RUXCOVID [COVID-19] [UPH]
Research type
Research Study
Full title
Phase 3 randomised, double-blind, placebo-controlled multi-center study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm.
IRAS ID
282417
Contact name
James Warburton
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-001662-11
Duration of Study in the UK
0 years, 2 months, 19 days
Research summary
In some people (~14%) COVID-19 infection leads to severe disease requiring assisted breathing in a hospital setting, and in 5% of cases people are admitted to an intensive care unit. The purpose of this study is to evaluate if ruxolitinib given to patients with COVID-19 pneumonia (lung infection) is effective and safe. Ruxolitinib inhibits Janus kinase/tyrosine kinase (enzymes). These enzymes affect a number of immune cells (cytokines and growth factors) and can lead to the overreaction of the immune system called Cytokine Release Syndrome (CRS) or cytokine storm. Many patients with severe respiratory (lung) disease due to COVID-19 show signs of CRS. Ruxolitinib may be useful in treating these patients by blocking the enzyme pathway that can lead to CRS. Patients 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 a single tablet twice a day for 14 days. Two in three patients will be given ruxolitinib (active) and one in three patients will be given placebo (no active drug) decided at random. Neither the patients nor doctors will know who is receiving placebo. After 14 days the treatment can be extended by a further 14 days if needed. Medical history, physical examination, 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 for a maximum of 29 days.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0126
Date of REC Opinion
28 Apr 2020
REC opinion
Further Information Favourable Opinion