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Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)
We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease.
Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.
This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. |
|
| Control | No Intervention | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Composite of all-cause mortality | 90 days |
| Mechanical Ventilation | Need for mechanical ventilation | 90 days |
| Mechanical Circulatory Support | Need for mechanical circulatory support | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Days) to the Primary End Point | Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support | 90 days |
| Peak and Delta (Change From Baseline) Troponin Level |
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Inclusion Criteria:
Men and Women ≥ 18 years of age
Covid-19 Positive
Hospitalized patients able to provide informed consent
Cardiac injury (as evidenced by any of the following)
Exclusion Criteria:
Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
History of severe hematologic or neuromuscular disorder
Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
Severe renal impairment with concomitant hepatic impairment
Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Chaparro, MD | Baptist Health South Florida | Principal Investigator |
| Raul E Herrera, MD | Baptist Health South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34658014 | Derived | Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045. |
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Patients who test positive for COVID-19, sign informed consent and have any of the study specific manifestations of cardiac injury were randomized 1:1 .
The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control - Standard of Care Alone | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
| FG001 | Active - Colchicine Plus Standard of Care | Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Composite of all-cause mortality | Posted | Count of Participants | Participants | 90 days |
|
Adverse event data was collected from baseline through the 90 day follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 840544004 | Non-systematic Assessment |
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The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raul Herrera, MD (Director Miami Cardiac & Vascular Institute) | baptist health south florida | 786-596-7609 | RaulH@BaptistHealth.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 | Mar 8, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D013812 | Therapeutics |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
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Change from baseline to the time when Troponin levels peak during the hospitalization
| baseline and 90 days |
| Baseline Brain Natriuretic Peptide (BNP) Level | Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization | baseline |
| Inflammatory Biomarkers | Baseline and delta (change from baseline) of C-Reactive Protein | baseline and 90 days |
| Hospital Length of Stay | Duration of Hospitalization on each arm | 90 days |
| Need for Re-hospitalization | 90-day re-hospitalization rate | 90 days |
| Change in Inflammatory Biomarkers | Baseline and delta (change from baseline) of D-Dimer | baseline and 90 days |
| BG001 | Control | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
|
|
| Primary | Mechanical Ventilation | Need for mechanical ventilation | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Primary | Mechanical Circulatory Support | Need for mechanical circulatory support | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Time (Days) to the Primary End Point | Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support | Posted | Number | days | 90 days |
|
|
|
| Secondary | Peak and Delta (Change From Baseline) Troponin Level | Change from baseline to the time when Troponin levels peak during the hospitalization | Posted | Number | ng/ml | baseline and 90 days |
|
|
|
| Secondary | Baseline Brain Natriuretic Peptide (BNP) Level | Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization | Posted | Number | pg/ml | baseline |
|
|
|
| Secondary | Inflammatory Biomarkers | Baseline and delta (change from baseline) of C-Reactive Protein | Posted | Number | mg/l | baseline and 90 days |
|
|
|
| Secondary | Hospital Length of Stay | Duration of Hospitalization on each arm | Posted | Number | days | 90 days |
|
|
|
| Secondary | Need for Re-hospitalization | 90-day re-hospitalization rate | Posted | Number | times hospitalized | 90 days |
|
|
|
| Secondary | Change in Inflammatory Biomarkers | Baseline and delta (change from baseline) of D-Dimer | Posted | Number | mcg/ml | baseline and 90 days |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 0 |
| 1 |
| EG001 | Control | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. | 0 | 1 | 1 | 1 | 0 | 1 |
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization due to COVID-19 |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |