Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Study Details
Study Description
Brief Summary
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Colchicine plus current care Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians |
Drug: Colchicine Tablets
COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Other Names:
Other: Current care per UCLA treating physicians
Current care
|
| Active Comparator: Current care alone Current care per UCLA physicians alone (control arm) |
Other: Current care per UCLA treating physicians
Current care
|
Outcome Measures
Primary Outcome Measures
- Composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) [90 Days]
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
Secondary Outcome Measures
- Delta (peak minus baseline) troponin level [Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized]
Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
- Delta (baseline to peak) brain natriuretic peptide (BNP) level [Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized]
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
- Change in left ventricular ejection fraction (LVEF) on echocardiography [Baseline, Day 30]
Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
- Delta (peak minus baseline) C-Reactive protein (CRP) inflammatory biomarker level [Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized]
- Delta (peak minus baseline) D-Dimer inflammatory biomarker level [Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized]
D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link
- Time (days) to primary endpoint [up to 90 days]
- Number of participants requiring mechanical ventilation [90 days]
- Number of participants requiring mechanical circulatory support (MCS) [90 days]
- Re-hospitalization at 90 days [90 days]
Number of participants released and re-admitted to the hospital within 90 days of enrollment
- All-cause mortality [90 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed COVID-19 infection by polymerase chain reaction
-
Cardiac injury, including any of the following:
-
Elevated troponin level
-
Elevated B-type natriuretic peptide (BNP) level
-
New ischemic or arrhythmogenic changes on ECG/telemetry
-
New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
-
Able to provide informed consent
Exclusion Criteria:
-
Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:
-
Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
-
Hormone methods with a barrier method
-
Two barrier methods
-
If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
-
Co-administration of CYPA3A4 and P-glycoprotein (P-gp) transport system inhibitors
-
Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
-
Severe hematologic or neuaromuscular disorders
-
Severe renal impairmant with concomitant hepatic impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA Ronald Reagan Medical Center | Los Angeles | California | United States | 90095 |
| 2 | UCLA Santa Monica Hospital | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Reza Ardehali, MD, PhD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-000685