Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

NCT04322682 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: MHIPS-2020-0013R01HL146206-02S1
• Study Type: interventional
• Target: 4,506
• Locations: 6 countries
• Sites: 32

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.

  The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.

  30 days post randomization

Secondary Outcomes (3)

• Number of Deaths in the 30 Days Following Randomization.

  30 days post randomization

• Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.

  30 days post randomization

• Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.

  30 days post randomization

Other Outcomes (4)

• Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19.

  30 Days post randomization

• Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Sex

  30 Days post randomization

• Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race

  30 Days post randomization

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

Patients 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: Colchicine

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo 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

Interventions

Colchicine DRUG

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.

Also known as: Immuno-modulatory

Colchicine

Placebo oral tablet DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, at least 40 years of age, capable and willing to provide informed consent;
• Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;
• Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
• Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count;
• Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
• Patient must be able and willing to comply with the requirements of this study protocol.

You may not qualify if:

• Patient currently hospitalized or under immediate consideration for hospitalization;
• Patient currently in shock or with hemodynamic instability;
• Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
• Patient with pre-existent progressive neuromuscular disease;
• Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of \< 30 mL/m in/1.73m2;
• Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
• Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication;
• Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);
• Patient with a history of an allergic reaction or significant sensitivity to colchicine;
• Patient undergoing chemotherapy for cancer;
• Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Bill and Melinda Gates Foundation: collaborator
• The Government of Quebec: collaborator
• Dacima Software Inc.: collaborator

Study Sites (32)

Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

Location

Yuma Regional Medical Center Cancer Center

Yuma, Arizona, 85364, United States

Location

Centric Health Resources Inc.

Bakersfield, California, 93308, United States

Location

Westside Medical Associates of Los Angeles

Beverly Hills, California, 90211, United States

Location

Rancho Research Institute

Downey, California, 90242, United States

Location

University of California San Francisco - Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

South Florida Research Organization

Medley, Florida, 33166, United States

Location

Miami Center for Advanced Cardiology

Miami Beach, Florida, 33140, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

North Mississippi Medical Clinics, Inc.

Tupelo, Mississippi, 38801, United States

Location

New York Langone Health

New York, New York, 10010, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Baylor Scott & White Research Institute - Pharmacy

Dallas, Texas, 75246, United States

Location

University of Texas(UT) Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Spring Clinical Research

Houston, Texas, 77002, United States

Location

Instituto do Coração (InCor), School of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Hospital Universitário Bragança Paulista

Bragança Paulista, 12916-542, Brazil

Location

Instituto Cruzaltense de Cardiologia

Cruz Alta, 98005-020, Brazil

Location

Hospital de Clínicas de Passo Fundo

Passo Fundo, 99010-260, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Hospital Samaritano Higienópolis

São Paulo, 01232-010, Brazil

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

University General Hospital of Athens "Attikon"

Chaïdári, Athens, 12462, Greece

Location

General Hospital of Kozani "Mamatsio"

Kozani, 50131, Greece

Location

Tread Research, Tygerberg Hospital

Cape Town, 7500, South Africa

Location

Hospital Universitario La Paz, IdiPaz

La Paz, Madrid, 28046, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

Related Publications (3)

• Alfehaid LS, Farah S, Omer A, Weber BN, Alkhezi O, Tawfik YMK, Shah AM, Libby P, Buckley LF. Drug-Drug Interactions and the Clinical Tolerability of Colchicine Among Patients With COVID-19: A Secondary Analysis of the COLCORONA Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2431309. doi: 10.1001/jamanetworkopen.2024.31309.

  PMID: 39240567 DERIVED

• Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

  PMID: 34658014 DERIVED

• Tardif JC, Bouabdallaoui N, L'Allier PL, Gaudet D, Shah B, Pillinger MH, Lopez-Sendon J, da Luz P, Verret L, Audet S, Dupuis J, Denault A, Pelletier M, Tessier PA, Samson S, Fortin D, Tardif JD, Busseuil D, Goulet E, Lacoste C, Dubois A, Joshi AY, Waters DD, Hsue P, Lepor NE, Lesage F, Sainturet N, Roy-Clavel E, Bassevitch Z, Orfanos A, Stamatescu G, Gregoire JC, Busque L, Lavallee C, Hetu PO, Paquette JS, Deftereos SG, Levesque S, Cossette M, Nozza A, Chabot-Blanchet M, Dube MP, Guertin MC, Boivin G; COLCORONA Investigators. Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Lancet Respir Med. 2021 Aug;9(8):924-932. doi: 10.1016/S2213-2600(21)00222-8. Epub 2021 May 27.

  PMID: 34051877 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Limitations and Caveats

Due to several considerations (logistical, human and budgetary), the study was stopped early. Furthermore, stopping the study after approximately 4500 patients had completed their 30-day follow-up would allow to communicate results in January 2021 in the hope of preventing complications of COVID-19 in ambulatory patients, instead of delivering results anywhere between April and October 2021 at a time when vaccination efforts might be successful.

Results Point of Contact

• Title: Dr. Jean-Claude Tardif (Principle Investigator)
• Organization: Montreal Heart Institute

jean-claude.tardif@icm-mhi.org

514 376-3330

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Zohar Bassevitch, B.SC.

  Montreal Health Innovations Coordinating Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized, double-blind, placebo-controlled, multi-center study. Following signature of the informed consent form, approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up phone or video assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: March 23, 2020
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: December 13, 2024
• Results First Posted: September 8, 2021

Record last verified: 2024-11

Locations

BR (6); CA (1); GR (2); ZA (1); US (16); ES (6)