Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID).
J Gen Intern Med
; 37(1): 4-14, 2022 01.
Article
in English
| MEDLINE | ID: covidwho-1611487
ABSTRACT
BACKGROUND:
Colchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated.OBJECTIVE:
To address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19.DESIGN:
We conducted a triple-blind parallel non-stratified placebo-controlled clinical trial.PARTICIPANTS:
We recruited 116 hospitalized patients with severe COVID-19 in Mexico.INTERVENTIONS:
Patients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment. MAINMEASURES:
The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients. KEYRESULTS:
Fifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35-1.93, P = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66-3.88, P = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.CONCLUSIONS:
Colchicine is safe but not effective in the treatment of severe COVID-19. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04367168.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Drug Treatment
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
J Gen Intern Med
Journal subject:
Internal Medicine
Year:
2022
Document Type:
Article
Affiliation country:
S11606-021-07203-8
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