Table 1. Patient Demographics and Baseline Clinical Characteristics.
| Characteristic | Bamlanivimab monotherapy | Combination therapy (2800 mg bamlanivimab and 2800 mg of etesevimab) (n = 112) |
Placebo (n = 156) |
||
|---|---|---|---|---|---|
| 700 mg (n = 101) |
2800 mg (n = 107) |
7000 mg (n = 101) |
|||
| Age | |||||
| Median (IQR), y | 39 (31-58) | 45 (31-56) | 46 (34-55) | 44 (30-60) | 46 (35-57) |
| ≥65 y, No. (%) | 11 (10.9) | 8 (7.5) | 14 (13.9) | 13 (11.6) | 23 (14.7) |
| Sex, No. (%) | |||||
| Female | 63 (62.4) | 51 (47.7) | 58 (57.4) | 58 (51.8) | 85 (54.5) |
| Male | 38 (37.6) | 56 (52.3) | 43 (42.6) | 54 (48.2) | 71 (45.5) |
| Self-reported race, No./total (%) | |||||
| White | 90/101 (89.1) | 90/104 (86.5) | 89/100 (89.0) | 105/111 (94.6) | 133/151 (88.1) |
| Black | 7/101 (6.9) | 7/104 (6.7) | 8/100 (8.0) | 4/111 (3.6) | 7/151 (4.6) |
| Asian | 1/101 (1.0) | 5/104 (4.8) | 3/100 (3.0) | 2/111 (1.8) | 8/151 (5.3) |
| American Indian or Alaska Native | 1/101 (1.0) | 0/104 | 0/100 | 0/111 | 2/151 (1.3) |
| Native Hawaiian or other Pacific Islander | 0/101 | 1/104 (1.0) | 0/100 | 0/111 | 0/151 |
| Multiple | 2/101 (2.0) | 1/104 (1.0) | 0/100 | 0/111 | 1/151 (0.7) |
| Self-reported ethnicity, No. (%) | |||||
| Hispanic | 49 (48.5) | 47 (43.9) | 39 (38.6) | 42 (37.5) | 68 (43.6) |
| Not Hispanic | 52 (51.5) | 60 (56.1) | 62 (61.4) | 70 (62.5) | 88 (56.4) |
| BMIa | |||||
| Median (IQR) | (n = 100) 28.8 (25.1-35.4) |
(n = 106) 30.4 (25.6-34.0) |
(n = 97) 27.8 (24.7-32.3) |
(n = 109) 27.2 (22.9-33.0) |
(n = 152) 29.2 (25.9-34.2) |
| ≥30 but <40, No./total (%) | 34/100 (34.0) | 50/106 (47.2) | 28/97 (28.9) | 33/109 (30.3) | 63/152 (41.4) |
| ≥40, No./total (%) | 11/100 (11.0) | 6/106 (5.7) | 7/97 (7.2) | 7/109 (6.4) | 9/152 (5.9) |
| Risk factors for severe COVID-19, No. (%)b | 74 (73.3) | 78 (72.9) | 63 (62.4) | 67 (59.8) | 105 (67.3) |
| COVID-19 severity, No. (%)c | |||||
| Mild | 83 (82.2) | 79 (73.8) | 70 (69.3) | 92 (82.1) | 125 (80.1) |
| Moderate | 18 (17.8) | 28 (26.2) | 31 (30.7) | 20 (17.9) | 31 (19.9) |
| Duration of symptoms, median (IQR), dd | 5 (3-6) | 4 (3-6) | 4 (2-7) | 4 (3-5) | 4 (3-6) |
| SARS-CoV-2 cycle threshold, mean (SD)e | 23.8 (6.5) | 24.5 (7.6) | 23.4 (6.8) | 22.7 (8.0) | 23.8 (7.8) |
Abbreviations: BMI, body mass index; COVID-19, coronavirus disease 2019; IQR, interquartile range; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Calculated as weight in kilograms divided by height in meters squared.
Aged 55 years or older; BMI of 30 or greater; medical history of diabetes, chronic kidney disease, cardiovascular disease, chronic respiratory disease, or immunosuppressive disease; or receiving immunosuppressive treatment.
Based on 8 symptom domains (cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache) that were rated from none or absent (score of 0) to severe (score of 3), which were combined to provide an overall score (range, 0-24; symptom score excluded loss of appetite, taste, and smell).
Calculated based on the patient-reported start date of symptom onset and compared with the date of treatment infusion.
The cycle threshold is the number of polymerase chain reaction cycles required for a viral sample to be detected. Lower numbers suggest more infecting organisms and an increased burden of disease. Values range between 0 and 45; the (log base 10) viral load was calculated from the cycle threshold value (45 − cycle threshold)/log210, or (45 − cycle threshold)/3.321928.