Placebo group (n=36) | Colchicine group (n=36) | P value | |
Demographics | |||
Men (n (%)) | 14 (39) | 19 (53) | 0.34 |
Age (years; median (IQR)) | 55.0 (42.0–67.0) | 54.5 (42.5–64.5) | 0.93 |
Time of symptoms (days; median (IQR)) | 8.0 (7.0–11.0) | 9.5 (7.5–11.0) | 0.15 |
Comorbidities (n (%)) | |||
Smoking currently or formerly | 9 (25) | 7 (19) | 0.78 |
Respiratory diseases | 5 (14) | 4 (11) | 1 |
Cardiovascular diseases | 16 (44) | 17 (47) | 1 |
Diabetes mellitus | 15 (42) | 13 (36) | 0.81 |
Dyslipidaemia | 12 (33) | 10 (28) | 0.80 |
BMI (kg/m2; median (IQR)) | 29.7 (26.3–36.0) | 33.5 (28.6–37.8) | 0.17 |
Clinical picture of COVID-19 (n (%)) | |||
Fever | 33 (92) | 32 (89) | 1 |
Cough | 36 (100) | 36 (100) | 1 |
Fatigue | 15 (42) | 19 (53) | 0.48 |
Myalgia | 22 (61) | 19 (53) | 0.63 |
Diarrhoea | 8 (22) | 11 (31) | 0.59 |
Without supplemental oxygen | 4 (11) | 1 (3) | 0.36 |
On oxygen support (n (%)), (L/min; median (IQR)) | 24 (67), (3; 2.0–3.5) | 28 (78), (3; 2.0–4.0) | 0.65 |
On high flow | 8 (22) | 7 (19) | 1 |
Mechanical ventilation | 0 | 0 | 1 |
PaO2/FiO2 at enrolment (median (IQR)) | 278 (197–313) | 228 (196–272) | 0.25 |
qSOFA ≥1 | 34 (94) | 34 (94) | 1 |
SOFA | 2.5 (1–3) | 2.0 (1–3) | 0.80 |
Laboratory findings | |||
Haemoglobin(g/dL; median (IQR)) | 12.9 (11.8–14.2) | 13.3 (12.5–14.6) | 0.44 |
Neutrophils(/mm3; median (IQR)) | 5450 (3800–7300) | 5750 (3500–7650) | 0.98 |
Lymphocytes(/mm3; median (IQR)) | 1300 (900–2050) | 1100 (900–1550) | 0.16 |
Neutrophil/Lymphocyte(median (IQR)) | 3.34 (2.46–6.00) | 3.86 (2.80–7.44) | 0.40 |
Platelets(/mm3; median (IQR)) | 2 40 000 (1 70 000–2 88 000) | 2 26 000 (2 01 000–3 18 000) | 0.79 |
Creatinine(mg/dL; median (IQR)) | 0.81 (0.64–1.05) | 0.90 (0.70–1.01) | 0.51 |
C-reactive protein(mg/dL; median (IQR)) | 9.3 (5.8–15.1) | 9.2 (6.6–12.6) | 0.91 |
Lactate dehydrogenase(U/L; median (IQR)) | 374 (301–477) | 351 (299–473) | 0.76 |
D-dimer(mcg/mL; median (IQR)) | 1.12 (0.63–1.77) | 1.40 (0.92–1.92) | 0.12 |
Ferritin(ng/mL; median (IQR)) | 597 (285–1289) | 723 (436–1173) | 0.43 |
Aspartate aminotransferase(U/L; median (IQR)) | 37 (27–63) | 44 (28–70) | 0.43 |
Alanine aminotransferase(U/L; median (IQR)) | 35 (24–48) | 45 (33–80) | 0.18 |
Medications | |||
Hydroxychloroquine(n (%)) | 36 (100) | 36 (100) | 1 |
Azithromycin(n (%)) | 36 (100) | 36 (100) | 1 |
Unfracionated heparin(n (%)) | 36 (100) | 36 (100) | 1 |
Methylprednisolone(n (%)) | 24 (67) | 25 (69) | 1 |
BMI, body mass index; D-dimer, dimerised plasma fragment D; FiO2, fractional inspired oxygen; PaO2, Arterial oxygen partial pressure; qSOFA, quick SOFA; SOFA, Sequential Organ Failure Assessment Score.