Study Detail

CANCOVID

Phase 3 multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab on cytokine release syndrome in patients with COVID-19-induced pneumonia (CAN-COVID)

Status: Open

Type: Interventional

Funder: Novartis

Sponsor: Novartis

CI: not available

IRAS-Number: 282416

CPMS-ID: 45567

Approval Date: 06 April 2020

Description:

The World Health Organisation (WHO) declared that a new human virus (Coronavirus COVID-19) as apandemic on 11th March 2019. In some people (~14%) COVID-19 infection leads to severe disease needing hospitalisation and support with breathing, and in 5% of cases admission to an intensive care unit. Over 100,000 deaths are reported worldwide. The purpose of this study is to evaluate if Canakinumab (investigational medication) given to patients with COVID-19 pneumonia (lung infection) is effective and safe at 3 hospital sites in the UK. Canakinumab is a controller of inflammation in a variety of conditions such as cardiovascular (heart) disease, cancer and diseases of the immune system. Canakinumab does this by reducing the production of cytokines immune cells) in the body. When the immune system overreacts, cytokine release syndrome (CRS) can develop leading to severe breathing difficulties (called acute respiratory distress syndrome - ARDS). Many patients with severe respiratory (lung) disease due to COVID-19 develop CRS and ARDS. This study is designed to assess whether canakinumab can safely and effectively be used to mitigate, treat, or cure COVID-19-induced pneumonia or limit the harm of the COVID-19 pandemic. Patients diagnosed with COVID-19 pneumonia will continue to have current standard of care and be offered the opportunity to take part in this study. Out of every 2 patients enrolled, one will be randomly assigned to receive Canakinumab (active) and one will be randomly assigned to placebo (no active drug). The investigator and patient will be blinded (will not know) which treatment is assigned. After a screening period of assessments which includes a review of medical history, physical examination, ECG (heart check), laboratory assessments (standard safety bloods) and a x-ray scan of the lungs, eligible patients will be given an infusion (direct into the blood stream) of study drug which will take 2 hours. After that patients will be monitored daily whilst in hospital and on Days 15, 29, 57 at Day 127. Patients will be in the study for a maximum of 127 days.

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