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

December 2021 in “ Cureus ”

Flavio Cadegiani, Ricardo Ariel Zimerman, Daniel Fonseca, Michael N Correia, Marcio P Muller, Diego Leonardo Bet, Marcio Rafael Slaviero, Ivan Zardo, Paulo Roberto Benites, Renan N Barros, Raysa Ws Paulain, Dirce Costa Onety, Karla Cristina Petruccelli Israel, Carlos Gustavo Wambier, Andy Goren

proxalutamide anti-androgen

TLDR Proxalutamide improved recovery, lowered death rates, and reduced hospital stay for COVID-19 patients.

A clinical trial involving 778 hospitalized COVID-19 patients tested the efficacy of proxalutamide, an anti-androgen drug. The patients were randomly given either proxalutamide 300mg/day or a placebo for 14 days. The recovery rate was 121% higher in the proxalutamide group than the placebo group at day 14, and 81% higher at day 28. The all-cause mortality rate was 80% lower in the proxalutamide group than the placebo group at Day 14, and 78% lower at Day 28. The time-to-discharge was shorter in the proxalutamide group (median, 5 days) than the placebo group (median, 9 days). The results were consistent across different regions and genders. The study concluded that proxalutamide significantly improved recovery rates, reduced mortality rates, and shortened hospital stay in hospitalized COVID-19 patients. However, further trials are recommended to confirm these findings.

View this study on cureus.com →

Discuss this study in the Community →

Research cited in this study

16 / 16 results

Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: An Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy with Proxalutamide

research Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: An Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy with Proxalutamide

5 citations, July 2021 in “medRxiv (Cold Spring Harbor Laboratory)”

Proxalutamide improved blood markers related to inflammation, immune response, and clotting in COVID-19 patients, potentially reducing hospitalizations.

Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

research Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

42 citations, July 2021 in “Frontiers in Medicine”

Proxalutamide significantly lowered hospital admissions for male COVID-19 patients compared to a placebo.

Proxalutamide Reduces Hospitalization Rate in Mild-to-Moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Trial

research Proxalutamide Reduces Hospitalization Rate in Mild-to-Moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Trial

5 citations, July 2021 in “medRxiv (Cold Spring Harbor Laboratory)”

Proxalutamide significantly lowered hospitalization rates in women with mild-to-moderate COVID-19.

research The Antiandrogen Enzalutamide Downregulates TMPRSS2 and Reduces Cellular Entry of SARS-CoV-2 in Human Lung Cells

50 citations, July 2021 in “Nature Communications”

The drug enzalutamide may reduce the ability of the virus causing COVID-19 to enter lung cells.

Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial

research Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial

41 citations, February 2021 in “Cureus”

Proxalutamide helps COVID-19 patients get rid of the virus faster and recover quicker.

research Expression of Concern: Potential Risk for Developing Severe COVID-19 Disease Among Anabolic Steroid Users

21 citations, February 2021 in “BMJ case reports”

Anabolic steroid users may face higher risk of severe COVID-19.

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

research 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

41 citations, February 2021 in “Cureus”

Dutasteride treatment in men with mild to moderate COVID-19 reduced viral shedding, inflammation, and recovery time without serious side effects.

research Anti-Androgens May Protect Against Severe COVID-19 Outcomes: Results From a Prospective Cohort Study of 77 Hospitalized Men

49 citations, January 2021 in “Journal of The European Academy of Dermatology and Venereology”

Anti-androgens, like finasteride, dutasteride, and spironolactone, may lessen the severity of COVID-19 in men, leading to fewer ICU admissions.

research 5-Alpha-Reductase Inhibitors Are Associated With Reduced Frequency of COVID-19 Symptoms in Males With Androgenetic Alopecia

36 citations, November 2020 in “Journal of The European Academy of Dermatology and Venereology”

5-alpha-reductase inhibitors may reduce COVID-19 symptoms in bald males.

research Clinical Symptoms of Hyperandrogenic Women Diagnosed with COVID-19

29 citations, October 2020 in “Journal of the European Academy of Dermatology and Venereology”

Women with high androgen levels may have more severe COVID-19 symptoms.

research Repurposing Existing Drugs for COVID-19: An Endocrinology Perspective

34 citations, September 2020 in “BMC Endocrine Disorders”

Existing drug dexamethasone may lower death risk in severe COVID-19 cases; more research needed for other drugs.

Androgen Receptor Genetic Variant Predicts COVID-19 Disease Severity: A Prospective Longitudinal Study of Hospitalized COVID-19 Male Patients

research Androgen Receptor Genetic Variant Predicts COVID-19 Disease Severity: A Prospective Longitudinal Study of Hospitalized COVID-19 Male Patients

26 citations, September 2020 in “Journal of the European Academy of Dermatology and Venereology”

A certain genetic variant in the androgen receptor may predict the severity of COVID-19 in men.

