Summary of baseline characteristics, overall, and by treatment arm of the safety population
| Variable . | Overall (N = 45) . | Placebo (N = 15) . | CK0802-100 (N = 15) . | CK0802-300 (N = 15) . |
|---|---|---|---|---|
| Age (y), median (min-max) | 60 (21-85) | 63 (21-77) | 64 (29-85) | 55 (27-71) |
| Age (y), n (%) | ||||
| <60 | 24 (53.3) | 8 (53.3) | 7 (46.7) | 9 (60.0) |
| ≥60 | 21 (46.7) | 7 (46.7) | 8 (53.3) | 6 (40.0) |
| Sex, n (%) | ||||
| Female | 18 (40.0) | 7 (46.7) | 5 (33.3) | 6 (40.0) |
| Male | 27 (60.0) | 8 (53.3) | 10 (66.7) | 9 (60.0) |
| Race, n (%) | ||||
| Black | 10 (22.2) | 4 (26.7) | 4 (26.7) | 2 (13.3) |
| Hispanic | 8 (17.8) | 4 (26.7) | 3 (20.0) | 1 (6.7) |
| Other | 5 (11.1) | 2 (13.3) | 0 (0.0) | 3 (20.0) |
| White | 22 (48.9) | 5 (33.3) | 8 (53.3) | 9 (60.0) |
| Hemodialysis, n (%) | ||||
| Yes | 4 (8.9) | 2 (13.3) | 1 (6.7) | 1 (6.7) |
| Vasopressor, n (%) | ||||
| Yes | 27 (60.0) | 7 (46.7) | 12 (80.0) | 8 (53.3) |
| Full anticoagulation, n (%) | ||||
| Yes | 22 (48.9) | 8 (53.3) | 6 (40) | 8 (53.3) |
| Time from diagnosis to intubation, d, median (range) | 7 (0-18) | 8 (0-16) | 5 (0-15) | 6 (0-18) |
| Time from intubation to first infusion, h, median (range) | 72 (0-144) | 72 (0-120) | 48 (24-144) | 72 (24-120) |
| Body mass index, median, (min-max) | 30 (20-74) | 30 (22-42) | 28 (21-51) | 34 (20-74) |
| PaO2:FiO2 ratio, median, (min-max) | 142 (66-248) | 174 (90-230) | 142 (66-248) | 114 (77-200) |
| Comorbidities, n (%) | ||||
| Hypertension | 25 (56.8) | 11 (73.3) | 6 (42.9) | 8 (53.3) |
| Coronary artery disease | 13 (28.9) | 4 (26.7) | 6 (40.0) | 3 (20.0) |
| Diabetes | 13 (28.9) | 4 (26.7) | 5 (33.3) | 4 (26.7) |
| Chronic kidney disease | 4 (8.9) | 1 (6.7) | 1 (6.7) | 2 (13.3) |
| GERD | 12 (26.7) | 2 (13.3) | 6 (40.0) | 4 (26.7) |
| Hyperlipidemia | 10 (22.2) | 3 (20.0) | 4 (26.7) | 3 (20.0) |
| COPD/asthma | 6 (13.3) | 3 (20.0) | 1 (6.7) | 2 (13.3) |
| WHO ordinal score median, (min-max) | 7 (6-8) | 7 (6-8) | 7 (6-8) | 7 (6-8) |
| SOFA score median, (min-max) | 9 (6-16) | 8 (6-16) | 10 (6-15) | 8 (6-14) |
| Mean arterial pressure, (mmHg) median, (min-max) | 74 (14-107) | 74 (14-89) | 74 (56-103) | 72 (20-107) |
| Glasgow coma score, median, (min-max) | 5 (3-10) | 7 (3-10) | 6 (3-10) | 3 (3-10) |
| Measures of inflammation | ||||
| CRP, mg/L, median, (min-max), missing | 84.1 (14.7-317.8), 2 | 88.5 (27-317.8), 1 | 58.5 (14.7-212.0), 1 | 105.5 (23.9-313.0), 0 |
| Ferritin, ng/mL, median, (min-max), missing | 692 (42-21068), 6 | 767 (216-21068), 1 | 572 (42-2220), 4 | 626 (179-21021), 1 |
| D-dimer, mg/L, median, (min-max), missing | 2.2 (0.32-30), 3 | 1.7 (0.53-20.82), 1 | 2.78 (0.32-30), 2 | 2.3 (0.42-19.44), 0 |
