Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury — COLHEART-19  

Covid19 Clinical Trial

Official title: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Status Suspended

Clinical Trial Summary

Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.

Clinical Trial Description

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 and randomized study comparing the treatment of colchicine plus current care (per institution treating physicians) as the active arm vs. current standard of care alone (per institution treating physicians) as the control arm. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Myocardial Injury
• Wounds and Injuries

• NCT number: NCT04510038
• Study type: Interventional
• Source: Miami Cardiac and Vascular Institute
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Completion date: December 31, 2022