Male Balding as a Major Risk Factor for Severe COVID-19: A Possible Role for Targeting Androgens and Transmembrane Protease Serine 2 to Protect Vulnerable Individuals

research Male Balding as a Major Risk Factor for Severe COVID-19: A Possible Role for Targeting Androgens and Transmembrane Protease Serine 2 to Protect Vulnerable Individuals

6 citations, September 2020 in “Journal of The American Academy of Dermatology”

Severe male balding may increase the risk of serious COVID-19, and treatments that reduce androgens or block a specific enzyme might help protect these individuals.

Spironolactone: An Anti-Androgenic and Anti-Hypertensive Drug That May Provide Protection Against the Novel Coronavirus (SARS-CoV-2) Induced Acute Respiratory Distress Syndrome (ARDS) in COVID-19

research Spironolactone: An Anti-Androgenic and Anti-Hypertensive Drug That May Provide Protection Against the Novel Coronavirus (SARS-CoV-2) Induced Acute Respiratory Distress Syndrome (ARDS) in COVID-19

36 citations, July 2020 in “Frontiers in Medicine”

Spironolactone might help protect against severe lung problems in COVID-19 patients.

research Male Balding Is a Major Risk Factor for Severe COVID-19

29 citations, July 2020 in “Journal of The American Academy of Dermatology”

Men with severe balding have a higher risk of getting very sick from COVID-19.

research Androgenetic Alopecia Present in the Majority of Patients Hospitalized with COVID-19: The 'Gabrin Sign'

119 citations, May 2020 in “Journal of The American Academy of Dermatology”

Most COVID-19 patients in hospitals have androgenetic alopecia, more in men, suggesting a link between androgen sensitivity and severe COVID-19 symptoms.

Similar Research

5 / 26 results

research Roles of Steroid Receptors in the Lung and COVID-19

9 citations, July 2021 in “Essays in Biochemistry”

Sex hormones may influence COVID-19 severity, with males at higher risk, and certain hormone therapies could potentially treat the virus.

research 5-Alpha-Reductase Inhibitors Are Associated With Reduced Frequency of COVID-19 Symptoms in Males With Androgenetic Alopecia

36 citations, November 2020 in “Journal of The European Academy of Dermatology and Venereology”

5-alpha-reductase inhibitors may reduce COVID-19 symptoms in bald males.

research Extraordinary Claims Without Extraordinary Evidence: Controversy on Anti-Androgen Therapy for COVID-19

3 citations, March 2021 in “Journal of the European Academy of Dermatology and Venereology”

The letter is skeptical about the effectiveness of anti-androgen therapy for COVID-19 and calls for strong evidence from clinical trials.

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

Research cited in this study

research Proxalutamide Improves Inflammatory, Immunologic, and Thrombogenic Markers in Mild-to-Moderate COVID-19 Males and Females: An Exploratory Analysis of a Randomized, Double-Blinded, Placebo-Controlled Trial Early Antiandrogen Therapy with Proxalutamide

research Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial

research Proxalutamide Reduces Hospitalization Rate in Mild-to-Moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Trial

research The Antiandrogen Enzalutamide Downregulates TMPRSS2 and Reduces Cellular Entry of SARS-CoV-2 in Human Lung Cells

research Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial

research Expression of Concern: Potential Risk for Developing Severe COVID-19 Disease Among Anabolic Steroid Users

research 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

research Anti-Androgens May Protect Against Severe COVID-19 Outcomes: Results From a Prospective Cohort Study of 77 Hospitalized Men

research 5-Alpha-Reductase Inhibitors Are Associated With Reduced Frequency of COVID-19 Symptoms in Males With Androgenetic Alopecia

research Clinical Symptoms of Hyperandrogenic Women Diagnosed with COVID-19

research Repurposing Existing Drugs for COVID-19: An Endocrinology Perspective

research Androgen Receptor Genetic Variant Predicts COVID-19 Disease Severity: A Prospective Longitudinal Study of Hospitalized COVID-19 Male Patients

research Male Balding as a Major Risk Factor for Severe COVID-19: A Possible Role for Targeting Androgens and Transmembrane Protease Serine 2 to Protect Vulnerable Individuals

research Spironolactone: An Anti-Androgenic and Anti-Hypertensive Drug That May Provide Protection Against the Novel Coronavirus (SARS-CoV-2) Induced Acute Respiratory Distress Syndrome (ARDS) in COVID-19

research Male Balding Is a Major Risk Factor for Severe COVID-19

research Androgenetic Alopecia Present in the Majority of Patients Hospitalized with COVID-19: The 'Gabrin Sign'

Related Community Posts Join

community Anyone else just waiting until the real pyrilutamide and then GT20029?

community No side effects on pyrilutamide / KX-826 so far

community Reminder that Kintors Pyrilutamide results will be out this month

Similar Research

research Roles of Steroid Receptors in the Lung and COVID-19

research 5-Alpha-Reductase Inhibitors Are Associated With Reduced Frequency of COVID-19 Symptoms in Males With Androgenetic Alopecia

research Extraordinary Claims Without Extraordinary Evidence: Controversy on Anti-Androgen Therapy for COVID-19