Trial · NCT04322682
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
NCT04322682, Phase 3, Terminated, Montreal Heart Institute; results first posted 2021-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA). Trials, record NCT04322682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04322682
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
- NCT number
- NCT04322682
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4,506 participants, actual
- Lead sponsor
- Montreal Heart Institute
- Conditions
- Corona Virus Infection
- Interventions
- Colchicine, Placebo oral tablet
- First posted
- 2020-03-26
- Last updated
- 2024-12-13
- Results first posted
- 2021-09-08
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 | 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. |
| Other | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Sex | 30 Days post randomization | NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Sex. |
| Other | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race | 30 Days post randomization | NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Race. |
| Other | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Ethnicity. | 30 Days post randomization | NIH-required analysis. The primary endpoint will be the composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization by Ethnicity. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | 30 days post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Deaths in the 30 Days Following Randomization. | 30 days post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | 30 days post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization. | 30 days post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Sex | 30 Days post randomization | Data were stratified by sex. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Race | 30 Days post randomization | Data were stratified by race. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization by Ethnicity. | 30 Days post randomization | Data were stratified by ethnicity. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Colchicine | 104 | Participants | ||
| Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Placebo | 131 | Participants | ||
| Number of Deaths in the 30 Days Following Randomization. | Colchicine | 5 | Participants | ||
| Number of Deaths in the 30 Days Following Randomization. | Placebo | 9 | Participants | ||
| Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Colchicine | 101 | Participants | ||
| Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Placebo | 128 | Participants | ||
| Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization. | Colchicine | 11 | Participants | ||
| Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization. | Placebo | 21 | Participants | ||
| 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. | Colchicine | 96 | Participants | ||
| 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. | Placebo | 126 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colchicine | 2,235 | |
| Overall Study | STARTED | Placebo | 2,253 | |
| Overall Study | COMPLETED | Colchicine | 2,192 | |
| Overall Study | COMPLETED | Placebo | 2,189 | |
| Overall Study | NOT COMPLETED | Colchicine | 43 | |
| Overall Study | NOT COMPLETED | Placebo | 64 |
Source ClinicalTrials.gov
Adverse events134
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Colchicine | 7 | 2,195 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 3 | 2,217 | |
| other | Abdominal distension | Gastrointestinal disorders | Colchicine | 1 | 2,195 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 2,217 | |
| other | Abdominal pain | Gastrointestinal disorders | Colchicine | 28 | 2,195 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 18 | 2,217 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Colchicine | 1 | 2,195 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Placebo | 0 | 2,217 | |
| other | Constipation | Gastrointestinal disorders | Colchicine | 2 | 2,195 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 2,217 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Colchicine | 5 | 2,195 |
| Total, all-cause mortality | Placebo | 9 | 2,217 |
| Total, other adverse events | Colchicine | 524 | 2,195 |
| Total, other adverse events | Placebo | 328 | 2,217 |
| Total, serious adverse events | Colchicine | 108 | 2,195 |
| Total, serious adverse events | Placebo | 139 | 2,217 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL146206 | Studies on the effects of colchicine on neutrophil biology in acute myocardial infarction | SHAH, BINITA | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2019 to 2022 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Colchicine vs Placebo: Number of Participants Who Required Mechanical Ventilation in the 30 Days Following Randomization. | Trial comparisons |
| Colchicine vs Placebo: 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. | Trial comparisons |
| Colchicine vs Placebo: Number of Deaths in the 30 Days Following Randomization. | Trial comparisons |
| Colchicine vs Placebo: Number of Participants Who Died or Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Trial comparisons |
| Colchicine vs Placebo: Number of Participants Who Were Hospitalized Due to COVID-19 Infection in the 30 Days Following Randomization. | Trial comparisons |
| Colchicine vs Placebo: deaths from any cause | Trial comparisons |
| Colchicine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04322682
GET https://conductscience.org/api/trials/v1/NCT04322682/results?page=2