NCT04322682

Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,506 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

Detailed description

The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population. Approximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events. Safety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol.

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	Colchicine	Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
DRUG	Placebo oral tablet	Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.

Timeline

• Start date: 2020-03-23
• Primary completion: 2021-01-21
• Completion: 2021-01-21
• First posted: 2020-03-26
• Last updated: 2024-12-13
• Results posted: 2021-09-08

Locations

32 sites across 6 countries: United States, Brazil, Canada, Greece, South Africa, Spain

Regulatory

• FDA-regulated drug study