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Título: | A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease |
Autor: | Mitjà, Oriol; Ubals, Maria; Corbacho, Marc; Alemany, Andrea; Suñer, Clara; Tebé, Cristian; Tobías, Aurelio CSIC ORCID; Peñafiel, Judith; Ballana, Ester; Pérez, Carla; 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; Gil-Ortega, Aroa; Prat, Nuria; Puig, Jordi; Quiñones, Carles; Ramírez-Vilaplana, Ferrán; 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; G-Beiras, Camila; Clotet, Bonaventura | Fecha de publicación: | 26-jul-2020 | Editor: | MedRxiv | Resumen: | Background Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are limited to non-pharmacological interventions. Hydroxychloroquine (HCQ) 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 including asymptomatic contacts exposed to a PCR-positive Covid-19 case in Catalonia, Spain. Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). The primary outcome was PCR-confirmed symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, either symptomatically compatible or a PCR-positive result regardless of symptoms. Adverse events (AEs) were assessed up to 28 days. Results The analysis included 2,314 healthy contacts of 672 Covid-19 index cases identified between Mar 17 and Apr 28, 2020. A total of 1,198 were randomly allocated to usual care and 1,116 to HCQ therapy. There was no significant difference in the primary outcome of PCR-confirmed, symptomatic Covid-19 disease (6.2% usual care vs. 5.7% HCQ; risk ratio 0.89 [95% confidence interval 0.54-1.46]), nor evidence of beneficial effects on prevention of SARS-CoV-2 transmission (17.8% usual care vs. 18.7% HCQ). The incidence of AEs was higher in the intervention arm than in the control arm (5.9% usual care vs 51.6% HCQ), but no treatment-related serious AEs were reported. Conclusions Postexposure therapy with HCQ did not prevent SARS-CoV-2 disease and infection in healthy individuals exposed to a PCR-positive case. Our findings do not support HCQ as postexposure prophylaxis for Covid-19. | Versión del editor: | https://doi.org/10.1101/2020.07.20.20157651 | URI: | http://hdl.handle.net/10261/217189 | DOI: | 10.1101/2020.07.20.20157651 |
Aparece en las colecciones: | (PTI Salud Global) Colección Especial COVID-19 (IDAEA) Artículos |
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