Efficacy and safety of hydroxychloroquine and azithromycin in patients with mild-to-moderate Covid-19
Study design: Multicenter, randomized, open-label, three-group, controlled trial
Population
- Number of patients studied: 667 (504 with confirmed Covid-19 in modified intention-to-treat analysis)
- Inclusion criteria: Patients aged 18 or older, hospitalized with suspected or confirmed Covid-19, 14 or fewer days since symptom onset, receiving no supplemental oxygen or a maximum of 4 L/min of supplemental oxygen
- Exclusion criteria: Use of more than 4 L/min supplemental oxygen, high-flow nasal cannula, invasive or noninvasive ventilation, history of severe ventricular tachycardia, or QTc of at least 480 msec
Interventions
- Experimental group 1: Standard care plus hydroxychloroquine (400 mg twice daily for 7 days)
- Experimental group 2: Standard care plus hydroxychloroquine (400 mg twice daily for 7 days) and azithromycin (500 mg once daily for 7 days)
- Control group: Standard care
Primary outcome: Clinical status at 15 days assessed using a seven-level ordinal scale (higher scores indicate worse condition) in the modified intention-to-treat population
Safety outcomes or Adverse Events
- QTc interval prolongation: Hydroxychloroquine plus azithromycin (39.3%), Hydroxychloroquine alone (33.7%), Control group (22.6%)
- Elevation of liver-enzyme levels: Hydroxychloroquine plus azithromycin more common than in the control group
Conclusion
Among 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.