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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322682
Recruitment Status : Terminated (Due to several considerations (logistical, human and budgetary), the study was stopped early.)
First Posted : March 26, 2020
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Corona Virus Infection
Interventions Drug: Colchicine
Drug: Placebo oral tablet
Enrollment 4506
Recruitment Details  
Pre-assignment Details

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
Hide 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
Reason Not Completed
Withdrawal by Subject             33             47
Death             5             9
Lost to Follow-up             4             8
Admitted to Hospital and Intubated             1             0
Arm/Group Title Colchicine Placebo Total
Hide 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 Number of Baseline Participants 2235 2253 4488
Hide Baseline Analysis Population Description
Characteristics of the patients at randomisation in the intent-to-treat population.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 2235 participants 2253 participants 4488 participants
53.0
(47.0 to 61.0)
54.0
(47.0 to 61.0)
54.0
(47.0 to 61.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 participants
Female
1238
  55.4%
1183
  52.5%
2421
  53.9%
Male
997
  44.6%
1070
  47.5%
2067
  46.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 participants
American Indian or Alaska Native
5
   0.2%
9
   0.4%
14
   0.3%
Asian
23
   1.0%
20
   0.9%
43
   1.0%
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
  93.0%
More than one race
2
   0.1%
4
   0.2%
6
   0.1%
Unknown or Not Reported
0
   0.0%
5
   0.2%
5
   0.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 participants
Canada 1817 1830 3647
United States 244 244 488
South Africa 0 2 2
Spain 94 94 188
Brazil 79 82 161
Greece 1 1 2
History of Respiratory Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 participants
Yes
583
  26.1%
605
  26.9%
1188
  26.5%
No
1652
  73.9%
1647
  73.1%
3299
  73.5%
Not Reported
0
   0.0%
1
   0.0%
1
   0.0%
History of Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2235 participants 2253 participants 4488 participants
Yes
444
  19.9%
450
  20.0%
894
  19.9%
No
1791
  80.1%
1803
  80.0%
3594
  80.1%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 2235 participants 2253 participants 4488 participants
30.0  (6.2) 30.0  (6.3) 30.0  (6.2)
1.Primary Outcome
Title Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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.
Overall Number of Participants Analyzed 2235 2253
Measure Type: Count of Participants
Unit of Measure: Participants
104
   4.7%
131
   5.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95.1%
0.61 to 1.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Deaths in the 30 Days Following Randomization.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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.
Overall Number of Participants Analyzed 2235 2253
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.2%
9
   0.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.291
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.19 to 1.67
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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.
Overall Number of Participants Analyzed 2235 2253
Measure Type: Count of Participants
Unit of Measure: Participants
101
   4.5%
128
   5.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.60 to 1.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization.
Hide Description The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
Time Frame 30 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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.
Overall Number of Participants Analyzed 2235 2253
Measure Type: Count of Participants
Unit of Measure: Participants
11
   0.5%
21
   0.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.25 to 1.09
Estimation Comments [Not Specified]
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colchicine Placebo
Hide 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.
