Summary of COVID-19 antiandrogen studies
Studies
Meta Analysis
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RCT with 98 hospitalized moderate/severe patients treated with sabizabulin and 52 control patients, showing lower mortality with treatment. Sabizabulin 9mg for up to 21 days. For more discussion see [twitter.com, twitter.com, twitter.com].
Jul 2022, NEJM Evidence, https://evidence.nejm.org/doi/10.1056/EVIDoa2200145, https://c19p.org/barnette
778 patient proxalutamide antiandrogen late treatment RCT: 78% lower mortality (p<0.0001), 45% improved recovery (p<0.0001), and 33% shorter hospitalization (p=0.0001).
RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 and NCT05126628. 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.
Dec 2021, Cureus, https://www.cureus.com/articles/80171-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, https://c19p.org/cadegiani10
Phase 2 RCT of sabizabulin showing lower mortality with treatment. For more discussion see [twitter.com].
Apr 2022, European Congress of Clinical Microbiology & Infectious Diseases, https://verupharma.com/news/veru-announces-oral-late-breaking-presentation-of-phase-2-data-of-sabizabulin-for-the-treatment-of-hospitalized-severe-covid-19-patients-at-high-risk-for-acute-respiratory-distress-syndrome-at-the-32n/, https://c19p.org/gordon2
RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. This paper was retracted, however no specific reason is provided, the editors have ignored the authors, and the "external expert" was reportedly funded by Pfizer. For details see [twitter.com]. The retraction notice states: "The investigation found that the claims made in the conclusions were not adequately supported by the methodology of the study. In particular, as confirmed by an external expert, the process of allocation to treatment and control was not sufficiently random." The lack of any detail on what conclusion is not supported and why, or details of any issues in randomization, suggests the paper was censored rather than retracted. This study was censored.
Dec 2020, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2021.668698/abstract, https://c19p.org/mccoy
RCT 120 hospitalized patients in India, 74 treated with spironolactone and dexamethasone, and 46 with dexamethasone, showing lower progression with treatment. Spironolactone 50mg once daily day 1, 25mg once daily until day 21.
Jul 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.07.01.22277163, https://c19p.org/wadhwa
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]
Apr 2022, Kintor, Press Release, https://www.prnewswire.com/news-releases/kintor-pharmas-proxalutamide-demonstrated-reduction-in-hospitalizationmortality-for-patients-with-mild-to-moderate-covid-19-in-phase-iii-mrct-study-301518525.html, https://c19p.org/kintorpx3
RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment.
Jul 2021, medRxiv, https://www.medrxiv.org/content/10.1101/2021.07.06.21260086v1, https://c19p.org/cadegiani5
PSM retrospective 64,349 COVID-19 patients in the USA, showing spironolactone associated with lower ICU admission. Authors also present In Vitro research showing dose-dependent inhibition in a human lung epithelial cell line.
Jul 2022, Cell Reports Methods, https://www.sciencedirect.com/science/article/pii/S2667237523001327, https://c19p.org/cousins
RCT 68 patients in Italy showing improved viral clearance with raloxifene.
Jun 2022, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537022001808, https://c19p.org/nicastri
87 patient dutasteride antiandrogen early treatment RCT: 62% improved recovery (p=0.009).
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.
Feb 2021, Cureus, 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, https://c19p.org/cadegiani7
Retrospective 5,273 prostate cancer patients on androgen-deprivation therapy (ADT), and 37,161 not on ADT, showing lower risk of cases with treatment.
May 2020, Annals of Oncology, https://www.sciencedirect.com/science/article/pii/S0923753420397970, https://c19p.org/montopoli
RCT 42 hospitalized patients in the USA, showing improved recovery and lower progression with progesterone treatment.
Jul 2021, Chest, https://www.sciencedirect.com/science/article/pii/S0012369221002890, https://c19p.org/ghandehari
Retrospective 6,462 liver cirrhosis patients in South Korea, with 67 COVID+ cases, showing significantly lower cases with spironolactone treatment. Death and ICU results per group are not provided.
Feb 2021, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2021.629176/full, https://c19p.org/jeon
Very small late stage RCT with 10 control patients and 29 enzalutamide patients, showing mixed results. Discharge and hospitalization time favored the control group, while viral load reduction was better with treatment on days 4&6 (day 4 ΔCt −5.6 p = 0.084), and the only death occurred in the control group. 27% of enzalutamide patients had diabetes compared to 0% of the control group. This paper also includes a retrospective study which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601. For discussion of issues with this study see [sciencedirect.com, sciencedirect.com, sciencedirect.com, sciencedirect.com].
Dec 2021, European Urology, https://www.europeanurology.com/article/S0302-2838(21)02224-7/fulltext, https://c19p.org/welen
RCT including 51 spironolactone patients and 87 control patients in Iran, showing improved recovery with spironolactone, sitagliptin, and the combination of both.
Feb 2022, J. the Endocrine Society, https://academic.oup.com/jes/article/6/4/bvac017/6523815, https://c19p.org/abbasi
Retrospective 58 prostate cancer patients in the USA, showing lower risk of hospitalization with ADT.
Jul 2020, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(20)39933-6/fulltext, https://c19p.org/patel3
RCT with 50 hospitalized COVID+ patients in Egypt, 25 treated with glycyrrhizin and boswellic acid, showing improved recovery with treatment. Glycyrrhizin 60mg and boswellic acid 200mg bid for 2 weeks. NCT04487964.
Mar 2022, Inflammopharmacology, https://link.springer.com/article/10.1007/s10787-022-00939-7, https://c19p.org/gomaa
Retrospective 3,057 androgen deprivation therapy patients in the USA, and 36,096 control patients with cancer, showing lower risk of cases and severity with ADT.
