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.,
An open-label prospective observational study of antiandrogen and non-antiandrogen early pharmacological..,
medRxiv, doi:10.1101/2020.10.05.20206870 (Preprint)
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.
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recovery time, 82.8% lower, relative time 0.17, p = 0.002, treatment 8, control 262, including anosmia.
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time to viral-, 37.9% lower, relative time 0.62, p = 0.02, treatment 8, control 262.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Cadegiani et al., 6 Oct 2020, prospective, Brazil, preprint, 4 authors, average treatment delay 3.0 days.
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preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in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,..
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