Table 1.
Selected baseline and day 1 characteristics by enrollment arm.
| Characteristics | Razuprotafib |
Razuprotafib controls |
Apremilast |
Apremilast controls |
Cenicriviroc |
Cenicriviroc controls |
Icatibant |
Icatibant controls |
Celecoxib/famotidine |
Celecoxib/famotidine controls |
Dornase |
Dornase controls |
IC14 |
IC14 controls |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (n = 22) | (n = 67) | (n = 67) | (n = 143) | (n = 92) | (n = 169) | (n = 96) | (n = 183) | (n = 30) | (n = 37) | (n = 39) | (n = 88) | (n = 67) | (n = 76) | |
| Baseline data | ||||||||||||||
| Demographics | ||||||||||||||
| Age (years, mean ± SD) | 67 ± 10 | 66 ± 13 | 66 ± 14 | 67 ± 14 | 67 ± 13 | 67 ± 15 | 64 ± 14 | 67 ± 14 | 65 ± 12 | 56 ± 17 | 63 ± 14 | 61 ± 17 | 59 ± 16 | 60 ± 17 |
| Female sex (n (%)) | 7 (32%) | 32 (48%) | 22 (33%) | 56 (39%) | 31 (34%) | 63 (37%) | 31 (32%) | 71 (39%) | 8 (27%) | 11 (30%) | 16 (41%) | 31 (35%) | 25 (37%) | 27 (36%) |
| Hispanic or Latino | 4 (18%) | 11 (16%) | 13 (19%) | 39 (27%) | 28 (30%) | 52 (31%) | 31 (32%) | 56 (31%) | 8 (27%) | 18 (49%) | 13 (33%) | 41 (47%) | 28 (42%) | 36 (47%) |
| Race (n (%)) | ||||||||||||||
| American Indian or Alaska Native | 0 (0%) | 2 (3%) | 0 (0%) | 2 (1%) | 1 (1%) | 2 (1%) | 1 (1%) | 2 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Asian | 0 (0%) | 0 (0%) | 3 (4%) | 2 (1%) | 5 (5%) | 3 (2%) | 3 (3%) | 3 (2%) | 1 (3%) | 1 (3%) | 2 (5%) | 2 (2%) | 4 (6%) | 1 (1%) |
| Black or African American | 3 (14%) | 13 (19%) | 14 (21%) | 27 (19%) | 11 (12%) | 29 (17%) | 15 (16%) | 34 (19%) | 9 (30%) | 7 (19%) | 9 (23%) | 15 (17%) | 10 (15%) | 14 (18%) |
| Native Hawaiian or other Pacific Islander | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | 1 (3%) | 1 (3%) | 1 (1%) | 0 (0%) | 1 (1%) |
| White or Caucasian | 15 (68%) | 36 (54%) | 37 (55%) | 72 (50%) | 44 (48%) | 81 (48%) | 49 (51%) | 86 (47%) | 12 (40%) | 15 (41%) | 20 (51%) | 37 (42%) | 31 (46%) | 33 (43%) |
| Two or more races not described above | 2 (9%) | 3 (4%) | 3 (4%) | 10 (7%) | 12 (13%) | 17 (10%) | 13 (14%) | 18 (10%) | 1 (3%) | 1 (3%) | 0 (0%) | 10 (11%) | 0 (0%) | 8 (11%) |
| Unknown or not reported | 2 (9%) | 14 (21%) | 10 (15%) | 30 (21%) | 19 (21%) | 38 (22%) | 14 (15%) | 41 (22%) | 7 (23%) | 12 (32%) | 7 (18%) | 23 (26%) | 22 (33%) | 19 (25%) |
| COVID severity at baseline, (n (%)) | ||||||||||||||
| WHO Level 5 (≥6 L supplemental oxygen) | 19 (86%) | 52 (78%) | 52 (78%) | 105 (73%) | 66 (72%) | 126 (75%) | 65 (68%) | 133 (73%) | 22 (73%) | 20 (54%) | 31 (79%) | 65 (74%) | 61 (91%) | 56 (74%) |
| WHO Level 5 (non-invasive ventilation or HFNO) | 3 (14%) | 2 (3%) | 8 (12%) | 15 (10%) | 13 (14%) | 16 (9%) | 15 (16%) | 17 (9%) | 5 (17%) | 1 (3%) | 4 (10%) | 6 (7%) | 2 (3%) | 3 (4%) |
| WHO Level 6 or 7 (mechanically ventilated) | 0 (0%) | 13 (19%) | 7 (10%) | 23 (16%) | 13 (14%) | 27 (16%) | 16 (17%) | 33 (18%) | 3 (10%) | 4 (11%) | 4 (10%) | 17 (19%) | 4 (6%) | 17 (22%) |
| Comorbidities at baseline (n (%)) | ||||||||||||||
| Any of listed conditions | 22 (100%) | 66 (96%) | 65 (97%) | 138 (97%) | 87 (95%) | 161 (95%) | 94 (98%) | 175 (96%) | 22 (73%) | 23 (62%) | 31 (79%) | 67 (76%) | 49 (73%) | 54 (71%) |
| Congestive heart failure | 1 (5%) | 4 (6%) | 8 (12%) | 8 (6%) | 6 (7%) | 12 (7%) | 8 (8%) | 11 (6%) | 3 (10%) | 2 (5%) | 0 (0%) | 6 (7%) | 3 (4%) | 5 (7%) |
