Table 2.
Primary and secondary efficacy outcomes
| Convalescent plasma group (n=60) | Usual care group (n=60) | Treatment effect | |
| Primary outcomes | |||
| No (%) of patients with WHO Clinical Progression Scale score ≥6 at day 4: | 13 (22) | 8 (13) | 8.0% (90% CrI −3.2% to 19.4%)* |
| Posterior probability of any benefit (%) | 11.9 | ||
| Posterior probability of moderate or greater benefit (%)† | 2.4 | ||
| No (%) of patients needing ventilation, additional immunomodulators, or death up to day 14: | 19 (32) | 20 (33) | 1.04 (90% CrI 0.61 to 1.78)‡ |
| Posterior probability of any benefit (%) | 45.2 | ||
| Posterior probability of moderate or greater benefit† | 26.9 | ||
| Secondary outcomes | |||
| Overall survival: | |||
| No (%) of patients who died days 0-14 | 3 (5) | 8 (13) | 0.40 (95% CI 0.10 to 1.53)§ |
| No (%) of patients who died days 0-28 | 7 (12) | 12 (20) | 0.51 (95% CI 0.20 to 1.32)§ |
| Median (IQR) WHO Clinical Progression Scale score: | |||
| Day 4 | 5 (5-5) | 5 (4-5) | 1.42 (95% CrI 0.70 to 2.91)¶ |
| Day 7 | 5 (4-5)** | 5 (4-5)†† | 1.20 (95% CrI 0.61 to 2.37)¶ |
| Day 14 | 3 (2-4)†† | 3 (2-5)†† | 0.59 (95% CrI 0.30 to 1.13)¶ |
| Days 2-14 (longitudinal analysis) | — | — | 1.04 (95% CrI 0.37 to 2.86)¶ |
| Time to discharge: | |||
| No (%) of patients discharged at day 28 | 48 (80) | 45 (75) | 0.99 (95% CI 0.65 to 1.49)‡‡ |
| Time to end of dependence on oxygen supply:† | |||
| No/total No (%) of patients not needing oxygen at day 28 | 42/51 (82) | 32/45 (71) | 1.18 (95% CI 0.73 to 1.91)‡‡ |
CI=confidence interval (frequentist analysis); CrI=credible interval (bayesian analysis); IQR=interquartile range.
Moderate or greater benefit was defined as an absolute risk difference <−5.5% for day 4 outcome and hazard ratio <0.85 for day 14 outcome.
*Median posterior absolute risk difference; median posterior odds ratio adjusted for age and centre was 1.88 (90% credible interval 0.83 to 4.44).
†For participants needing oxygen at randomisation (WHO Clinical Progression Scale score ≥5).
‡Median posterior hazard ratio adjusted for age and centre.
§Hazard ratio adjusted for age and centre.
¶Median posterior odds ratio in a proportional odds model adjusted for age and centre.
**n=58 with available data.
††n=59 with available data.
‡‡Subdistribution hazard ratio adjusted for age and centre.