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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 MESHD. The Pre-AndroCoV Female Trial.

    Authors: Flavio A Cadegiani; Carlos Gustavo Wambier; Andy Goren

    doi:10.1101/2020.10.05.20206870 Date: 2020-10-06 Source: medRxiv

    Background: While COVID-19 MESHD 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 MESHD. Although females seem to be less affected than females, hyperandrogenic MESHD ( HA MESHD) phenotype, like polycystic ovary syndrome MESHD ( PCOS MESHD), idiopathic hirsutism MESHD, congenital adrenal hyperplasia MESHD ( CAH MESHD) female androgenetic alopecia (AGA), or idiopathic HA MESHD 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 MESHD before seven days of symptoms, as well as investigate whether HA MESHD is an additional risk factor in this population. Materials and methods: Females with symptoms for less than seven days confirmed for COVID-19 MESHD through positive real-time polymerase chain reaction (rtPCR-SARS-CoV-2) were classified and divided as non- HA MESHD, HA MESHD, and HA MESHD using spironolactone ( HA MESHD-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 MESHD 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 MESHD clinical course, clinical and viral duration, and disease progression. Results: In total, 270 females were enrolled, including 195, 67, and eight in non- HA MESHD, HA MESHD, and HA MESHD-spiro groups, respectively. Prevailing symptoms were anosmia MESHD (71.1%), ageusia MESHD (67.0%), headache MESHD (48.1%), myalgia MESHD (37.4%), dry cough MESHD (36.3%), nasal congestion or rhinorrhea MESHD (34.1%), fatigue MESHD (33.3%), weakness MESHD (29.5%), hyporexia (27.8%), thoracic pain MESHD (24.8%), diarrhea MESHD (24.1%) and dizziness MESHD (21.5%). Earliest symptoms (days) were dizziness MESHD (1.0 +- 0.2 day), abdominal pain MESHD (1.1 +- 0.3); conjunctival hyperemia MESHD (1.1 +- 0.5), nasal congestion or rhinorrhea MESHD (1.2 +- 0.5), headache MESHD (1.2 +- 0.5), dry cough MESHD (1.2 +- 61617; 0.5), myalgia MESHD (1.2 +- 0.4), nauseas MESHD (1.3 +- 0.5) and weakness MESHD (1.3 +- 0.5). Time-to-treat, positive rtPCR, and duration of symptoms with and without anosmia and ageusia MESHD were significantly lower in HA MESHD-spiro than non- HA MESHD, HA MESHD, 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 MESHD than HA MESHD. Spironolactone users were more likely to be asymptomatic than non-users during COVID-19 MESHD. Fewer non- HA MESHD than HA MESHD females were affected by anosmia MESHD, ageusia, dry cough MESHD, fatigue MESHD, weakness and hyporexia MESHD. Ageusia, weakness MESHD and myalgia MESHD lasted shorter in non- HA MESHD than HA MESHD. None of the patients needed hospitalization or any other COVID-19 MESHD complication. Conclusions: A sensitive, early detection of COVID-19 MESHD 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 MESHD due to the marked improvements. HA MESHD females presented more severe and prolonged clinical manifestations, although none progressed to worse outcomes. Spironolactone mitigated the additional risks due to HA MESHD.

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MeSH Disease
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