Mar 2022, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2022.774773/full, https://c19p.org/lee5
49 patient potassium canrenoate antiandrogen late treatment RCT: 17% lower mortality (p=1), 11% lower ICU admission (p=1), and 30% improved recovery (p=0.51).
RCT with 24 patients treated with potassium canrenoate and 25 placebo patients in Poland, showing no significant differences.
Feb 2022, Pharmaceuticals, https://www.mdpi.com/1424-8247/15/2/200, https://c19p.org/kotfis
Retrospective 30 COVID-19 ARDS ICU patients and 30 control patients, showing lower mortality with treatment.
Oct 2021, Aydin Sağlik Dergi̇si̇, https://dergipark.org.tr/en/pub/asder/issue/65413/959218, https://c19p.org/ersoy
Retrospective 69 consecutive hospitalized COVID-19 patients in Italy, 30 patients receiving canrenone, and 39 treated with vasodilator agents or renin–angiotensin–aldosterone system (RAAS) inhibitors, showing lower mortality with canrenone.
Sep 2020, J. Clinical Medicine, https://www.mdpi.com/2077-0383/9/9/2943, https://c19p.org/vicenzi
Prospective study of 206 outpatients in Iran, 103 treated with spironolactone and sitagliptin, showing lower hospitalization and faster recovery with treatment. spironolactone 100mg and sitagliptin 100mg daily.
Jan 2022, J. Endocrinological Investigation, https://link.springer.com/10.1007/s40618-023-02141-0, https://c19p.org/davarpanah
Prospective study of 260 hospitalized patients in Taiwan, 117 treated with herbal formula Jing Si Herbal Tea which includes antiandrogen glycyrrhiza glabra, showing improved recovery with treatment, with statistical significance for SpO2, Ct score, CRP, and Brixia score.
Mar 2022, Frontiers in Nutrition, https://www.frontiersin.org/articles/10.3389/fnut.2022.832321/full, https://c19p.org/hsieh
Prospective 103 PCR+ patients in Russia, 33 treated with bromexhine+spironolactone, showing lower PCR+ at day 10 or hospitalization >10 days with treatment. Bromhexine 8mg 4 times daily, spironolactone 25-50 mg/day for 10 days.
Dec 2020, Кардиология, https://lib.ossn.ru/jour/article/view/1440, https://c19p.org/mareevaa
PSM retrospective 898,303 hospitalized COVID-19 patients in the USA, 16,324 on spironolactone, showing lower mortality and ventilation with spironolactone use.
Mar 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.02.28.23286515v1, https://c19p.org/cousins2
Retrospective 26,508 consecutive COVID+ veterans in the USA, showing lower mortality with multiple treatments including anti-androgens. Treatment was defined as drugs administered ≥50% of the time within 2 weeks post-COVID+, and may be a continuation of prophylactic treatment in some cases, and may be early or late treatment in other cases. Further reduction in mortality was seen with combinations of treatments.
Jun 2022, J. General Internal Medicine, https://link.springer.com/10.1007/s11606-022-07701-3, https://c19p.org/huntaa
Case control study examining medication usage with a healthcare database in Israel, showing lower risk of hospitalization with dutasteride.
Jul 2021, Epidemiology and Global Health Microbiology and Infectious Disease, https://elifesciences.org/articles/68165, https://c19p.org/israel2aa
RCT 80 hospitalized COVID-19 patients in Iran, 40 treated with finasteride, showing no significant differences other than improved oxygen saturation on the 5th day with treatment. There was significantly more patients with diabetes in the control group. 5mg finasteride for 7 days. IRCT20200505047318N1.
Apr 2021, Medical J. The Islamic Republic of Iran, https://mjiri.iums.ac.ir/article-1-7160-en.html, https://c19p.org/zarehoseinzade
Retrospective survey of 41,529 participants, including 571 on antiandrogen therapy, showing no significant association between antiandrogen use and COVID-19 incidence, hospitalization, or ICU admission/mechanical ventilation.
Sep 2020, Dermatologic Therapy, https://onlinelibrary.wiley.com/doi/10.1111/dth.14166, https://c19p.org/ianhez
Retrospective 352 prostate cancer patients in Finland, showing no significant differences in COVID-19 with ADT.
Jun 2020, Annals of Oncology, https://www.sciencedirect.com/science/article/pii/S0923753420399257, https://c19p.org/koskinen
Prospective study of 270 female COVID-19 patients in Brazil, 75 with hyperandrogenism, of which 8 were on spironolactone. Results suggest that HA patients may be at increased risk, and that spironolactone use may reduce the risk compared to both other HA patients and non-HA patients. SOC included other treatments and there was no mortality or hospitalization.
Oct 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.10.05.20206870v1, https://c19p.org/cadegiani9
Prospective study of 77 men hospitalized with COVID-19, 12 taking antiandrogens (9 dutasteride, 2 finasteride, 1 spironolactone), showing lower ICU admission with treatment (statistically significant with age-matched controls only when excluding the spironolactone patient). NCT04368897.
Sep 2020, J. the European Academy of Dermatology and Venereology, https://onlinelibrary.wiley.com/doi/10.1111/jdv.16953, https://c19p.org/goren
Retrospective 118 prostate cancer patients, 4 on androgren deprivation therapy, not showing significant differences (as expected with only 4 patients in the treatment group).
Aug 2020, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(20)42103-9/fulltext, https://c19p.org/bennani
Retrospective 1,106 prostate cancer patients, showing no significant differences in COVID-19 outcomes with ADT.