| Procalcitonin, ng/mL, median, (min-max), missing | 0.26 (0.05-38.22), 7 | 0.57 (0.15-34.97), 3 | 0.2 (0.1-1.90) | 0.22 (0.05-38.22), 1 |
| IL-6, pg/mL, median, (min-max), missing | 43.9 (2.7-3409), 12 | 70.3 (8.5-669), 3 | 38.2 (2.7-992), 4 | 427.32 (4.3-3409), 5 |
| Immunogenicity | ||||
| HLA antibodies-type 1, positive, n (%), missing | 16 (39), 4 | 6 (40), 0 | 5 (38.4), 2 | 5 (38.4), 2 |
| HLA antibodies-type 2, positive, n (%), missing | 21 (51.2), 4 | 8 (53.3), 0 | 7 (46.7), 2 | 6 (40), 2 |
| COVID treatments (before first infusion) | ||||
| Dexamethasone, n (%) | 42 (93.3) | 15 (100) | 14 (93.3) | 13 (86.7) |
| Dexamethasone duration, d, median, (min-max), missing | 4.5, (0-16), 2 | 5, (1-16), 0 | 4.5, (1-14), 1 | 4 (0-14), 10 |
| Dexamethasone duration > 5 d before first infusion, n (%) | 16 (35.6) | 6 (40) | 6 (40) | 4 (26.7) |
| Remdesivir, n (%) | 40 (88.9) | 14 (93.3) | 12 (80) | 14 (93.3) |
| Remdesivir duration, d, median, (min-max), missing | 4 (0-15), 5 | 4 (0-15), 1 | 4.5 (1-14), 3 | 4.5 (1-15), 1 |
| Remdesivir duration >5 d before first infusion, n (%), missing | 13 (32.5), 5 | 4 (28.6), 1 | 4 (33.3), 3 | 5 (35.7), 1 |
| Dexamethasone and remdesivir, n (%) | 38 (84.4) | 14 (93.3%) | 12 (80) | 12 (80) |
| Convalescent plasma, n (%) | 4 (8.9) | 2 (13.3) | 0 | 2 (13.3) |
| Tocilizumab, n (%) | 7 (15.6) | 1 (6.7) | 2 (13.3) | 4 (26.7) |
| Variable . | Overall (N = 45) . | Placebo (N = 15) . | CK0802-100 (N = 15) . | CK0802-300 (N = 15) . |
|---|---|---|---|---|
| Age (y), median (min-max) | 60 (21-85) | 63 (21-77) | 64 (29-85) | 55 (27-71) |
| Age (y), n (%) | ||||
| <60 | 24 (53.3) | 8 (53.3) | 7 (46.7) | 9 (60.0) |
| ≥60 | 21 (46.7) | 7 (46.7) | 8 (53.3) | 6 (40.0) |
| Sex, n (%) | ||||
| Female | 18 (40.0) | 7 (46.7) | 5 (33.3) | 6 (40.0) |
| Male | 27 (60.0) | 8 (53.3) | 10 (66.7) | 9 (60.0) |
| Race, n (%) | ||||
| Black | 10 (22.2) | 4 (26.7) | 4 (26.7) | 2 (13.3) |
| Hispanic | 8 (17.8) | 4 (26.7) | 3 (20.0) | 1 (6.7) |
| Other | 5 (11.1) | 2 (13.3) | 0 (0.0) | 3 (20.0) |
| White | 22 (48.9) | 5 (33.3) | 8 (53.3) | 9 (60.0) |
| Hemodialysis, n (%) | ||||
| Yes | 4 (8.9) | 2 (13.3) | 1 (6.7) | 1 (6.7) |
| Vasopressor, n (%) | ||||
| Yes | 27 (60.0) | 7 (46.7) | 12 (80.0) | 8 (53.3) |
| Full anticoagulation, n (%) | ||||
| Yes | 22 (48.9) | 8 (53.3) | 6 (40) | 8 (53.3) |
| Time from diagnosis to intubation, d, median (range) | 7 (0-18) | 8 (0-16) | 5 (0-15) | 6 (0-18) |
| Time from intubation to first infusion, h, median (range) | 72 (0-144) | 72 (0-120) | 48 (24-144) | 72 (24-120) |
| Body mass index, median, (min-max) | 30 (20-74) | 30 (22-42) | 28 (21-51) | 34 (20-74) |
