Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID)

Figures & data

Table 1 Baseline Characteristics at Inclusion by Group

	Global (n=103)	Control (n=51)	Colchicine (n=52)	P value
Age	51.0±12.0	50.3±12.4	51.8±11.7	0.536
Male sex	54 (52.4)	27 (52.9)	27 (51.9)	1.000
Prior history
Hypertension	28 (27.2)	14 (27.5)	14 (26.9)	1.000
Dyslipidaemia	25 (24.3)	14 (27.5)	11 (21.2)	0.606
Diabetes	15 (14.6)	9 (17.6)	6 (11.5)	0.549
Obesity (BMI > 30 kg/m^2)	22 (21.4)	9 (17.6)	13 (25.0)	0.503
Smoking	9 (8.7)	3 (5.9)	6 (11.5)	0.505
Cardiovascular disease	3 (2.9)	3 (5.9)	0 (0.0)	0.234
Cerebrovascular disease	2 (1.9)	0 (0.0)	2 (3.8)	0.484
Renal insufficiency	7 (6.8)	4 (7.8)	3 (5.8)	0.979
COPD	1 (1.0)	1 (2.0)	0 (0.0)	0.992
Obstructive sleep apnoea	7 (6.8)	3 (5.9)	4 (7.7)	1.000
Characteristics at admission
Time from admission (days)	1.3±0.6	1.3±0.6	1.2±0.6	0.601
Time with symptoms (days)	7.6±4.4	8.3±5.1	6.9±3.4	0.107
WHO clinical scale		1.000
3	34 (33.0)	1720 (33.3)	17 (32.7)
4	69 (67.0)	34 (66.7)	35 (67.3)
NEWS scale	2.5±1.8	2.3±1.8	2.7±1.9	0.272
Systolic blood pressure (mmHg)	122±17	123±15	123±19	0.918
Diastolic blood pressure (mmHg)	74.8±11.3	73.7±9.8	75.9±12.6	0.323
Oxygen saturation (%)	96.3±1.9	96.4±1.7	96.1±2.2	0.537
Temperature (°C)	36.5±0.6	36.6±0.7	36.4±0.6	0.038
Heart rate (bpm)	78.1±12.5	77.5±12.7	78.6±12.3	0.655
Breathing rate (rpm)	17.7±3.7	17.5±3.5	17.9±4.0	0.614
Serum creatinine (mg/dL)	0.7±0.2	0.7±0.2	0.8±0.2	0.495
GFR e (mL/min/.73m^2)	102±27.9	106±31.6	98.5±23.6	0.162
Lymphocytes (x10^3/µL)	1.2±0.5	1.2±0.5	1.3±0.4	0.840
Serum D-dimer (ng/mL)	332±297	318±301	345±295	0.636
Il-6 (pg/mL)	35.1±39.1	36.7±45.3	33.5±32.6	0.679
Serum ferritin (ng/mL)	712±734	756±732	670±741	0.557
AST (U/L)	39.7±24.5	39.4±25.1	40.1±24.1	0.888
C-reactive protein (mg/dl)	7.9±6.3	8.5±6.3	7.3±6.4	0.367
Troponin T (pg/mL)	7.0±11.3	8.2±15.6	5.9±4.5	0.320
NT-proBNP	139.8±290.1	141.1±327.8	138.5±253.1	0.965

Note: Numbers (%) and mean ± standard deviation.

Abbreviations: WHO, world health organization; IL, interleukin; GFR, glomerular filtration rate (MDRD equation); NT-proBNP, N-terminal pro-B-type natriuretic peptide; ALT, alanine aminotransferase; AST, aspartate aminotransferase.

Figure 1 Head map showing the 7-point ordinal WHO scale across the study period of 24 weeks. Number refers to patients’ identification in the study.

Table 2 Study End-Points by Group

	Global (n=103)	Control (n=51)	Colchicine (n=52)	P value
WHO scale
≥1-grade deterioration	10 (9.7)	7 (13.7)	3 (5.8)	0.303
≥ 2-grade deterioration	2 (1.9)	2 (3.9)	0 (0.0)	0.467
Days to 1-grade improvement	5.36±4.12	4.96±4.71	5.73±3.49	0.350
Change at 14 days	−2.29 (1.01)	−2.24 (1.21)	−2.35 (0.76)	0.579
Change at 28 days	−2.48 (0.96)	−2.35 (1.25)	−2.60 (0.53)	0.199
Adverse events
Death	2 (1.9)	2 (3.9)	0 (0.0)	0.467
ICU admission	6 (5.8)	4 (7.8)	2 (3.8)	0.656
Days in ICU	7.17±6.49	8.25±8.10	5.00±0.00	0.621
Advanced respiratory support	6 (5.8)	4 (7.8)	2 (3.8)	0.656
High outflow oxygen	2 (1.9)	1 (2.0)	1 (1.9)
Non-invasive ventilation	2 (1.9)	1 (2.0)	1 (1.9)
Invasive ventilation	2 (1.9)	2 (3.9)	0 (0.0)
Length of hospitalization	6.18±4.40	5.76±4.89	6.60±3.86	0.340

Abbreviation: ICU, intensive care unit.

Figure 2 Adjusted multiple logistic regression analysis for the event of 1-point deterioration on the WHO scale of clinical severity. Age, Il-6, and ferritin were dichotomized above the median value.

Figure 3 Concentrations of IL-6 (panel A) and C-reactive protein (panel B) in the colchicine group (red) and the control group (blue).