Table 2:
Summary of Major Efficacy Outcomes for the Aviptadil versus Placebo Comparison: Modified Intention to Treat Cohort
| Aviptadil | Placebo | |||||
|---|---|---|---|---|---|---|
| Primary Outcome at Day 90 | No. in Group | No. with Event (%in Group) | No. in Group | No. with Event (% in Group) | Odds Ratio for Aviptadil/Placebo (95% CI) | p value |
| 6-category primary ordinal outcome at Day 90a,b | 225 | 225 | 1.11 (0.80, 1.55) | 0.54 | ||
| Dichotomized outcomes for the 6-category primary ordinal outcome at Day 90a,c Category 1 Category 2–6 (reference) Category 1–2 Category 3–6 (reference) Category 1–3 Category 4–6 (reference) Category 1–4 Category 5–6 (reference) Category 1–5 Category 6 (reference) |
225 |
36 (16.0) 189 (84.0) 73 (32.4) 152 (67.6) 116 (51.6) 109 (48.4) 131 (58.2) 94 (41.8) 139 (61.8) 86 (38.2) |
225 |
31 (13.8) 194 (86.2) 66 (29.3) 159 (70.7) 98 (43.6) 127 (56.4) 129 (57.3) 96 (42.7) 142 (63.1) 83 (36.9) |
1.19 (0.71, 2.01) 1.16 (0.77, 1.73) 1.38 (0.95, 2.00) 1.04 (0.71, 1.51) 0.94 (0.64, 1.38) |
0.51 0.48 0.09 0.85 0.77 |
| Dichotomized outcomes for the 6-category primary ordinal outcome at Day 90a,c Category 1 Category 2–6 (reference) Category 1–2 Category 3–6 (reference) Category 1–3 Category 4–6 (reference) Category 1–4 Category 5–6 (reference) Category 1–5 Category 6 (reference) |
225 |
36 (16.0) 189 (84.0) 73 (32.4) 152 (67.6) 116 (51.6) 109 (48.4) 131 (58.2) 94 (41.8) 139 (61.8) 86 (38.2) |
225 |
31 (13.8) 194 (86.2) 66 (29.3) 159 (70.7) 98 (43.6) 127 (56.4) 129 (57.3) 96 (42.7) 142 (63.1) 83 (36.9) |
1.19 (0.71, 2.01) 1.16 (0.77, 1.73) 1.38 (0.95, 2.00) 1.04 (0.71, 1.51) 0.94 (0.64, 1.38) |
0.51 0.48 0.09 0.85 0.77 |
| Other Efficacy Outcomes Through Day 90 | No. in Group | No. with Event (Estimated Cumulative % in Group) | No. in Group | No. with Event (Estimated Cumulative % in Group) | Hazard Ratio or Sub-Hazard Ratio for Aviptadil/Placebo (95% CI) | p value |
| Deathd | 231 | 86 (37.5) | 230 | 83 (36.2) | 1.04 (0.77, 1.41) | 0.78 |
| Dischargede | 231 | 139 (60.4) | 230 | 138 (60.3) | 0.99 (0.78, 1.24) | 0.90 |
| Discharged homee | 231 | 132 (57.4) | 230 | 133 (58.1) | 0.97 (0.77, 1.23) | 0.81 |
| Discharged home for 14 consecutive days (sustained recovery) e | 231 | 126 (55.1) | 230 | 128 (56.2) | 0.97 (0.76, 1.23) | 0.78 |
| Death, end-organ failure or serious infectiond | 231 | 165 (71.6) | 230 | 158 (69.0) | 1.13 (0.91, 1.40) | 0.29 |
| Worsening respiratory failure or deathd | 231 | 106 (46.2) | 230 | 106 (46.3) | 1.00 (0.77, 1.31) | 0.98 |
| Hospital readmission or death, after initial discharged,f | 139 | 10 (7.8) | 138 | 15 (11.2) | 0.66 (0.30, 1.47) | 0.31 |
| Through Day 180 | ||||||
| Deathd | 231 | 90 (39.3) | 230 | 86 (37.6) | 1.06 (0.79, 1.42) | 0.71 |
Category 1: At home and off oxygen ≥ 77 days (best) Category 2: At home and off oxygen 49–76 days Category 3: At home and off oxygen 1–48 days Category 4: Discharged, but not at home, or at home requiring supplemental oxygen Category 5: Hospitalized or receiving hospice care Category 6: Died (worst)
Summary odds ratio for being in a better category, aviptadil vs. placebo. Proportional odds regression model with 1 indicator for treatment group stratified by disease severity. Computed for the 450 participants with known status at day 90; refer to the Supplementary Appendix (Figure S4) for the odds ratio after imputation for those with missing data.
Odds ratio for being in a better category compared to designated reference group, aviptadil vs. placebo. Logistic regression model with 1 indicator for treatment group stratified by disease severity.
Hazard ratio for time to first event, aviptadil vs. placebo. Cox proportional hazards regression model with 1 indicator for treatment group stratified by disease severity.
Sub-hazard ratio for time to first event, aviptadil vs. placebo. Fine-Gray model considering death a competing risk with 1 indicator for treatment group stratified by disease severity.
Among participants who were discharged from the index hospital. Time=0 set to the date of discharge.