Nov 2021, JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786026, https://c19p.org/schmidt
Retrospective 944 5ARI users in the USA and 944 matched controls, showing lower risk of COVID-19 cases with treatment.
Jan 2022, J. Urology, https://www.auajournals.org/doi/10.1097/JU.0000000000002180, https://c19p.org/lyon
Retrospective 26,121 cases and 2,369,020 controls ≥65yo in Canada, showing lower cases with chronic use of spironolactone.
Mar 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofac156/6555707, https://c19p.org/macfaddenaa
PSM retrospective 144 alopecia patients in the USA, showing no significant difference in COVID-19 cases with anti-androgen use. The supplemental appendix is not available.
Jul 2021, J. Drugs in Dermatology, https://jddonline.com/articles/dermatology/S1545961621P0914X, https://c19p.org/shawaa
Retrospective 199 prostate cancer patients hospitalized with COVID-19 in Brazil, showing no significant difference in mortality with active ADT.
Nov 2021, Infectious Agents and Cancer, https://link.springer.com/article/10.1186/s13027-021-00406-y/fulltext.html, https://c19p.org/duarte
Retrospective 5,211 prostate cancer patients, 799 on ADT, showing no significant differences in COVID-19 outcomes with treatment.
Jan 2021, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(21)00095-8/fulltext, https://c19p.org/kwon
Retrospective 655 prostate cancer patients in Sweden, showing no significant difference in seropositivity with ADT.
Jan 2023, The Prostate, https://onlinelibrary.wiley.com/doi/10.1002/pros.24485, https://c19p.org/davidsson
Retrospective 1,349 prostate cancer patients in Spain, 156 on ADT, showing no significant differences in COVID-19 outcomes with treatment.
Sep 2021, The Prostate, https://onlinelibrary.wiley.com/doi/full/10.1002/pros.24232, https://c19p.org/jimenezalcaide
Early terminated RCT with 62 very late stage (79% on oxygen) degarelix patients and 34 placebo patients, showing no significant differences with treatment. For discussion of many issues with this study see [twitter.com].
Apr 2022, JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791293, https://c19p.org/nickols
Retrospective 7,894 COVID+ prostate cancer patients, analyzing patients on antiandrogen treatment, ADT, and ADT + abiraterone acetate or enzalutamide, showing mixed results and higher mortality for ADT + abiraterone acetate or enzalutamide. This paper also includes a small RCT which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601. For discussion of issues with this study see [sciencedirect.com, sciencedirect.com, sciencedirect.com, sciencedirect.com].
Dec 2021, European Urology, https://www.europeanurology.com/article/S0302-2838(21)02224-7/fulltext, https://c19p.org/welen2
Retrospective case-control study in Italy with 943 male COVID-19 patients, 45 on chronic 5ARI treatment (finasteride/dutasteride). There was significantly fewer COVID-19 patients >55 on 5ARI treatment compared to age-matched controls (5.57 vs. 8.14%, p=0.0083). The difference was greater for men aged >65 (7.14 vs. 12.31%, p=0.0001). There was no significant difference for ICU admission or death.
Sep 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.04.20.20068056v2, https://c19p.org/lazzeri
Retrospective 465 prostate cancer patients, showing no significant difference in COVID-19 outcomes with ADT.
May 2022, JNCI Cancer Spectrum, https://academic.oup.com/jncics/article/6/3/pkac035/6584832, https://c19p.org/shah3
Retrospective 365 prostate cancer patients in Turkey, 138 treated with ADT, showing no significant differences with treatment.
Nov 2021, Türk Üroloji Dergisi/Turkish J. Urology, https://turkishjournalofurology.com/en/the-clinical-impact-of-androgen-deprivation-therapy-on-sars-cov-2-infection-rates-and-disease-severity-133775, https://c19p.org/kazan
Case control study with 474 patients that died of COVID-19 in Sweden, showing higher risk with ADT, without statistical significance.
Dec 2021, Scandinavian J. Urology, https://www.tandfonline.com/doi/pdf/10.1080/21681805.2021.2019304, https://c19p.org/gedeborg
Retrospective 689 hospitalized COVID-19 patients in Denmark, showing higher risk of ICU/death with spironolactone use in unadjusted results subject to confounding by indication.
May 2020, J. Hypertension, https://journals.lww.com/10.1097/HJH.0000000000002515, https://c19p.org/holt2
Retrospective 1,779 prostate cancer patients, showing no significant differences in COVID-19 outcomes with ADT.
Feb 2021, J. Urology, https://www.auajournals.org/doi/10.1097/JU.0000000000001338, https://c19p.org/klein
1. Barnette et al., Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis
150 patient sabizabulin antiandrogen late treatment RCT: 55% lower mortality (p=0.002), 49% shorter ventilation (p=0.001), 44% shorter ICU admission (p=0.001), and 26% shorter hospitalization (p=0.03).RCT with 98 hospitalized moderate/severe patients treated with sabizabulin and 52 control patients, showing lower mortality with treatment. Sabizabulin 9mg for up to 21 days. For more discussion see [twitter.com, twitter.com, twitter.com].
Jul 2022, NEJM Evidence, https://evidence.nejm.org/doi/10.1056/EVIDoa2200145, https://c19p.org/barnette
778 patient proxalutamide antiandrogen late treatment RCT: 78% lower mortality (p<0.0001), 45% improved recovery (p<0.0001), and 33% shorter hospitalization (p=0.0001).
RCT 778 hospitalized patients in Brazil, 423 treated with proxalutamide, showing significantly lower mortality and improved recovery with treatment. NCT04728802 and NCT05126628. 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.
