COVID-19: Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Sponsor
Montreal Heart Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT04322682
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Bill and Melinda Gates Foundation (Other), The Government of Quebec (Other), DACIMA Software (Other)
4,506
32
2
10
140.8
14.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4506 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.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:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Actual Study Start Date :
Mar 23, 2020
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Jan 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Other Outcome Measures

    1. Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19. [30 Days post randomization]

      In the prespecified analysis of the 4159 patients with Covid-19 confirmed by PCR, the primary endpoint (composite of death or hospitalization due to Covid-19 infection in the 30 Days following randomization) was compared between the two treatment groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Rancho Research Institute Downey California United States 90242
    6 University of California San Francisco - Zuckerberg San Francisco General Hospital San Francisco California United States 94110
    7 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
    8 South Florida Research Organization Medley Florida United States 33166
    9 Miami Center for Advanced Cardiology Miami Beach Florida United States 33140
    10 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    11 North Mississippi Medical Clinics, Inc. Tupelo Mississippi United States 38801
    12 New York Langone Health New York New York United States 10010
    13 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    14 Baylor Scott & White Research Institute - Pharmacy Dallas Texas United States 75246
    15 University of Texas(UT) Southwestern Medical Center Dallas Texas United States 75390
    16 Spring Clinical Research Houston Texas United States 77002
    17 Instituto do Coração (InCor), School of Medicine, University of Sao Paulo São Paulo Sao Paulo Brazil 05403-900
    18 Hospital Universitário Bragança Paulista Bragança Paulista Brazil 12916-542
    19 Instituto Cruzaltense de Cardiologia Cruz Alta Brazil 98005-020
    20 Hospital de Clínicas de Passo Fundo Passo Fundo Brazil 99010-260
    21 Hospital de Clinicas de Porto Alegre Porto Alegre Brazil 90035-903
    22 Hospital Samaritano Higienópolis São Paulo Brazil 01232-010
    23 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
    24 University General Hospital of Athens "Attikon" Chaïdári Athens Greece 12462
    25 General Hospital of Kozani "Mamatsio" Kozáni Greece 50131
    26 Tread Research, Tygerberg Hospital Cape Town South Africa 7500
    27 Hospital Universitario La Paz, IdiPaz La Paz Madrid Spain 28046
    28 Hospital Universitario de La Princesa Madrid Spain 28006
    29 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    30 Fundación Jiménez Díaz Madrid Spain 28040
    31 Hospital Universitario 12 de Octubre Madrid Spain 28041
    32 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222

    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

    • Principal Investigator: Jean-Claude Tardif, MD, Montreal Heart Institute
    • Study Director: Zohar Bassevitch, B.SC., Montreal Health Innovations Coordinating Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Montreal Heart Institute
    ClinicalTrials.gov Identifier:
    NCT04322682
    Other Study ID Numbers:
    • MHIPS-2020-001
    • 3R01HL146206-02S1
    First Posted:
    Mar 26, 2020
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    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:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 18 patients were not included: 11 study medication was not delivered at home; 7 ineligible or condition deteriorated before study medication was delivered.
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 2235 2253
    COMPLETED 2192 2189
    NOT COMPLETED 43 64

