Phase 2
Completed N=93
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Source: ClinicalTrials.gov NCT04355143 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS) — 9; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS) |
9; 6 | — |
| SECONDARY Delta (Peak Minus Baseline) Troponin Level |
0.1; 0.10; 0.2; 0.1; 0.1; 0 | — |
| SECONDARY Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level |
503; 389; 611; 514; 108; 134 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography |
— | — |
| SECONDARY Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level |
9.9; 7.2; 13.6; 9.8; 3.9; 2.6 | — |
| SECONDARY Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level |
493.4; 669; 638.9; 861; 145.5; 212 | — |
| SECONDARY Composite Event-Free Survival Over Time (Days) |
48; 41; 40; 40; 36; 38 | — |
| SECONDARY Number of Participants Requiring Mechanical Ventilation |
4; 2 | — |
| SECONDARY Number of Participants Requiring Mechanical Circulatory Support (MCS) |
0; 0 | — |
| SECONDARY Re-hospitalization at 90 Days |
7; 10 | — |
| SECONDARY All-cause Mortality |
8; 6 | — |
Eligibility 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 Cytochrome P450 3A4 (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 neuromuscular disorders
- Severe renal impairment with concomitant hepatic impairment
Data sourced from ClinicalTrials.gov (NCT04355143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.