Dec 2021, Cureus, https://www.cureus.com/articles/80171-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, https://c19p.org/cadegiani10
3. Gordon et al., Phase 2 study of oral sabizabulin for the treatment of SARS-CoV-2 in hospitalized patients at high risk for ARDS
sabizabulin antiandrogen late treatment RCT: 82% lower mortality (p=0.04), 76% shorter ventilation (p=0.14), and 73% shorter ICU admission (p=0.03).Phase 2 RCT of sabizabulin showing lower mortality with treatment. For more discussion see [twitter.com].
Apr 2022, European Congress of Clinical Microbiology & Infectious Diseases, https://verupharma.com/news/veru-announces-oral-late-breaking-presentation-of-phase-2-data-of-sabizabulin-for-the-treatment-of-hospitalized-severe-covid-19-patients-at-high-risk-for-acute-respiratory-distress-syndrome-at-the-32n/, https://c19p.org/gordon2
4. McCoy et al., Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial
268 patient proxalutamide antiandrogen early treatment RCT: 97% lower ventilation (p<0.0001) and 91% lower hospitalization (p<0.0001).RCT 268 male patients in Brazil, 134 treated with proxalutamide, showing significantly lower hospitalization and mechanical ventilation. This paper was retracted, however no specific reason is provided, the editors have ignored the authors, and the "external expert" was reportedly funded by Pfizer. For details see [twitter.com]. The retraction notice states: "The investigation found that the claims made in the conclusions were not adequately supported by the methodology of the study. In particular, as confirmed by an external expert, the process of allocation to treatment and control was not sufficiently random." The lack of any detail on what conclusion is not supported and why, or details of any issues in randomization, suggests the paper was censored rather than retracted. This study was censored.
Dec 2020, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2021.668698/abstract, https://c19p.org/mccoy
5. Wadhwa et al., Phase 2 randomised placebo-controlled trial of spironolactone and dexamethasone versus dexamethasone in COVID-19 hospitalised patients in Delhi
120 patient spironolactone antiandrogen late treatment RCT: 72% lower progression (p=0.03), 49% higher hospital discharge (p=0.05), and 18% faster recovery (p=0.06).RCT 120 hospitalized patients in India, 74 treated with spironolactone and dexamethasone, and 46 with dexamethasone, showing lower progression with treatment. Spironolactone 50mg once daily day 1, 25mg once daily until day 21.
Jul 2022, medRxiv, https://www.medrxiv.org/content/10.1101/2022.07.01.22277163, https://c19p.org/wadhwa
6. Kintor et al., Kintor Pharma's Proxalutamide Demonstrated Reduction in Hospitalization/Mortality for Patients with Mild to Moderate COVID-19 in Phase III MRCT Study
730 patient proxalutamide antiandrogen early treatment RCT: 50% lower hospitalization (p=0.38) and 74% improved viral clearance (p=0.0001).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]
Apr 2022, Kintor, Press Release, https://www.prnewswire.com/news-releases/kintor-pharmas-proxalutamide-demonstrated-reduction-in-hospitalizationmortality-for-patients-with-mild-to-moderate-covid-19-in-phase-iii-mrct-study-301518525.html, https://c19p.org/kintorpx3
7. Cadegiani et al., Proxalutamide (GT0918) Reduces the Rate of Hospitalization in mild-to-moderate COVID-19 Female Patients: A Randomized Double-Blinded Placebo-Controlled Two-Arm Parallel Trial
177 patient proxalutamide antiandrogen early treatment RCT: 90% lower ventilation (p=0.07) and 86% lower hospitalization (p=0.0008).RCT 177 women in Brazil, 75 treated with proxalutamide, showing significantly lower hospitalization with treatment.
Jul 2021, medRxiv, https://www.medrxiv.org/content/10.1101/2021.07.06.21260086v1, https://c19p.org/cadegiani5
8. Cousins et al., Integrative analysis of functional genomic screening and clinical data identifies a protective role for spironolactone in severe COVID-19
64,349 patient spironolactone antiandrogen prophylaxis PSM study: 81% lower ventilation (p=0.006) and 66% lower ICU admission (p=0.002).PSM retrospective 64,349 COVID-19 patients in the USA, showing spironolactone associated with lower ICU admission. Authors also present In Vitro research showing dose-dependent inhibition in a human lung epithelial cell line.
Jul 2022, Cell Reports Methods, https://www.sciencedirect.com/science/article/pii/S2667237523001327, https://c19p.org/cousins
9. Nicastri et al., A phase 2 randomized, double-blinded, placebo-controlled, multicenter trial evaluating the efficacy and safety of raloxifene for patients with mild to moderate COVID-19
41 patient raloxifene antiandrogen late treatment RCT: 52% lower need for oxygen therapy (p=0.43) and 69% improved viral clearance (p=0.22).RCT 68 patients in Italy showing improved viral clearance with raloxifene.
Jun 2022, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537022001808, https://c19p.org/nicastri
87 patient dutasteride antiandrogen early treatment RCT: 62% improved recovery (p=0.009).
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.
Feb 2021, Cureus, 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, https://c19p.org/cadegiani7
11. Montopoli et al., Androgen-deprivation therapies for prostate cancer and risk of infection by SARS-CoV-2: a population-based study (N = 4532)
42,434 patient various antiandrogen prophylaxis study: 95% lower mortality (p=0.15), 75% lower severe cases (p=0.01), and 75% fewer cases (p=0.004).Retrospective 5,273 prostate cancer patients on androgen-deprivation therapy (ADT), and 37,161 not on ADT, showing lower risk of cases with treatment.
