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Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 N+Engl+J+Med 2021 ; 384 (5): 417-427 Nephropedia Template TP
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A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19 #MMPMID33289973
Mitja O; Corbacho-Monne M; Ubals M; Alemany A; Suner C; Tebe C; Tobias A; Penafiel J; Ballana E; Perez CA; Admella P; Riera-Marti N; Laporte P; Mitja J; Clua M; Bertran L; Sarquella M; Gavilan S; Ara J; Argimon JM; Cuatrecasas G; Canadas P; Elizalde-Torrent A; Fabregat R; Farre M; Forcada A; Flores-Mateo G; Lopez C; Muntada E; Nadal N; Narejos S; Nieto A; Prat N; Puig J; Quinones C; Ramirez-Viaplana F; Reyes-Uruena J; Riveira-Munoz E; Ruiz L; Sanz S; Sentis A; Sierra A; Velasco C; Vivanco-Hidalgo RM; Zamora J; Casabona J; Vall-Mayans M; Gonzalez-Beiras C; Clotet B
N Engl J Med 2021[Feb]; 384 (5): 417-427 PMID33289973show ga
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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N+Engl+J+Med 2021 ; 384 (5): 417-427