    Baseline Characteristics

    Arm/Group Title Colchicine Placebo Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 2235 2253 4488
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    53.0
    54.0
    54.0
    Sex: Female, Male (Count of Participants)
    Female
    1238
    55.4%
    1183
    52.5%
    2421
    53.9%
    Male
    997
    44.6%
    1070
    47.5%
    2067
    46.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    327
    14.6%
    349
    15.5%
    676
    15.1%
    Not Hispanic or Latino
    1869
    83.6%
    1872
    83.1%
    3741
    83.4%
    Unknown or Not Reported
    39
    1.7%
    32
    1.4%
    71
    1.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    5
    0.2%
    9
    0.4%
    14
    0.3%
    Asian
    23
    1%
    20
    0.9%
    43
    1%
    Native Hawaiian or Other Pacific Islander
    7
    0.3%
    7
    0.3%
    14
    0.3%
    Black or African American
    114
    5.1%
    116
    5.1%
    230
    5.1%
    White
    2084
    93.2%
    2092
    92.9%
    4176
    93%
    More than one race
    2
    0.1%
    4
    0.2%
    6
    0.1%
    Unknown or Not Reported
    0
    0%
    5
    0.2%
    5
    0.1%
    Region of Enrollment (participants) [Number]
    Canada
    1817
    81.3%
    1830
    81.2%
    3647
    81.3%
    United States
    244
    10.9%
    244
    10.8%
    488
    10.9%
    South Africa
    0
    0%
    2
    0.1%
    2
    0%
    Spain
    94
    4.2%
    94
    4.2%
    188
    4.2%
    Brazil
    79
    3.5%
    82
    3.6%
    161
    3.6%
    Greece
    1
    0%
    1
    0%
    2
    0%
    History of Respiratory Disease (Count of Participants)
    Yes
    583
    26.1%
    605
    26.9%
    1188
    26.5%
    No
    1652
    73.9%
    1647
    73.1%
    3299
    73.5%
    Not Reported
    0
    0%
    1
    0%
    1
    0%
    History of Diabetes (Count of Participants)
    Yes
    444
    19.9%
    450
    20%
    894
    19.9%
    No
    1791
    80.1%
    1803
    80%
    3594
    80.1%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    30.0
    (6.2)
    30.0
    (6.3)
    30.0
    (6.2)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
    Description The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization.
    Time Frame 30 days post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Measure Participants 2235 2253
    Count of Participants [Participants]
    104
    4.7%
    131
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.081
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95.1%
    0.61 to 1.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Deaths in the 30 Days Following Randomization.
    Description The secondary endpoint consisted of two components of the composite primary endpoint and included death in the 30 days following randomization.
    Time Frame 30 days post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Measure Participants 2235 2253
    Count of Participants [Participants]
    5
    0.2%
    9
    0.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.291
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.56
    Confidence Interval (2-Sided) 95%
    0.19 to 1.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
    Description 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.
    Time Frame 30 days post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Measure Participants 2235 2253
    Count of Participants [Participants]
    101
    4.5%
    128
    5.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.077
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.60 to 1.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.
    Description The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
    Time Frame 30 days post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Measure Participants 2235 2253
    Count of Participants [Participants]
    11
    0.5%
    21
    0.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.080
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.53
    Confidence Interval (2-Sided) 95%
    0.25 to 1.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Other Pre-specified Outcome
    Title Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization in the Subgroup of Patients With PCR-confirmed COVID-19.
    Description In the prespecified analysis of the 4159 patients with Covid-19 confirmed by PCR, the primary endpoint (composite of death or hospitalization due to Covid-19 infection in the 30 Days following randomization) was compared between the two treatment groups.
    Time Frame 30 Days post randomization

