NCT04365153

Canakinumab in Covid-19 Cardiac Injury (The Three C Study)

Canakinumab to Reduce Deterioration of Cardiac and Respiratory Function in SARSCoV2 Associated Acute Myocardial Injury With Heightened Inflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, Phase 2, single center, blinded randomized-controlled study designed as a proof of concept to demonstrate that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID 19 infection, myocardial injury and hyperinflammation. These results will lead to a Phase III randomized placebo-controlled trial. The study will be performed in approximately 7 months total, starting from the first patient enrolled with enrollment expected to complete within 2 months. The follow-up period is 5 months for each patient enrolled. The end of the study, including statistical analysis and drafting of the final report is expected within 1 month from the last patient enrolled. A total of 45 patients will be randomized using a 1:1:1 allocation ratio: 15 subjects will receive 600 mg intravenous canakinumab (8 mg/kg if \</= 40 kg), 15 subjects will receive 300 mg intravenous canakinumab (4 mg/kg if \</= 40 kg), and 15 patients will receive placebo infusion. The investigator, clinical team, and subject will be blinded to treatment assignment.

Conditions

• COVID-19
• SARS-CoV 2

Interventions

Type	Name	Description
DRUG	Canakinumab Injection 600mg	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
DRUG	Canakinumab Injection 300mg	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
DRUG	Placebos	250 mL of 5% dextrose infused IV over 2 hours

Timeline

• Start date: 2020-04-24
• Primary completion: 2021-02-02
• Completion: 2021-04-01
• First posted: 2020-04-28
• Last updated: 2021-04-15
• Results posted: 2021-04-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study