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.
Keywords: COVID-19; SARS-CoV-2; hydroxychloroquine; randomized controlled trial; therapy.
【저자키워드】 COVID-19, Randomized controlled trial, SARS-CoV-2, therapy, Hydroxychloroquine, 【초록키워드】 Treatment, coronavirus disease, therapy, Open-label, randomization, Hospitalization, risk, Intervention, Disease progression, Randomized, Nasopharyngeal swab, Viral load, early treatment, adverse event, Patient, Spain, Mild, age, HCQ, Outpatient, reduction, symptom onset, Adverse, control arm, usual care, median time, intervention arm, intention-to-treat, randomized, controlled trial, Complete, effective, benefit, event, reported, diagnosed, conducted, determine, assigned, did not reduce, the mean, receive, baseline, eligible, resolution of symptom, resolution of symptoms, were assessed, with COVID-19, 【제목키워드】 Controlled,