Table 2.
Primary, Secondary, and Key Exploratory End Points
| Day 8 (n = 81) | Day 29 (n = 81) | |
|---|---|---|
| Any AE, No. (%) | 0 | 1 (1.2) |
| AEs related to study treatment | 0 | 0 |
| AEs leading to study treatment discontinuation, dose interruption, or delay | 0 | 0 |
| Maximum grade 3/4 AEs | 0 | 1 (1.2) |
| Any SAEs | 0 | 1 (1.2) |
| SAEs related to study treatment | 0 | 0 |
| Fatal SAEs | 0 | 0 |
| DRE | 2 (2.5) | 4 (4.9) |
| Progression of COVID-19 through day 29, No. (%) | 0 | 0 |
| Hospitalization >24 h for acute management of illness due to any cause | 0 | 1 (1.2) |
| Death | 0 | 0 |
| Visit to a hospital emergency room for management of illness or hospitalization for acute management of illness for any duration and any cause | 0 | 1 (1.2) |
| Development of severe and/or critical respiratory COVID-19 as manifested by requirement for respiratory support (including oxygen) | 0 | 0 |
| ICU stay or mechanical ventilation | 0 | 0 |
| Missing | 0 | 1 (1.2) |
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; DRE, disease-related event; ICU, intensive care unit; SAE, serious adverse event.