Table 3.
Endpoint | Regdanvimab (n = 113) | Control (n = 161) | P value* |
---|---|---|---|
Patients with severe symptoms or death due to SARS-CoV-2 infection up to Day 10, n (%) | 7 (6.2) | 21 (13.0) | 0.0654 |
Patients requiring mechanical ventilation up to Day 28, n (%) | 0 | 1 (0.6) | 1.0000† |
Duration of mechanical ventilation, days, mean (SD) | 0 | 22.79 (NC) | NC |
Patients requiring supplemental oxygen therapy up to Day 28, n (%) | 9 (8.0) | 30 (18.6) | 0.0128 |
Duration of supplemental oxygen therapy, days, mean (SD) | 4.7 (7.1) | 8.6 (6.1) | 0.1070 |
Duration of hospitalization up to Day 28‡, days, mean (SD) | 12.4 (3.7) | 14.6 (5.6) | <0.0001 |
Patients requiring corticosteroid therapy up to Day 28, n (%) | 0 | 20 (12.4) | <0.0001 |
Patients requiring remdesivir therapy up to Day 28, n (%) | 1 (0.9) | 23 (14.3) | 0.0001 |
Duration of fever, days, mean (SD) | 2.3 (1.1) | 2.5 (1.7) | 0.5252 |
Patients dying of any cause, n (%) | 0 | 2 (1.2) | 0.5136† |
NC, not calculated; SD, standard deviation.
P-value is derived from Student t-test for continuous variables and chi-squared test for categorical variables.
P-value derived from Fisher’s exact test, since chi-squared test may not be valid due to 50% of the cells having expected counts<5.
Two patients in the control group who died were not included for the purpose of this endpoint (regdanvimab = 113; control = 153). Duration of hospitalization for patients hospitalized over Day 28 was calculated as being hospitalized for 28 days. Patients transferred to other hospitals were included in this analysis, with duration calculated as the duration of admission at the study site.