Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial.

Autor: Mitjà O; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain.; Lihir Medical Centre-International SOS, Lihir Island, Papua New Guinea., Corbacho-Monné M; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.; Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain., Ubals M; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain.; Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain., Tebé C; Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain., Peñafiel J; Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain., Tobias A; Institute of Environmental Assessment and Water Research (IDAEA), Spanish Council for Scientific Research (CSIC), Barcelona, Spain., Ballana E; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain., Alemany A; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Riera-Martí N; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Pérez CA; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Suñer C; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Laporte P; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Admella P; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Mitjà J; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Clua M; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Bertran L; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Sarquella M; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Gavilán S; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Ara J; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain., Argimon JM; Direcció-gerència, Institut Català de la Salut, Barcelona, Spain., Casabona J; Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain., Cuatrecasas G; Equip d'atenció primària de Sarria, Barcelona, Spain., Cañadas P; SYNLAB, Barcelona, Spain., Elizalde-Torrent A; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain., Fabregat R; Direcció General de Recerca i Innovació en Salut, Generalitat de Catalunya, Barcelona, Catalonia, Spain., Farré M; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain., Forcada A; Gerència territorial de Catalunya Central, Institut Català de la Salut, St Fruitós del Bages, Spain., Flores-Mateo G; Xarxa Sanitària i Social Santa Tecla, Tarragona, Spain., Muntada E; Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain., Nadal N; Gerència territorial de Barcelona, Institut Català de la Salut, Barcelona, Spain., Narejos S; Entitat de Base Asociativa Centelles- Atenció Primària, Centelles, Spain., Nieto A; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Prat N; Gerència territorial de Àmbit Metropolità nord, Institut Català de la Salut, Sabadell, Spain., Puig J; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Quiñones C; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain., Reyes-Ureña J; Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain.; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain., Ramírez-Viaplana F; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Ruiz L; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain., Riveira-Muñoz E; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain., Sierra A; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Velasco C; Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain., Vivanco-Hidalgo RM; Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain., Sentís A; Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Catalan Institute of Oncology (ICO)-Departament de Salut, Generalitat de Catalunya, Barcelona, Spain., G-Beiras C; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain., Clotet B; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.; IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain.; Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC), Vic, Spain., Vall-Mayans M; Fight AIDS and Infectious Diseases Foundation, Badalona, Spain.; Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain.
Jazyk: angličtina
Zdroj: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Dec 06; Vol. 73 (11), pp. e4073-e4081.
DOI: 10.1093/cid/ciaa1009
Abstrakt: Background: No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19.
Methods: Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.
Results: A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (-1.41 vs -1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (-3.37 vs -3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported.
Conclusions: In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.
(© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
Databáze: MEDLINE