Clinical trial NCT04762771: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2021-02-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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)

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)

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 90 days
measure: Mechanical Ventilation
timeFrame: 90 days
measure: Mechanical Circulatory Support
timeFrame: 90 days
Secondary outcomes:
measure: Time (Days) to the Primary End Point
timeFrame: 90 days
measure: Peak and Delta (Change From Baseline) Troponin Level
timeFrame: baseline and 90 days
measure: Baseline Brain Natriuretic Peptide (BNP) Level
timeFrame: baseline
measure: Inflammatory Biomarkers
timeFrame: baseline and 90 days
measure: Hospital Length of Stay
timeFrame: 90 days
measure: Need for Re-hospitalization
timeFrame: 90 days
measure: Change in Inflammatory Biomarkers
timeFrame: baseline and 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Sandra Chaparro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Health South Florida
name: Raul E Herrera, MD
role: STUDY_DIRECTOR
References:
citation: 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.