Moving fast but going slow: coordination challenges for trials of COVID-19 post-exposure prophylaxis
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COMMENTARY
Open Access
Moving fast but going slow: coordination challenges for trials of COVID-19 postexposure prophylaxis Darrell H. S. Tan1,2,3* , Rupesh Agrawal4,5,6, Ruanne V. Barnabas7,8, Jon T. Giles9 and Peter Dull10 Abstract An unprecedented volume of research has been generated in response to the COVID-19 pandemic. However, there are risks of inefficient duplication and of important work being impeded if efforts are not synchronized. Excessive reliance on observational studies, which can be more rapidly conducted but are inevitably subject to measured and unmeasured confounders, can foil efforts to conduct rigorous randomized trials. These challenges are illustrated by recent global efforts to conduct clinical trials of post-exposure prophylaxis (PEP) as a strategy for preventing COVID19. Innovative strategies are needed to help overcome these issues, including increasing communication between the Data Safety and Monitoring Committees (DSMCs) of similar trials. It is important to reinforce the primacy of high-quality trials in generating unbiased answers to pressing prevention and treatment questions about COVID-19. The proliferation of research on COVID-19 treatment and prevention since SARS-CoV-2 first emerged has been unprecedented. Since SARS-CoV-2 first emerged in Wuhan, China, and triggered a global pandemic, nearly 3000 trials have been registered on ClinicalTrials.gov. While this volume of research is impressive, there are risks of inefficient duplication, and important work may also be impeded if efforts are not synchronized. Ongoing efforts to conduct rigorous randomized trials of COVID-19 post-exposure prophylaxis (PEP) provide illustrative examples. PEP is a commonly used strategy for the prevention of infectious diseases, in which people who have recently been exposed to a pathogen use a short course of targeted, antimicrobial chemotherapy to decrease the chance of acquiring infection. In the absence of a preventive vaccine against SARS-CoV-2, PEP is an intuitively attractive option to impact the progression of the epidemic, and numerous * Correspondence: [email protected] 1 Division of Infectious Diseases, St. Michael’s Hospital, 30 Bond St., Toronto, ON M5B 1W8, Canada 2 MAP Centre for Urban Health Solutions, St. Michael’s Hospital, 30 Bond St., Toronto, ON M5B 1W8, Canada Full list of author information is available at the end of the article
research groups around the globe have launched randomized controlled trials. Based on pre-clinical data suggesting in vitro inhibition of both SARS-CoV and SARS-CoV-2 [1, 2], plausible mechanisms of action including the alkalinization of endosomes required for viral replication [3], and early clinical case series from France suggesting a reduction in the SARS-CoV-2 viral load in the upper respiratory tract [4], chloroquine (CQ) and hydroxychloroquine (HCQ) have been leading candidates for COVID-19 PEP. The HIV protease inhibitor lopinavir/ritonavir is also being evaluated, based on reports showing in vitro activity against SARSCoV [5], and observ
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