A cluster-randomized trial of hydroxychloroquine for prevention of Covid-19

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 i...

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Detalhes bibliográficos
Autores: Mitjà Villar, Oriol, Corbacho-Monné, Marc, Ubals Cazorla, Maria, Alemany Ortiz, Andrea, Suñer Navarro, Clara, Tebé, Cristian, Tobias, Aurelio, Peñafiel, Judith, Ballana, Ester, Pérez, Carla A., Admella, Pol, Riera-Martí, Núria, Laporte, Pep, Mitjà, Jordi, Clua, Mireia, Bertran, Laia, Sarquella, Maria, Gavilán, Sergi, Ara, Jordi, Argimón Pallás, José M., Cuatrecasas, Gabriel, Cañadas, Paz, Elizalde Torrent, Aleix, Fabregat, Robert, Farré Albaladejo, Magí, Forcada, Anna, Flores Mateo, Gemma, López González, Cristina, Muntada, Esteve, Nadal, Núria, Narejos, Silvia, Nieto, Aroa, Prat, Núria, Puig Pla, Jordi, Quiñones, Carles, Ramírez-Viaplana, Ferran, Reyes Urueña, Juliana, Riveira Muñoz, Eva, Ruiz Sainz, Lidia, Sanz, Sergi
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Recursos:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/180762
Acesso em linha:https://hdl.handle.net/2445/180762
Access Level:acceso abierto
Palavra-chave:Agents antiinfecciosos
Ús terapèutic
COVID-19
Anti-infective agents
Therapeutic use
Descrição
Resumo: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.).

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