Status:
TERMINATED
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Bill and Melinda Gates Foundation
Conditions:
Corona Virus Infection
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 leas...
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 det...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
4506 Patients enrolled
Trial Details
Trial ID
NCT04322682
Start Date
March 23 2020
End Date
January 21 2021
Last Update
December 13 2024
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
2
Yuma Regional Medical Center Cancer Center
Yuma, Arizona, United States, 85364
3
Centric Health Resources Inc.
Bakersfield, California, United States, 93308
4
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211