Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Abstract (PubMed)

Background: Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). Methods: We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale. Results: Among 667 patients who underwent randomization, 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. The odds ratio for improvement in clinical status was 1.21 (95% CI, 0.69 to 2.11) with hydroxychloroquine alone and 0.99 (95% CI, 0.57 to 1.73) with hydroxychloroquine plus azithromycin. QTc interval prolongation >480ms was observed in 14.7% of patients in the hydroxychloroquine-plus-azithromycin group, 14.6% in the hydroxychloroquine-alone group, and 1.7% in the control group. In patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care.