1. Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial.
- Author
-
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, and Argimon, Josep M
- Subjects
- *
RESEARCH , *COVID-19 , *VIRAL load , *TIME , *MEDICAL cooperation , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *DESCRIPTIVE statistics , *HOSPITAL care , *HYDROXYCHLOROQUINE , *STATISTICAL sampling , *EARLY medical intervention , *EVALUATION , *ADULTS - 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 FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF