Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2020-07, Vol.21 (1), p.688-3, Article 688
• Main Authors: Grau-Pujol, Berta, Camprubí, Daniel, Marti-Soler, Helena, Fernández-Pardos, Marc, Guinovart, Caterina, Muñoz, Jose
• Format: Article
• Language: English
• Subjects: Clinical trials; Coronaviruses; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; Disease prevention; Double-Blind Method; Drug therapy; Health Personnel; Hospitals; Humans; Hydroxychloroquine; Hydroxychloroquine - adverse effects; Hydroxychloroquine - therapeutic use; Infections; Infectious Disease Transmission, Patient-to-Professional - prevention & control; Letter; Management; Medical personnel; Methods; Multicenter Studies as Topic; Occupational Exposure - adverse effects; Pandemics - prevention & control; Patient outcomes; pre-exposure; Pre-Exposure Prophylaxis; Prevention; Prophylaxis; protocol; Randomised controlled trial; Randomized Controlled Trials as Topic; SARS-CoV-2; Serology; Severe acute respiratory syndrome coronavirus 2
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04621-7

The aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in reducing their risk of coronavirus disease 2019 (COVID-19) disease during an epidemic period. As secondary objectives, we would like to: i) assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during an epidemic period, ii) evaluate the safety of PrEP with hydroxychloroquine in adults, iii) describe the incidence of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 infection, iv) identify clinical, analytical and microbiological predictors of COVID-19 among healthcare workers at high risk of SARS-CoV-2 infection, v) set up a repository of serum samples obtained from healthcare workers at high risk of SARS-CoV-2 infection for future research on blood markers to predict SARS-CoV-2 infection. Multicentre double-blind parallel design (ratio 1:1) randomized controlled clinical trial. Approximately 440 healthcare workers of four Spanish hospitals (Hospital Clínic of Barcelona, Hospital de la Santa Creu i Sant Pau of Barcelona, Hospital Plató of Barcelona, Hospital General de Granollers, Barcelona) will be recruited. Participants are considered to be at high-risk of SARS-CoV-2 infection due to their frequent contact with suspected and confirmed cases of COVID-19. For eligibility, healthcare workers with 18 years old or older working at least 3 days a week in a hospital with both negative SARS-CoV-2 polymerase chain reaction (PCR) assays and serological COVID-19 rapid diagnostic tests (RDT) are invited to participate. Participants with any of the following conditions are excluded: pregnancy, breastfeeding, ongoing antiviral, antiretroviral or corticosteroids treatment, chloroquine or hydroxychloroquine uptake the last month or any contraindication to hydroxychloroquine treatment. Eligible participants will be allocated to one of the two study groups: Intervention group (PrEP): participants will receive the standard of care and will take 400mg of hydroxychloroquine (2 tablets of 200 mg per Dolquine® tablet) daily the first four consecutive days, followed by 400 mg weekly for a period of 6 months. participants will receive placebo tablets