Table 1. Demographic and Baseline Medical Characteristics.*.
| Characteristic | REGN-COV2 | Placebo (N=93) |
Total (N=275) |
||
|---|---|---|---|---|---|
| 2.4 g (N=92) |
8.0 g (N=90) |
Combined (N=182) |
|||
| Median age (IQR) — yr† | 43.0 (33.5–51.0) | 44.0 (36.0–53.0) | 43.0 (35.0–52.0) | 45.0 (34.0–54.0) | 44.0 (35.0–52.0) |
| Male sex — no. (%) | 46 (50) | 38 (42) | 84 (46) | 50 (54) | 134 (49) |
| Hispanic or Latino ethnic group — no. (%)‡ | 52 (57) | 55 (61) | 107 (59) | 46 (49) | 153 (56) |
| Race — no. (%)‡ | |||||
| White | 74 (80) | 78 (87) | 152 (84) | 72 (77) | 224 (81) |
| Black or African American | 15 (16) | 6 (7) | 21 (12) | 14 (15) | 35 (13) |
| Asian | 0 | 1 (1) | 1 (1) | 2 (2) | 3 (1) |
| American Indian or Alaska Native | 0 | 0 | 0 | 2 (2) | 2 (1) |
| Unknown | 0 | 1 (1) | 1 (1) | 2 (2) | 3 (1) |
| Not reported | 3 (3) | 4 (4) | 7 (4) | 1 (1) | 8 (3) |
| Median weight (IQR) — kg† | 85.65 (72.20–97.10) | 86.25 (72.60–98.30) | 86.10 (72.60–97.30) | 83.90 (72.90–97.70) | 86.00 (72.60–97.50) |
| Body-mass index§ | 30.39±6.578 | 30.63±7.216 | 30.51±6.874 | 29.73±7.149 | 30.25±6.961 |
| Obesity — no. (%)¶ | 39 (42) | 42 (47) | 81 (45) | 34 (37) | 115 (42) |
| Baseline viral load in nasopharyngeal swab | |||||
| Raw values | |||||
| No. of patients | 84 | 83 | 167 | 91 | 258 |
| Mean viral load — copies/ml | 16,080,000±27,810,000 | 19,170,000±29,120,000 | 17,620,000±28,420,000 | 12,950,000±25,620,000 | 15,970,000±27,510,000 |
| Median viral load (range) — copies/ml | 260,000 (1–71,000,000) | 195,000 (1–71,000,000) | 200,000 (1–71,000,000) | 50,500 (1–71,000,000) | 156,000 (1–71,000,000) |
| Log10 scale | |||||
| No. of patients | 84 | 83 | 167 | 91 | 258 |
| Mean viral load — log10 copies/ml | 5.04±2.495 | 5.00±2.527 | 5.02±2.503 | 4.67±2.366 | 4.90±2.457 |
| Median viral load (range) — log10 copies/ml | 5.41 (0.0–7.9) | 5.29 (0.0–7.9) | 5.30 (0.0–7.9) | 4.70 (0.0–7.9) | 5.19 (0.0–7.9) |
| Positive baseline qualitative RT-PCR — no. (%)‖ | 73 (79) | 74 (82) | 147 (81) | 81 (87) | 228 (83) |
| Baseline serum C-reactive protein level | |||||
| No. of patients | 87 | 86 | 173 | 92 | 265 |
| Mean level — mg/liter | 11.1±28.1 | 12.2±20.0 | 11.7±24.4 | 21.5±43.5 | 15.1±32.6 |
| Median level (range) — mg/liter | 3.0 (0.2–239.7) | 4.8 (0.1–138.7) | 3.7 (0.1–239.7) | 4.8 (0.1–232.0) | 4.1 (0.1–239.7) |
| Baseline serum antibody status — no. (%) | |||||
| Negative | 41 (45) | 39 (43) | 80 (44) | 33 (35) | 113 (41) |
| Positive | 37 (40) | 39 (43) | 76 (42) | 47 (51) | 123 (45) |
| Unknown** | 14 (15) | 12 (13) | 26 (14) | 13 (14) | 39 (14) |
| Median time from symptom onset to randomization (range) — days | 3.5 (0–7) | 3.0 (0–8) | 3.0 (0–8) | 3.0 (0–8) | 3.0 (0–8) |
| At least one risk factor for hospitalization — no. (%)†† | 57 (62) | 61 (68) | 118 (65) | 58 (62) | 176 (64) |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. RT-PCR denotes reverse-transcriptase polymerase chain reaction.
The interquartile range (IQR) is defined as quartile 1 to quartile 3.
Race and ethnic group were reported by the patients.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
Obesity is defined as a body-mass index of greater than 30.
A positive result was defined as a viral load greater than or equal to the lower limit of detection (714 copies per milliliter [2.85 log10 copies per milliliter]).
An unknown serum antibody status indicates that the status could not be evaluated or that the results were borderline.
Risk factors for hospitalization include an age of more than 50 years, obesity, cardiovascular disease (including hypertension), chronic lung disease (including asthma), chronic metabolic disease (including diabetes), chronic kidney disease (including receipt of dialysis), chronic liver disease, and immunocompromise (immunosuppression or receipt of immunosuppressants).