Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID).
Int J Gen Med
; 14: 5517-5526, 2021.
Article
in English
| MEDLINE | ID: covidwho-1416998
ABSTRACT
BACKGROUND:
Colchicine has been proposed as a potential therapy in coronavirus disease 2019 (COVID-19) due to their anti-inflammatory actions.METHODS:
The COL-COVID study was a prospective, randomized, controlled and open-label clinical trial that compared colchicine added to standard treatment vs standard treatment in hospitalized COVID-19 patients that do not need mechanical ventilatory support. Colchicine was initiated within the first 48 hours of admission at a 1.5 mg loading dose, followed by 0.5 mg b.i.d. for one week and 0.5 mg per day for 28 days. The study endpoints were clinical status (7-points WHO ordinal scale) and inflammatory biomarkers (IL-6 and CRP).RESULTS:
A total of 103 patients (51±12 years, 52% male) were randomly allocated to colchicine arm (n=52) and control arm (n=51). At day 28, all patients in the colchicine group were alive and discharged, whereas in the control group, two patients died in-hospital and one patient remained hospitalized. Clinical improvement in terms of changes on WHO scale at day 14 and 28 and time to 1-point clinical improvement did not differ between the two groups. Clinical deterioration (increase of at least 1-point in WHO scale) was observed in a higher proportion of cases in colchicine group (13.8%) vs control group (5.8%) (p=0.303); after adjustment by baseline risk factors and concomitant therapies, colchicine therapy was associated with a lower risk of clinical deterioration (p=0.030). Inflammatory biomarkers CRP and IL-6 concentrations course did not differ between the two arms.CONCLUSION:
In hospitalized COVID-19 patients, colchicine treatment neither improved the clinical status, nor the inflammatory response, over the standard treatment. Nevertheless, a preventive effect for further clinical deterioration might be possible. TRIAL REGISTRATION NCT04350320.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Case report
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Int J Gen Med
Year:
2021
Document Type:
Article
Affiliation country:
IJGM.S329810
Similar
MEDLINE
...
LILACS
LIS