A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19
Oriol Mitjà, Marc Corbacho-Monné, Maria Ubals, Andrea Alemany, Clara Suñer, Cristian Tebé, Aurelio Tobias, Judith Peñafiel, Ester Ballana, Carla A Pérez, Pol Admella, Núria Riera-Martí, Pep Laporte, Jordi Mitjà, Mireia Clua, Laia Bertran, Maria Sarquella, Sergi Gavilán, Jordi Ara, Josep M Argimon, Gabriel Cuatrecasas, Paz Cañadas, Aleix Elizalde-Torrent, Robert Fabregat, Magí Farré, Anna Forcada, Gemma Flores-Mateo, Cristina López, Esteve Muntada, Núria Nadal, Silvia Narejos, Aroa Nieto, Nuria Prat, Jordi Puig, Carles Quiñones, Ferran Ramírez-Viaplana, Juliana Reyes-Urueña, Eva Riveira-Muñoz, Lidia Ruiz, Sergi Sanz, Alexis Sentís, Alba Sierra, César Velasco, Rosa M Vivanco-Hidalgo, Juani Zamora, Jordi Casabona, Martí Vall-Mayans, Camila González-Beiras, Bonaventura Clotet
New England Journal of Medicine, doi:10.1056/nejmoa2021801
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.
Appendix
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DOI record:
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