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    Measure Participants 2075 2084
    Count of Participants [Participants]
    96
    4.3%
    126
    5.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.042
    Comments P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.
    Method Regression, Logistic
    Comments Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.57 to 0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame From randomization/baseline to End of Study visit which planned 30 days after baseline.
    Adverse Event Reporting Description 2 additional Serious Adverse Events were added to the definition : cancer; overdose (intentional or accidental). Adverse events reporting are presented on the Safety population where subjects took at least one dose of study medication and are assigned according to the true treatment received. The Safety population includes 2217 subjects have received placebo and 2195 subjects have received colchicine.
    Arm/Group Title Colchicine Placebo
    Arm/Group Description 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. 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.
    All Cause Mortality
    Colchicine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/2195 (0.2%) 9/2217 (0.4%)
    Serious Adverse Events
    Colchicine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 108/2195 (4.9%) 139/2217 (6.3%)
    Cardiac disorders
    Arrhythmia 1/2195 (0%) 0/2217 (0%)
    Atrial fibrillation 1/2195 (0%) 1/2217 (0%)
    Myocardial infarction 0/2195 (0%) 1/2217 (0%)
    Pericarditis 0/2195 (0%) 2/2217 (0.1%)
    Tachycardia 2/2195 (0.1%) 1/2217 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/2195 (0%) 1/2217 (0%)
    Gastrointestinal disorder 3/2195 (0.1%) 2/2217 (0.1%)
    Gastrointestinal haemorrhage 1/2195 (0%) 0/2217 (0%)
    Pancreatitis 1/2195 (0%) 0/2217 (0%)
    General disorders
    Death 1/2195 (0%) 1/2217 (0%)
    General physical health deterioration 0/2195 (0%) 1/2217 (0%)
    Pyrexia 0/2195 (0%) 1/2217 (0%)
    Immune system disorders
    Hypersensitivity 0/2195 (0%) 1/2217 (0%)
    Infections and infestations
    Appendicitis 0/2195 (0%) 1/2217 (0%)
    Corona virus infection 2/2195 (0.1%) 0/2217 (0%)
    Diverticulitis 1/2195 (0%) 0/2217 (0%)
    Pneumonia 63/2195 (2.9%) 92/2217 (4.1%)
    Pneumonia bacterial 4/2195 (0.2%) 2/2217 (0.1%)
    Pneumonia viral 2/2195 (0.1%) 2/2217 (0.1%)
    Pyelonephritis 1/2195 (0%) 0/2217 (0%)
    Septic shock 0/2195 (0%) 1/2217 (0%)
    Viral infection 0/2195 (0%) 1/2217 (0%)
    Investigations
    Blood magnesium abnormal 1/2195 (0%) 0/2217 (0%)
    Oxygen saturation decreased 0/2195 (0%) 2/2217 (0.1%)
    Metabolism and nutrition disorders
    Dehydration 3/2195 (0.1%) 6/2217 (0.3%)
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis 0/2195 (0%) 1/2217 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-Hodgkin's lymphoma 0/2195 (0%) 1/2217 (0%)
    Nervous system disorders
    Aphasia 0/2195 (0%) 1/2217 (0%)
    Cerebrovascular accident 1/2195 (0%) 0/2217 (0%)
    Dizziness 1/2195 (0%) 0/2217 (0%)
    Headache 0/2195 (0%) 3/2217 (0.1%)
    Loss of proprioception 0/2195 (0%) 1/2217 (0%)
    Multiple sclerosis 0/2195 (0%) 1/2217 (0%)
    Neuropathy peripheral 1/2195 (0%) 0/2217 (0%)
    Syncope 0/2195 (0%) 1/2217 (0%)
    Renal and urinary disorders
    Acute kidney injury 1/2195 (0%) 1/2217 (0%)
    Nephrolithiasis 1/2195 (0%) 0/2217 (0%)
    Respiratory, thoracic and mediastinal disorders
    Bronchitis 1/2195 (0%) 0/2217 (0%)
    Dyspnoea 5/2195 (0.2%) 4/2217 (0.2%)
    Dyspnoea at rest 0/2195 (0%) 1/2217 (0%)
    Interstitial lung disease 1/2195 (0%) 0/2217 (0%)
    Pleural effusion 0/2195 (0%) 1/2217 (0%)
    Pneumonia 0/2195 (0%) 1/2217 (0%)
    Pneumothorax 1/2195 (0%) 0/2217 (0%)
    Pulmonary embolism 11/2195 (0.5%) 2/2217 (0.1%)
    Respiratory distress 12/2195 (0.5%) 13/2217 (0.6%)
    Respiratory failure 0/2195 (0%) 2/2217 (0.1%)
    Vascular disorders
    Haemorrhage 1/2195 (0%) 0/2217 (0%)
    Other (Not Including Serious) Adverse Events
    Colchicine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 524/2195 (23.9%) 328/2217 (14.8%)
    Gastrointestinal disorders
    Abdominal discomfort 7/2195 (0.3%) 3/2217 (0.1%)
    Abdominal distension 1/2195 (0%) 0/2217 (0%)
    Abdominal pain 28/2195 (1.3%) 18/2217 (0.8%)
    Abdominal pain lower 1/2195 (0%) 0/2217 (0%)
    Constipation 2/2195 (0.1%) 7/2217 (0.3%)
    Diarrhoea 300/2195 (13.7%) 161/2217 (7.3%)
    Dry mouth 1/2195 (0%) 0/2217 (0%)
    Dyspepsia 8/2195 (0.4%) 13/2217 (0.6%)
    Epigastric discomfort 1/2195 (0%) 2/2217 (0.1%)
    Faeces soft 10/2195 (0.5%) 2/2217 (0.1%)
    Flatulence 1/2195 (0%) 0/2217 (0%)
    Gastric disorder 12/2195 (0.5%) 8/2217 (0.4%)
    Gastritis 1/2195 (0%) 1/2217 (0%)
    Gastrointestinal disorder 114/2195 (5.2%) 72/2217 (3.2%)
    Gastrointestinal haemorrhage 1/2195 (0%) 0/2217 (0%)
    Gastrooesophageal reflux disease 3/2195 (0.1%) 2/2217 (0.1%)
    Nausea 43/2195 (2%) 47/2217 (2.1%)
    Pancreatitis 1/2195 (0%) 0/2217 (0%)
    Vomiting 6/2195 (0.3%) 4/2217 (0.2%)

    Limitations/Caveats

    Due to several considerations (logistical, human and budgetary), the study was stopped early. Furthermore, stopping the study after approximately 4500 patients had completed their 30-day follow-up would allow to communicate results in January 2021 in the hope of preventing complications of COVID-19 in ambulatory patients, instead of delivering results anywhere between April and October 2021 at a time when vaccination efforts might be successful.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Jean-Claude Tardif (Principle Investigator)
    Organization Montreal Heart Institute
    Phone 514 376-3330 ext 3612
    Email jean-claude.tardif@icm-mhi.org
    Responsible Party:
    Montreal Heart Institute
    ClinicalTrials.gov Identifier:
    NCT04322682
    Other Study ID Numbers:
    • MHIPS-2020-001
    • 3R01HL146206-02S1
    First Posted:
    Mar 26, 2020
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021