Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

• Status: Terminated
• Trial end date: 2021-01-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montreal Heart Institute
• Collaborators: Bill and Melinda Gates Foundation; DACIMA Software; National Heart, Lung, and Blood Institute (NHLBI); The Government of Quebec
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. Males and females, at least 40 years of age, capable and willing to provide informed consent;

2. Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;

3. Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);

4. 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;

5. 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;

6. Patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Patient currently hospitalized or under immediate consideration for hospitalization;

2. Patient currently in shock or with hemodynamic instability;

3. Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;

4. Patient with pre-existent progressive neuromuscular disease;

5. 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;

6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;

7. 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;

8. Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);

9. Patient with a history of an allergic reaction or significant sensitivity to colchicine;

10. Patient undergoing chemotherapy for cancer;

11. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.