TABLE 1

Baseline demographics, clinical parameters, laboratory investigations, and disease severity at baseline

ParameterMwPlaceboTotalp-value
Subjects n222042
Demographics
 Age years59 (52–62.5)51 (45–65)56 (50–65)0.16
 Male13 (59)16 (80)29 (69)0.19
Clinical parameters
 Time from symptom onset to randomisation days9 (5–14)7 (4–10)7 (5–10)0.16
 Symptoms at presentation
  Fever18 (81.8)18 (90)36 (85.7)0.61
  Cough18 (81.8)14 (70)32 (76.2)0.44
  Dyspnoea9 (40.9)15 (75)24 (57.1)0.03
 Presence of any comorbid illness12 (54.5)12 (60)24 (57.1)0.76
  Hypertension6 (27.3)7 (35)13 (31)0.74
  Diabetes mellitus5 (22.7)9 (45)14 (33.3)0.19
  COPD1 (4.5)1 (5)2 (4.8)1.00
  Asthma1 (4.5)1 (5)2 (4.8)1.00
 Two or more comorbid illnesses2 (4.8)6 (30)8 (19)0.12
 Respiratory rate breaths·min−126 (26–30)28 (26–30)28 (26–30)0.19
 Heart rate beats·min−182 (80–94)83 (78–94)83 (78–94)0.85
PaO2/FIO2 ratio184 (114–244)188 (152–225)186 (135–234)0.68
 Baseline SOFA score3 (2–4)3 (2–4)3 (2–4)0.85
Investigations
 Haemoglobin g·dL−112 (11–13)12 (11–13)12 (1–13)0.33
 Total leukocyte count µL9570 (7465–13 033)8400 (5090–12 215)8720 (5670–12 523)0.23
 Neutrophil/lymphocyte ratio7.6 (6–13.5)6.7 (4.7–17.7)7.5 (5.3–13.7)0.66
 Platelet count µL287 (201–357)170 (127–309)226 (156–323)0.03
 Serum creatinine mg·dL−10.7 (0.6–0.8)0.9 (0.6–1.1)0.7 (0.6–1)0.33
 Serum albumin g·dL−13.5 (3.3–3.7)3.5 (3.2–3.9)3.5 (3.2–3.8)0.61
 Serum bilirubin mg·dL−10.5 (0.4–0.8)0.5 (0.4–0.6)0.5 (0.4–0.6)0.44
 ALT U·L−139 (29.3–85.3)42 (26.5–77.7)39 (28.8–78.5)0.92
 AST U·L−145 (30.5–61)46 (37.8–58)45 (32.8–55.6)0.61
 D-dimer ng·mL−1603 (254–840)621 (245–1484)621 (263–1145)0.58
Score on the ordinal scale at baseline0.49
 4: Hospitalised, requiring oxygen supplementation14 (63.6)15 (75)29 (69)
 5: Hospitalised, requiring high-flow oxygen devices or NIV7 (31.8)5 (25)12 (28.6)
 6: Hospitalised, receiving invasive MV or ECMO1 (4.5)01 (2.4)
Concomitant medication
 Systemic glucocorticoids22 (100)20 (100)42 (100)
 Anticoagulation22 (100)20 (100)42 (100)
 Tocilizumab3 (13.6)2 (10)5 (12)1.00
 Convalescent plasma therapy2 (9.1)1 (5)3 (7)1.00
 Hydroxychloroquine4 (18.2)7 (35)11 (26.2)0.03
 Antibiotics20 (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.