Parameter | Mw | Placebo | Total | p-value |
Subjects n | 22 | 20 | 42 | |
Demographics | ||||
Age years | 59 (52–62.5) | 51 (45–65) | 56 (50–65) | 0.16 |
Male | 13 (59) | 16 (80) | 29 (69) | 0.19 |
Clinical parameters | ||||
Time from symptom onset to randomisation days | 9 (5–14) | 7 (4–10) | 7 (5–10) | 0.16 |
Symptoms at presentation | ||||
Fever | 18 (81.8) | 18 (90) | 36 (85.7) | 0.61 |
Cough | 18 (81.8) | 14 (70) | 32 (76.2) | 0.44 |
Dyspnoea | 9 (40.9) | 15 (75) | 24 (57.1) | 0.03 |
Presence of any comorbid illness | 12 (54.5) | 12 (60) | 24 (57.1) | 0.76 |
Hypertension | 6 (27.3) | 7 (35) | 13 (31) | 0.74 |
Diabetes mellitus | 5 (22.7) | 9 (45) | 14 (33.3) | 0.19 |
COPD | 1 (4.5) | 1 (5) | 2 (4.8) | 1.00 |
Asthma | 1 (4.5) | 1 (5) | 2 (4.8) | 1.00 |
Two or more comorbid illnesses | 2 (4.8) | 6 (30) | 8 (19) | 0.12 |
Respiratory rate breaths·min−1 | 26 (26–30) | 28 (26–30) | 28 (26–30) | 0.19 |
Heart rate beats·min−1 | 82 (80–94) | 83 (78–94) | 83 (78–94) | 0.85 |
PaO2/FIO2 ratio | 184 (114–244) | 188 (152–225) | 186 (135–234) | 0.68 |
Baseline SOFA score | 3 (2–4) | 3 (2–4) | 3 (2–4) | 0.85 |
Investigations | ||||
Haemoglobin g·dL−1 | 12 (11–13) | 12 (11–13) | 12 (1–13) | 0.33 |
Total leukocyte count µL | 9570 (7465–13 033) | 8400 (5090–12 215) | 8720 (5670–12 523) | 0.23 |
Neutrophil/lymphocyte ratio | 7.6 (6–13.5) | 6.7 (4.7–17.7) | 7.5 (5.3–13.7) | 0.66 |
Platelet count µL | 287 (201–357) | 170 (127–309) | 226 (156–323) | 0.03 |
Serum creatinine mg·dL−1 | 0.7 (0.6–0.8) | 0.9 (0.6–1.1) | 0.7 (0.6–1) | 0.33 |
Serum albumin g·dL−1 | 3.5 (3.3–3.7) | 3.5 (3.2–3.9) | 3.5 (3.2–3.8) | 0.61 |
Serum bilirubin mg·dL−1 | 0.5 (0.4–0.8) | 0.5 (0.4–0.6) | 0.5 (0.4–0.6) | 0.44 |
ALT U·L−1 | 39 (29.3–85.3) | 42 (26.5–77.7) | 39 (28.8–78.5) | 0.92 |
AST U·L−1 | 45 (30.5–61) | 46 (37.8–58) | 45 (32.8–55.6) | 0.61 |
D-dimer ng·mL−1 | 603 (254–840) | 621 (245–1484) | 621 (263–1145) | 0.58 |
Score on the ordinal scale at baseline | 0.49 | |||
4: Hospitalised, requiring oxygen supplementation | 14 (63.6) | 15 (75) | 29 (69) | |
5: Hospitalised, requiring high-flow oxygen devices or NIV | 7 (31.8) | 5 (25) | 12 (28.6) | |
6: Hospitalised, receiving invasive MV or ECMO | 1 (4.5) | 0 | 1 (2.4) | |
Concomitant medication | ||||
Systemic glucocorticoids | 22 (100) | 20 (100) | 42 (100) | |
Anticoagulation | 22 (100) | 20 (100) | 42 (100) | |
Tocilizumab | 3 (13.6) | 2 (10) | 5 (12) | 1.00 |
Convalescent plasma therapy | 2 (9.1) | 1 (5) | 3 (7) | 1.00 |
Hydroxychloroquine | 4 (18.2) | 7 (35) | 11 (26.2) | 0.03 |
Antibiotics | 20 (90.9) | 17 (85) | 37 (88.1) | 0.59 |
Data are presented as median (first and third quartile) or n (%), unless otherwise stated. Mw: Mycobacterium w; PaO2: arterial oxygen tension; FIO2: inspiratory oxygen fraction; SOFA: sequential organ failure assessment score; ALT: alanine transaminase; AST: aspartate transaminase; NIV: noninvasive ventilation; MV: mechanical ventilation; ECMO: extracorporeal membrane oxygenation.