Outcomes
| Treated group n=86 | Control group n=86 | P value* | |
| Primary outcome | |||
| Clinical improvement (2 points) in WHO score | 64 | 44 | 0.0025 |
| Daily incidence rate (95% CI) | 6.9% (5.4% to 8.8%) | 4.0% (3.0% to 5.4%) | |
| 25% improvement time (days) | 6 | 8 | |
| 50% improvement time (days) | 11 | 18 | |
| Key secondary outcomes | |||
| Hospital mortality | 14 | 41 | 0.0004 |
| Daily incidence rate (95% CI) | 1.4% (0.9% to 2.4%) | 3.5% (2.6% to 4.7%) | |
| 25% survival time (days) | 16 | 5 | |
| 50% survival time (days) | – | 18 | |
| Mechanical ventilation | 10 | 24 | 0.0003 |
| Daily incidence rate (95% CI) | 1.3% (0.7% to 2.5%) | 5.4% (3.6% to 8.0%) | |
| 25% survival time (days) | – | 3 | |
| 50% survival time (days) | – | - | |
| Other key secondary outcomes | |||
| Clinical improvement (1 point) in WHO score | 69 | 45 | 0.0003 |
| Daily incidence rate (95% CI) | 8.6% (6.8% to 10.9%) | 4.6% (3.4% to 6.2%) | |
| 25% improvement time (days) | 5 | 7 | |
| 50% improvement time (days) | 9 | 16 | |
| Clinical improvement (1 point) in WHO score if no death takes later place | 65 | 44 | 0.0009 |
| Daily incidence rate (95% CI) | 8.0% (6.3% to 10.2%) | 4.5% (3.3% to 6.0%) | |
| 25% improvement time (days) | 6 | 7 | |
| 50% improvement time (days) | 9 | 16 | |
| WHO score at day 7 | |||
| 2: no hospitalisation | 18/84 (21%) | 9/86 (11%) | <0.0001 |
| 3: hospitalisation, not requiring oxygen | 6/84 (7%) | 6/86 (7%) | |
| 4: hospitalisation, requiring oxygen | 29/84 (35%) | 15/86 (17%) | |
| 5: hospitalisation requiring high-flow nasal oxygen therapy or non-invasive ventilation | 17/84 (20%) | 2/86 (2%) | |
| 6: hospitalisation requiring ECMO, invasive mechanical ventilation or both | 7/84 (8%) | 30/86 (35%) | |
| 7: death | 7/84 (8%) | 24/86 (28%) | |
| WHO score at day 14 | |||
| 2: no hospitalisation | 48/83 (58%) | 21/86 (24%) | <0.0001 |
| 3: hospitalisation, not requiring oxygen | 6/83 (7%) | 4/86 (5%) | |
| 4: hospitalisation, requiring oxygen | 10/83 (12%) | 7/86 (8%) | |
| 5: hospitalisation requiring high-flow nasal oxygen therapy or non-invasive ventilation | 4/83 (5%) | 2/86 (2%) | |
| 6: hospitalisation requiring ECMO, invasive mechanical ventilation or both | 5/83 (6%) | 19/86 (22%) | |
| 7: death | 10/83 (12%) | 33/86 (38%) | |
| Independence from oxygen therapy | 61 | 40 | 0.0038 |
| Daily incidence rate (95% CI) | 5.9% (4.6% to 7.5%) | 3.3% (2.4% to 4.4%) | |
| 25% improvement time (days) | 6 | 10 | |
| 50% improvement time (days) | 11 | 19 | |
| Duration of mechanical ventilation in survivors (days) | 16.3 (11.9) | 18.8 (10.2) | 0.5809 |
| Duration of hospitalisation in survivors and discharged (days) | 10.8 (6.8) | 15.9 (12.7) | 0.0196 |
Data are number of cases, n/N (%), incidence rate with 95% CI, number of days or mean (SD), as indicated.
*Calculated with t-test, χ2 or log-rank test, as appropriate.
ECMO, extracorporeal membrane oxygenation.