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Supported by the crowdfunding campaign YoMeCorono (www.yomecorono.com/), Generalitat de Catalunya, Zurich Seguros, Synlab Diagnosticos, Laboratorios Rubio, and Laboratorios Gebro Pharma. Laboratorios Rubio donated and supplied the hydroxychloroquine (Dolquine).

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

Publicated to:New England Journal Of Medicine. 384 (5): 417-427 - 2021-02-04 384(5), DOI: 10.1056/nejmoa2021801

Authors: 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

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Abstract

BackgroundCurrent 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. MethodsWe 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. ResultsThe 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. ConclusionsPostexposure 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.) In a trial involving asymptomatic contacts of patients with PCR-confirmed Covid-19 in Spain, the authors compared the use of hydroxychloroquine with usual care. Postexposure therapy with hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons.

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