May 2020, Annals of Oncology, https://www.sciencedirect.com/science/article/pii/S0923753420397970, https://c19p.org/montopoli
12. Ghandehari et al., Progesterone in Addition to Standard of Care vs Standard of Care Alone in the Treatment of Men Hospitalized With Moderate to Severe COVID-19
40 patient antiandrogen late treatment RCT: 85% lower ventilation (p=0.24), 76% lower progression (p=0.2), and 100% improved recovery (p=0.02).RCT 42 hospitalized patients in the USA, showing improved recovery and lower progression with progesterone treatment.
Jul 2021, Chest, https://www.sciencedirect.com/science/article/pii/S0012369221002890, https://c19p.org/ghandehari
13. Jeon et al., Effect of Spironolactone on COVID-19 in Patients With Underlying Liver Cirrhosis: A Nationwide Case-Control Study in South Korea
294 patient spironolactone antiandrogen prophylaxis study: 77% fewer cases (p=0.005).Retrospective 6,462 liver cirrhosis patients in South Korea, with 67 COVID+ cases, showing significantly lower cases with spironolactone treatment. Death and ICU results per group are not provided.
Feb 2021, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2021.629176/full, https://c19p.org/jeon
14. Welén et al., A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data
39 patient enzalutamide antiandrogen late treatment RCT: 80% lower mortality (p=0.26), 133% lower hospital discharge (p=0.03), and 50% longer hospitalization (p=0.01).Very small late stage RCT with 10 control patients and 29 enzalutamide patients, showing mixed results. Discharge and hospitalization time favored the control group, while viral load reduction was better with treatment on days 4&6 (day 4 ΔCt −5.6 p = 0.084), and the only death occurred in the control group. 27% of enzalutamide patients had diabetes compared to 0% of the control group. This paper also includes a retrospective study which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601. For discussion of issues with this study see [sciencedirect.com, sciencedirect.com, sciencedirect.com, sciencedirect.com].
Dec 2021, European Urology, https://www.europeanurology.com/article/S0302-2838(21)02224-7/fulltext, https://c19p.org/welen
15. Abbasi et al., A Randomized Trial of Sitagliptin and Spironolactone With Combination Therapy in Hospitalized Adults With COVID-19
138 patient spironolactone antiandrogen late treatment RCT: 55% lower mortality (p=0.1), 34% lower ventilation (p=0.36), 19% lower ICU admission (p=0.67), and 47% improved recovery (p<0.0001).RCT including 51 spironolactone patients and 87 control patients in Iran, showing improved recovery with spironolactone, sitagliptin, and the combination of both.
Feb 2022, J. the Endocrine Society, https://academic.oup.com/jes/article/6/4/bvac017/6523815, https://c19p.org/abbasi
16. Patel et al., Does androgen deprivation therapy protect against severe complications from COVID-19?
58 patient various antiandrogen prophylaxis study: 55% lower mortality (p=0.22), 69% lower ventilation (p=0.19), and 77% lower hospitalization (p=0.02).Retrospective 58 prostate cancer patients in the USA, showing lower risk of hospitalization with ADT.
Jul 2020, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(20)39933-6/fulltext, https://c19p.org/patel3
17. Gomaa et al., Advancing combination treatment with glycyrrhizin and boswellic acids for hospitalized patients with moderate COVID-19 infection: a randomized clinical trial
50 patient glycyrrhizin antiandrogen late treatment RCT: 91% lower mortality (p=0.05), 91% lower ventilation (p=0.05), and 44% faster recovery (p=0.001).RCT with 50 hospitalized COVID+ patients in Egypt, 25 treated with glycyrrhizin and boswellic acid, showing improved recovery with treatment. Glycyrrhizin 60mg and boswellic acid 200mg bid for 2 weeks. NCT04487964.
Mar 2022, Inflammopharmacology, https://link.springer.com/article/10.1007/s10787-022-00939-7, https://c19p.org/gomaa
18. Lee et al., A population-level analysis of the protective effects of androgen deprivation therapy against COVID-19 disease incidence and severity
39,153 patient various antiandrogen prophylaxis study: 21% lower severe cases (p=0.03) and 11% fewer cases (p=0.001).Retrospective 3,057 androgen deprivation therapy patients in the USA, and 36,096 control patients with cancer, showing lower risk of cases and severity with ADT.
Mar 2022, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2022.774773/full, https://c19p.org/lee5
49 patient potassium canrenoate antiandrogen late treatment RCT: 17% lower mortality (p=1), 11% lower ICU admission (p=1), and 30% improved recovery (p=0.51).
RCT with 24 patients treated with potassium canrenoate and 25 placebo patients in Poland, showing no significant differences.
Feb 2022, Pharmaceuticals, https://www.mdpi.com/1424-8247/15/2/200, https://c19p.org/kotfis
20. Ersoy et al., Assessment Of The Efficacy Of Spironolactone For COVID-19 ARDS Patients
60 patient spironolactone antiandrogen ICU study: 46% lower mortality (p=0.002).Retrospective 30 COVID-19 ARDS ICU patients and 30 control patients, showing lower mortality with treatment.
Oct 2021, Aydin Sağlik Dergi̇si̇, https://dergipark.org.tr/en/pub/asder/issue/65413/959218, https://c19p.org/ersoy
21. Vicenzi et al., The Efficacy of the Mineralcorticoid Receptor Antagonist Canrenone in COVID-19 Patients
69 patient canrenone antiandrogen late treatment study: 93% lower mortality (p<0.0001) and 81% lower combined mortality/intubation (p=0.002).Retrospective 69 consecutive hospitalized COVID-19 patients in Italy, 30 patients receiving canrenone, and 39 treated with vasodilator agents or renin–angiotensin–aldosterone system (RAAS) inhibitors, showing lower mortality with canrenone.
