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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

    nsofat@sgul.ac.uk

  • 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

    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