Table 1.
Baseline demographic and clinical characteristics of patients with severe COVID-19
| Characteristics | Meplazumab + SoC | |||
|---|---|---|---|---|
| 0.12 mg/kg (N = 41) n (%) | 0.2 mg/kg (N = 41) n (%) | 0.3 mg/kg (N = 44) n (%) | Placebo + SoC (N = 41) n (%) | |
| Median age (Min–Max)a | 46.0 (18–74) | 48.0 (19–80) | 49.0 (27–77) | 48.0 (25–73) |
| <65 years | 37 (90.2) | 38 (92.7) | 40 (90.9) | 38 (92.7) |
| ≥65 years | 4 (9.8) | 3 (7.3) | 4 (9.1) | 3 (7.3) |
| Male | 31 (75.6) | 31 (75.6) | 28 (63.6) | 27 (65.9) |
| Race or ethnic group | 41 | 39 | 44 | 39 |
| Multipleb | 0 | 0 | 0 | 0 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 (5.7) | 3 (10.3) | 4 (11.8) | 1 (3.0) |
| Black or African American | 4 (11.4) | 3 (10.3) | 5 (14.7) | 4 (12.1) |
| Native Hawaiian or Other Pacific Islanders | 0 | 0 | 1 (2.9) | 0 |
| White | 29 (82.9) | 21 (72.4) | 24 (70.6) | 26 (78.8) |
| Not reported | 0 | 3 (7.3) | 0 | 2 (4.9) |
| Unknown | 6 (14.6) | 9 (22.0) | 10 (22.7) | 6 (14.6) |
| Baseline weight (kg) | ||||
| No. of patients | 40 | 41 | 41 | 41 |
| Median body weight (Min–Max) | 89.50 (67.0–129.0) | 84.00 (62.9–133.4) | 93.00 (60.0–146.3) | 80.00 (59.0–127.0) |
| Concomitant antiviral agents used | 41 | 41 | 44 | 41 |
| None | 36 (87.8) | 37 (90.2) | 40 (90.9) | 36 (87.8) |
| Single antiviral | 5 (12.2) | 4 (9.8) | 4 (9.1) | 4 (9.8) |
| Multiple antiviral | 0 | 0 | 0 | 1 (2.4) |
| Prior Remdesivir used | 41 | 41 | 44 | 41 |
| Yes | 2 (4.9) | 2 (4.9) | 2 (4.5) | 1 (2.4) |
| No | 39 (95.1) | 39 (95.1) | 42 (95.5) | 40 (97.6) |
| Concomitant Remdesivir used | 41 | 41 | 44 | 41 |
| Yes | 2 (4.9) | 2 (4.9) | 3 (6.8) | 1 (2.4) |
| No | 39 (95.1) | 39 (95.1) | 41 (93.2) | 40 (97.6) |
| Vaccine received | 41 | 41 | 44 | 41 |
| Yes | 3 (7.3) | 2 (4.9) | 1 (2.3) | 0 |
| No | 38 (92.7) | 39 (95.1) | 43 (97.7) | 41 (100.0) |
| Baseline ordinal scale for clinical severity | 37 | 41 | 41 | 40 |
| Grade 3 | 17 (45.9) | 20 (48.8) | 21 (51.2) | 19 (47.5) |
| Grade 4 | 20 (54.1) | 21 (51.2) | 17 (41.5) | 21 (52.5) |
| Grade 5 | 0 | 0 | 3 (7.3) | 0 |
| Conditions meeting the risk factors of COVID-19c | 41 | 41 | 43 | 40 |
| Yes | 21 (51.2) | 18 (43.9) | 27 (62.8) | 22 (55.0) |
| No | 20 (48.8) | 23 (56.1) | 16 (37.2) | 18 (45.0) |
| Chest imaging performedd | 31 | 31 | 33 | 34 |
| Yes | 31 (100.0) | 31 (100.0) | 33 (100.0) | 34 (100.0) |
| Normal | 0 | 1 (3.2) | 2 (6.1) | 2 (5.9) |
| Abnormal | 31 (100.0) | 29 (93.5) | 31 (93.9) | 30 (88.2) |
| No | 0 | 0 | 0 | 0 |
Note: Baseline is defined as the last non-missing measurement before randomization (including unscheduled measurements, if any)
Note: For first level summaries, percentages are based on the number of patients with available data (n) in the analysis set by treatment group. For second level summaries, percentages are based on the number of patients in the first level
aAge, in years, is relative to the date of signed informed consent
bPatients who reported more than one race are reported under ‘Multiple’
cCOVID-19 risk factors include: chronic lung disease, chronic renal disease, diabetes, heart disease, hypertension, autoimmune disease, women within 2 weeks postpartum and not breastfeeding, residents of long-term care facility, cancer, and organ transplant
dChest imaging includes: X-ray, computerized tomography scan, MRI, PET, or others
Abbreviations: N Number of patients in analysis set, n Number of patients, SoC Standard of Care