Primary and secondary outcomes in the intention-to-treat population (n = 148)
| Outcome | No. (%) of participants* | p value | |
|---|---|---|---|
| Hydroxychloroquine n = 111 | Placebo n = 37 | ||
| Primary outcome†‡ | 4 (3.6) | 0 | 0.6¶ |
| Secondary outcomes | |||
| Time to COVID-19 recovery, d, median (95% CI)§ | 14 (10–20) | 12 (7–18) | 0.3** |
| Disposition at 30 d‡ | NC | ||
| Recovered | 67 (60.9) | 29 (78.4) | |
| Ongoing symptoms, not hospitalized | 23 (20.9) | 6 (16.2) | |
| Unknown, not hospitalized or deceased | 20 (18.2) | 2 (5.4) | |
| Mortality within 30 d | 0 | 0 | NC |
| Admission to ICU within 30 d‡ | 1 (0.9) | 0 | NC |
| Hospitalization within 30 d‡ | 4 (3.6) | 0 | NC |
Note: CI = confidence interval, ICU = intensive care unit, NC = secondary outcomes were not compared between groups following the prespecified protected hierarchy.
↵* Unless stated otherwise.
↵† Primary outcome: hospitalization, invasive mechanical ventilation or death within 30 days of randomization.
↵‡ Missing for 1 participant in the hydroxychloroquine group who declined consent for data collection after they withdrew from the study. This participant was confirmed to be alive beyond 30 days when contacted for re-consent.
↵§ Includes 89 participants in the hydroxychloroquine group and 35 in the placebo group with data on symptoms duration. Participants who recovered before randomization or were asymptomatic (1 was enrolled in error) were removed, as were 12 without follow-up at day 7 or day 30 whose symptoms at randomization were unconfirmed.
↵¶ Two-sided Fisher exact test.
↵** Log-rank test.