Table 2.
Primary and Secondary Outcomes
| Outcome | Treatment Arm | Measure of Association | ||
|---|---|---|---|---|
| Placebo | Favipiravir | aHR (95% CI) | P Value | |
| Primary outcomea | ||||
| Days until viral shedding cessation, median (IQR) | 13 (9–14) | 14 (9–21) | 0.76 (.48–1.20) | .24 |
| Secondary clinical outcomes | ||||
| Hospitalizations by day 28b, No. (%) of participants | 4/74 (5) | 0 | … | .06 |
| ED visits by day 28b, No. (%) of participants | 7/74 (10) | 5/75 (7) | … | .56 |
| Days until initial resolution of symptomsc, median (IQR) | 14 (11–18) | 15 (12–26) | 0.84 (.54–1.29) | .43 |
| Days until sustained resolution of symptomsc, median (IQR) | 24 (21–NA) | NA (26–NA) | 0.87 (.52–1.45) | .59 |
| Secondary virologic outcomesa | Δ Reverse Ctd (95% CI) |
P Value | ||
| Change in reverse Ctd from day 1 to 7, mean (SD) | −7.0 (5.6) | −9.2 (5.0) | −2.06 (−4.34 to .22) | .08 |
| Change in reverse Ctd from day 1 to 10, mean (SD) | −10.5 (5.1) | −12.9 (5.9) | −1.83 (−4.19 to .53) | .13 |
| Negative by RT-PCR on day 7, No. (%) of participants | 10/47 (21) | 10/42 (24) | … | .80 |
| Negative by RT-PCR on day 10, No. (%) of participants | 23/45 (51) | 20/35 (57) | … | .65 |
| Safety outcomesb | ||||
| Serious AEs, No. (%) of events | 1 (1.4) | 0 | … | … |
| Resulting in death | 0 | 0 | … | … |
| Resulting in hospitalization | 1 (100.0) | 0 | … | … |
| AEs, No. of events | 15 | 27 | … | … |
| AEs, No. (%) of participants | 10 (13.5) | 19 (25.3) | … | .11 |
| Grade 3 AEs, No. (%) | 2 (13.3) | 2 (7.4) | … | … |
| Most common AEs, No. (%) of participants | ||||
| Dizziness | 2 (2.7) | 3 (4.0) | … | … |
| Nausea | 3 (4.1) | 1 (1.3) | … | … |
| Day 10 uric acid, mg/dL, median (IQR) | 4.9 (4.1–6.0) | 7.4 (6.3–9.0) | … | … |
All virologic endpoints use anterior nares swab results unless otherwise noted.
Abbreviations: AE, adverse event; aHR, adjusted hazard ratio (adjusted for age ≥50 years and sex); CI, confidence interval; Ct, cycle threshold; ED, emergency department; IQR, interquartile range; NA, undefined; RT-PCR, reverse-transcription polymerase chain reaction; SD, standard deviation.
a
Among the modified intention-to-treat (mITT) population.
b
Among the ITT population.
c
Among the symptomatic mITT (smITT) population.
d
Reverse Ct was defined by subtracting the Ct value from 40 (the limit of detection; see Supplementary Methods for details).