Purpose

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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Colchicine 0.5 mg
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
    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.
    Other names:
    • Immuno-modulatory
Placebo Comparator
Placebo
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
    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.

Recruiting Locations

Mayo Clinic - Arizona
Phoenix, Arizona 85054
Contact:
Matthew Rank, MD
480-301-4284
rank.matthew@mayo.edu

Yuma Regional Medical Center Cancer Center
Yuma, Arizona 85364
Contact:
Oday Al Rabadi, MD
928-336-1675
OALRabadi@yumaregional.org

University of Arkansas for medical Sciences
Little Rock, Arkansas 72205
Contact:
Seth M Berney, MD
501-686-5586
SBerne@uams.edu

Centric Health Resources Inc.
Bakersfield, California 93308
Contact:
William F Baker, MD
661-616-9300
wfbaker@wfbakermd.com

Westside Medical Associates of Los Angeles
Beverly Hills, California 90211
Contact:
Norman E Lepor, MD
310-289-5221
norman.lepor@gmail.com

Rancho Research Institute
Downey, California 90242
Contact:
Sylvia Shaw, MD
562-385-8090
sjshaw@dhs.lacounty.gov

University of California, San Francisco - San Francisco General Hospital
San Francisco, California 94110
Contact:
Priscilla Hsue, MD
628-206-8257
priscilla.hsue@ucsf.edu

Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
Contact:
Leigh Speicher, MD
904-953-2824
Speicher.Leigh@mayo.edu

South Florida Research Organization
Medley, Florida 33166
Contact:
Giralt Yanez, MD
850-658-8059
yanez.sfro@gmail.com

Miami Center for Advanced Cardiology
Miami Beach, Florida 33140
Contact:
Ralph Nader, MD
305-532-6006
drralphnader@icloud.com

Mayo Clinic - Rochester
Rochester, Minnesota 55905
Contact:
Avni Joshi, MD
507-538-0127
Joshi.Avni@mayo.edu

North Mississippi Medical Clinics, Inc.
Tupelo, Mississippi 38801
Contact:
Charles King, MD
662-377-5131
cking@nmhs.net

New York University School of Medecine
New York, New York 10010
Contact:
Binita Shah, MD
212-263-4235
binita.shah@nyumc.org

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Saira Z Sheikh, MD
919-843-6619
szsheikh@email.unc.edu

Prisma Health
Greenville, South Carolina 29605
Contact:
Amanda Schnee, MD
864-455-9033
Amanda.Schnee@PrismaHealth.org

Baylor Scott & White Research Institute - Pharmacy
Dallas, Texas 75246
Contact:
Harold M Szerlip, MD
214-818-2525
Harold.Szerlip@BSWHealth.org

University of Texas(UT) Southwestern Medical Center
Dallas, Texas 75390
Contact:
Jessica Meisner, MD
214-648-7095
Jessica.Meisner@UTSouthwestern.edu

Spring Clinical Research
Houston, Texas 77002
Contact:
Thu A Hoang, MD
832-653-9490
ahoangmd@yahoo.com

More Details

NCT ID
NCT04322682
Status
Recruiting
Sponsor
Montreal Heart Institute

Study Contact

Jean-Claude Tardif, MD
514-376-3330
jean-claude.tardif@icm-mhi.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.