A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19

A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19

Fecha de publicación online: 24/11/2020 Fecha de publicación en papel: 24 Noviembre 2020 Revista: The New England Journal of Medicine

Abstract:

Background
Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking.

Methods
We conducted an open-label, cluster-randomized trial involving asymptomatic contacts of patients with polymerase-chain-reaction (PCR)-confirmed Covid-19 in Catalonia, Spain. We randomly assigned clusters of contacts to the hydroxychloroquine group (which received the drug at a dose of 800 mg once, followed by 400 mg daily for 6 days) or to the usual-care group (which received no specific therapy). The primary outcome was PCR-confirmed, symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, defined by symptoms compatible with Covid-19 or a positive PCR test regardless of symptoms. Adverse events were assessed for up to 28 days.

Results
The analysis included 2314 healthy contacts of 672 index case patients with Covid-19 who were identified between March 17 and April 28, 2020. A total of 1116 contacts were randomly assigned to receive hydroxychloroquine and 1198 to receive usual care. Results were similar in the hydroxychloroquine and usual-care groups with respect to the incidence of PCR-confirmed, symptomatic Covid-19 (5.7% and 6.2%, respectively; risk ratio, 0.86 [95% confidence interval, 0.52 to 1.42]). In addition, hydroxychloroquine was not associated with a lower incidence of SARS-CoV-2 transmission than usual care (18.7% and 17.8%, respectively). The incidence of adverse events was higher in the hydroxychloroquine group than in the usual-care group (56.1% vs. 5.9%), but no treatment-related serious adverse events were reported.

Conclusions
Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.).

Autores: Mitjà O, Corbacho-Monné M, Ubals M, Alemany A, Suñer C, Tebé C, Tobias A, Peñafiel J, Ballana E, Pérez CA, Admella P, Riera-Martí N, Laporte P, Mitjà J, Clua M, Bertran L, Sarquella M, Gavilán S, Ara J, Argimon JM, Cuatrecasas G, Cañadas P, Elizalde-Torrent A, Fabregat R, Farré M, Forcada A, Flores-Mateo G, López C, Muntada E, Nadal N, Narejos S, Nieto A, Prat N, Puig J, Quiñones C, Ramírez-Viaplana F, Reyes-Urueña J, Riveira-Muñoz E, Ruiz L, Sanz S, Sentís A, Sierra A, Velasco C, Vivanco-Hidalgo RM, Zamora J, Casabona J, Vall-Mayans M, González-Beiras C, Clotet B; BCN-PEP-CoV2 Research Group

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Irsi Caixa

Impulsado por:

Fundación 'La Caixa' Generalitat de Catalunya - Departament de Salut

 

HR Excellence in Research

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