Overall Number of Participants Analyzed 2075 2084
Measure Type: Count of Participants
Unit of Measure: Participants
96
   4.6%
126
   6.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Colchicine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   5/2195 (0.23%)   9/2217 (0.41%) 
Hide Serious Adverse Events
Colchicine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   108/2195 (4.92%)   139/2217 (6.27%) 
Cardiac disorders     
Arrhythmia * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Atrial fibrillation * 1  1/2195 (0.05%)  1/2217 (0.05%) 
Myocardial infarction * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Pericarditis * 1  0/2195 (0.00%)  2/2217 (0.09%) 
Tachycardia * 1  2/2195 (0.09%)  1/2217 (0.05%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/2195 (0.05%)  1/2217 (0.05%) 
Gastrointestinal disorder * 1  3/2195 (0.14%)  2/2217 (0.09%) 
Gastrointestinal haemorrhage * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Pancreatitis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
General disorders     
Death * 1  1/2195 (0.05%)  1/2217 (0.05%) 
General physical health deterioration * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Pyrexia * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Immune system disorders     
Hypersensitivity * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Infections and infestations     
Appendicitis * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Corona virus infection * 1  2/2195 (0.09%)  0/2217 (0.00%) 
Diverticulitis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Pneumonia * 1  63/2195 (2.87%)  92/2217 (4.15%) 
Pneumonia bacterial * 1  4/2195 (0.18%)  2/2217 (0.09%) 
Pneumonia viral * 1  2/2195 (0.09%)  2/2217 (0.09%) 
Pyelonephritis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Septic shock * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Viral infection * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Investigations     
Blood magnesium abnormal * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Oxygen saturation decreased * 1  0/2195 (0.00%)  2/2217 (0.09%) 
Metabolism and nutrition disorders     
Dehydration * 1  3/2195 (0.14%)  6/2217 (0.27%) 
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-Hodgkin's lymphoma * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Nervous system disorders     
Aphasia * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Cerebrovascular accident * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Dizziness * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Headache * 1  0/2195 (0.00%)  3/2217 (0.14%) 
Loss of proprioception * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Multiple sclerosis * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Neuropathy peripheral * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Syncope * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Renal and urinary disorders     
Acute kidney injury * 1  1/2195 (0.05%)  1/2217 (0.05%) 
Nephrolithiasis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Dyspnoea * 1  5/2195 (0.23%)  4/2217 (0.18%) 
Dyspnoea at rest * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Interstitial lung disease * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Pleural effusion * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Pneumonia * 1  0/2195 (0.00%)  1/2217 (0.05%) 
Pneumothorax * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Pulmonary embolism * 1  11/2195 (0.50%)  2/2217 (0.09%) 
Respiratory distress * 1  12/2195 (0.55%)  13/2217 (0.59%) 
Respiratory failure * 1  0/2195 (0.00%)  2/2217 (0.09%) 
Vascular disorders     
Haemorrhage * 1  1/2195 (0.05%)  0/2217 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colchicine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   524/2195 (23.87%)   328/2217 (14.79%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  7/2195 (0.32%)  3/2217 (0.14%) 
Abdominal distension * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Abdominal pain * 1  28/2195 (1.28%)  18/2217 (0.81%) 
Abdominal pain lower * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Constipation * 1  2/2195 (0.09%)  7/2217 (0.32%) 
Diarrhoea * 1  300/2195 (13.67%)  161/2217 (7.26%) 
Dry mouth * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Dyspepsia * 1  8/2195 (0.36%)  13/2217 (0.59%) 
Epigastric discomfort * 1  1/2195 (0.05%)  2/2217 (0.09%) 
Faeces soft * 1  10/2195 (0.46%)  2/2217 (0.09%) 
Flatulence * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Gastric disorder * 1  12/2195 (0.55%)  8/2217 (0.36%) 
Gastritis * 1  1/2195 (0.05%)  1/2217 (0.05%) 
Gastrointestinal disorder * 1  114/2195 (5.19%)  72/2217 (3.25%) 
Gastrointestinal haemorrhage * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Gastrooesophageal reflux disease * 1  3/2195 (0.14%)  2/2217 (0.09%) 
Nausea * 1  43/2195 (1.96%)  47/2217 (2.12%) 
Pancreatitis * 1  1/2195 (0.05%)  0/2217 (0.00%) 
Vomiting * 1  6/2195 (0.27%)  4/2217 (0.18%) 
1
Term from vocabulary, MedDRA 22.1
*
Indicates events were collected by non-systematic assessment
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.
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
Layout table for Results Point of Contact information
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
Layout table for additonal information
Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT04322682    
Other Study ID Numbers: MHIPS-2020-001
3R01HL146206-02S1 ( U.S. NIH Grant/Contract )
First Submitted: March 23, 2020
First Posted: March 26, 2020
Results First Submitted: August 10, 2021
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021