Sep 2020, J. Clinical Medicine, https://www.mdpi.com/2077-0383/9/9/2943, https://c19p.org/vicenzi
22. Davarpanah et al., Combination of spironolactone and sitagliptin improves clinical outcomes of outpatients with COVID-19: a prospective cohort study
206 patient spironolactone antiandrogen late treatment study: 78% lower hospitalization (p=0.0008), 67% lower progression (p=0.003), and 64% faster recovery (p=0.0001).Prospective study of 206 outpatients in Iran, 103 treated with spironolactone and sitagliptin, showing lower hospitalization and faster recovery with treatment. spironolactone 100mg and sitagliptin 100mg daily.
Jan 2022, J. Endocrinological Investigation, https://link.springer.com/10.1007/s40618-023-02141-0, https://c19p.org/davarpanah
23. Hsieh et al., Efficacy and Safety of Complementary Therapy With Jing Si Herbal Tea in Patients With Mild-To-Moderate COVID-19: A Prospective Cohort Study
260 patient antiandrogen late treatment study: 88% lower mortality (p=0.13), 30% lower ICU admission (p=0.76), 88% improved recovery (p=0.13), and 36% improved viral clearance (p=0.0002).Prospective study of 260 hospitalized patients in Taiwan, 117 treated with herbal formula Jing Si Herbal Tea which includes antiandrogen glycyrrhiza glabra, showing improved recovery with treatment, with statistical significance for SpO2, Ct score, CRP, and Brixia score.
Mar 2022, Frontiers in Nutrition, https://www.frontiersin.org/articles/10.3389/fnut.2022.832321/full, https://c19p.org/hsieh
24. Mareev et al., Results of Open-Label non-Randomized Comparative Clinical Trial: “BromhexIne and Spironolactone for CoronаvirUs Infection requiring hospiTalization (BISCUIT)
66 patient spironolactone antiandrogen late treatment RCT: 11% improved recovery (p=0.47), 8% shorter hospitalization (p=0.35), and 87% improved viral clearance (p=0.08).Prospective 103 PCR+ patients in Russia, 33 treated with bromexhine+spironolactone, showing lower PCR+ at day 10 or hospitalization >10 days with treatment. Bromhexine 8mg 4 times daily, spironolactone 25-50 mg/day for 10 days.
Dec 2020, Кардиология, https://lib.ossn.ru/jour/article/view/1440, https://c19p.org/mareevaa
25. Cousins et al., Association between spironolactone use and COVID-19 outcomes in population-scale claims data: a retrospective cohort study
898,303 patient spironolactone antiandrogen prophylaxis PSM study: 18% lower mortality (p=0.004) and 17% lower ventilation (p<0.0001).PSM retrospective 898,303 hospitalized COVID-19 patients in the USA, 16,324 on spironolactone, showing lower mortality and ventilation with spironolactone use.
Mar 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.02.28.23286515v1, https://c19p.org/cousins2
26. Hunt et al., Medications Associated with Lower Mortality in a SARS-CoV-2 Positive Cohort of 26,508 Veterans
26,508 patient antiandrogen early treatment study: 39% lower mortality (p<0.0001).Retrospective 26,508 consecutive COVID+ veterans in the USA, showing lower mortality with multiple treatments including anti-androgens. Treatment was defined as drugs administered ≥50% of the time within 2 weeks post-COVID+, and may be a continuation of prophylactic treatment in some cases, and may be early or late treatment in other cases. Further reduction in mortality was seen with combinations of treatments.
Jun 2022, J. General Internal Medicine, https://link.springer.com/10.1007/s11606-022-07701-3, https://c19p.org/huntaa
27. Israel et al., Identification of drugs associated with reduced severity of COVID-19: A case-control study in a large population
39,180 patient dutasteride antiandrogen prophylaxis study: 38% lower hospitalization (p=0.01).Case control study examining medication usage with a healthcare database in Israel, showing lower risk of hospitalization with dutasteride.
Jul 2021, Epidemiology and Global Health Microbiology and Infectious Disease, https://elifesciences.org/articles/68165, https://c19p.org/israel2aa
28. Zarehoseinzade et al., Finasteride in hospitalized adult males with COVID-19: A risk factor for severity of the disease or an adjunct treatment: A randomized controlled clinical trial
80 patient finasteride antiandrogen late treatment RCT: 75% lower mortality (p=0.36) and no change in ICU admission (p=1).RCT 80 hospitalized COVID-19 patients in Iran, 40 treated with finasteride, showing no significant differences other than improved oxygen saturation on the 5th day with treatment. There was significantly more patients with diabetes in the control group. 5mg finasteride for 7 days. IRCT20200505047318N1.
Apr 2021, Medical J. The Islamic Republic of Iran, https://mjiri.iums.ac.ir/article-1-7160-en.html, https://c19p.org/zarehoseinzade
29. Ianhez et al., Androgen sensitivity in COVID‐19 and antiandrogens: Prospective data are still needed
12,732 patient antiandrogen prophylaxis study: 80% lower ICU admission (p=0.26), 66% lower hospitalization (p=0.32), and 1% more cases (p=0.9).Retrospective survey of 41,529 participants, including 571 on antiandrogen therapy, showing no significant association between antiandrogen use and COVID-19 incidence, hospitalization, or ICU admission/mechanical ventilation.
Sep 2020, Dermatologic Therapy, https://onlinelibrary.wiley.com/doi/10.1111/dth.14166, https://c19p.org/ianhez
30. Koskinen et al., Androgen deprivation and SARS-CoV-2 in men with prostate cancer
352 patient various antiandrogen prophylaxis study: 46% lower mortality (p=1), 46% lower combined mortality/ICU admission (p=1), and 11% fewer cases (p=1).Retrospective 352 prostate cancer patients in Finland, showing no significant differences in COVID-19 with ADT.
