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Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

NCT04997551 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2021-08-09

No results posted yet for this study

Summary

EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:

* Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.
* Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.

Conditions

  • COVID-19 Infection

Interventions

DRUG

Colchcine

In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs: * Day 1: 1 single dose of 1 mg orally, in a single dose. * Days 2 to 6: 0.5 mg every 12 hours v.o. * Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts. or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day. In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be: o Days 1 to 14: 0.5 mg / day

Sponsors & Collaborators

  • Biogipuzkoa Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-09-01
Completion
2022-01-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997551 on ClinicalTrials.gov