Table 1.
Baseline Demographics and Clinical Characteristics of All the Enrolled and Randomized Intubated Patients with COVID-19 Who Were Included in the Modified Intention-to-Treat Analysis
| Treatment Group (n = 94) |
Control Group (n = 99) |
SMD | |
|---|---|---|---|
| Age | 64 (53.0–70.0) | 62 (50.0–69.5) | 0.142 |
| Sex, female | 31 (33.0) | 34 (34.3) | 0.029 |
| Race | 0.282 | ||
| American Indian/Alaska Native | 1 (1.1) | 0 (0.0) | |
| Asian | 6 (6.4) | 7 (7.1) | |
| Black/African American | 23 (24.5) | 20 (20.2) | |
| Other | 14 (14.9) | 11 (11.1) | |
| Unknown | 1 (1.1) | 0 (0.0) | |
| White | 49 (52.1) | 61 (61.6) | |
| Hispanic or Latino ethnicity | 27 (28.7) | 30 (30.3) | 0.035 |
| BMI, kg/m2 | 31.0 (26.9–35.8) | 30.2 (26.8–35.4) | <0.001 |
| Smoking history | 0.202 | ||
| Current smoker | 4 (4.3) | 6 (6.1) | |
| Former smoker | 25 (26.6) | 30 (30.3) | |
| Never smoked | 49 (52.1) | 42 (42.4) | |
| Unknown | 16 (17.0) | 21 (21.2) | |
| Hypertension | 63 (67.0) | 46 (46.5) | 0.424 |
| History of myocardial infarction | 13 (13.8) | 11 (11.1) | 0.082 |
| Diabetes | 39 (41.5) | 29 (29.3) | 0.257 |
| Cerebrovascular disease | 5 (5.3) | 8 (8.1) | 0.111 |
| Chronic kidney disease | 10 (10.6) | 8 (8.1) | 0.088 |
| COPD | 4 (4.3) | 8 (8.1) | 0.160 |
| Connective tissue disease | 6 (6.4) | 1 (1.0) | 0.288 |
| Dementia | 4 (4.3) | 3 (3.0) | 0.065 |
| Hemiplegia | 4 (4.3) | 0 (0.0) | 0.065 |
| Immune deficiency | 5 (5.3) | 3 (3.0) | 0.115 |
| Liver disease | 8 (8.5) | 0 (0.0) | 0.431 |
| History of malignancy | 7 (7.4) | 0 (0.0) | 0.401 |
| History of peptic ulcer | 3 (3.2) | 4 (4.0) | 0.045 |
| ARDS class | |||
| COVID-19, PaO2/FiO2 300–400 mm Hg | 9 (9.6) | 5 (5.1) | 0.170 |
| Mild ARDS, PaO2/FiO2 200–300 mm Hg | 28 (29.8) | 36 (36.4) | 0.140 |
| Moderate ARDS, PaO2/FiO2 100–200 mm Hg | 43 (45.7) | 37 (37.4) | 0.170 |
| Severe ARDS, PaO2/FiO2 < 100 mm Hg | 14 (14.9) | 21 (21.2) | 0.165 |
| APACHE II score, mean (SD) | 24.6 (7.7) | 21.1 (6.5) | 0.499 |
| SOFA score | 8.5 (7–11) | 8 (7–10) | 0.100 |
| Compliance, ml/cm H2O, mean (SD) | 36.7 (18.7) | 36.8 (15.6) | 0.004 |
| PEEP, cm H2O | 12 (10–14) | 12 (10–14) | 0.019 |
| Vt, ml/kg, mean (SD) | 4.7 (1.5) | 4.7 (1.4) | 0.009 |
| PaO2/FiO2 ratio, mm Hg | 177 (125–241) | 195 (120–235) | 0.066 |
| FiO2, mean (SD) | 0.59 (0.21) | 0.61 (0.21) | 0.110 |
| PaCO2, mm Hg, mean (SD) | 42 (37–47) | 43 (39–50) | 0.228 |
| e, L/min | 8.7 (7.3–10.5) | 8.5 (7.2–9.7) | 0.186 |
| Creatinine, mg/dl | 1.08 (0.84–1.96) | 0.99 (0.72–1.42) | 0.261 |
| D-dimer | 2492 (1,414–5,377) | 1,815 (1,014–5,018) | 0.200 |
Definition of abbreviations: APACHE = Acute Physiology and Chronic Health Evaluation; ARDS = acute respiratory distress syndrome; BMI = body mass index; COPD = chronic obstructive pulmonary disease; COVID-19 = coronavirus disease; PEEP = positive end-expiratory pressure; SMD = standardized mean difference; SOA = Sequential Organ Failure Assessment.
Data are presented as median (interquartile range) or n (%) unless otherwise noted. Vt has been calculated for the ideal body weight (ml/kg). Patients with COVID-19 pneumonia and impaired PaO2/FiO2 but with PaO2/FiO2 between 300 and 400 mm Hg are listed as “COVID-19 with PaO2/FiO2 300–400 mm Hg.” Patients with ARDS are classified as mild PaO2/FiO2 200–300 mm Hg, moderate PaO2/FiO2 100–200 mm Hg, and severe PaO2/FiO2 < 100 mm Hg according to the Berlin Definition.