TABLE 1.
Patient characteristics at baseline
| All patients | Low-dose dexamethasone | High-dose dexamethasone | |
| Patients | 200 | 102 | 98 |
| Age years | 64.3±14.3 | 64.8±14.1 | 63.9±14.5 |
| <50 | 37 (18.5) | 18 (17.6) | 19 (19.4) |
| 50–70 | 91 (45.5) | 46 (45.1) | 45 (45.9) |
| >70 | 72 (36.0) | 38 (37.3) | 34 (34.7) |
| Male | 123 (61.8) | 61 (60.4) | 62 (63.3) |
| Weight kg | 85.0 (74.0–95.5) | 84.0 (72.0–95.5) | 87.9 (79.6–95.7) |
| BMI kg·m−2 | 31.0 (27.1–34.1) | 29.8 (27.0–34.0) | 31.2 (27.8–34.2) |
| Coexisting condition | |||
| Hypertension | 96 (48.0) | 49 (48.0) | 47 (48.0) |
| Hyperlipidaemia | 83 (39.8) | 44 (43.1) | 39 (39.8) |
| Obesity (BMI ≥30 kg·m−2) | 106 (53.0) | 48 (47.1) | 58 (59.2) |
| Diabetes | 38 (19.0) | 20 (19.6) | 18 (18.4) |
| Chronic pulmonary disease | 14 (7.0) | 6 (5.9) | 8 (8.0) |
| Asthma | 10 (5.0) | 7 (6.9) | 3 (3.1) |
| Cardiovascular disease | 27 (13.5) | 15 (14.8) | 12 (12.2) |
| History of cancer | 10 (5.0) | 6 (5.9) | 4 (4.1) |
| Chronic kidney disease | 7 (3.5) | 4 (3.9) | 3 (3.1) |
| Previous medication use | |||
| ACE inhibitors | 28 (14.0) | 13 (12.7) | 15 (15.3) |
| Antihypertensive therapy | 52 (26.1) | 25 (24.8) | 27 (27.6) |
| Anticoagulants | 11 (5.5) | 7 (6.9) | 4 (4.1) |
| Antiplatelet therapy | 26 (13.0) | 14, 13.7 | 12 (12.2) |
| Inhaled corticosteroids | 15 (7.5) | 9 (8.8) | 6 (6.1) |
| Statins | 64 (32.0) | 32 (31.4) | 32 (32.7) |
| Immunosuppressants | 4 (2.0) | 1 (1.0) | 3 (3.1) |
| Insulin | 14 (7.0) | 8 (7.8) | 6 (6.1) |
| Laboratory parameters | |||
| Absolute leukocyte count cells·mm−3 | 5210 (3975–6625) | 5190 (3980–6542) | 5290 (3960–7077) |
| Absolute lymphocyte count cells·mm−3 | 860 (612–1080) | 905 (680– 1145) | 780 (507–1010) |
| Lactate dehydrogenase U·L−1 | 384 (284–509)) | 357.00 (242–497) | 415 (310–535) |
| D-dimer ng·mL−1 | 742 (490–1181) | 664 (457– 1160) | 763 (499–1244) |
| C-reactive protein mg·L−1 | 7.0 (2.9–11.3) | 6.1(2.8–9.6) | 8.3 (4.6– 12.9) |
| Procalcitonin ng·mL−1 | 0.10 (0.06–0.16) | 0.09 (0.05–0.15) | 0.11 (0.07–0.17) |
| Ferritin level ng·mL−1 | 599 (284–1226) | 539 (293–1203) | 623 (269–1244) |
| Interleukin-6# pg·mL−1 | 13.1 (6.8–25.1) | 14.5 (7.1–33.8) | 10.8 (6.4–21.6) |
| Symptoms | |||
| Dyspnoea | 128 (64.0) | 61 (59.8) | 67 (68.4) |
| Cough | 155 (77.5) | 84 (82.4) | 71 (72.4) |
| Fever | 146 (73.0) | 76 (74.5) | 70 (71.0) |
| Asthaenia | 46 (23.0) | 21 (20.6) | 25 (25.5) |
| Diarrhoea | 40 (20.3) | 17 (16.8) | 32 (24.0) |
| Disease | |||
| Temperature °C | 36.6 (36.0–37.5) | 36.6 (36.0–37.5) | 36.6 (36.0–37.4) |
| Respiratory rate breaths·min−1 | 16.0 (15.0–17.0) | 16.0 (15.0–18.5) | 16.0 (15.0–16.0) |
| Oxygen saturation % | 92.8 (90.3–94.0) | 93.0 (90.0–94.0) | 92.7 (90.0–94.0) |
| PaCO2 on admission | 34.0 (31.3–37.2) | 34.1 (31.9–37.4) | 34.0 (31.0–37.2) |
| PaO2/FiO2 ratio | 294.0 (264.9–317.7) | 295.2 (266.3–314.3) | 291.4 (262.9–321.1) |
| Days from symptom onset to randomisation | 8 (7–10) | 8 (7–9) | 8 (7–10) |
| Days from hospital admission to randomisation | 0 (0–0) | 0 (0–0) | 0 (0–0) |
| Type of oxygen therapy on randomisation | |||
| Nasal cannula | 150 (75.0) | 80 (79.2) | 70 (73.7) |
| Simple mask | 46 (23.0) | 21 (20.8) | 25 (26.3) |
| FiO2 on randomisation | 0.28 (0.28–0.32) | 0.28 (0.28–0.32) | 0.28 (0.28–0.32) |
| SpO2/FiO2 ratio on randomisation | 339.3 (300.0–350.0) | 342.8 (302.3–350.0) | 335.7 (300.0–350.0) |
| Hospital medical treatments | |||
| Remdesivir | 20 (10.0) | 11 (10.8) | 9 (9.2) |
| Prophylactic anticoagulant dose | 140 (70.0) | 76 (74.5) | 64 (65.3) |
| Intermediate anticoagulant dose | 53 (26.5) | 22 (21.6) | 31 (31.6) |
| High anticoagulant dose | 28 (14.0) | 16 (15.7) | 12 (12.2) |
| Tocilizumab | 24 (12.0) | 12 (11.8) | 12 (12.2) |
| Antibiotics | 182 (91.0) | 95 (93.1) | 87 (88.8) |
Data are presented as n, mean±sd, n (%) or median (interquartile range). Percentages may not total 100 because of rounding. There was a significant difference in four laboratory parameters (absolute lymphocyte count, lactate dehydrogenase, D-dimer, procalcitonin) between patients in the low-dose dexamethasone group and those in the high-dose dexamethasone group. There were no significant differences between the groups in any other baseline characteristic. BMI: body mass index; ACE: angiotensin-converting enzyme; PaCO2: partial pressure of carbon dioxide; PaO2: partial pressure of arterial oxygen; FiO2: inspiratory oxygen fraction; SpO2: peripheral oxygen saturation. #: interleukin-6 levels were missing for 14 patients (six patients in the low-dose dexamethasone group and eight patients in the high-dose dexamethasone group).