Jun 2020, Annals of Oncology, https://www.sciencedirect.com/science/article/pii/S0923753420399257, https://c19p.org/koskinen
31. Cadegiani et al., An open-label prospective observational study of antiandrogen and non-antiandrogen early pharmacological approaches in females with mild-to-moderate COVID-19. The Pre-AndroCoV Female Trial
270 patient spironolactone antiandrogen early treatment study: 77% faster recovery (p=0.006) and 38% faster viral clearance (p=0.02).Prospective study of 270 female COVID-19 patients in Brazil, 75 with hyperandrogenism, of which 8 were on spironolactone. Results suggest that HA patients may be at increased risk, and that spironolactone use may reduce the risk compared to both other HA patients and non-HA patients. SOC included other treatments and there was no mortality or hospitalization.
Oct 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.10.05.20206870v1, https://c19p.org/cadegiani9
32. Goren et al., Anti-androgens may protect against severe COVID-19 outcomes: results from a prospective cohort study of 77 hospitalized men
77 patient various antiandrogen late treatment study: 81% lower ICU admission (p=0.08).Prospective study of 77 men hospitalized with COVID-19, 12 taking antiandrogens (9 dutasteride, 2 finasteride, 1 spironolactone), showing lower ICU admission with treatment (statistically significant with age-matched controls only when excluding the spironolactone patient). NCT04368897.
Sep 2020, J. the European Academy of Dermatology and Venereology, https://onlinelibrary.wiley.com/doi/10.1111/jdv.16953, https://c19p.org/goren
33. Bennani et al., Androgen deprivation therapy may constitute a more effective COVID-19 prophylactic than therapeutic strategy
118 patient various antiandrogen prophylaxis study: 95% lower mortality (p=1), 119% higher ICU admission (p=0.4), 25% lower hospitalization (p=0.6), and 8% lower severe cases (p=1).Retrospective 118 prostate cancer patients, 4 on androgren deprivation therapy, not showing significant differences (as expected with only 4 patients in the treatment group).
Aug 2020, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(20)42103-9/fulltext, https://c19p.org/bennani
34. Schmidt et al., Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19
477 patient various antiandrogen prophylaxis PSM study: 20% lower mortality (p=0.41) and 2% lower severe cases (p=0.94).Retrospective 1,106 prostate cancer patients, showing no significant differences in COVID-19 outcomes with ADT.
Nov 2021, JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786026, https://c19p.org/schmidt
35. Lyon et al., 5α-Reductase Inhibitors Are Associated with Reduced Risk of SARS-CoV-2 Infection: A Matched-Pair, Registry-Based Analysis
1,938 patient various antiandrogen prophylaxis study: 17% lower mortality (p=0.61) and 7% fewer cases (p=0.04).Retrospective 944 5ARI users in the USA and 944 matched controls, showing lower risk of COVID-19 cases with treatment.
Jan 2022, J. Urology, https://www.auajournals.org/doi/10.1097/JU.0000000000002180, https://c19p.org/lyon
36. MacFadden et al., Screening Large Population Health Databases for Potential COVID-19 Therapeutics: A Pharmacopeia-Wide Association Study (PWAS) of Commonly Prescribed Medications
spironolactone antiandrogen prophylaxis study: 7% fewer cases (p=0.008).Retrospective 26,121 cases and 2,369,020 controls ≥65yo in Canada, showing lower cases with chronic use of spironolactone.
Mar 2022, Open Forum Infectious Diseases, https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofac156/6555707, https://c19p.org/macfaddenaa
37. Shaw et al., COVID-19 in Individuals Treated With Long-Term Hydroxychloroquine: A Propensity Score-Matched Analysis of Cicatricial Alopecia Patients
144 patient antiandrogen prophylaxis PSM study: 6% fewer cases (p=0.006).PSM retrospective 144 alopecia patients in the USA, showing no significant difference in COVID-19 cases with anti-androgen use. The supplemental appendix is not available.
Jul 2021, J. Drugs in Dermatology, https://jddonline.com/articles/dermatology/S1545961621P0914X, https://c19p.org/shawaa
38. Duarte et al., Impact of androgen deprivation therapy on mortality of prostate cancer patients with COVID-19: a propensity score-based analysis
199 patient various antiandrogen prophylaxis study: 11% lower mortality (p=0.37).Retrospective 199 prostate cancer patients hospitalized with COVID-19 in Brazil, showing no significant difference in mortality with active ADT.
Nov 2021, Infectious Agents and Cancer, https://link.springer.com/article/10.1186/s13027-021-00406-y/fulltext.html, https://c19p.org/duarte
39. Kwon et al., Androgen-deprivation therapy and SARS-CoV-2 in men with prostate cancer: findings from the University of California Health System registry
5,211 patient various antiandrogen prophylaxis study: 21% lower mortality (p=1) and 18% more cases (p=0.54).Retrospective 5,211 prostate cancer patients, 799 on ADT, showing no significant differences in COVID-19 outcomes with treatment.
Jan 2021, Annals of Oncology, https://www.annalsofoncology.org/article/S0923-7534(21)00095-8/fulltext, https://c19p.org/kwon
40. Davidsson et al., Androgen deprivation therapy in men with prostate cancer is not associated with COVID‐2019 infection
655 patient antiandrogen prophylaxis study: 2% lower IgG positivity (p=0.95).Retrospective 655 prostate cancer patients in Sweden, showing no significant difference in seropositivity with ADT.
