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A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19.
Mitjà, Oriol; Corbacho-Monné, Marc; Ubals, Maria; Alemany, Andrea; Suñer, 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; Argimon, Josep M; Cuatrecasas, Gabriel; Cañadas, Paz; Elizalde-Torrent, Aleix; Fabregat, Robert; Farré, Magí; Forcada, Anna; Flores-Mateo, Gemma; López, Cristina; Muntada, Esteve; Nadal, Núria; Narejos, Silvia; Nieto, Aroa; Prat, Nuria; Puig, Jordi; Quiñones, Carles; Ramírez-Viaplana, Ferran; Reyes-Urueña, Juliana; Riveira-Muñoz, Eva; Ruiz, Lidia; Sanz, Sergi; Sentís, Alexis; Sierra, Alba; Velasco, César; Vivanco-Hidalgo, Rosa M; Zamora, Juani; Casabona, Jordi; Vall-Mayans, Martí; González-Beiras, Camila; Clotet, Bonaventura.
  • Mitjà O; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Corbacho-Monné M; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Ubals M; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Alemany A; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Suñer C; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Tebé C; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Tobias A; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Peñafiel J; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Pérez CA; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Riera-Martí N; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Clua M; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Sarquella M; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Gavilán S; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Ara J; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Argimon JM; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Cuatrecasas G; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Cañadas P; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Fabregat R; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
  • Farré M; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Flores-Mateo G; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Narejos S; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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  • Puig J; From the Fight AIDS and Infectious Diseases Foundation (O.M., M.C.-M., M.U., A.A., C.S., E.B., C.A.P., P.A., N.R.-M., P.L., J.M., M.C., L.B., M.S., S.G., A.N., J. Puig, F.R.-V., A. Sierra, M.V.-M., C.G.-B., B.C.), Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona (O.M.,
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N Engl J Med ; 384(5): 417-427, 2021 02 04.
Article in English | MEDLINE | ID: covidwho-963653
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.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Hydroxychloroquine / Anti-Infective Agents Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Hydroxychloroquine / Anti-Infective Agents Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article