| PaO2:FiO2 ratio, median, (min-max) | 142 (66-248) | 174 (90-230) | 142 (66-248) | 114 (77-200) |
| Comorbidities, n (%) | ||||
| Hypertension | 25 (56.8) | 11 (73.3) | 6 (42.9) | 8 (53.3) |
| Coronary artery disease | 13 (28.9) | 4 (26.7) | 6 (40.0) | 3 (20.0) |
| Diabetes | 13 (28.9) | 4 (26.7) | 5 (33.3) | 4 (26.7) |
| Chronic kidney disease | 4 (8.9) | 1 (6.7) | 1 (6.7) | 2 (13.3) |
| GERD | 12 (26.7) | 2 (13.3) | 6 (40.0) | 4 (26.7) |
| Hyperlipidemia | 10 (22.2) | 3 (20.0) | 4 (26.7) | 3 (20.0) |
| COPD/asthma | 6 (13.3) | 3 (20.0) | 1 (6.7) | 2 (13.3) |
| WHO ordinal score median, (min-max) | 7 (6-8) | 7 (6-8) | 7 (6-8) | 7 (6-8) |
| SOFA score median, (min-max) | 9 (6-16) | 8 (6-16) | 10 (6-15) | 8 (6-14) |
| Mean arterial pressure, (mmHg) median, (min-max) | 74 (14-107) | 74 (14-89) | 74 (56-103) | 72 (20-107) |
| Glasgow coma score, median, (min-max) | 5 (3-10) | 7 (3-10) | 6 (3-10) | 3 (3-10) |
| Measures of inflammation | ||||
| CRP, mg/L, median, (min-max), missing | 84.1 (14.7-317.8), 2 | 88.5 (27-317.8), 1 | 58.5 (14.7-212.0), 1 | 105.5 (23.9-313.0), 0 |
| Ferritin, ng/mL, median, (min-max), missing | 692 (42-21068), 6 | 767 (216-21068), 1 | 572 (42-2220), 4 | 626 (179-21021), 1 |
| D-dimer, mg/L, median, (min-max), missing | 2.2 (0.32-30), 3 | 1.7 (0.53-20.82), 1 | 2.78 (0.32-30), 2 | 2.3 (0.42-19.44), 0 |
| Procalcitonin, ng/mL, median, (min-max), missing | 0.26 (0.05-38.22), 7 | 0.57 (0.15-34.97), 3 | 0.2 (0.1-1.90) | 0.22 (0.05-38.22), 1 |
| IL-6, pg/mL, median, (min-max), missing | 43.9 (2.7-3409), 12 | 70.3 (8.5-669), 3 | 38.2 (2.7-992), 4 | 427.32 (4.3-3409), 5 |
| Immunogenicity | ||||
| HLA antibodies-type 1, positive, n (%), missing | 16 (39), 4 | 6 (40), 0 | 5 (38.4), 2 | 5 (38.4), 2 |
| HLA antibodies-type 2, positive, n (%), missing | 21 (51.2), 4 | 8 (53.3), 0 | 7 (46.7), 2 | 6 (40), 2 |
| COVID treatments (before first infusion) | ||||
| Dexamethasone, n (%) | 42 (93.3) | 15 (100) | 14 (93.3) | 13 (86.7) |
| Dexamethasone duration, d, median, (min-max), missing | 4.5, (0-16), 2 | 5, (1-16), 0 | 4.5, (1-14), 1 | 4 (0-14), 10 |
| Dexamethasone duration > 5 d before first infusion, n (%) | 16 (35.6) | 6 (40) | 6 (40) | 4 (26.7) |
| Remdesivir, n (%) | 40 (88.9) | 14 (93.3) | 12 (80) | 14 (93.3) |
| Remdesivir duration, d, median, (min-max), missing | 4 (0-15), 5 | 4 (0-15), 1 | 4.5 (1-14), 3 | 4.5 (1-15), 1 |
| Remdesivir duration >5 d before first infusion, n (%), missing | 13 (32.5), 5 | 4 (28.6), 1 | 4 (33.3), 3 | 5 (35.7), 1 |
| Dexamethasone and remdesivir, n (%) | 38 (84.4) | 14 (93.3%) | 12 (80) | 12 (80) |
| Convalescent plasma, n (%) | 4 (8.9) | 2 (13.3) | 0 | 2 (13.3) |
| Tocilizumab, n (%) | 7 (15.6) | 1 (6.7) | 2 (13.3) | 4 (26.7) |