Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
Grau-Pujol et al.
, Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized..
, Trials, doi:10.1186/s13063-021-05758-9
Small PrEP RCT showing that PrEP with HCQ is safe at the dosage used. There were no deaths, hospitalizations, or serious adverse events.
The paper states: "Among all trial participants at the end of the first month (n=253), only one participant from the placebo arm (1/116, 0.8%), tested positive for SARS-CoV-2 PCR and for a SARS-CoV-2 serology test".
The abstract states: "only one participant in each group was diagnosed with COVID-19".
risk of case, 10.6% lower, RR 0.89, p = 1.00, treatment 1 of 142 (0.7%), control 1 of 127 (0.8%), NNT 1202.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Grau-Pujol et al., 21 Sep 2020, Randomized Controlled Trial, Spain, peer-reviewed, 22 authors.
Abstract: Grau-Pujol et al. Trials
Pre-exposure prophylaxis with
hydroxychloroquine for COVID-19: a
randomized clinical trial
Berta Grau-Pujol1,2,3*† , Daniel Camprubí-Ferrer1†, Helena Marti-Soler1, Marc Fernández-Pardos1,
Clara Carreras-Abad1, Maria Velasco-de Andrés1, Elisabet Ferrer1, Magdalena Muelas-Fernandez1, Sophie Jullien1,
Giuseppe Barilaro1, Sara Ajanovic1, Isabel Vera1, Laura Moreno4, Eva Gonzalez-Redondo4, Núria Cortes-Serra1,
Montserrat Roldán1, Ana Artes-de Arcos1, Isabel Mur5, Pere Domingo5, Felipe Garcia4,6, Caterina Guinovart1 and
Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although
hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19
PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against
placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.
Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona,
Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2
infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2).
Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four
consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group
followed the same treatment schedule with placebo tablets.
Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo
arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit
regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse
event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild
gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm
(27.4% (39/142) vs 15.7% (20/127), p=0.041).
* Correspondence: email@example.com
Berta Grau-Pujol and Daniel Camprubí-Ferrer contributed equally to this
Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - University of
Barcelona, Rosselló 132 4rt 1a, 08036 Barcelona, Spain
Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
Full list of author information is available at the end of the article
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