CANCOVID [COVID-19] [UPH]
Research type
Research Study
Full title
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)
IRAS ID
282416
Contact name
John Forni
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-001370-30
Duration of Study in the UK
0 years, 5 months, 5 days
Research summary
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. The purpose of this study is to evaluate if canakinumab given to patients with COVID-19 pneumonia (lung infection) is effective and safe. Canakinumab controls inflammation in a variety of illnesses such as cardiovascular (heart and blood vessel) disease, cancer and diseases of the immune system. It does this by reducing the production of cytokines (substances produced by certain cells of the immune system) in the body. When the immune system overreacts cytokine release syndrome (CRS) can happen 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 show whether canakinumab can safely and effectively be used to treat, or cure COVID-19-induced pneumonia. \n\nPatients diagnosed with COVID-19 pneumonia at three hospital sites in the UK will be studied. They will all receive normal hospital treatment. In addition patients will be given an infusion (direct into the blood stream) of canakinumab or placebo (one with no active ingredient) infusion which will take two hours. One in two patients will be given canakinumab and one will be given placebo, decided at random. Neither the patients nor doctors will know who is receiving placebo. Medical history, physical examination including an electrocardiogram (ECG heart check), blood tests and a chest x-ray/ scan of the lungs will be taken before treatment. Patients will then be monitored daily whilst in hospital and on Days 15, 29, 57 at Day 127 after leaving hospital. Patients will be in the study for a maximum of 127 days.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0125
Date of REC Opinion
28 Apr 2020
REC opinion
Further Information Favourable Opinion