Towards Precision Medicine: Inclusion of Sex and Gender Aspects in COVID-19 Clinical Studies—Acting Now before It Is Too Late—A Joint Call for Action

Bischof, Evelyne; Oertelt‐Prigione, Sabine; Morgan, Rosemary; Klein, Sabra L.

doi:10.3390/ijerph17103715

Cited by 23 publications

(20 citation statements)

References 14 publications

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“…The data, however, show no difference in the numbers of infected cases between sexes overall, so gender differences in hygiene behaviours and testing are unlikely to explain the sex disparity in disease severity. Regional gender differences in health-seeking behaviours and access to care may predispose men towards access to hospital and ITU admission [153][154][155][156] . However, the ubiquitous nature of the sex-bias in these data argues for a true biological difference in the response to SARS-CoV-2 between sexes.…”

Section: Discussionmentioning

confidence: 99%

Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission

et al. 2020

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Anecdotal evidence suggests that Coronavirus disease 2019 (COVID-19), caused by the coronavirus SARS-CoV-2, exhibits differences in morbidity and mortality between sexes. Here, we present a meta-analysis of 3,111,714 reported global cases to demonstrate that, whilst there is no difference in the proportion of males and females with confirmed COVID-19, male patients have almost three times the odds of requiring intensive treatment unit (ITU) admission (OR = 2.84; 95% CI = 2.06, 3.92) and higher odds of death (OR = 1.39; 95% CI = 1.31, 1.47) compared to females. With few exceptions, the sex bias observed in COVID-19 is a worldwide phenomenon. An appreciation of how sex is influencing COVID-19 outcomes will have important implications for clinical management and mitigation strategies for this disease.

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Section: Discussionmentioning

confidence: 99%

Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission

et al. 2020

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“… 4 Incorporating sex and gender considerations into clinical research on COVID-19 from the outset would help to identify differential patterns of risk, underlying reasons for disparate outcomes and to develop interventions to effectively respond to the various needs of women and men. 5 Given the growing recognition of the relevance of sex and gender in the COVID-19 pandemic, the rationale for this analysis was to examine whether these dimensions are taken into account in clinical research on COVID-19.…”

Section: Introductionmentioning

confidence: 99%

Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

2021

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“…There is growing evidence that sex differences play a role in the immunological, hormonal, and cardiovascular pathophysiological responses to SARS-CoV-2 [ 10 , 11 ]. Historically, in medical research on other cardiovascular and infectious diseases, women seem underrepresented in clinical and pharmacological trials, and data are rarely reported separately for males and females [10] , [11] , [12] . Consequently, unrevealed differences in disease presentation and progression between men and women may have been missed, and system-biological differences in (side)-effects of pharmacological therapy undetected.…”

Section: Introductionmentioning

confidence: 99%

“…Consequently, unrevealed differences in disease presentation and progression between men and women may have been missed, and system-biological differences in (side)-effects of pharmacological therapy undetected. In COVID-19 patients, it is expected that these disparities also affect the severity of the virus infection, disease course, and (side)-effects of initiated therapy [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

The “sex gap” in COVID-19 trials: a scoping review

et al. 2020

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Background Many studies investigate the role of pharmacological treatments on disease course in Corona Virus Disease 2019 (COVID-19). Sex disparities in genetics, immunological responses, and hormonal mechanisms may underlie the substantially higher fatality rates reported in male COVID-19 patients. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. Therefore, in this scoping review, we investigated whether studies on pharmacological treatment in COVID-19 were performed based on a priori sex-specific design or post-hoc sex-specific analyses. Methods We systematically searched PubMed, EMBASE, UpToDate, clinical trial.org, and MedRxiv for studies on pharmacological treatment for COVID-19 until June 6th, 2020. We included case series, randomized controlled trials, and observational studies in humans (≥18 years) investigating antiviral, antimalarial, and immune system modulating drugs. Data were collected on 1) the proportion of included females, 2) whether sex stratification was performed (a priori by design or post-hoc), and 3) whether effect modification by sex was investigated. Findings 30 studies were eligible for inclusion, investigating remdesivir ( n = 2), lopinavir/ritonavir ( n = 5), favipiravir ( n = 1), umifenovir ( n = 1), hydroxychloroquine/chloroquine ( n = 8), convalescent plasma ( n = 6), interleukin-6 (IL-6) pathway inhibitors ( n = 5), interleukin-1 (IL-1) pathway inhibitors ( n = 1) and corticosteroids ( n = 3). Only one study stratified its data based on sex in a post-hoc analysis, whereas none did a priori by design. None of the studies investigated effect modification by sex. A quarter of the studies included twice as many males as females. Interpretation Analyses assessing potential interference of sex with (side-)effects of pharmacological therapy for COVID-19 are rarely reported. Considering sex differences in case-fatality rates and genetic, immunological, and hormonal mechanisms, studies should include sex-specific analyses in their design to optimise COVID-19 care. Funding None

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Towards Precision Medicine: Inclusion of Sex and Gender Aspects in COVID-19 Clinical Studies—Acting Now before It Is Too Late—A Joint Call for Action

Abstract: The COVID-19 global pandemic is accelerating investigations for effective vaccines and repurposable validated therapeutics [...]

Cited by 23 publications

References 14 publications

Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission

Male sex identified by global COVID-19 meta-analysis as a risk factor for death and ITU admission

Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

The “sex gap” in COVID-19 trials: a scoping review

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