Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
- Conditions
- Corona Virus Infection
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04322682
- Lead Sponsor
- Montreal Heart Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4506
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo oral tablet 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. Colchicine Colchicine 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.
- Primary Outcome Measures
Name Time Method Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. 30 days post randomization The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization. 30 days post randomization The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
Number of Deaths in the 30 Days Following Randomization. 30 days post randomization The secondary endpoint consisted of two components of the composite primary endpoint and included death in the 30 days following randomization.
Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. 30 days post randomization The secondary endpoint consisted of two components of the composite primary endpoint and included hospitalization due to COVID-19 infection in the 30 days following randomization.
Trial Locations
- Locations (32)
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
South Florida Research Organization
🇺🇸Medley, Florida, United States
Baylor Scott & White Research Institute - Pharmacy
🇺🇸Dallas, Texas, United States
Instituto Cruzaltense de Cardiologia
🇧🇷Cruz Alta, Brazil
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Hospital Universitario La Paz, IdiPaz
🇪🇸La Paz, Madrid, Spain
Rancho Research Institute
🇺🇸Downey, California, United States
University of Texas(UT) Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Hospital de Clínicas de Passo Fundo
🇧🇷Passo Fundo, Brazil
Tread Research, Tygerberg Hospital
🇿🇦Cape Town, South Africa
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitário Bragança Paulista
🇧🇷Bragança Paulista, Brazil
Miami Center for Advanced Cardiology
🇺🇸Miami Beach, Florida, United States
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Centric Health Resources Inc.
🇺🇸Bakersfield, 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
New York Langone Health
🇺🇸New York, New York, United States
North Mississippi Medical Clinics, Inc.
🇺🇸Tupelo, Mississippi, United States
Instituto do Coração (InCor), School of Medicine, University of Sao Paulo
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital Samaritano Higienópolis
🇧🇷São Paulo, Brazil
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Mayo Clinic - Phoenix
🇺🇸Phoenix, Arizona, United States
Yuma Regional Medical Center Cancer Center
🇺🇸Yuma, Arizona, United States
University General Hospital of Athens "Attikon"
🇬🇷Chaïdári, Athens, Greece
General Hospital of Kozani "Mamatsio"
🇬🇷Kozáni, Greece
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Spring Clinical Research
🇺🇸Houston, Texas, United States