CLiCK Study [COVID-19]
Research type
Research Study
Full title
A study to assess the safety and efficacy of Clazakizumab in patients with COVID-19 and kidney disease.\n
IRAS ID
282936
Contact name
Michelle Willicombe
Contact email
Sponsor organisation
Imperial College London
Eudract number
2020-002476-13
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
As of 7th April 2020, Coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been confirmed in over 1.25 million people globally with a mortality rate of 5.7%. Evidence has emerged which suggests that acute respiratory distress syndrome (ARDS) is the leading cause of death following infection with SARS-CoV-2, and that severe disease may be associated with a hyperinflammatory state or cytokine release syndrome. Proinflammatory cytokines including IL6, have been shown to be significantly higher in patients with increased mortality risk. Given this, tocilizumab, an IL-6 receptor monoclonal antibody has already been utilised as a potential therapeutic agent. A randomised placebo controlled study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 Pneumonia [COVACTA], is currently open to recruitment. Patients who have significant co-morbidity or are receiving immunosuppression are excluded from this study, this includes patients receiving dialysis and who have received a renal transplant. Clazakizumab is a monoclonal antibody against the IL-6 which is currently being studied in a phase III trial for the treatment of antibody mediated rejection in kidney transplantation. The aim of this study is to investigate the efficacy of Clazakizumab in the treatment of 10 renal patients with severe COVID-19.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0140
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion