Table 1.
Baseline Characteristics
| Characteristic | mITT (n = 116) | smITT (n = 135) | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 57) | Favipiravir (n = 59) | SMD | Placebo (n = 70) | Favipiravir (n = 65) | SMD | |
| Age at randomization, y, mean (SD) | 43.4 (12.8) | 42.9 (12.3) | 0.04 | 42.8 (12.6) | 42.5 (12.0) | 0.03 |
| Female sex | 29 (50.9) | 28 (47.5) | 0.07 | 37 (52.9) | 32 (49.2) | 0.07 |
| Race/ethnicity | 0.14 | 0.20 | ||||
| Latinx | 24 (42.1) | 26 (44.1) | 29 (41.4) | 28 (43.1) | ||
| White | 21 (36.8) | 19 (32.2) | 26 (37.1) | 22 (33.8) | ||
| Asian | 5 (8.8) | 6 (10.2) | 7 (10.0) | 6 (9.2) | ||
| Native Hawaiian/Pacific Islander | 1 (1.8) | 2 (3.4) | 1 (1.4) | 3 (4.6) | ||
| Other/unknown | 6 (10.5) | 6 (10.2) | 7 (10.0) | 6 (9.2) | ||
| Mean BMI, kg/m2 (SD) | 29.3 (6.0) | 27.8 (5.7) | 0.25 | 28.9 (5.9) | 28.0 (5.8) | 0.15 |
| BMI ≥30 kg/m2 | 25 (43.9) | 18 (30.5) | 0.33 | 29 (41.4) | 21 (32.3) | 0.19 |
| Comorbid conditions | ||||||
| None | 39 (68.4) | 41 (69.5) | 0.02 | 48 (68.6) | 47 (72.3) | 0.08 |
| Diabetes mellitus | 3 (5.3) | 7 (11.9) | 0.24 | 4 (5.7) | 8 (12.3) | 0.23 |
| Hypertension | 5 (8.8) | 5 (8.5) | 0.01 | 8 (11.4) | 6 (9.2) | 0.07 |
| Chronic lung disease | 3 (5.3) | 2 (3.4) | 0.09 | 3 (4.3) | 2 (3.1) | 0.06 |
| Asymptomatic | 1 (1.8) | 3 (5.1) | 0.18 | 0 | 0 | <0.01 |
| Days from symptom onset to randomization, median (IQR) | 5 (4–6) | 5 (3–7) | 0.01 | 5 (4–7) | 5 (3–7) | 0.08 |
| No. of symptoms reported at randomization, median (IQR) | 6 (4–9) | 6 (4–8.5) | 0.28 | 6 (4–9) | 6 (4–8) | 0.16 |
| Symptoms at randomization | ||||||
| Fever | 2 (3.5) | 1 (1.7) | 0.11 | 3 (4.3) | 1 (1.5) | 0.16 |
| Cough/dyspnea | 44 (77.2) | 42 (71.2) | 0.14 | 48 (68.6) | 47 (72.3) | 0.08 |
| Fatigue | 41 (71.9) | 40 (67.8) | 0.09 | 51 (72.9) | 47 (72.3) | 0.01 |
| Joint pain | 18 (31.6) | 20 (33.9) | 0.05 | 20 (28.6) | 22 (33.8) | 0.11 |
| Myalgias | 36 (63.2) | 36 (61.0) | 0.04 | 42 (60.0) | 38 (58.5) | 0.03 |
| Headache | 37 (64.9) | 40 (67.8) | 0.06 | 45 (64.3) | 43 (66.2) | 0.04 |
| Received at least 1 dose of COVID-19 vaccine | 2 (3.5) | 0 (0.0) | 0.27 | 2 (2.9) | 0 (0.0) | 0.24 |
| Baseline seropositivity | 4 (7.0) | 6 (10.2) | 0.30 | 11 (15.7) | 9 (13.8) | 0.14 |
| Baseline anterior nares RT-PCR Ct, median, (IQR) | 25.1 (22.2–28.9) | 22.2 (19.7–27.2) | 0.30 | 28.3 (23.2–38.4) | 24.3 (20.7–31.9) | 0.38 |
| Baseline oropharyngeal RT-PCR positivity | 50 (87.7) | 54 (91.5) | 0.18 | 52 (74.3) | 53 (81.5) | 0.24 |
| Baseline laboratory values, median (IQR) | ||||||
| AST, U/L | 32.0 (26.0–42.5) | 29.0 (25.0–34.0) | 0.39 | 29.5 (25.8–39.3) | 29.0 (25.0–34.0) | 0.31 |
| ALT, U/L | 29.0 (20.0–48.0) | 25.0 (19.5–38.0) | 0.18 | 24.5 (18.8–46.5) | 25.0 (19.0–37.0) | 0.16 |
| Creatinine, mg/dL | 0.8 (0.6–1.0) | 0.8 (0.6–1.0) | 0.09 | 0.8 (0.7–1.0) | 0.8 (0.6–1.0) | 0.12 |
| Uric acid, mg/dL | 4.5 (3.5–5.8) | 4.4 (3.9–5.3) | <0.01 | 4.5 (3.5–5.6) | 4.4 (3.9–5.3) | 0.02 |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; Ct, cycle threshold; COVID-19, coronavirus disease 2019; IQR, interquartile range; mITT, modified intention-to-treat population; RT-PCR, reverse-transcription polymerase chain reaction; SD, standard deviation; SMD, standardized mean difference; smITT, symptomatic modified intention-to-treat population.