Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.10.05.20206870; this version posted October 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . 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. Flavio A. Cadegiani1,2, Andy Goren3, Carlos G. Wambier4, John McCoy3 1 Adrenal and Hypertension Unit, Division of Endocrinology and Metabolism, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM/UNIFESP), São Paulo, SP, Brazil 2 Corpometria Institute, Brasília, DF, Brazil 3 Applied Biology Inc., Irvine, CA, USA 4 Brown University, RI, USA Address correspondence: Flavio A. Cadegiani, MD, MSc, PhD Division of Endocrinology and Metabolism, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo Rua Pedro de Toledo 781 – 13th floor, 04039-032 São Paulo, SP – Brazil Email: flavio.cadegiani@unifesp.br ; f.cadegiani@gmail.com Telephone: +55 61 996506111, Fax: +55 61 33464733 Key-words: COVID-19, SARS-CoV-2, antiandrogen, dutasteride, spironolactone, Abstract 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any early pharmacological approach to females diagnosed with COVID-19 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.10.05.20206870; this version posted October 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . before seven days of symptoms, as well as investigate whether HA is an additional risk factor in this population. Materials and methods: 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,..