Table 3.
Summary of secondary efficacy endpoint data up to day 28, by cohort.
| Overall regdanvimab n = 418 |
Overall SoC n = 304 |
P-valuea | Delta variant subgroup regdanvimab n = 297 |
Delta variant subgroup SoC n = 115 |
P-valuea | |
|---|---|---|---|---|---|---|
| Patients with SpO2 deterioration to <94% in room air, n (%) | 32 (7.7) | 87 (28.6) | <0.0001 | 19 (6.4) | 13 (11.3) | 0.0951 |
| Patients with SpO2 deterioration to <90% in room air, n (%) | 5 (1.2) | 24 (7.9) | <0.0001 | 3 (1.0) | 4 (3.5) | 0.0987b |
| Patients requiring low-flow oxygen therapy, n (%) | 92 (22.0) | 130 (42.8) | <0.0001 | 66 (22.2) | 32 (27.8) | 0.2308 |
| Patients requiring high-flow oxygen therapy, n (%) | 10 (2.4) | 13 (4.3) | 0.1547 | 6 (2.0) | 6 (5.2) | 0.1029b |
| Patients requiring mechanical ventilation, n (%) | 0 | 0 | NA | 0 | 0 | NA |
| Duration of hospitalization due to COVID-19, mean (SD), days | 10.27 (2.94) | 11.69 (4.71) | <0.0001 | 9.93 (2.53) | 8.55 (4.01) | 0.0009 |
| Patients discharged, n (%) Up to day 14 |
387 (92.6) | 234 (77.0) | <0.0001 | 281 (94.6) | 102 (88.7) | 0.0352 |
| Patients requiring therapy, n (%) Remdesivir |
62 (14.8) | 110 (36.2) | <0.0001 | 48 (16.2) | 29 (25.2) | 0.0344 |
| Patients with all-cause mortality, n (%) | 0 | 1 (0.3) | 0.4211b | 0 | 1 (0.9) | 0.2791b |
a
P-values were derived from Student's t-test for continuous variables and chi-squared test or Fisher exact test for categorical variables
b
P-value derived from Fisher exact test; chi-squared test may not be valid because 25% or 50% of the cells have expected counts <5.
NA, not applicable; SoC, standard of care; SpO2, peripheral oxygen saturation.