NCT04997551

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Biogipuzkoa Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-09-08
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2021-08-09
• Last updated: 2021-08-09

Locations

1 site across 1 country: Spain