Efficacy of hydroxychloroquine with azithromycin in mild COVID-19: randomized clinical trial

This study aims to determine the efficacy and safety of a fixed combination of hydroxychloroquine (HCQ) + azithromycin (AZT) compared to HCQ alone or placebo in mild COVID-19 to avoid hospitalization.

This is a randomized, double-blind clinical trial that included participants with mild COVID-19. They were randomly assigned to one of the three treatment arms: (1) HCQ + AZT 200 mg/250 mg every 12 h for 5 days followed by HCQ 200 mg every 12 h for 5 days; (2) HCQ 200 mg every 12 h for 10 days; or (3) placebo every 12 h for 10 days.

A total of 92 participants were included. The incidence of hospitalization was 6.7% (2/30) in the HCQ + AZT group compared to the HCQ or placebo groups, in which there were no hospitalizations. Progression of disease was higher in the HCQ group (relative risk [RR] = 3.25 [95% confidence interval [CI], 1.19-8.87]) compared with the placebo group. There was a significant risk of pneumonia in the HCQ group compared with the placebo group (RR = 3.33 [95% CI, 1.01-10.9]). No lengthening of the QT interval prolongation was observed in patients receiving HCQ + AZT or HCQ.

The use of HCQ + AZT does not decrease the risk of hospitalization. The use of HCQ increases the risk of progression and pneumonia.