Double-blind randomized proof-of-concept trial of canakinumab in patients with COVID-19 associated cardiac injury and heightened inflammation

Authors

Paul C Cremer
Calvin C Sheng
Debasis Sahoo
Siddharth Dugar
Robier Aguillon Prada
Tom Kai Ming Wang
Ossama K Abou Hassan
Jamie Hernandez-Montfort
David A Wolinsky
Daniel A Culver
Prabalini Rajendram
Abhijit Duggal
Danielle M Brennan
Katherine E Wolski
A Michael Lincoff
Steven E Nissen
Venu Menon

Publication Date

8-1-2021

Journal

European Heart Journal Open

Abstract

AIMS: In coronavirus disease 2019 (COVID-19), myocardial injury is associated with systemic inflammation and higher mortality. Our aim was to perform a proof of concept trial with canakinumab, a monoclonal antibody to interleukin-1β, in patients with COVID-19, myocardial injury, and heightened inflammation.

METHODS AND RESULTS: This trial required hospitalization due to COVID-19, elevated troponin, and a C-reactive protein concentration more than 50 mg/L. The primary endpoint was time to clinical improvement at Day 14, defined as either an improvement of two points on a seven-category ordinal scale or discharge from the hospital. The secondary endpoint was mortality at Day 28. Forty-five patients were randomly assigned to canakinumab 600 mg (

CONCLUSION: There was no difference in time to clinical improvement at Day 14 in patients treated with canakinumab, and no safety concerns were identified. Future studies could focus on high dose canakinumab in the treatment arm and assess efficacy outcomes at Day 28.

Keywords

COVID-19, Myocardial injury, Canakinumab, Interleukin-1