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Trial record 1 of 1 for:    COLCORONA
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Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322682
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Bill and Melinda Gates Foundation
The Government of Quebec
DACIMA Software
Information provided by (Responsible Party):
Montreal Heart Institute

Brief Summary:
This is a phase 3, multi-center, 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 or disease Intervention/treatment Phase
Corona Virus Infection Drug: Colchicine Drug: Placebo oral tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
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 Name: 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.




Primary Outcome Measures :
  1. Number of participants who die or require hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]
    The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.


Secondary Outcome Measures :
  1. Number of participants who die [ Time Frame: 30 days post randomization ]
    The secondary endpoint is the occurrence of death in the 30 days following randomization.

  2. Number of participants requiring hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]
    The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.

  3. Number of participants requiring mechanical ventilation [ Time Frame: 30 days post randomization ]
    The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322682


Contacts
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Contact: Jean-Claude Tardif, MD 514-376-3330 ext 3612 jean-claude.tardif@icm-mhi.org
Contact: Zohar Bassevitch, B.SC. 514-461-1300 ext 2214 zohar.bassevitch@mhicc.org

Locations
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United States, California
University of California, San Francisco - San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Priscilla Hsue, MD    628-206-8257    priscilla.hsue@ucsf.edu   
Contact: Kelvin Moore    628-206-5145    kelvin.moorejr@ucsf.edu   
Sub-Investigator: Priscilla Hsue, MD         
Sub-Investigator: David Waters, MD         
United States, New York
New York University School of Medecine Recruiting
New York, New York, United States, 10010
Contact: Binita Shah, MD    212-263-4235    binita.shah@nyumc.org   
Sub-Investigator: Binita Shah, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Jean-Claude Tardif, MD    514 376-3330 ext 3612    jean-claude.tardif@icm-mhi.org   
Contact: Andreas Orfanos, MBBCH    514-461-1300 ext 3480    andreas.orfanos@mhicc.org   
Principal Investigator: Jean-Claude Tardif, M.D         
Spain
Hospital Universitario La Paz, IdiPaz Recruiting
La Paz, Madrid, Spain, 28046
Contact: Jose Lopez-Sendon, MD    (+34) 639 148 765    jlopezsendon@gmail.com   
Sub-Investigator: Jose Lopez-Sendon, MD         
Sponsors and Collaborators
Montreal Heart Institute
National Heart, Lung, and Blood Institute (NHLBI)
Bill and Melinda Gates Foundation
The Government of Quebec
DACIMA Software
Investigators
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Principal Investigator: Jean-Claude Tardif, MD Montreal Heart Institute
Study Director: Zohar Bassevitch, B.SC. Montreal Health Innovations Coordinating Center
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT04322682    
Other Study ID Numbers: MHIPS-2020-001
3R01HL146206-02S1 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents