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0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 97% Hospitalization 91% c19early.org/aa McCoy et al. NCT04446429 Proxalutamide RCT EARLY TREATMENT Is early treatment with antiandrogens beneficial for COVID-19? Double-blind RCT 268 patients in Brazil Lower ventilation (p<0.0001) and hospitalization (p<0.0001) McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 Favors proxalutamide Favors control
Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
McCoy et al., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (date from earlier preprint), NCT04446429 (history)
McCoy et al., Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized.., Frontiers in Medicine, doi:10.3389/fmed.2021.668698 (date from earlier preprint), NCT04446429
Dec 2020   Source   PDF  
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RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. NCT04446429 (history).
This paper was censored without details or author response, and the editors have ignored the authors, see [twitter.com].
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 134 (0.0%), control 2 of 134 (1.5%), NNT 67, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 97.1% lower, RR 0.03, p < 0.001, treatment 0 of 134 (0.0%), control 17 of 134 (12.7%), NNT 7.9, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 91.0% lower, RR 0.09, p < 0.001, treatment 3 of 134 (2.2%), control 35 of 134 (26.1%), NNT 4.2.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
McCoy et al., 30 Dec 2020, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 15 authors, trial NCT04446429 (history).
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This PaperAntiandrogensAll
Abstract: JEADV COVID-19 SPECIAL FORUM 5-alpha-reductase inhibitors are associated with reduced frequency of COVID-19 symptoms in males with androgenetic alopecia Dear Editor We have previously reported that men with androgenetic alopecia (AGA) are more likely to present with severe COVID-19 symptoms, potentially implicating androgen sensitivity as a risk factor for COVID-19.1–3 As such, we hypothesized that 5-alphareductase inhibitors (5ARi) may reduce the severity of COVID- 19 disease. To test this hypothesis, we conducted a retrospective cohort analysis on male subjects with laboratory confirmed SARS-CoV-2 infection. The subjects presented at one of five outpatient clinics (Corpometria Institute Brasilia, Brazil) from 15 June to 28 July 2020. At the time of visit, 29 clinical symptoms associated with SARS-CoV-2 infection were documented. For analysis, male subjects with AGA were selected. The frequency of clinical symptoms in males with AGA using 5ARis was compared to those not using 5ARis. Among the men presenting at the clinic, 300 were positive for SARS-CoV-2. Of these, 65 had AGA but were not using 5ARis, and 48 had AGA and were taking a 5ARi for at least six months prior to the study. The only 5ARi used in this cohort was dutasteride (0.5 mg) for the treatment of AGA. Propensity score Table 1 Baseline characteristics of androgenetic alopecia men with COVID-19 by use and non-use of 5-alpha-reductase inhibitors All SARS-CoV-2 positive 5ARi (n = 48) Group-determing data, No (%) Baseline data, No (%) JEADV 2021, 35, e243–e307 No 5ARi (n = 48) Androgenetic alopecia 48 (100) 48 (100) Dutasteride use 48 (100) 0 (0) Average Age, No.(SD) 45.6 (12) 45.7 (9) BMI >30 kg/m2 9 (19) 8 (17) Hypertension 12 (25) 11 (23) Myocardial infarction 2 (4) 2 (4) Stroke 0 (0) 0 (0) Heart Failure 0 (0) 0 (0) Lipid Disorder 24 (50) 17 (35) Diabeties 9 (19) 5 (10) Prediabeties 3 (6) 1 (2) Obesity 9 (19) 8 (17) Asthma 2 (4) 5 (10) COPD 0 (0) 0 (0) Cancer (current) 0 (0) 0 (0) Cancer (previous) 0 (0) 1 (2) Benign prostatic hyperplasia 5 (10) 2 (4) Prostate Cancer 0 (0) 0 (0) Chronic renal disease 0 (0) 0 (0) Liver fibrosis/cirrhosis 0 (0) 0 (0) Clinical depression 5 (10) 0 (0) Anxiety 7 (15) 5 (10) ADHD 6 (13) 4 (8) Insomnia 5 (10) 2 (4) Hypogonadism 3 (6) 4 (8) Hypothyroidism 2 (4) 1 (2) Autoimmune 0 (0) 0 (0) Other Diseases 0 (0) 0 (0) © 2020 European Academy of Dermatology and Venereology Letters to the Editor e244 Table 1 Continued All SARS-CoV-2 positive 5ARi (n = 48) No 5ARi (n = 48) Medications used, No. (%) Anti-hypertensives Lipid-reducing agents Anti-coagulants Anti-diabetics Hypothyroidism Hypogonadism Central-acting drugs Androgenetic alopecia (others) Beta-blocker 4 (8) 3 (6) ECAi 5 (10) 4 (8) Angiotensin II receptor blockers 9 (19) 9 (19) Loop diuretics 1 (2) 0 (0) Thiazide diuretics 4 (8) 4 (8) Calcium channel blockers 6 (13) 4 (8) K-sparing diuretics 0 (0) 1 (2) Statins 23 (48) 14 (29) Others 2 (4) 2 (4) Aspirin 2 (4) 2 (4) Clopidogrel 0 (0) 0 (0) Xa factor inhibitors 3 (6) 0 (0) Metformin 11 (23) 10 (21) GLP1R analogue 3 (6) 2 (4) SGLT2 inhibitors 5 (10) 2 (4) DPP4 inhibitors 4 (8) 3 (6) Sylfonylureas 1 (2) 0 (0) Glitazone 0 (0) 1 (2) Acarbose 0 (0) 0 (0) Insulin 0 (0) 1 (2) Orlistat 2 (4) 5 (10) Levothyroxine 2 (4) 1 (2) Liothyronine 0 (0) 0 (0) Testosterone 1 (2) 4 (8) Aromatase..
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