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 size 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 size 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 size approximated.
risk of no viral clearance, 73.9% lower, RR 0.26, p < 0.001, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kintor et al., 5 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04870606 (history).
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