Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial. (16th July 2020)

• Record Type: Journal Article
• Authors: Mitjà, Oriol; Corbacho-Monné, Marc; Ubals, Maria; Tebé, Cristian; Peñafiel, Judith; Tobias, Aurelio; Ballana, Ester; Alemany, Andrea; Riera-Martí, Núria; Pérez, Carla A; Suñer, Clara; Laporte, Pep; Admella, Pol; Mitjà, Jordi; Clua, Mireia; Bertran, Laia; Sarquella, Maria; Gavilán, Sergi; Ara, Jordi; Argimon, Josep M; Casabona, Jordi; Cuatrecasas, Gabriel; Cañadas, Paz; Elizalde-Torrent, Aleix; Fabregat, Robert; Farré, Magí; Forcada, Anna; Flores-Mateo, Gemma; Muntada, Esteve; Nadal, Núria; Narejos, Silvia; Nieto, Aroa; Prat, Nuria; Puig, Jordi; Quiñones, Carles; Reyes-Ureña, Juliana; Ramírez-Viaplana, Ferran; Ruiz, Lidia; Riveira-Muñoz, Eva; Sierra, Alba; Velasco, César; Vivanco-Hidalgo, Rosa Maria; Sentís, Alexis; G-Beiras, Camila; Clotet, Bonaventura; Vall-Mayans, Martí;
• Is Part Of: Clinical infectious diseases. Volume 73:Number 11(2021)
• Page Start: e4073
• Page End: e4081
• Publication Date: 2020-07-16
• Subjects: hydroxychloroquine -- SARS-CoV-2 -- COVID-19 -- therapy -- randomized controlled trial; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciaa1009
• Languages: English
• ISSNs: 1058-4838

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. Abstract : Compared with usual care, early treatment with HCQ failed to reduce the viral load in nasopharyngeal swabs after 3 and 7 days of treatment and shorten the time to resolve symptoms in adults with mild coronavirus disease 2019.