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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 78% Improvement Relative Risk Mortality (b) 79% Recovery rate 45% Recovery rate (b) 55% primary Hospitalization time 33% Proxalutamide  Cadegiani et al.  LATE TREATMENT  DB RCT Is late treatment with proxalutamide beneficial for COVID-19? Double-blind RCT 778 patients in Brazil (February - April 2021) Lower mortality (p<0.0001) and improved recovery (p<0.0001) c19early.org Cadegiani et al., Cureus, December 2021 Favors proxalutamide Favors control

Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial

Cadegiani et al., Cureus, doi:10.7759/cureus.20691, NCT04728802
Dec 2021  
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RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 (history) and NCT05126628 (history). Authors note that cases in this trial were predominantly the P.1 Gamma variant, for which proxalutamide may be more effective compared to other variants.
risk of death, 78.0% lower, RR 0.22, p < 0.001, treatment 45 of 423 (10.6%), control 171 of 355 (48.2%), NNT 2.7, adjusted per study, 28 days, Cox proportional hazards.
risk of death, 79.0% lower, RR 0.21, p < 0.001, treatment 34 of 423 (8.0%), control 138 of 355 (38.9%), NNT 3.2, adjusted per study, 14 days, Cox proportional hazards.
recovery rate, RR 0.55, p < 0.001, treatment 423, control 355, adjusted per study, inverted to make RR<1 favor treatment, 28 days, Cox proportional hazards.
recovery rate, RR 0.45, p < 0.001, treatment 423, control 355, adjusted per study, inverted to make RR<1 favor treatment, 14 days, Cox proportional hazards, primary outcome.
hospitalization time, 33.3% lower, relative time 0.67, p < 0.001, treatment 423, control 355.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cadegiani et al., 25 Dec 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 15 authors, study period 1 February, 2021 - 15 April, 2021, trial NCT04728802 (history).
This PaperProxalutamideAll
Final Results of a Randomized, Placebo-Controlled, Two-Arm, Parallel Clinical Trial of Proxalutamide for Hospitalized COVID-19 Patients: A Multiregional, Joint Analysis of the Proxa-Rescue AndroCoV Trial
Flavio A Cadegiani, Ricardo A Zimerman, Daniel N Fonseca, Michael N Correia, Marcio P Muller, Diego Leonardo Bet, Marcio Rafael Slaviero, Ivan Zardo, Paulo Roberto Benites, Renan N Barros, Raysa W Paulain, Dirce C Onety, Karla Cristina P Israel, Carlos Gustavo Wambier, Andy Goren
Cureus, doi:10.7759/cureus.20691
Background The role of androgens on COVID-19 is well established. Proxalutamide is a second-generation, nonsteroidal antiandrogen (NSAA) with the highest antiandrogen potency among NSAAs and concurrent regulation of angiotensin-converting enzyme 2 (ACE2) expression and inflammatory response. Proxalutamide has been demonstrated to be effective to prevent hospitalizations in early COVID-19 in randomized clinical trials (RCTs). Conversely, in hospitalized COVID-19 patients, preliminary results from two different arms of an RCT (The Proxa-Rescue AndroCoV Trial) also demonstrated a reduction in all-cause mortality. This study aims to report the final, joint results of the two arms (North arm and South arm) of the Proxa-Rescue AndroCoV trial of the two arms (North and South arms) combined, and to evaluate whether COVID-19 response to proxalutamide was consistent across different regions (Northern Brazil and Southern Brazil). Materials and methods Upon randomization, hospitalized COVID-19 patients received either proxalutamide 300mg/day or placebo for 14 days, in addition to usual care, in a proxalutamide:placebo ratio of 1:1 in the North arm and 4:1 in the South arm (ratio was modified due to preliminary report of high drug efficacy). Datasets of the South and North arms were combined, and statistical analysis was performed for the overall study population. Proxalutamide was compared to placebo group for 14-day and 28-day recovery (discharge alive from the hospital) and mortality rates, and overall and post-randomization hospitalization stay. Results of proxalutamide and placebo groups were also compared between the North and South arms. Analysis was also performed stratified by sex and baseline WHO COVID Ordinary Score. Results A total of 778 subjects were included (645 from the North, 317 from the proxalutamide group and 328 from the placebo group; 133 from the South arm, 106 from the proxalutamide group and 27 from the placebo group). Recovery rate was 121% higher in proxalutamide than placebo group at day 14 [81.1% vs 36.6%; Recovery ratio (RecR) 2.21; 95% confidence interval (95% CI), 1.92-2.56; p<0.0001], and 81% higher at day 28 (98.1% vs 47.6%; RecR, 1.81; 95% CI, 1.61-2.03; p<0.0001). All-cause mortality rate was 80% lower in proxalutamide than placebo group at Day 14 [8.0% vs 39.2%; Risk ratio (RR), 0.20; 95% CI, 0.14-0.29; p<0.0001], and 78% lower at Day 28 (10.6% vs 48.2%; RR, 0.22; 95% CI 0.16-0.30). Post-randomization timeto-discharge was shorter in proxalutamide [median, 5 days; interquartile range (IQR), 3-8] than placebo group (median, 9 days; IQR, 6-14) (p<0.0001). Results were statistically similar between North and South arms for all measured outcomes. Males and females presented similar results in all outcomes. Patients that did not require oxygen use (scores 3 and 4) did not present statistically significant improvement in recovery and mortality rates, whereas scores 5 and 6 presented significant improvements in..
Additional Information Disclosures Human subjects: Consent was obtained or waived by all participants in this study. National Ethics Committee (CEP/CONEP/MS) issued approval 4.513.425. The present study was approved by the National Ethics Committee (CEP/CONEP/MS), unrestricted to a specific site, once the research protocol was followed as approved and the study conducted until September 3, 2021, when the approval number to continue the study, in case the study was ongoing, was ceased (the study ended in April 16, 2021) . Approval number 4.513.425; process number (CAAE) 41909121.0.0000.5553. This trial is registered in clinicaltrials.gov under two different numbers, one for each arm. (North arm, NCT04728802; South arm, NCT05126628). Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: Kintor Pharmaceuticals, Ltd., the manufacturer of proxalutamide, provided the drugs for this trial, and is conducting phase 3 trials for COVID-19. In case efficacy of..
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Late treatment
is less effective
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