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Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) — Colheart-19  

Covid19 Clinical Trial

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)

Clinical Trial 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)

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04762771
Study type Interventional
Source Baptist Health South Florida
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date December 23, 2020
Completion date September 20, 2021
View Details
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