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Clinical trials in COVID-19 management & prevention: A meta-epidemiological study examining methodological quality

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Objective To describe the characteristics of Covid-19 randomized clinical trials (RCTs) and examine the association between trial characteristics and the likelihood of finding a significant effect. Study design We conducted… Click to show full abstract

Objective To describe the characteristics of Covid-19 randomized clinical trials (RCTs) and examine the association between trial characteristics and the likelihood of finding a significant effect. Study design We conducted a systematic review to identify RCTs (up to October 21, 2020) evaluating drugs or blood products to treat or prevent Covid-19. We extracted trial characteristics (number of centres, funding sources, and sample size) and assessed risk of bias (RoB) using the Cochrane RoB 2.0 tool. We performed logistic regressions to evaluate the association between RoB due to randomization, single vs. multicentre, funding source, and sample size, and finding a statistically significant effect. Results We included 91 RCTs (n=46,802); 40 (44%) were single-centre, 23 (25.3%) enrolled <50 patients, 28 (30.8%) received industry funding, and 75 (82.4%) had high or probably high RoB. Thirty-eight trials (41.8%) reported a statistically significant effect. RoB due to randomization and being a single-centre trial were associated with increased odds of finding a statistically significant effect. Conclusions There is high variability in RoB among Covid-19 trials. Researchers, funders, and knowledge-users should be cognizant of the impact of RoB due to randomization and single-centre trial status in designing, evaluating, and interpreting the results of RCTs. Registration CRD42020192095

Keywords: significant effect; trial; study; rob; clinical trials

Journal Title: Journal of Clinical Epidemiology
Year Published: 2021

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