Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial
Oriol Mitjà, Marc Corbacho‐Monné, María Ubals, Cristian Tebé, Judith Peñafiel, Aurelio Tobı́as, Ester Ballana, Andrea Alemany, Nuria Martí, Carla A. Pérez, Clara Suñer, Pep Laporte, Pol Admella, Jordi Mitjà, Mireia Clua, Laia Bertran, Maria Sarquella, Sergi Gavilán, Jordi Ara, Josep M. Argimón, Jordi Casabona, Gabriel Cuatrecasas, M. Paz Cañadas, Aleix Elizalde‐Torrent, Robert Fabregat, Magı́ Farré, Anna Forcada, Gemma Flores‐Mateo, Esteve Muntada, Núria Nadal, Silvia Narejos, Aroa Nieto, Núria Prat, Jordi Puig, Carles Quiñones, Juliana Reyes‐Urueña, Ferran Ramírez-Viaplana, Lı́dia Ruiz, Eva Riveira‐Muñoz, Alba Sierra, César Velasco, Rosa Maria Vivanco‐Hidalgo, Alexis Sentís, Camila González-Beiras, Bonaventura Clotet, Martí Vall-Mayans
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.