Table 1.
Patient Characteristics at Baseline
| Patient Characteristic | MSC (n = 112) | Placebo (n = 110) |
|---|---|---|
| Age (yr), mean ± SD | 61.8 ± 13.0 | 59.6 ± 13.8 |
| <45, n (%) | 12/112 (10.7) | 15/110 (13.6) |
| 45–65, n (%) | 46/112 (41.1) | 52/110 (47.3) |
| >65, n (%) | 54/112 (48.2) | 43/110 (39.1) |
| Female, n (%) | 33/112 (29.5) | 35/110 (31.8) |
| Race, n (%) | ||
| White | 46/112 (41.1) | 53/110 (48.2) |
| Black | 21/112 (18.8) | 15/110 (13.6) |
| Other* | 45/112 (40.2) | 42/110 (38.2) |
| Ethnicity, Hispanic or Latino, n (%) | 41/112 (36.6) | 47/110 (42.7) |
| BMI, n (%) | ||
| <30 | 47/112 (42.0) | 38/110 (34.5) |
| 30–40 | 49/112 (43.8) | 48/110 (43.6) |
| ⩾40 | 16/112 (14.3) | 24/110 (21.8) |
| Coexisting illness, n (%) | ||
| Hypertension | 65/110 (59.1) | 63/107 (58.9) |
| Diabetes mellitus | 46/109 (42.2) | 42/107 (39.3) |
| Renal disease | 14/109 (12.8) | 13/107 (12.1) |
| Prior pulmonary disease | 18/109 (16.5) | 15/106 (14.2) |
| Heart failure | 6/109 (5.5) | 4/108 (3.7) |
| Cancer | 12/109 (11.0) | 11/106 (10.4) |
| History of smoking/e-cigarette/vaping | 35/101 (34.7) | 31/101 (30.7) |
| COVID-19 medications, n (%) | ||
| Remdesivir | 76/112 (67.9) | 74/110 (67.3) |
| Convalescent plasma | 25/112 (22.3) | 30/110 (27.3) |
| IL-6 inhibitor | 6/112 (5.4) | 5/110 (4.5) |
| Glucocorticoid | 92/112 (82.1) | 96/110 (87.3) |
| Adjunctive medications, n (%) | ||
| Antibiotics | 92/112 (82.1) | 83/110 (75.5) |
| Anticoagulation | 103/112 (92.0) | 106/110 (96.4) |
| Antiplatelets | 22/112 (19.6) | 20/110 (18.2) |
| ACE inhibitor or ARB | 4/112 (3.6) | 1/110 (0.9) |
| Neuromuscular blockade or paralytic | 75/112 (67.0) | 71/110 (64.5) |
| Pulmonary vasodilators | 16/112 (14.3) | 15/110 (13.6) |
| Disease severity, n (%) | ||
| Moderate | 79/112 (70.5) | 76/110 (69.1) |
| Severe | 33/112 (29.5) | 34/110 (30.9) |
| SOFA score, n (%) | 6.6 ± 2.1 | 6.7 ± 1.9 |
| D on ventilation before randomization, median (IQR) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) |
| Use of prone ventilation, n (%) | 47/112 (42.0) | 50/110 (45.5) |
| Labs, median (IQR) | ||
| C-Reactive protein, mg/dl | 13.0 (6.6–21.5) | 15.2 (8.8–22.3) |
| IL-6, pg/ml | 58.2 (23.2–248.9) | 56.0 (22.1–205.2) |
| IL-8, pg/ml | 22.4 (16.5–36.5) | 24.9 (14.5–33.6) |
| Creatinine, mg/dl | 0.9 (0.7–1.3) | 1.0 (0.7–1.4) |
| Blood urea nitrogen, mg/dl | 26.0 (19.0–37.0) | 28.0 (21.0–40.0) |
| Lymphocytes, % | 7.0 (4.5–9.8) | 5.5 (3.7–9.5) |
| Neutrophil–lymphocyte ratio, % | 12.1 (8.5–19.3) | 15.3 (8.6–25.8) |
| Aspartate aminotransferase, U/L | 38.0 (29.0–61.0) | 32.0 (26.0–52.5) |
| Alanine aminotransferase, U/L | 30.0 (21.5–46.0) | 33.0 (22.0–55.0) |
Definition of abbreviations: ACE = angiotensin-converting-enzyme; ARB = angiotensin receptor blocker; BMI = body mass index; COVID-19 = coronavirus disease; IQR = interquartile range; MSC = mesenchymal stromal cell; SOFA = Sequential Organ Failure Assessment.
Categorical measures are presented as number/number observed (%), and continuous measures are presented as median (IQR) or mean ± SD.
*
“Other” race includes seven unknowns in the MSC group and six in the placebo group.