Table 2.
Changes in the primary outcome due to monitoring
| Patient | Arm | Outcome | Day (pre-monitoring) | Day (post-monitoring) |
|---|---|---|---|---|
| 1 | Narsoplimab | Recovered | 3 | 7 |
| 2 | Cyclosporine | Recovered | 3 | 5 |
| 3 | Control | Recovered | 11 | 10 |
| 4 | Cyproheptadine | Recovered | 16 | 17 |
| 5 | Control | Recovered | 6 | 5 |
| 6 | Control* | Recovered | 11 | 4 |
| 7 | Control | Recovered | 6 | 5 |
| 8 | Control | Recovered | 44 | 48 |
| 9 | Control | Recovered | 3 | 5 |
Changes in the primary outcome, recovery or death, that were due to retrospective monitoring. All changes were in the day of recovery. There were no changes in the type of outcome that occurred, and no changes amongst patients who had an outcome other than recovered.
* This was due to a monitoring query of the daily form, which changed to reflect a lower level of oxygen support. As a result, the WHO COVID level was corrected to 4 on days 4 and 5, meeting the definition for recovery. However, on day 6 the patient’s WHO COVID level increased to 5 and remained there until day 11.