1. While there has been a rise in clinical trials on COVID-19, a large proportion of these studies are expected to yield low levels of evidence.
Evidence Rating Level: 3 (Average)
The rapid and widespread transmission of coronavirus disease 2019 (COVID-19) has resulted in a wide range of clinical research to better understand its characteristics and course. It has been speculated that the inherent urgency imposed by the pandemic may have an impact on the methodologies being used by researchers, though this has not been formally assessed. This cross-sectional analysis sought to characterize these studies and methodologies through a March 19, 2020 search of ClinicalTrials.gov. Only active studies were included. A total of 1,551 studies registered between March 1, 2011 and May 19, 2020 met inclusion criteria. Of these, 76.1% were single-center, 41.3% observational studies, and 42.8% randomized clinical trials (RCTs). Treatment complications (23.1%), ventilation requirements (26.6%), and mortality (33.9%) were common primary and secondary outcomes. Of all studies, 29.1% harbored the capacity to yield the highest level of individual study evidence (OCEBM level 2). Across the 664 RCTs, clinical course was the most common primary outcome (48.6%) while 7.7% had a primary outcome of mortality. Approximately 54.8% of the RCTs were blinded, such that they could achieve OCEBM level 2 evidence. Only 11.3% were placebo-controlled and blinded. Most evaluated drugs and biologic agents: hydroxychloroquine or chloroquine (23.3%), remdesivir (1.1%), other antivirals (7.2%), tocilizumab (3.2%), and corticosteroids (3.0%). Overall, this analysis of clinical trials suggests that majority of studies are expected to yield a low level of evidence. With rising rates of COVID-19 cases and difficulty controlling its spread on a national scale, it is important that researchers do not forego methodology in favour of speed and convenience, in order to maximize the ability to generate clinically meaningful results.
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