Abstract
Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences influence the frequency and severity of pharmacological side effects. A large number of clinical trials to develop new therapeutic approaches and vaccines for COVID-19 are ongoing. We investigated the inclusion of sex and/or gender in COVID-19 studies on ClinicalTrials.gov, collecting data for the period January 1, 2020 to January 26, 2021. Here, we show that of the 4,420 registered SARS-CoV-2/COVID-19 studies, 935 (21.2%) address sex/gender solely in the context of recruitment, 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting, and only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable. Just eight (17.8%) of the 45 COVID-19 related clinical trials published in scientific journals until December 15, 2020 report sex-disaggregated results or subgroup analyses.
Highlights
Available data point towards an increased risk of mortality for male patients with COVID-19 worldwide compared to female patients[1]
Not addressing the gender dimension hampers the opportunity to reduce inequality in healthcare, promote preventative action and modulate the course of the infection and pharmacological access[15]. Given these potential health risks for a large fraction of the infected population, we investigated the consideration of sex and/or gender as an analytical variable in currently registered and published trials for SARS-CoV-2/COVID-19
Of the 45 publications for randomized control trials (RCTs) of pharmacological interventions for COVID-19 we identified, eight (17.8%) report sex-disaggregated results or subgroup analyses
Summary
Available data point towards an increased risk of mortality for male patients with COVID-19 worldwide compared to female patients[1] This could be related to intrinsic sex differences in the immune reaction[2] or specific characteristics of the SARS-CoV-2 infectious process. Not addressing the gender dimension hampers the opportunity to reduce inequality in healthcare, promote preventative action and modulate the course of the infection and pharmacological access[15]. Given these potential health risks for a large fraction of the infected population, we investigated the consideration of sex and/or gender as an analytical variable in currently registered and published trials for SARS-CoV-2/COVID-19. Of the 45 publications for randomized control trials (RCTs) of pharmacological interventions for COVID-19 we identified, eight (17.8%) report sex-disaggregated results or subgroup analyses
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
