Table 1.
Baseline demographics and clinical characteristics of the study population.
| n (%) | |||
|---|---|---|---|
| Total (n = 30) | Sarilumab + SC (n = 20) | SC (n = 10) | |
| Median Age in years (IQR) | 61.5 (56–72) | 61.5 (50.5–72) | 62 (58–71) |
| Male sex, n (%) | 20 (67) | 15 (75) | 5 (50) |
| Race, ethnicity (%) | |||
| White | 14 (47) | 10 (50) | 4 (40) |
| Asian | 1 (3) | 0 (0) | 1 (10) |
| Hispanic or latino | 15 (50) | 10 (50) | 5 (50) |
| Coexisting Disorders, n (%) | 19 (63) | 14 (70) | 5(50) |
| Hypertension | 13(43) | 8 (40) | 5 (50) |
| Diabetes Mellitus | 5 (17) | 3 (15) | 2 (20) |
| Obesity | 3 (10) | 2 (10) | 1 (10) |
| History of Malignancy | 2 (7) | 2 (10) | 0 (0) |
| COPD | 2 (7) | 1 (5) | 1 (10) |
| Stage III Chronic kidney disease | 4 (13) | 2 (10) | 2 (20) |
| Coronary artery disease | 3 (10) | 3 (15) | 0 |
| Median days from symptom onset to randomization (IQR) | 11 (8-16) | 10.5 (8-12.5) | 16 (12-23) |
| Median days from admission to randomization (IQR) | 2 (1-4) | 2 (1-4) | 3 (1-6) |
| Median body temperature at randomization (IQR), °C | 37 (36.4-37.7) | 37.1 (36.6-38.1) | 36.5 (36.3-37.2) |
| Fever ≥37,5°C, n (%) | 10 (33) | 9 (45) | 1 (10) |
| Oxygen support at randomization (7-category ordinal scale) n (%) | |||
| 5. No supplemental oxygen therapy | 4 (13.3) | 4 (20) | 0 (0) |
| 4. Supplemental low flow oxygen therapya | 22 (73.3) | 12 (60) | 10 (100) |
| 3. High-flow supplemental oxygen therapy or NIVb | 4 (13.3) | 4 (20) | 0 (0) |
| Median PaO2/FiO2 mmHg (IQR) at randomization | 318 (233-358) | 298 (223-348) | 341 (261-404) |
| Additional treatment during hospitalization | |||
| Hydroxychloroquine | 6 (20) | 4 (20) | 2 (20) |
| Lopinavir/Ritonavir | 5 (17) | 4 (20) | 1 (10) |
| Azithromycin | 18 (60) | 12 (60) | 6 (60) |
| Interferon | 0 (0) | 0 (0) | 0 (0) |
| Remdesivir at randomization | 0 (0) | 0 (0) | 0 (0) |
| Corticosteroids at randomizationc | 25 (83) | 17 (85) | 8 (80) |
| Methylprednisolone bolus | 17 (57) | 14 (70) | 3 (30) |
COPD, Chronic obstructive pulmonary disease; IQR, interquartile range; NIV, noninvasive ventilation; PaO2/Fi02, partial pressure of arterial oxygen/fraction of inspired oxygen; SC, standard care.
a
O2 flow ≤ 15 l/min e.g., by face mask, nasal cannula (NC).
b
O2 flow >15 l/min, e.g., by face mask, ‘High Flow' devices (e.g., HFNC), CPAP or NIV including BiPAP and other devices.
c
Corticosteroids: ≥ 30 mg Prednisone/d or equivalent; endovenous bolus of 6-Metilprednisolone 120–125 mg/d, except for 1 patient 80 mg/dl.