| Diabetes | 7 (32%) | 22 (33%) | 21 (31%) | 49 (34%) | 38 (41%) | 57 (34%) | 39 (41%) | 63 (34%) | 14 (47%) | 13 (34%) | 10 (26%) | 31 (35%) | 19 (28%) | 26 (34%) |
| Kidney disease | 4 (18%) | 9 (13%) | 7 (10%) | 24 (17%) | 13 (14%) | 24 (14%) | 10 (10%) | 28 (15%) | 3 (10%) | 3 (8%) | 2 (5%) | 9 (10%) | 3 (4%) | 7 (9%) |
| Hypertension | 13 (59%) | 39 (58%) | 40 (60%) | 90 (63%) | 58 (63%) | 105 (62%) | 64 (67%) | 113 (62%) | 18 (60%) | 15 (41%) | 23 (59%) | 45 (51%) | 37 (55%) | 36 (47%) |
| Pulmonary disease | 2 (9%) | 14 (21%) | 15 (22%) | 28 (20%) | 21 (23%) | 35 (21%) | 26 (27%) | 38 (21%) | 5 (17%) | 1 (3%) | 7 (18%) | 12 (14%) | 10 (15%) | 12 (16%) |
| Solid organ transplant | 1 (5%) | 4 (6%) | 7 (10%) | 7 (5%) | 4 (4%) | 7 (4%) | 7 (7%) | 10 (5%) | 0 (0%) | 3 (8%) | 1 (3%) | 7 (8%) | 0 (0%) | 4 (5%) |
| Medication use at enrollment: steroids (n (%)) | ||||||||||||||
| Yes | 22 (100%) | 62 (93%) | 65 (97%) | 134 (94%) | 86 (93%) | 155 (92%) | 89 (93%) | 169 (92%) | 26 (86%) | 33 (89%) | 35 (90%) | 80 (91%) | 56 (84%) | 67 (88%) |
| No | 0 (0%) | 4 (6%) | 1 (1.5%) | 7 (5%) | 6 (7%) | 9 (5%) | 5 (5%) | 9 (5%) | 2 (7%) | 1 (3%) | 4 (10%) | 2 (2%) | 6 (9%) | 2 (3%) |
| Unknown | 0 (0%) | 1 (1%) | 1 (1.5%) | 2 (1%) | 0 (0%) | 5 (3%) | 2 (2%) | 5 (3%) | 2 (7%) | 3 (8%) | 0 (0%) | 6 (7%) | 5 (7%) | 7 (9%) |
| Medication use at enrollment: remdesivir (n (%)) | ||||||||||||||
| Yes | 20 (91%) | 53 (79%) | 62 (93%) | 106 (74%) | 79 (86%) | 123 (73%) | 79 (82%) | 135 (74%) | 23 (77%) | 28 (75%) | 32 (82%) | 67 (76%) | 57 (85%) | 57 (75%) |
| No | 2 (9%) | 12 (27%) | 4 (6%) | 34 (24%) | 12 (13%) | 41 (24%) | 16 (17%) | 43 (23%) | 4 (13%) | 8 (22%) | 7 (18%) | 18 (21%) | 8 (12%) | 16 (21%) |
| Unknown | 0 (0%) | 2 (3%) | 1 (1%) | 3 (2%) | 1 (1%) | 5 (3%) | 1 (1%) | 5 (3%) | 3 (10%) | 1 (3%) | 0 (0%) | 3 (3%) | 2 (3%) | 3 (4%) |
| Cointerventions on day 1 (n (%)) | ||||||||||||||
| Shock on vasopressors | 0 (0%) | 10 (15%) | 8 (12%) | 22 (15%) | 8 (9%) | 24 (14%) | 11 (11%) | 29 (16%) | 2 (7%) | 2 (5%) | 6 (15%) | 11 (13%) | 4 (6%) | 9 (12%) |
| Treatment dose antimicrobials | 12 (55%) | 37 (55%) | 41 (61%) | 81 (57%) | 53 (58%) | 94 (56%) | 67 (70%) | 104 (57%) | 17 (57%) | 15 (41%) | 20 (51%) | 48 (55%) | 36 (54%) | 41 (54%) |
| On RRT (renal replacement therapy) on day 1 (n (%)) | ||||||||||||||
| Yes | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 2 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Creatinine, mg/dL on day 1 | ||||||||||||||
| Mean ± SD | 1.1 ± 0.5 | 1.1 ± 0.7 | 1.2 ± 0.6 | 1.2 ± 0.8 | 1.2 ± 0.7 | 1.2 ± 0.8 | 1.1 ± 0.8 | 1.2 ± 0.8 | 0.9 ± 0.3 | 1.0 ± 0.0.6 | 1.0 ± 0.7 | 1.2 ± 1.0 | 0.9 ± 0.4 | 1.2 ± 0.8 |
| Platelets, thousands on day 1 | ||||||||||||||
| Mean ± SD | 269 ± 95 | 275 ± 109 | 266 ± 121 | 270 ± 101 | 255 ± 112 | 267 ± 101 | 263 ± 90 | 264 ± 98 | 254 ± 90 | 286 ± 135 | 268 ± 94 | 247 ± 83 | 292 ± 115 | 250 ± 81 |
| Total bilirubin (mg/dL) on day 1 | ||||||||||||||
| Mean ± SD | 0.8 ± 0.5 | 0.6 ± 0.3 | 0.6 ± 0.4 | 0.6 ± 0.5 | 0.6 ± 0.7 | 0.6 ± 0.5 | 0.5 ± 0.3 | 0.6 ± 0.5 | 0.6 ± 0.2 | 0.7 ± 0.5 | 0.7 ± 0.6 | 0.6 ± 0.6 | 0.7 ± 0.4 | 0.5 ± 0.3 |
Patients randomised to the Control arm were “shared” among investigational agent if they were randomised during the same time epoch that the investigational agent was on the Platform.