Abstract
BackgroundIn April 2020, two independent clinical trials to assess SARS-CoV-2 prophylaxis strategies among health care workers were initiated at our hospital: MeCOVID (melatonin vs placebo) and EPICOS (tenofovir disoproxil/emtricitabine vs hydroxychloroquine vs combination therapy vs placebo).ObjectiveThis study aimed to evaluate the reasons why health care workers chose to participate in the MeCOVID and EPICOS trials, as well as why they chose one over the other.MethodsBoth trials were offered to health care workers through an internal news bulletin. After an initial screening visit, all subjects were asked to respond to a web-based survey.ResultsIn the first month, 206 health care workers were screened and 160 were randomized. The survey participation was high at 73.3%. Health care workers cited “to contribute to scientific knowledge” (n=80, 53.0%), followed by “to avoid SARS-CoV-2 infection” (n=33, 21.9%) and “the interest to be tested for SARS-CoV-2” (n=28, 18.5%), as their primary reasons to participate in the trials. We observed significant differences in the expected personal benefits across physicians and nurses (P=.01). The vast majority of volunteers (n=202, 98.0%) selected the MeCOVID trial, their primary reason being their concern regarding adverse reactions to treatments in the EPICOS trial (n=102, 69.4%).ConclusionsHealth care workers’ reasons to participate in prophylaxis trials in an acute pandemic context appear to be driven largely by their desire to contribute to science and to gain health benefits. Safety outweighed efficacy when choosing between the two clinical trials.
Highlights
Therapeutic and phase I clinical studies have primarily focused on motivations for participating in clinical trials
No pre-exposure prophylaxis therapy has been approved for COVID-19, but numerous clinical trials have been initiated in Europe and the United States, most of them assessing the potential of hydroxychloroquine as a prophylactic agent [1-5]
As of April 21, 2020, two independent clinical trials to assess COVID-19 prophylaxis strategies among health care workers have been initiated at the Clinical Trials Unit, La Paz University Hospital (Madrid, Spain): the MeCOVID trial and the EPICOS trial
Summary
Therapeutic and phase I clinical studies have primarily focused on motivations for participating in clinical trials. Limited information is available regarding subjects’ motivators to participate in prophylaxis trials in an acute pandemic context, with particular reference to COVID-19, especially in Western countries. As of April 21, 2020, two independent clinical trials to assess COVID-19 prophylaxis strategies among health care workers have been initiated at the Clinical Trials Unit, La Paz University Hospital (Madrid, Spain): the MeCOVID trial (melatonin vs placebo; EudraCT-2020-001530-35) and the EPICOS trial (a four-arm clinical trial comparing the efficacy of tenofovir disoproxil/emtricitabine, hydroxychloroquine, combination therapy, and placebo; EudraCT-2020-001385-11). In April 2020, two independent clinical trials to assess SARS-CoV-2 prophylaxis strategies among health care workers were initiated at our hospital: MeCOVID (melatonin vs placebo) and EPICOS (tenofovir disoproxil/emtricitabine vs hydroxychloroquine vs combination therapy vs placebo). Safety outweighed efficacy when choosing between the two clinical trials
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