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Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) (Colheart-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: NCT04762771
Recruitment Status : Terminated (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.)
First Posted : February 21, 2021
Results First Posted : March 14, 2022
Last Update Posted : July 25, 2022
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Covid19 Drug: Colchicine Phase 1 Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
Actual Study Start Date : December 23, 2020
Actual Primary Completion Date : May 12, 2021
Actual Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Active Comparator: Active
Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.
Drug: 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

Other Name: Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19

No Intervention: Control
Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.



Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    Composite of all-cause mortality

  2. Mechanical Ventilation [ Time Frame: 90 days ]
    Need for mechanical ventilation

  3. Mechanical Circulatory Support [ Time Frame: 90 days ]
    Need for mechanical circulatory support


Secondary Outcome Measures :
  1. Time (Days) to the Primary End Point [ Time Frame: 90 days ]
    Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support

  2. Peak and Delta (Change From Baseline) Troponin Level [ Time Frame: baseline and 90 days ]
    Change from baseline to the time when Troponin levels peak during the hospitalization

  3. Baseline Brain Natriuretic Peptide (BNP) Level [ Time Frame: baseline ]
    Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization

  4. Inflammatory Biomarkers [ Time Frame: baseline and 90 days ]
    Baseline and delta (change from baseline) of C-Reactive Protein

  5. Hospital Length of Stay [ Time Frame: 90 days ]
    Duration of Hospitalization on each arm

  6. Need for Re-hospitalization [ Time Frame: 90 days ]
    90-day re-hospitalization rate

  7. Change in Inflammatory Biomarkers [ Time Frame: baseline and 90 days ]
    Baseline and delta (change from baseline) of D-Dimer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

    1. Elevated troponin level
    2. Elevated BNP level
    3. New ischemic or arrhythmogenic ECG/telemetry changes
    4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

Exclusion Criteria:

  • Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:

    1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
    2. Hormone method with a barrier method
    3. Two barrier methods
    4. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762771


Locations
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United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Sponsors and Collaborators
Baptist Health South Florida
University of California, Los Angeles
Investigators
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Principal Investigator: Sandra Chaparro, MD Baptist Health South Florida
Study Director: Raul E Herrera, MD Baptist Health South Florida
  Study Documents (Full-Text)

Documents provided by Baptist Health South Florida:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT04762771    
Obsolete Identifiers: NCT04510038
Other Study ID Numbers: 152247
First Posted: February 21, 2021    Key Record Dates
Results First Posted: March 14, 2022
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents