Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesComparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionalsTrial designSingle centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trialParticipantsTreatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency.Intervention and comparatorIntervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical. Control group: placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran).Main outcomesConfirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose.RandomisationThe randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a b...
Source: Trials - Category: Research Source Type: clinical trials