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

2020; Massachusetts Medical Society; Volume: 384; Issue: 5 Linguagem: Inglês

10.1056/nejmoa2021801

1533-4406

Natàlia Casamitjana, Marc Corbacho-Monné, María Ubals, Andrea Alemany, Clara Suñer, Cristian Tebé, Aurelio Tobı́as, Judith Peñafiel, Ester Ballana, Carla A. Pérez, Pol Admella, Nuria Martí, Pep Laporte, Jordi Mitjà, Mireia Clua, Laia Bertran, Maria Sarquella, Sergi Gavilán, Jordi Ara, Josep M. Argimón, Gabriel Cuatrecasas, M. Paz Cañadas, Aleix Elizalde‐Torrent, Robert Fabregat, Magı́ Farré, Anna Forcada, Gemma Flores‐Mateo, Cristina López, Esteve Muntada, Núria Nadal, Silvia Narejos, Aroa Nieto, Núria Prat, Jordi Puig, Carles Quiñones, Ferran Ramírez-Viaplana, Juliana Reyes‐Urueña, Eva Riveira‐Muñoz, Lı́dia Ruiz, Sergi Sanz, Alexis Sentís, Alba Sierra, César Velasco, Rosa Maria Vivanco‐Hidalgo, Juani Zamora, Jordi Casabona, Martí Vall-Mayans, Camila González-Beiras, Bonaventura Clotet,

Long-Term Effects of COVID-19

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.)