INTRODUCTION
infection, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, ASYMPTOMATIC COVID-19, DISEASE, INFECTION, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
In 2020, there was no proven effective prophylaxis and no globally available proven effective antiviral treatment of coronavirus disease 2019 (COVID-19). Vaccines were not yet available. In vitro studies suggested that hydroxychloroquine (HCQ) was effective in inhibiting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a cell culture model.In the setting of this uncertainty, a global multicentric, double-blind, randomized, placebo-controlled trial (COPCOV) was set to evaluate the use of HCQ to prevent healthcare workers and staff working in a health facility involved in COVID-19 management from being infected and developing symptomatic disease. After informed consent was obtained, participants were randomly assigned to receive either 200 mg HCQ daily or placebo for 90 days. The primary outcome was the incidence of symptomatic COVID-19 infection. In Niger, potential participants were recruited from Lamorde Hospital, in the capital Niamey.Community engagement activities started in mid-January 2021 and included meetings with administrative and health authorities. The first step in the process was to discuss the study with all heads of departments in the hospital and ensure that their questions and any concerns were addressed. Study information was extended to all hospital staff on February 10, 2021. In addition to these meetings, study staff were permanently present at the hospital to answer questions and discuss participation in a confidential manner.Of the 240 persons with whom participation was discussed, only five participants provided their informed consent through mid-April 2021. Here, we describe the key difficulties encountered in the conduct of this trial from the perspective of the site study team, with four major considerations: the context, the investigational product, the participants, and the design of the trial itself.