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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
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)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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.

Recruiting Locations

More Details

NCT ID
NCT04762771
Status
Terminated
Sponsor
Baptist Health South Florida

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)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.