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

Author:

Mitjà Oriol123,Corbacho-Monné Marc14,Ubals Maria24,Tebé Cristian5,Peñafiel Judith5,Tobias Aurelio6,Ballana Ester7,Alemany Andrea1,Riera-Martí Núria1,Pérez Carla A1,Suñer Clara1,Laporte Pep1,Admella Pol1,Mitjà Jordi1,Clua Mireia1,Bertran Laia1,Sarquella Maria1,Gavilán Sergi1,Ara Jordi2,Argimon Josep M8,Casabona Jordi910,Cuatrecasas Gabriel11,Cañadas Paz12,Elizalde-Torrent Aleix7,Fabregat Robert13,Farré Magí2,Forcada Anna14,Flores-Mateo Gemma15,Muntada Esteve9,Nadal Núria16,Narejos Silvia17,Nieto Aroa1,Prat Nuria18,Puig Jordi1,Quiñones Carles2,Reyes-Ureña Juliana910,Ramírez-Viaplana Ferran1,Ruiz Lidia7,Riveira-Muñoz Eva7,Sierra Alba1,Velasco César19,Vivanco-Hidalgo Rosa Maria19,Sentís Alexis9ORCID,G-Beiras Camila1,Clotet Bonaventura17720,Vall-Mayans Martí12

Affiliation:

1. Fight AIDS and Infectious Diseases Foundation, Badalona, Spain

2. Hospital Universitari Germans Trias i Pujol and Universitat Autònoma de Barcelona, Badalona, Spain

3. Lihir Medical Centre—International SOS, Lihir Island, Papua New Guinea

4. Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain

5. Bellvitge Biomedical Research Institute (IDIBELL), L’Hospitalet de Llobregat, Spain

6. Institute of Environmental Assessment and Water Research (IDAEA), Spanish Council for Scientific Research (CSIC), Barcelona, Spain

7. IrsiCaixa AIDS Research Institute, Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain

8. Direcció-gerència, Institut Català de la Salut, Barcelona, Spain

9. 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

10. Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain

11. Equip d’atenció primària de Sarria, Barcelona, Spain

12. SYNLAB, Barcelona, Spain

13. Direcció General de Recerca i Innovació en Salut, Generalitat de Catalunya, Barcelona, Catalonia, Spain

14. Gerència territorial de Catalunya Central, Institut Català de la Salut, St Fruitós del Bages, Spain

15. Xarxa Sanitària i Social Santa Tecla, Tarragona, Spain

16. Gerència territorial de Barcelona, Institut Català de la Salut, Barcelona, Spain

17. Entitat de Base Asociativa Centelles- Atenció Primària, Centelles, Spain

18. Gerència territorial de Àmbit Metropolità nord, Institut Català de la Salut, Sabadell, Spain

19. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), Barcelona, Spain

20. Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC), Vic, Spain

Abstract

Abstract 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.

Funder

JoEmCorono

Laboratorios Rubió

Laboratorios Gebro Pharma

Zurich Seguros

SYNLAB Barcelona

Generalitat de Catalunya

Foundation Dorneur

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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