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

Schiffer, V.; Janssen, Emma B. N. J.; Bussel, Bas C.T. van; Jorissen, Laura L.M.; Tas, Jeanette; Sels, Jan Willem; Bergmans, Dennis C. J. J.; Dinh, Trang; Kuijk, Sander M. J. van; Hana, Anisa; Mehagnoul-Schipper, Jannet; Scheeren, Clarissa I.E.; Mesotten, Dieter; Stessel, Björn; Marx, Gernot; Hof, Arnoud W J van ‘t; Spaanderman, Marc E. A.; Mook, Walther N. K. A. van; Horst, Iwan C. C. van der; Ghossein‐Doha, Chahinda

doi:10.1016/j.eclinm.2020.100652

Cited by 30 publications

(34 citation statements)

References 72 publications

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“…Sex differences in immune responses have been shown to cause differences in vaccine effectiveness [ 35 , 36 ]. Interestingly, analyses for sex differences are mostly lacking or of a rudimentary level in reports of trials investigating antiviral drugs, corticosteroids, and–importantly–vaccines [ 35 , 36 , 37 ].…”

Section: Sex-specific Differences In Immune Responses and Inflammamentioning

confidence: 99%

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Farkouh

Baumgärtel

Gottardi³

et al. 2021

JCM

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There is increasing evidence of sex differences in the action of anti-inflammatory drugs, with women being at significantly higher risk of adverse effects. Nevertheless, clinicians’ awareness of the implications of these sex differences on dosing and adverse event monitoring in routine practice is still in need of improvement. We reviewed the literature evaluating sex differences in terms of pharmacokinetics and pharmacodynamics of anti-inflammatory drugs. The anti-thrombotic activity of selective and non-selective COX-inhibitors tends to be stronger in men than women. Side effect profiles differ with regards to gastro-intestinal, renal and hepatic complications. Glucocorticosteroids were found to be more effective in men; women were more sensitive to corticosteroids when their oestradiol levels were high, a finding important for women taking hormonal contraception. TNF-alpha inhibitors have a longer half-life in men, leading to stronger immunosuppression and this a higher incidence of infections as side effects. Although research on sex differences in the effectiveness and safety of drugs is increasing, findings are often anecdotal and controversial. There is no systematic sex-differentiated reporting from clinical trials, and women are often under-represented. As personalized medicine is gaining in importance, sex, and gender aspects need to become integral parts of future research and policy making.

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Section: Sex-specific Differences In Immune Responses and Inflammamentioning

confidence: 99%

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Farkouh

Baumgärtel

Gottardi³

et al. 2021

JCM

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“…For example, previous works have suggested that factors associated with COVID-19 outcomes are different in men and women [4]. However, further research is warranted and several authors have pointed to the need of studies stratified by sex [5].…”

Section: Introductionmentioning

confidence: 99%

Sex Differences and Predictors of In-Hospital Mortality among Patients with COVID-19: Results from the ANCOHVID Multicentre Study

Fernández-Martínez

Ortiz-González-Serna

Serrano-Ortiz

et al. 2021

IJERPH

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Spain is one of the countries most affected by the COVID-19 pandemic. Although risk factors for severe disease are published, sex differences have been widely neglected. In this multicentre study, we aimed to identify predictors of in-hospital mortality in men and women hospitalised with COVID-19. An observational longitudinal study was conducted in the cohort of patients admitted to four hospitals in Andalusia, Spain, from 1 March 2020 to 15 April 2020. Sociodemographic and clinical data were collected from hospital records. The Kaplan–Meier method was used to estimate 30-day survival and multiple Cox regression models were applied. All analyses were stratified by sex. A total of 968 patients were included (54.8% men, median age 67.0 years). In-hospital mortality reached 19.1% in men and 16.0% in women. Factors independently associated with an increased hazard of death were advanced age, higher CURB-65 score and not receiving azithromycin treatment, in both sexes; active cancer and autoimmune disease, in men; cardiovascular disease and chronic lung disease, in women. Disease outcomes and predictors of death differed between sexes. In-hospital mortality was higher in men, but the long-term effects of COVID-19 merit further research. The sex-differential impact of the pandemic should be addressed in public health policies.

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“…It is not fully understood if immune responses, hormonal mechanisms or underlying genetics plays a role in determining the severity of illness in male COVID-19 patients. Furthermore, most studies investigating therapeutic interventions in COVID-19 lacked either a gender-based design or a post-hoc gender-specific analysis [ 20 ]. In our study, males were more likely to have an improvement in oxygenation status after receiving CP therapy when compared to females.…”

Section: Discussionmentioning

confidence: 99%

Potential predictors of outcomes among hospitalized COVID-19 patients treated with convalescent plasma: a single-center study

Chilimuri

Zahid

Mantri

et al. 2021

Journal of Community Hospital Internal Medicine Perspectives

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Background:The coronavirus disease 2019 pandemic is a major international public health crisis, which has led to over 3 million deaths as of April 2021. Several therapeutics have been tried for this deadly illness including antivirals, immunosuppressive agents and convalescent plasma (CP). In this study, we present our inner-city safety net hospital experience with CP therapy. Methods: This was a retrospective chart review of hospitalized patients with confirmed COVID-19 who were treated with CP. Results: A total of 60 patients received CP during the study period. The mean age for patients in this study was 58.95 years. The most common presenting symptoms were shortness of breath (85%) and cough (73%). Hypertension (65%) and diabetes mellitus (55%) were the most common comorbidities in our patients. In our multivariate regression analysis, male sex, nausea and loss of appetite at presentation were associated with improvement in oxygenation after CP. Total survival time, history of obstructive airway disease, home use of angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers were associated with decreased survival, whereas Hispanic ethnicity showed a trend towards lower survival after CP therapy. Conclusions: Our study highlights several important characteristics of inner-city safety net hospital patient population who might benefit from CP therapy.

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

Cited by 30 publications

References 72 publications

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Sex-Related Differences in Drugs with Anti-Inflammatory Properties

Sex Differences and Predictors of In-Hospital Mortality among Patients with COVID-19: Results from the ANCOHVID Multicentre Study

Potential predictors of outcomes among hospitalized COVID-19 patients treated with convalescent plasma: a single-center study

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