At a glance
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Canakinumab to Reduce Deterioration of Cardiac and Respiratory Function in SARSCoV2 Associated Acute Myocardial Injury With Heightened Inflammation
In Brief
A Phase 2 clinical trial evaluating Canakinumab Injection 600mg, Canakinumab Injection 300mg, and 1 other intervention for COVID-19 and SARS-CoV 2. Completed, enrolled 45 participants across 2 sites.
Detailed Summary
TThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled study is to demonstrate as a proof of concept that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID-19 infection. These results will lead to and inform a Phase III randomized placebo-controlled trial.
Study Details
Timeline
Interventions
Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
250 mL of 5% dextrose infused IV over 2 hours