COV-BARRIER [COVID-19]
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection
IRAS ID
284327
Contact name
Nidhi Sofat
Contact email
Sponsor organisation
Eli Lily and Company
Eudract number
2020-001517-21
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
Research Summary
COVID-19 is an infectious disease first discovered in December 2019 in Wuhan China. COVID-19 belongs to the coronavirus family that can cause illnesses ranging from the common cold to more severe diseases such as SARS and MERS. COVID-19 is mainly spread in sneeze or cough droplets and common symptoms include fever, dry cough and shortness of breath. The majority of individuals infected with COVID-19 experience a mild respiratory disease, however some patients will experience more severe symptoms and require hospitalisation. At this time, there are no specific vaccines or treatments for COVID-19. According to the WHO (Situation Report 129) as of 28th May 2020 there have been 5,593,631 cases of COVID-19 reported globally and 353,334 deaths.\nThere are currently no approved therapies for the treatment of COVID-19 infection. Management of COVID-19 is supportive, and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. The cause of ARDS is a hyperinflammatory response to the infection.\nBaricitinib, an approved therapy for the treatment of moderate to severe active rheumatoid\narthritis (RA) in adults, is being proposed as a potential therapy for patients with COVID-19. Baricitinib reduces inflammation within the body and could be a therapeutic option for COVID-19 because of its potential to block signalling from multiple proteins that are involved in the hyperinflammatory response to COVID-19.\nPatients will be eligible for the COV-BARRIER study if they are hospitalised with COVID-19 and do not require mechanical ventilation at the time of study entry. Study participants will be randomly assigned to receive placebo or baricitinib orally for up to 14 days or until hospital discharge, whichever comes first. There will be around 400 people taking part in this study globally. The main aim of the study is to evaluate the effect of baricitinib 4-mg compared to placebo on disease progression in patients with COVID-19.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0257
Date of REC Opinion
30 Jun 2020
REC opinion
Further Information Favourable Opinion