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N Engl J Med
. 2020 Nov 24.
doi: 10.1056/NEJMoa2021801. Online ahead of print.
A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19
Oriol Mitj? 1 , Marc Corbacho-Monn? 1 , Maria Ubals 1 , Andrea Alemany 1 , Clara Su?er 1 , Cristian Teb? 1 , Aurelio Tobias 1 , Judith Pe?afiel 1 , Ester Ballana 1 , Carla A P?rez 1 , Pol Admella 1 , N?ria Riera-Mart? 1 , Pep Laporte 1 , Jordi Mitj? 1 , Mireia Clua 1 , Laia Bertran 1 , Maria Sarquella 1 , Sergi Gavil?n 1 , Jordi Ara 1 , Josep M Argimon 1 , Gabriel Cuatrecasas 1 , Paz Ca?adas 1 , Aleix Elizalde-Torrent 1 , Robert Fabregat 1 , Mag? Farr? 1 , Anna Forcada 1 , Gemma Flores-Mateo 1 , Cristina L?pez 1 , Esteve Muntada 1 , N?ria Nadal 1 , Silvia Narejos 1 , Aroa Nieto 1 , Nuria Prat 1 , Jordi Puig 1 , Carles Qui?ones 1 , Ferran Ram?rez-Viaplana 1 , Juliana Reyes-Urue?a 1 , Eva Riveira-Mu?oz 1 , Lidia Ruiz 1 , Sergi Sanz 1 , Alexis Sent?s 1 , Alba Sierra 1 , C?sar Velasco 1 , Rosa M Vivanco-Hidalgo 1 , Juani Zamora 1 , Jordi Casabona 1 , Mart? Vall-Mayans 1 , Camila Gonz?lez-Beiras 1 , Bonaventura Clotet 1 , BCN-PEP-CoV2 Research Group
Affiliations
- PMID: 33289973
- DOI: 10.1056/NEJMoa2021801
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.).