Just as Covid-19 does not strike all age groups equally, it does not affect men and women in the same manner. For every 10 women hospitalized with Covid-19 symptoms, there are 18 men, and for every 10 women dying, 15 men have. There is an increased risk of mortality for male Covid-19 patients worldwide compared to female patients. Yet almost all clinical trials still lump the gender data together. Should they start reporting results separately for men and women?

In December 2020, results of 45 randomized controlled trials were published in various journals, but only eight of them had specific data for men and women, says a paper published this month in Nature Communications.Moststudies give only aggregate numbers for cases and vaccinations.

‘Lack of consideration of sex and gender in COVID-19 clinical studies’
https://www.nature.com/articles/s41467-021-24265-8

The researchers collected data from ClinicalTrials.gov, for the period between January 1, 2020 and January 26, 2021. Of the 4,420 registered SARS-CoV-2/COVID-19 studies, they found that

* 935 (21.2%) refer to sex/gender only for recruitment,
* 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting
* Only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable.

The research team notes that several calls urging the inclusion of sex and gender into Covid-19 trials have been published. “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,” they write.

“I would have assumed that [sex] would be picked up in the trials, simply because it’s such an evident piece of the puzzle,” says Sabine Oertelt-Prigione, one of the researchers. Skipping that step is potentially dangerous in trials of drugs that may affect men and women differently, given their physiological differences, she adds.

Earlier, a small study of 30 Covid-19 trials found none of them explored whether their results were affected by sex. A paper in the British Medical Journal in April analyzed 121 Covid-related papers, and found only 14 of them checked whether sex affected the results.

Also see:

https://www.sciencemag.org/news/2021/07/covid-19-affects-men-and-women-differently-so-why-don-t-clinical-trials-report-gender?utm_source=pocket-newtab-intl-en

https://www.eurekalert.org/pub_releases/2021-07/rumc-nsl070521.php

https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30396-5/fulltext