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

{ 'institution': [{'name': 'medRxiv'}], 'indexed': {'date-parts': [[2024, 3, 8]], 'date-time': '2024-03-08T12:23:36Z', 'timestamp': 1709900616169}, 'posted': {'date-parts': [[2020, 10, 6]]}, 'group-title': 'Infectious Diseases (except HIV/AIDS)', 'reference-count': 28, 'publisher': 'Cold Spring Harbor Laboratory', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2020, 10, 6]]}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>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 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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