Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial
Por:
Grau-Pujol, B, Camprubi-Ferrer, D, Marti-Soler, H, Fernandez-Pardos, M, Carreras-Abad, C, Velasco-de Andres, M, Ferrer, E, Muelas-Fernandez, M, Jullien, S, Barilaro, G, Ajanovic, S, Vera, I, Moreno, L, Gonzalez-Redondo, E, Cortes-Serra, N, Roldan, M, Artes-de Arcos, A, Mur, I, Domingo, P, Garcia, F, Guinovart, C, Munoz, J
Publicada:
15 nov 2021
Resumen:
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 COVID-19. 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).
Conclusions: Although the efficacy of PrEP with hydroxychloroquine for preventing COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low doses is safe.
Filiaciones:
Grau-Pujol, B:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Ctr Invest Saude Manhica CISM, Maputo, Mozambique
Mundo Sano Fdn, Buenos Aires, DF, Argentina
Camprubi-Ferrer, D:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Marti-Soler, H:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Fernandez-Pardos, M:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Carreras-Abad, C:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Velasco-de Andres, M:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Ferrer, E:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Muelas-Fernandez, M:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Jullien, S:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Barilaro, G:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Ajanovic, S:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Vera, I:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Moreno, L:
Univ Barcelona, Hosp Clin, Infect Dis Dept, IDIBAPS, Barcelona, Spain
Gonzalez-Redondo, E:
Univ Barcelona, Hosp Clin, Infect Dis Dept, IDIBAPS, Barcelona, Spain
Cortes-Serra, N:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Roldan, M:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Artes-de Arcos, A:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Mur, I:
Hosp Santa Creu & Sant Pau, Infect Dis Unit, Inst Invest Biomed St Pau, Barcelona 08025, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Infect Dis Unit, Inst Invest Biomed St Pau, Barcelona 08025, Spain
Garcia, F:
Univ Barcelona, Hosp Clin, Infect Dis Dept, IDIBAPS, Barcelona, Spain
Univ Barcelona, Hosp Clin, IDIBAPS, Aids Res Grp,Retrovirol & Viral Immunopathol, Barcelona, Spain
Guinovart, C:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
Munoz, J:
Univ Barcelona, Barcelona Inst Global Hlth ISGlobal, Hosp Clin, Rossello 132 4rt 1a, Barcelona 08036, Spain
gold, Green Published
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