Table 1.
Baseline Demographics and Characteristics (ITT Population)
| Characteristics | Regdanvimab 40 mg/kg | Regdanvimab 80 mg/kg | Regdanvimab Combined | Placebo |
|---|---|---|---|---|
| n = 105 | n = 111 | n = 216 | n = 111 | |
| Age | ||||
| Median (IQR), y | 51.0 (42–60) | 51.0 (40–60) | 51.0 (40–60) | 52.0 (41–61) |
| ≥60 y, n (%) | 27 (25.7) | 28 (25.2) | 55 (25.5) | 30 (27.0) |
| <60 y, n (%) | 78 (74.3) | 83 (74.8) | 161 (74.5) | 81 (73.0) |
| Male sex, n (%) | 59 (56.2) | 59 (53.2) | 118 (54.6) | 48 (43.2) |
| Race, n (%) | ||||
| White | 94 (89.5) | 96 (86.5) | 190 (88.0) | 96 (86.5) |
| Asian | 11 (10.5) | 15 (13.5) | 26 (12.0) | 15 (13.5) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 6 (5.7) | 11 (9.9) | 17 (7.9) | 10 (9.0) |
| Non-Hispanic or non-Latino | 99 (94.3) | 100 (90.1) | 199 (92.1) | 101 (91.0) |
| Region, n (%) | ||||
| USA | 1 (1.0) | 4 (3.6) | 5 (2.3) | 3 (2.7) |
| Asia | 11 (10.5) | 15 (13.5) | 26 (12.0) | 14 (12.6) |
| Europe | 93 (88.6) | 92 (82.9) | 185 (85.6) | 94 (84.7) |
| BMI | ||||
| Mean (SD), kg/m2 | 27.1 (4.8) | 27.1 (4.1) | 27.1 (4.5) | 26.8 (4.2) |
| Baseline comorbidities, n (%) | ||||
| Yes | 78 (74.3) | 80 (72.1) | 158 (73.1) | 82 (73.9) |
| Confirmed SARS-CoV-2 infection,a n (%) | 101 (96.2) | 103 (92.8) | 204 (94.4) | 103 (92.8) |
| Moderate disease,b n (%) | 64 (61.0) | 65 (58.6) | 129 (59.7) | 60 (54.1) |
| High-risk disease,c n (%) | 73 (69.5) | 82 (73.9) | 155 (71.8) | 76 (68.5) |
| Time since symptom onset | ||||
| All patients, median (IQR), d | 3.0 (2–4) | 3.0 (2–4) | 3.0 (2–4) | 3.0 (2–4) |
| Moderate disease, median (IQR), d | 3.0 (2–4) | 3.0 (2–4) | 3.0 (2–4) | 3.0 (2–4) |
| Received ≥1 prior medication,d n (%) | 19 (18.1) | 23 (20.7) | 42 (19.4) | 26 (23.4) |
Abbreviations: BMI, body mass index; IQR, interquartile range; ITT, intent-to-treat; RT-PCR, reverse transcription polymerase chain reaction; RT-qPCR, quantitative reverse transcription polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
All patients were enrolled based on a local rapid SARS-CoV-2 diagnostic test or RT-PCR-positive result; following enrollment, SARS-CoV-2 infection was confirmed centrally by RT-qPCR.
Based on the presence of x-ray-confirmed or computed tomography–confirmed pneumonia at screening.
High risk of progression to severe disease was defined as patients aged >50 years, with BMI >30 kg/m², cardiovascular disease (including hypertension), chronic lung disease (including asthma), type 1 or type 2 diabetes mellitus, chronic kidney disease (including those on dialysis), chronic liver disease, or immunosuppressed at baseline.
The most commonly reported prior medication by drug class in all groups was analgesics (9 [8.6%], 14 [12.6%], and 15 [13.5%] patients in the regdanvimab 40 mg/kg, regdanvimab 80 mg/kg, and placebo groups, respectively).