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