COVID-19: Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
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
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:
|
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
- 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
- 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.
- 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.
- 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
- 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
Inclusion Criteria:
-
Males and females, at least 40 years of age, capable and willing to provide informed consent;
-
Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;
-
Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
-
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;
-
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;
-
Patient must be able and willing to comply with the requirements of this study protocol.
Exclusion Criteria:
-
Patient currently hospitalized or under immediate consideration for hospitalization;
-
Patient currently in shock or with hemodynamic instability;
-
Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
-
Patient with pre-existent progressive neuromuscular disease;
-
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;
-
Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;
-
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;
-
Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);
-
Patient with a history of an allergic reaction or significant sensitivity to colchicine;
-
Patient undergoing chemotherapy for cancer;
-
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.- MHIPS-2020-001
- 3R01HL146206-02S1
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
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 |
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 |
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 |
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 |
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
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 |
jean-claude.tardif@icm-mhi.org |
- MHIPS-2020-001
- 3R01HL146206-02S1