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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

Cadegiani et al., medRxiv, doi:10.1101/2020.10.05.20206870
Oct 2020  
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Recovery time 77% Improvement Relative Risk Recovery time (b) 83% Time to viral- 38% Spironolactone  Cadegiani et al.  EARLY TREATMENT Is early treatment with spironolactone beneficial for COVID-19? Prospective study of 270 patients in Brazil Faster recovery (p=0.0062) and viral clearance (p=0.015) c19early.org Cadegiani et al., medRxiv, October 2020 Favorsspironolactone Favorscontrol 0 0.5 1 1.5 2+
33rd treatment shown to reduce risk in February 2022
 
*, now with p = 0.00046 from 12 studies.
Lower risk for mortality, progression, and recovery.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 98 treatments. c19early.org
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.
This study is excluded in the after exclusion results of meta analysis: significant unadjusted differences between groups.
recovery time, 76.7% lower, relative time 0.23, p = 0.006, treatment 8, control 262, excluding anosmia.
recovery time, 82.8% lower, relative time 0.17, p = 0.002, treatment 8, control 262, including anosmia.
time to viral-, 37.9% lower, relative time 0.62, p = 0.02, treatment 8, control 262.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Cadegiani et al., 6 Oct 2020, prospective, Brazil, preprint, 4 authors, average treatment delay 3.0 days.
This PaperSpironolactoneAll
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
MD, MSc Flavio A Cadegiani, Andy Goren, Carlos G Wambier, John Mccoy
doi:10.1101/2020.10.05.20206870
Background: While COVID-19 remains largely unclear and mortality continues to raise, early effective approaches prior to complications lack, as well as researches for characterization and therapeutical potential options in actual early COVID-19. Although females seem to be less affected than females, hyperandrogenic (HA) phenotype, like polycystic ovary syndrome (PCOS), idiopathic hirsutism, congenital adrenal hyperplasia (CAH) female androgenetic alopecia (AGA), or idiopathic HA may be at higher risk due to its inherent enhanced androgenic activity. The present study aimed to evaluate the effects of any early pharmacological approach to females diagnosed with COVID-19 .
References
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Cadegiani, Goren, Wambier, Spironolactone may provide protection from SARS-CoV-2: Targeting androgens, angiotensin converting enzyme 2 (ACE2), and renin-angiotensin-aldosterone system (RAAS), Med Hypotheses, doi:10.1016/j.mehy.2020.110112
Cadegiani, Repurposing existing drugs for COVID-19: an endocrinology perspective, BMC Endocr Disord, doi:10.1186/s12902-020-00626-0
Cadegiani, Wambier, Goren, 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
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Goren, Mccoy, Wambier, What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy
Goren, Vano-Galvan, Wambier, A preliminary observation: male pattern hair loss among hospitalized COVID-19 patients in Spain -A potential clue to the role of androgens in COVID-19 severity
Goren, Wambier, Herrera, Mccoy, Vaño-Galván et al., Anti-androgens may protect against severe COVID-19 outcomes: results from a prospective cohort study of 77 hospitalized men, J Eur Acad Dermatol Venereol, doi:10.1111/jdv.16953
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Mccoy, Wambier, Herrera, Vaño-Galván, Gioia et al., Androgen Receptor Genetic Variant Predicts COVID-19 Disease Severity: A Prospective Longitudinal Study of Hospitalized COVID-19 Male Patients, J Eur Acad Dermatol Venereol
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Although females seem to be less affected than ' 'females, hyperandrogenic (HA) phenotype, like polycystic ovary syndrome (PCOS), idiopathic ' 'hirsutism, congenital adrenal hyperplasia (CAH) female androgenetic alopecia (AGA), or ' 'idiopathic HA may be at higher risk due to its inherent enhanced androgenic activity. The ' 'present study aimed to evaluate the effects of any early pharmacological approach to females ' 'diagnosed with COVID-19 before seven days of symptoms, as well as investigate whether HA is ' 'an additional risk factor in this ' 'population.