Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Corona Virus Infection

In brief

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.

Key facts

Study ID: NCT04322682
Run by: Montreal Heart Institute
People needed: 4506
Starts: 2020-03-23
Expected to finish: 2021-01-21
Last updated by the study team: 2024-12-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Mayo Clinic - Phoenix — Phoenix, Arizona, United States
Yuma Regional Medical Center Cancer Center — Yuma, Arizona, United States
Centric Health Resources Inc. — Bakersfield, California, United States
Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
Rancho Research Institute — Downey, California, United States
University of California San Francisco - Zuckerberg San Francisco General Hospital — San Francisco, California, United States
Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
South Florida Research Organization — Medley, Florida, United States
Miami Center for Advanced Cardiology — Miami Beach, Florida, United States
Mayo Clinic - Rochester — Rochester, Minnesota, United States
North Mississippi Medical Clinics, Inc. — Tupelo, Mississippi, United States
New York Langone Health — New York, New York, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Baylor Scott & White Research Institute - Pharmacy — Dallas, Texas, United States
University of Texas(UT) Southwestern Medical Center — Dallas, Texas, United States
Spring Clinical Research — Houston, Texas, United States
Instituto do Coração (InCor), School of Medicine, University of Sao Paulo — São Paulo, São Paulo, Brazil
Hospital Universitário Bragança Paulista — Bragança Paulista, Brazil
Instituto Cruzaltense de Cardiologia — Cruz Alta, Brazil
Hospital de Clínicas de Passo Fundo — Passo Fundo, Brazil
Hospital de Clinicas de Porto Alegre — Porto Alegre, Brazil
Hospital Samaritano Higienópolis — São Paulo, Brazil
Montreal Heart Institute — Montreal, Quebec, Canada
University General Hospital of Athens "Attikon" — Chaïdári, Athens, Greece
General Hospital of Kozani "Mamatsio" — Kozani, Greece

Full record on ClinicalTrials.gov

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