Table 3.
End points and adverse events in enrolled patients.
| Parameter | Leflunomide (n = 27) | Control (n = 30) | p-value |
|---|---|---|---|
| Primary end point | |||
| Time to sustained clinical recovery, days, [M (IQR)] | 6.0 (6.0–8.0) | 7.0 (5–8.5) | 0.207 |
| Hazard ratio vs. Control group, 95% CI | 1.329 (0.878–2.529) | – | |
| Secondary end points | |||
| Conversion to severe COVID-19 or death by day 21, n (%) | 0 (0) | 0 (0) | 1.000 |
| Duration of viral shedding, days, [M (IQR)] | 7.0 (6.0–9.5) | 9 (7.5–12) | 0.044* |
| Duration of fever, days, [M (IQR)] | 3.0 (2.0–4.0) | 4.0 (3.0–6.0) | 0.027* |
| Hospitalization rate, n (%) | 8 (29.6) | 13 (43.3) | 0.426 |
| Incidence of pneumonia, n (%) | 9 (33.3) | 12 (40.0) | 0.806 |
| Side effects after enrollment, n (%) | 4 (14.8) | 3 (10) | 0.882 |
| Total symptoms | 3 (11.1) | 3 (10) | 0.768 |
| Headaches | 0 (0) | 1 (3.3) | 0.958 |
| Nausea | 2 (7.4) | 2 (6.7) | 0.682 |
| Vomiting | 1 (3.7) | 0 (0) | 0.958 |
| Abdominal pain | 1 (3.7) | 0 (0) | 0.958 |
| Abnormal laboratory results, n (%) | 4 (14.8) | 3 (10) | 0.882 |
| Leukopenia | 0 (0) | 1 (3.3) | 0.958 |
| Lymphopenia | 1 (3.7) | 0 (0) | 0.958 |
| AST elevation | 2 (7.4) | 1 (3.3) | 0.925 |
| ALT elevation | 4 (14.8) | 1 (3.3) | 0.289 |
| Hypoalbuminemia | 0 (0) | 1 (3.3) | 0.958 |
Sustained clinical recovery refers to a total score ≤ 1 for all COVID-19-related symptoms (higher scores indicate more severe disease on a scale of 0 to 3, with a total score of 20 items ranging from 0 to 60) on two consecutive days. The first day of the two consecutive-day period was considered to be the event date. Leukopenia: WBC count <4.0 × 109/L; Leukopenia: Lymphocyte count <1.1 × 109/L; AST elevation: AST > 40 U/L; ALT elevation: ALT >50 U/L. Hypoalbuminemia: Albumin <40 g/L. M, medians; IQR, interquartile range.