</jats:p></jats:sec><jats:sec><jats:title>Materials and ' 'methods</jats:title><jats:p>Females with symptoms for less than seven days confirmed for ' 'COVID-19 through positive real-time polymerase chain reaction (rtPCR-SARS-CoV-2) were ' 'classified and divided as non-HA, HA, and HA using spironolactone (HA-spiro) groups. Patients ' 'were questioned for baseline characteristics, 23 different diseases, 44 drug classes and ' 'vaccines, 28 different symptoms, and eight different parameters to measure COVID-19 related ' 'clinical outcomes. Treatment was then provided, including azithromycin 500mg/day for five ' 'days in all cases, associated with hydroxychloroquine 400mg/day for five days, nitazoxanide ' '500mg twice a day for six days, or ivermectin 0.2mg/kg/day por three days, and optionally ' 'spironolactone 100mg twice a day until cure. Patients were assessed for COVID-19 clinical ' 'course, clinical and viral duration, and disease ' 'progression.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In total, ' '270 females were enrolled, including 195, 67, and eight in non-HA, HA, and HA-spiro groups, ' 'respectively. Prevailing symptoms were anosmia (71.1%), ageusia (67.0%), headache (48.1%), ' 'myalgia (37.4%), dry cough (36.3%), nasal congestion or rhinorrhea (34.1%), fatigue (33.3%), ' 'weakness (29.5%), hyporexia (27.8%), thoracic pain (24.8%), diarrhea (24.1%) and dizziness ' '(21.5%). Earliest symptoms (days) were dizziness (<jats:italic>1</jats:italic>.<jats:italic>0 ' '± 0</jats:italic>.<jats:italic>2 day), abdominal pain</jats:italic> ' '(<jats:italic>1</jats:italic>.<jats:italic>1 ± 0</jats:italic>.<jats:italic>3);</jats:italic> ' 'conjunctival hyperemia (<jats:italic>1</jats:italic>.<jats:italic>1 ± ' '0</jats:italic>.<jats:italic>5)</jats:italic>, nasal congestion or rhinorrhea ' '(<jats:italic>1</jats:italic>.<jats:italic>2 ± 0</jats:italic>.<jats:italic>5)</jats:italic>, ' 'headache (<jats:italic>1</jats:italic>.<jats:italic>2 ± 0</jats:italic>.<jats:italic>5), dry ' 'cough</jats:italic> (<jats:italic>1</jats:italic>.<jats:italic>2 ± ' '0</jats:italic>.<jats:italic>5)</jats:italic>, myalgia ' '(<jats:italic>1</jats:italic>.<jats:italic>2 ± 0</jats:italic>.<jats:italic>4)</jats:italic>, ' 'nauseas (<jats:italic>1</jats:italic>.<jats:italic>3 ± ' '0</jats:italic>.<jats:italic>5)</jats:italic> and weakness ' '(<jats:italic>1</jats:italic>.<jats:italic>3 ± 0</jats:italic>.<jats:italic>5)</jats:italic>. ' 'Time-to-treat, positive rtPCR, and duration of symptoms with and without anosmia and ageusia ' 'were significantly lower in HA-spiro than non-HA, HA, and overall non-users. Time-to-treat ' 'was similar while all duration of symptoms and positive rtPCR-SARS-CoV-2 were significantly ' 'shorter in non-HA than HA. Spironolactone users were more likely to be asymptomatic than ' 'non-users during COVID-19. Fewer non-HA than HA females were affected by anosmia, ageusia, ' 'dry cough, fatigue, weakness and hyporexia. Ageusia, weakness and myalgia lasted shorter in ' 'non-HA than HA. None of the patients needed hospitalization or any other COVID-19 ' 'complication.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>A ' 'sensitive, early detection of COVID-19 followed by a pharmaceutical approach with different ' 'drug combinations yielded irrefutable differences compared to sex-, age-, body mass index ' '(BMI)-, and disease-matched non-treated controls in terms of clinical outcomes, ethically ' 'disallowing placebo-control randomized clinical trials in the early stage of COVID-19 due to ' 'the marked improvements. HA females presented more severe and prolonged clinical ' 'manifestations, although none progressed to worse outcomes. Spironolactone mitigated the ' 'additional risks due to HA.</jats:p></jats:sec>', 'DOI': '10.1101/2020.10.05.20206870', 'type': 'posted-content', 'created': {'date-parts': [[2020, 10, 6]], 'date-time': '2020-10-06T17:55:16Z', 'timestamp': 1602006916000}, 'source': 'Crossref', 'is-referenced-by-count': 5, 'title': 'An open-label prospective observational study of antiandrogen and non-antiandrogen early ' 'pharmacological approaches in females with mild-to-moderate COVID-19. 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A preliminary observation: ' 'male pattern hair loss among hospitalized COVID-19 patients in Spain - A ' 'potential clue to the role of androgens in COVID-19 severity [published ' 'online ahead of print, 2020 Apr 16]. J Cosmet Dermatol. 2020;10. ' '1111/jocd.13443.', 'DOI': '10.1111/jocd.13443'}, { 'key': '2020101915400542000_2020.10.05.20206870v1.16', 'doi-asserted-by': 'crossref', 'unstructured': 'Goren A , McCoy J , Wambier CG , et al. What does androgenetic alopecia ' 'have to do with COVID-19? An insight into a potential new therapy ' '[published online ahead of print, 2020 Apr 1]. Dermatol Ther. ' '2020;e13365.', 'DOI': '10.1111/dth.13365'}, { 'key': '2020101915400542000_2020.10.05.20206870v1.17', 'doi-asserted-by': 'crossref', 'unstructured': 'McCoy J , Wambier CG , Herrera S , Vaño-Galván S , Gioia F , Comeche B , ' 'Ron R , Serrano-Villar S , Iwasiow RM , Tayeb MA , Cadegiani FA , ' 'Mesinkovska NA , Shapiro J , Sinclair R , Goren A. 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