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Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

NCT04322682 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4506

Last updated 2024-12-13

Study results available
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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.

Conditions

  • Corona Virus Infection

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • The Government of Quebec

    collaborator OTHER_GOV

  • Dacima Software Inc.

    collaborator INDUSTRY

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Jean-Claude Tardif, MD · Montreal Heart Institute

  • Zohar Bassevitch, B.SC. · Montreal Health Innovations Coordinating Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2021-01-21
Completion
2021-01-21
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Greece
  • South Africa
  • 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 NCT04322682 on ClinicalTrials.gov