Study Detail

RUXCOVID

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.

Status: Open

Type: Interventional

Funder: Novartis

Sponsor: Novartis

CI: not available

IRAS-Number: 282417

CPMS-ID: 45565

Approval Date: 06 April 2020

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.

Description:

The World Health Organisation (WHO) declared that a new human virus (Coronavirus COVID-19) as a pandemic 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 64,000 deaths are reported worldwide. The purpose of this study is to evaluate if ruxolitinib (investigational medication) given to patients with COVID-19 pneumonia is effective and safe at 3 hospital sites in the UK. Ruxolitinib is a well-established, potent and selective inhibitor of Janus kinase/tyrosine kinase (enzymes). These enzymes are involved with the signaling of a number of immune cells (cytokines and growth factors) that can lead to the overreaction of the immune system called Cytokine Release Syndrome (CRS) Many patients with severe respiratory (lung) disease due to COVID-19 have features consistent with the CRS. It is thought that ruxolitinib might be useful in treating these patients by blocking the enzyme pathway that can lead to CRS. Patients diagnosed with COVID-19 pneumonia (infection of the lungs) will continue to have current standard of care and be offered the opportunity to take part in this study. Out of every 3 patients enrolled, two will be randomly assigned to receive ruxolitinib (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 serology) and a chest x-ray/scan of the lungs, eligible patients will take a single tablet twice a day for 14 days. After 14 days the treatment can be extended by a further 14 days if needed. Patients will be in the study for a maximum of 29 days.

Study URL:

https://research.cmft.nhs.uk/research/covid-19-research/ruxcovid

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