Phase 3 multi-centre, 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)
This is a randomised controlled trial, looking at the effect of a canakinumab on those with significant Covid-19 induced acquired pneumonia. Canakinumab is a human monoclonal antibody, which has been used to treat inflammatory conditions such as rheumatoid arthritis.
This is a study which is considered a national priority.
Participants will be randomised into one of two arms:
- Canakinumab plus standard care
- Placebo plus standard care
Data will be collected daily while in hospital and then followed up 2 months and 4 months later.
Who can participate?
Patients will be eligible if they are
- Hospitalised with Symptoms
- Confirmation of SARS-CoV-2 infection by PCR
- Pneumonia evidence by chest x-ray or CT scan with pulmonary infiltrates
- SpO2 ≤ 93%
- Fever of ≥38°C/100.4°F within 48 hours prior to randomisation
- Known sensitivity to canakinumab
- Those on mechanical ventilation
- Pregnant or breast feeding
- Suspected active bacterial, fungal, viral and parasitic infection with the exception of Covid-19