TABLE 1.
Demographics, baseline characteristics, and outcome.
| Male (n = 237) | Female (n = 274) | |
|---|---|---|
| Age in years—median (interquartile range) a | 56 (46, 62) | 51 (37, 60) |
| Race—no. (%) | ||
| Asian | 3 (1.3) | 15 (5.5) |
| Black | 43 (18.1) | 60 (21.9) |
| Other | 24 (10.1) | 29 (10.6) |
| White | 167 (70.5) | 170 (62) |
| Ethnicity—no. (%) | ||
| Hispanic or Latino | 69 (29.1) | 87 (31.8) |
| Not Hispanic or Latino | 167 (70.5) | 182 (66.4) |
| Unknown | 1 (0.4) | 5 (1.8) |
| Eligibility risk factors—no. (%) | ||
| Age ≥ 50 a | 162 (68.4) | 148 (54) |
| BMI greater than or equal to 30 | 131 (55.3) | 171 (62.4) |
| Hypertension | 102 (43) | 114 (41.6) |
| Tobacco use (current or former) a | 82 (34.6) | 70 (25.5) |
| Diabetes mellitus | 74 (31.2) | 68 (24.8) |
| COPD or asthma | 48 (20.3) | 76 (27.7) |
| Coronary artery disease a | 32 (13.5) | 19 (6.9) |
| Immunosuppression | 21 (8.9) | 29 (10.6) |
| Chronic lung disease | 14 (5.9) | 17 (6.2) |
| Chronic kidney disease | 16 (6.8) | 12 (4.4) |
| Congestive heart failure | 13 (5.5) | 7 (2.6) |
| Currently pregnant | 0 (0) | 6 (3.2) |
| Organ transplant | 3 (1.3) | 2 (0.7) |
| Active cancer | 2 (0.8) | 2 (0.7) |
| Sickle cell | 1 (0.4) | 0 (0) |
| Number of eligibility risk factors—no. (%) | ||
| 1 | 50 (21.1) | 67 (24.5) |
| 2 | 60 (25.3) | 70 (25.5) |
| 3 or more | 127 (53.6) | 137 (50) |
| Other comorbidities—no. (%) | ||
| Alcohol abuse (current or former) | 19 (8) | 17 (6.2) |
| Drug abuse (current or former) | 21 (8.9) | 14 (5.1) |
| Thromboembolic disorder | 10 (4.2) | 15 (5.5) |
| Liver disease | 10 (4.2) | 8 (2.9) |
| Other hematologic disorders | 4 (1.7) | 13 (4.7) |
| Number of symptoms at baseline—median (interquartile range) | 5 (4, 7) | 6 (4,8) |
| Post‐infection characteristics | ||
| Symptom duration prior to randomization (day)—median (interquartile range) | 4 (2, 6) | 3 (2, 5) |
| Time from randomization to infusion start (min)—median (interquartile range) | 80 (61, 109) | 81 (64, 111) |
| Viremia (denominator indicates those with viral data available) a | 162/233 (70) | 153/259 (59) |
| Outcome | ||
| Composite outcome a —Disease progression within 15 days | 87 (36.7) | 71 (25.9) |
| Outcome components | ||
| Seeking emergency or urgent care | 24 (10.1) | 26 (9.5) |
| Hospital admission for any reason | 63 (26.6) | 44 (16.1) |
| Death without hospitalization | 0 (0) | 1 (0.4) |
ap‐values < 0.05 (age: p = 0.002; age ≥ 50: p = 0.001; tobacco: p = 0.026; CAD: p = 0.01; viremia: p = 0.02; outcome: p = 0.001). Abbreviation: CAD, coronary artery disease.