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Early Antiandrogen Therapy With Dutasteride Reduces Viral Shedding, Inflammatory Responses, and Time-to-Remission in Males With COVID-19: A Randomized, Double-Blind, Placebo-Controlled Interventional Trial (EAT-DUTA AndroCoV Trial – Biochemical)

Cadegiani et al., Cureus, doi:10.7759/cureus.13047
Feb 2021  
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Recovery 62% Improvement Relative Risk Recovery time 44% Recovery time (b) 40% Dutasteride  Cadegiani et al.  EARLY TREATMENT  DB RCT Is early treatment with antiandrogens beneficial for COVID-19? Double-blind RCT 87 patients in Brazil Improved recovery with antiandrogens (p=0.0094) c19early.org Cadegiani et al., Cureus, February 2021 Favorsdutasteride Favorscontrol 0 0.5 1 1.5 2+
7th treatment shown to reduce risk in September 2020, now with p = 0.000000056 from 49 studies.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 110 treatments. c19early.org
RCT 130 outpatients in Brazil, 54 treated with dutasteride, showing faster recovery with treatment. All patients received nitazoxanide. There were no hospitalizations, mechanical ventilation, or deaths. Some percentages for viral clearance in Table 3 do not match the group sizes, and a third-party analysis suggests possible randomization failure. 34110420.2.0000.0008.
This study is excluded in the after exclusion results of meta analysis: potential randomization failure.
risk of no recovery, 62.0% lower, RR 0.38, p = 0.009, treatment 7 of 44 (15.9%), control 18 of 43 (41.9%), NNT 3.9.
recovery time, 43.6% lower, relative time 0.56, p < 0.001, treatment 44, control 43, all symptoms.
recovery time, 40.2% lower, relative time 0.60, p < 0.001, treatment 44, control 43, all symptoms except loss of smell or taste.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cadegiani et al., 1 Feb 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 4 authors.
This PaperAntiandrogensAll
Early Antiandrogen Therapy With Dutasteride Reduces Viral Shedding, Inflammatory Responses, and Time-to-Remission in Males With COVID-19: A Randomized, Double-Blind, Placebo-Controlled Interventional Trial (EAT-DUTA AndroCoV Trial – Biochemical)
Flavio A Cadegiani, John Mccoy, Carlos Gustavo Wambier, Andy Goren
Cureus, doi:10.7759/cureus.13047
Background and objective Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cell entry and subsequent infectivity are mediated by androgens and the androgen receptors through the regulation of transmembrane protease, serine 2 (TMPRSS2). Androgenetic alopecia (AGA) predisposes males to severe coronavirus disease 2019 (COVID-19) disease, while the use of 5-alpha-reductase inhibitors (5ARis) and androgen receptor antagonists reduce COVID-19 disease severity. In this study, we aimed to determine the potential benefit of dutasteride, a commonly used broad and potent 5ARi, as a treatment for COVID-19. Design, setting, and participants The study was conducted at outpatient clinics. Subjects presented to the clinics with a positive reverse transcription-polymerase chain reaction (RT-PCR) test taken within 24 hours of recruitment. All subjects presented with mild to moderate symptoms. Interventions Subjects were given either dutasteride 0.5 mg/day or placebo for 30 days or until full COVID-19 remission. All subjects received standard therapy with nitazoxanide 500 mg twice a day for six days and azithromycin 500 mg/day for five days. Main outcome(s) and measure(s) The main outcome(s) and measure(s) were as follows: time to remission, oxygen saturation (%), positivity rates of RT-PCR-SARS-CoV-2, and biochemical analysis [ultrasensitive C-reactive protein (usCRP), D-dimer, lactate, lactate dehydrogenase (LDH), erythrocyte sedimentation rate (ESR), ultrasensitive troponin, and ferritin]. Results Subjects taking dutasteride (n=43) demonstrated reduced fatigue, anosmia, and overall disease duration compared to subjects taking a placebo (n=44) (p<.0001 for all). Compared to the placebo group, on Day seven, subjects taking dutasteride had a higher virologic remission rate (64.3% versus 11.8%; p=.0094), higher clinical recovery rate (84.7% versus 57.5%; p=.03), higher mean [standard deviation: SD] oxygen saturation (97.0% [1.4%] versus 95.7% [2.0%]; p=.02), lower median [Interquartile range: IQR] usCRP (0.34 mg/L [0.23 mg/L-0.66 mg/L] versus 1.47 mg/L [0.70 mg/L-3.37 mg/L]; p<.0001), lower median [IQR] lactate (2.01 mmol/L [1.12 mmol/L-2.43 mmol/L] versus 2.66 mmol/L [2.05 mmol/L-3.55 mmol/L]; p=.0049), lower median [IQR] ESR (5.0 mm/1h [3.0 mm/1h-11.0 mm/1h] versus 14.0 mm/1h [7.25 mm/1h-18.5 mm/1h]; p=.
Additional Information Disclosures
References
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Res Sq. 2020, ' '10.21203/rs.3.rs-88952/v1', 'journal-title': 'Res Sq'}], 'container-title': 'Cureus', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.cureus.com/articles/50511-early-antiandrogen-therapy-with-dutasteride-reduces-viral-shedding-inflammatory-responses-and-time-to-remission-in-males-with-covid-19-a-randomized-double-blind-placebo-controlled-interventional-trial-eat-duta-androcov-trial---biochemical', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 2, 9]], 'date-time': '2024-02-09T19:29:14Z', 'timestamp': 1707506954000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://www.cureus.com/articles/50511-early-antiandrogen-therapy-with-dutasteride-reduces-viral-shedding-inflammatory-responses-and-time-to-remission-in-males-with-covid-19-a-randomized-double-blind-placebo-controlled-interventional-trial-eat-duta-androcov-trial---biochemical'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 2, 1]]}, 'references-count': 21, 'URL': 'http://dx.doi.org/10.7759/cureus.13047', 'relation': {}, 'ISSN': ['2168-8184'], 'subject': ['Aerospace Engineering'], 'published': {'date-parts': [[2021, 2, 1]]}}
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