ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesPrimary objectiveTo determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.Secondary objectivesTo determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers.To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology)To compare the percentage of COVID-19 positive individuals with current testing methods versus serologically-proven COVID-19 in each trial armTo compare COVID-19 disease severity in each trial armTo compare recovery time from COVID-19 infection in each trial armExploratory objectivesTo determine compliance (as measured by trough pharmacokinetic hydroxychloroquine levels) on COVID-19 positive testsTo determine if genetic factors determine susceptibility to COVID-19 disease or response to treatmentTo determine if blood group determines susceptibility to COVID-19 diseaseTo compare serum biomarkers of COVID-19 disease in each armTrial designDouble-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trialParticipantsNational Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19.Participants in the trial will be recruited from a number of NHS hospitals directly caring for p...
Source: Trials - Category: Research Source Type: clinical trials