Table 2. Primary and Secondary Outcomes through Day 28.*.
| Outcome | Inhaled Fluticasone Furoate (N=621) |
Placebo (N=656) |
Estimated Difference or Ratio (95% Credible Interval or Confidence Interval) |
Posterior Probability of Efficacy |
|---|---|---|---|---|
| Time to recovery† | ||||
| Skeptical prior: primary analysis | 1.01 (0.91 to 1.12)‡ | 0.56 | ||
| Weakly informative prior: sensitivity analysis | 1.01 (0.89 to 1.14)‡ | 0.57 | ||
| No prior: sensitivity analysis | 1.01 (0.89 to 1.14)§ | — | ||
| Mean no. of days unwell¶ | 11.2 (11.0 to 11.4) | 11.3 (11.1 to 11.5) | −0.10 (−0.45 to 0.26)‖ | 0.70 |
| Hospitalization or death through day 28 — no. (%) | 3 (0.5) | 3 (0.5) | 0.94 (0.19 to 4.68)** | — |
| Composite of hospitalization, urgent-care visit, emergency department visit, or death — no. (%) | 24 (3.7) | 13 (2.1) | 1.9 (0.8 to 3.5)‡ | 0.04 |
| Value on Covid-19 clinical progression ordinal outcome scale†† | ||||
| Day 7 | 1.10 (0.62 to 1.63) | 0.41 | ||
| Day 14 | 0.91 (0.42 to 1.50) | 0.67 | ||
| Day 28 | 2.74 (0.50 to 5.94) | 0.06 |
There were no deaths reported in either group. Covid-19 denotes coronavirus disease 2019.
The skeptical and weakly informative priors were zero-centered normal distributions with standard deviations of 0.1 and 2.5, respectively. No prior indicates that the hazard ratio was estimated with maximum partial likelihood methods, which do not incorporate a prior distribution. A hazard ratio of more than 1.0 is favorable for faster recovery.
The value is a hazard ratio and the range is the credible interval.
The value is a hazard ratio and the range is the confidence interval (CI).
The mean number of days unwell with ongoing symptoms was estimated from the day of receipt of the trial drug through trial day 14.
The value is the mean difference, and the range is the credible interval. Figure S5C shows the posterior distribution of the difference in mean days unwell.
A low incidence of events precluded covariate adjustment.
The clinical progression ordinal outcome scale is based on the World Health Organization Ordinal Scale for Clinical Improvement. The value is an odds ratio, and the range is the credible interval. Values greater than 1 indicate greater odds of progression with fluticasone than with placebo.