Abstract
BackgroundMany 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.MethodsWe 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.Findings30 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.InterpretationAnalyses 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.FundingNone
Highlights
In early 2020, a novel b-coronavirus causing Severe Acute Respiratory Syndrome (SARS-CoV-2) rapidly spread around the world, resulting in a pandemic with global impact [1,2]
Given the impact of sex on diseases and therapy as revealed in the past, we systematically reviewed this potential knowledge gap by performing a scoping review on clinical trials investigating pharmacological therapies for COVID-19
Only one study stratified its results based on sex by post-hoc analysis
Summary
In early 2020, a novel b-coronavirus causing Severe Acute Respiratory Syndrome (SARS-CoV-2) rapidly spread around the world, resulting in a pandemic with global impact [1,2]. On June 9th, 2020, SARS-CoV-2, causing Corona Virus Disease 2019 (COVID-19), reached a worldwide case fatality rate of 5.7% [3,4]. To optimise care for COVID-19 patients, prophylactic and therapeutic studies should include sex-specific design and analyses. 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. 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. 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
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