Table 1.
Characteristics of the study population and outcomes by assigned I-SPY COVID trial arm
| Control arm (N = 142) |
Investigational arm (N = 258) |
P value* | |
|---|---|---|---|
| Age (mean ± SD) | 59.3 ± 14.4 | 60.1 ± 14.0 | 0.6 |
| Male sex | 93 (66%) | 174 (67%) | 0.78 |
| BMI (median (IQR)) | 32 (28 to 39) | 32 (28 to 36) | 0.26 |
| Race | 0.38 | ||
| Black or African American | 38 (27%) | 51 (20%) | |
| White or Caucasian | 73 (51%) | 141 (55%) | |
| Other | 8 (6%) | 21 (8%) | |
| Unknown | 23 (16%) | 45 (17%) | |
| Ethnicity | 0.17 | ||
| Hispanic/Latinx | 42 (30%) | 69 (27%) | |
| Not Hispanic/Latinx | 98 (69%) | 176 (68%) | |
| Unknown | 2 (1%) | 13 (5%) | |
| Comorbidities | |||
| Cerebrovascular disease | 8 (6%) | 13 (5%) | 0.98 |
| Congestive heart failure | 11 (8%) | 14 (5%) | 0.48 |
| Diabetes | 56 (39%) | 87 (34%) | 0.3 |
| Chronic kidney disease | 21 (15%) | 25 (10%) | 0.22 |
| End stage kidney disease | 1 (0.7%) | 1 (0.4%) | 1 |
| Dialysis | 0 (0%) | 2 (0.8%) | 0.76 |
| Hypertension | 84 (59%) | 144 (56%) | 0.59 |
| Liver disease—mild | 2 (1%) | 3 (1%) | 1 |
| Liver disease—moderate to severe | 1 (0.7%) | 1 (0.4%) | 1 |
| Myocardial infarction | 5 (3%) | 6 (2%) | 0.7 |
| Peripheral vascular disease | 7 (5%) | 6 (2%) | 0.27 |
| Chronic Lung disease | 30 (21%) | 49 (19%) | 0.7 |
| Chronic rheumatologic disease | 8 (6%) | 13 (5%) | 0.98 |
| COVID-19 severity—enrollment† | 0.58 | ||
| WHO 5 | 117 (82%) | 221 (86%) | |
| WHO 6 | 12 (9%) | 15 (6%) | |
| WHO 7 | 13 (9%) | 22 (9%) | |
| Respiratory support, enrollment | 0.84 | ||
| ≤ 15 LPM oxygen | 14 (10%) | 28 (11%) | |
| > 15 LPM oxygen | 90 (63%) | 165 (64%) | |
| Noninvasive mechanical ventilation | 13 (9%) | 27 (11%) | |
| Invasive Mechanical ventilation | 25 (18%) | 37 (14%) | |
| Dexamethasone ≥ 6 mg‡ | 136 (96%) | 251 (97%) | 0.60 |
| Other COVID-19 treatments | |||
| Tocilizumab | 23 (16%) | 45 (17%) | 0.86 |
| Convalescent plasma | 6 (4%) | 14 (5%) | 0.77 |
| Inhaled nitric oxide | 12 (8%) | 24 (9%) | 0.92 |
| Epoprostenol | 29 (20%) | 49 (19%) | 0.83 |
| Neuromuscular blockade | 41 (29%) | 83 (32%) | 0.57 |
| Baricitinib | 2 (1%) | 6 (2%) | 0.72 |
| Investigational agents | |||
| Razuprotafib | – | 10 (4%) | |
| Apremilast | – | 31 (12%) | |
| Aviptadil | – | 20 (8%) | |
| Celecoxib/Famotidine | – | 18 (7%) | |
| Cenicriviroc | – | 43 (17%) | |
| Cyclosporine | – | 9 (3%) | |
| Cyproheptadine | – | 6 (2%) | |
| IC14 | – | 40 (16%) | |
| Icatibant | – | 38 (15%) | |
| Narsoplimab | – | 22 (9%) | |
| Pulmozyme | – | 21 (8%) | |
| 28-day mortality | 30 (21%) | 71 (28%) | 0.2 |
| 60-day mortality | 36 (25%) | 82 (32%) | 0.22 |
Numbers are presented as n (%) unless otherwise stated
BMI body mass index, LPM liters per minute
*Determined via Welch’s t-test for normally distributed continuous variables, Wilcoxon rank-sum for non-normally distributed continuous variables, and Chi-squared test or Fisher’s exact test for categorical variables
†Using the WHO ordinal scale for COVID-19 severity; 5: hospitalized, noninvasive mechanical ventilation or high-flow nasal cannula (HFNC); 6: hospitalized, intubation and invasive mechanical ventilation (IMV); 7: hospitalized, IMV + additional support such as pressors or extracardiac membranous oxygenation
‡Completed course of steroid therapy prior to trial enrollment or receiving dexamethasone at the time of trial enrollment