Jan 2023, The Prostate, https://onlinelibrary.wiley.com/doi/10.1002/pros.24485, https://c19p.org/davidsson
41. Jiménez-Alcaide et al., Influence of androgen deprivation therapy on the severity of COVID-19 in prostate cancer patients
1,349 patient various antiandrogen prophylaxis study: 33% lower mortality (p=0.41), 8% higher progression (p=0.77), and 68% more cases (p=0.15).Retrospective 1,349 prostate cancer patients in Spain, 156 on ADT, showing no significant differences in COVID-19 outcomes with treatment.
Sep 2021, The Prostate, https://onlinelibrary.wiley.com/doi/full/10.1002/pros.24232, https://c19p.org/jimenezalcaide
42. Nickols et al., Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19
96 patient degarelix antiandrogen late treatment RCT: 18% lower mortality (p=0.66), 19% higher ventilation (p=0.7), 17% worse results (p=0.7), and 20% longer hospitalization (p=0.94).Early terminated RCT with 62 very late stage (79% on oxygen) degarelix patients and 34 placebo patients, showing no significant differences with treatment. For discussion of many issues with this study see [twitter.com].
Apr 2022, JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791293, https://c19p.org/nickols
43. Welén et al., A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data
5,338 patient various antiandrogen prophylaxis study: 2% lower mortality (p=0.94), 28% higher ICU admission (p=0.28), and 23% higher hospitalization (p=0.09).Retrospective 7,894 COVID+ prostate cancer patients, analyzing patients on antiandrogen treatment, ADT, and ADT + abiraterone acetate or enzalutamide, showing mixed results and higher mortality for ADT + abiraterone acetate or enzalutamide. This paper also includes a small RCT which is listed separately, and an In Vitro HBEC study showing no significant differences (p = 0.084). The supplementary data is not currently available. NCT04475601. For discussion of issues with this study see [sciencedirect.com, sciencedirect.com, sciencedirect.com, sciencedirect.com].
Dec 2021, European Urology, https://www.europeanurology.com/article/S0302-2838(21)02224-7/fulltext, https://c19p.org/welen2
44. Lazzeri et al., Impact of anti-androgen therapies on COVID-19 susceptibility: a case-control study in male population from two COVID-19 regional centers of Lombardy (Italy)
various antiandrogen prophylaxis study: 23% higher combined mortality/ICU admission (p=0.33).Retrospective case-control study in Italy with 943 male COVID-19 patients, 45 on chronic 5ARI treatment (finasteride/dutasteride). There was significantly fewer COVID-19 patients >55 on 5ARI treatment compared to age-matched controls (5.57 vs. 8.14%, p=0.0083). The difference was greater for men aged >65 (7.14 vs. 12.31%, p=0.0001). There was no significant difference for ICU admission or death.
Sep 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.04.20.20068056v2, https://c19p.org/lazzeri
45. Shah et al., The Impact of Androgen Deprivation Therapy on COVID-19 Illness in Men With Prostate Cancer
465 patient antiandrogen prophylaxis study: 16% higher mortality (p=0.59), 19% lower ventilation (p=0.73), 3% higher severe cases (p=0.91), and 4% lower hospitalization (p=0.9).Retrospective 465 prostate cancer patients, showing no significant difference in COVID-19 outcomes with ADT.
May 2022, JNCI Cancer Spectrum, https://academic.oup.com/jncics/article/6/3/pkac035/6584832, https://c19p.org/shah3
46. Kazan et al., The clinical impact of androgen deprivation therapy on SARS-CoV-2 infection rates and disease severity
365 patient various antiandrogen prophylaxis study: 229% higher hospitalization (p=0.2) and 29% fewer cases (p=0.32).Retrospective 365 prostate cancer patients in Turkey, 138 treated with ADT, showing no significant differences with treatment.
Nov 2021, Türk Üroloji Dergisi/Turkish J. Urology, https://turkishjournalofurology.com/en/the-clinical-impact-of-androgen-deprivation-therapy-on-sars-cov-2-infection-rates-and-disease-severity-133775, https://c19p.org/kazan
47. Gedeborg et al., Androgen deprivation therapy, comorbidity, cancer stage and mortality from COVID-19 in men with prostate cancer
24,174 patient antiandrogen prophylaxis study: 25% higher mortality (p=0.11).Case control study with 474 patients that died of COVID-19 in Sweden, showing higher risk with ADT, without statistical significance.
Dec 2021, Scandinavian J. Urology, https://www.tandfonline.com/doi/pdf/10.1080/21681805.2021.2019304, https://c19p.org/gedeborg
48. Holt et al., Influence of inhibitors of the renin–angiotensin system on risk of acute respiratory distress syndrome in Danish hospitalized COVID-19 patients
689 patient spironolactone antiandrogen prophylaxis study: 129% higher combined mortality/ICU admission (p=0.0007).Retrospective 689 hospitalized COVID-19 patients in Denmark, showing higher risk of ICU/death with spironolactone use in unadjusted results subject to confounding by indication.
May 2020, J. Hypertension, https://journals.lww.com/10.1097/HJH.0000000000002515, https://c19p.org/holt2
49. Klein et al., Androgen Deprivation Therapy in Men with Prostate Cancer Does Not Affect Risk of Infection with SARS-CoV-2
1,779 patient various antiandrogen prophylaxis study: 124% higher mortality (p=0.12) and 7% fewer cases (p=0.8).Retrospective 1,779 prostate cancer patients, showing no significant differences in COVID-19 outcomes with ADT.
Feb 2021, J. Urology, https://www.auajournals.org/doi/10.1097/JU.0000000000001338, https://c19p.org/klein
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