Table 1.
Baseline characteristics of the patient population (modified intention to treat population).
| Placebo (N = 20) | IC14 (N = 20) | |
|---|---|---|
| Age | 48.0 (36.5–54.5) | 53.0 (48.0–66.2) |
| Gender | ||
| Male | 13 (65%) | 11 (55%) |
| Female | 7 (35%) | 9 (45%) |
| Ethnicity | ||
| Hispanic or Latino | 4 (20%) | 4 (20%) |
| Not Hispanic or Latino | 9 (45%) | 10 (50%) |
| Unknown | 7 (35%) | 6 (30%) |
| Race | ||
| White | 15 (75%) | 15 (75%) |
| Black or African American | 1 (5%) | 0 (0%) |
| Asian | 0 (0%) | 3 (15%) |
| American Indian or Alaska Native | 0 (0%) | 0 (0%) |
| Native Hawaiian or Other Pacific Islander | 1 (5%) | 0 (0%) |
| Other | 1 (5%) | 0 (0%) |
| Unknown | 2 (10%) | 2 (10%) |
| Weight (kg) | 98.5 ± 25.0 | 96.0 ± 24.0 |
| Height (cm) | 170.6 ± 12.4 | 164.6 ± 24.5 |
| Eight-point ordinal scale | ||
| 4 | 4 (20%) | 1 (5%) |
| 5 | 14 (70%) | 18 (90%) |
| 6 | 2 (10%) | 1 (5%) |
| Sequential organ failure assessment | 2 (1–2) | 2 (1–3) |
| SpO2 (%) | 93.0 ± 2.3 (N = 19) | 93.8 ± 2.9 (N = 20) |
| O2 flow (LPM) | 3.9 ± 2.0 (N = 14) | 3.8 ± 2.4 (N = 19) |
| Systolic blood pressure (mmHg) | 125.1 ± 16.8 | 124.0 ± 15.7 |
| Diastolic blood pressure (mmHg) | 76.7 ± 11.8 | 73.6 ± 9.3 |
| Heart rate (beats/min) | 84.4 ± 13.7 | 79.8 ± 11.5 |
| Temperature (°C) | 36.9 ± 0.9 | 36.7 ± 0.8 |
| Respiratory rate (breaths/min) | 20.8 ± 3.1 | 21.6 ± 5.8 |
| CXR opacities | ||
| Bilateral | 19 (95%) | 19 (95%) |
| Unilateral | 1 (5%) | 1 (5%) |
| Treatment with corticosteroids | ||
| Yes | 19 (95%) | 18 (90%) |
| No | 1 (5%) | 2 (10%) |
| Use of remdesivir prior to enrollment | ||
| Yes | 11 (55%) | 12 (60%) |
| No | 9 (45%) | 8 (40%) |
| Study site | ||
| University of Washington- Harborview | 5 (25%) | 5 (25%) |
| University of Washington- Montlake | 0 (0%) | 4 (20%) |
| Swedish Medical Center | 2 (10%) | 2 (10%) |
| Virginia Mason Medical Center | 2 (10%) | 0 (0%) |
| Sarasota Memorial Healthcare System | 11 (55%) | 9 (45%) |
Mean ± SD or Median (IQR) presented for continuous variables.
Frequency (proportion) presented for categorical variables.
NIH Ordinal Scale: 1) Not hospitalized, no limitations; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen—no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen—requiring ongoing medical care; 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.