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Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With Coronavirus Disease-19
Amir Rabbani1, Asim Rafique1, Xiaoyan Wang2
1Division of Cardiology, University of California, Los Angeles, Los Angeles, CA, United States.
Insights
Colchicine did not benefit hospitalized patients with COVID-19 related cardiac injury. This randomized trial found no significant difference in mortality or need for mechanical support between colchicine and standard care groups.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- Cardiac injury is a known complication of Coronavirus disease-19 (COVID-19).
- The efficacy of colchicine in treating COVID-19 related cardiac injury remains unclear.
- Hospitalized patients with COVID-19 and cardiac injury represent a vulnerable population.
Purpose of the Study:
- To investigate the impact of colchicine on COVID-19 related cardiac injury in hospitalized patients.
- To evaluate the effect of colchicine on major adverse cardiac and respiratory outcomes.
- To assess the change in clinical status using the World Health Organization Ordinal Scale.
Main Methods:
- A multicenter, randomized, open-label clinical trial was conducted.
- 93 hospitalized adult patients with COVID-19 and cardiac injury were randomized 1:1 to colchicine plus standard of care or standard of care alone.
- Cardiac injury was defined by elevated biomarkers, new arrhythmias, left ventricular dysfunction, or pericardial effusion. The primary endpoint was a composite of mortality, mechanical ventilation, or mechanical circulatory support at 90 days.
Main Results:
- No significant difference was observed in the primary composite outcome between the colchicine and control groups (19% vs. 15%, p=0.78).
- Individual components, including all-cause mortality and need for mechanical ventilation, also showed no significant differences.
- Changes in the WHO Ordinal Scale and rates of at least 2-grade reduction were similar between the groups.
Conclusions:
- Colchicine therapy did not demonstrate a significant benefit for hospitalized patients with COVID-19 and cardiac injury.
- The findings suggest that colchicine is not effective in improving major clinical outcomes in this patient population.
- Further research may be needed to explore other therapeutic strategies for COVID-19 related cardiac complications.
Introduction:
The impact of colchicine on hospitalized patients with Coronavirus disease-19 (COVID-19) related cardiac injury is unknown.
Materials And Methods:
In this multicenter randomized controlled open-label clinical trial, we randomized hospitalized adult patients with documented COVID-19 and evidence of cardiac injury in a 1:1 ratio to either colchicine 0.6 mg po twice daily for 30 days plus standard of care or standard of care alone. Cardiac injury was defined as elevated cardiac biomarkers, new arrhythmia, new/worsened left ventricular dysfunction, or new pericardial effusion. The primary endpoint was the composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) at 90 days. Key secondary endpoints included the individual components of the primary endpoint and change in and at least 2-grade reduction in the World Health Organization (WHO) Ordinal Scale at 30 days. The trial is registered with clinicaltrials.gov (NCT04355143).
Results:
We enrolled 93 patients, 48 patients in the colchicine arm and 45 in the control arm. There was no significant difference in the primary outcome between the colchicine and control arms (19 vs. 15%, p = 0.78), nor in the individual components of all-cause mortality (17 vs. 15%, p = 1.0) and need for mechanical ventilation (8 vs. 5%, p = 0.68); no patients in either group required MCS. The change in (-1.8 ± 2.4 vs. -1.2 ± 2.0, p = 0.12) and at least 2-grade reduction (75 vs. 75%, p = 1.0) in the WHO ordinal scale was also similar between groups.
Conclusion:
Patients hospitalized with COVID-19 and evidence of cardiac injury did not benefit from colchicine therapy.
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