REVIRAL 1

• Research type

  Research Study

• Full title

  A Phase 2a Open-Label Study in Infants with REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebo controlled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)

• IRAS ID

  1004145

• Contact name

  Heather Welch

• Contact email

  hwelch@reviral.co.uk

• Sponsor organisation

  ReViral Ltd.

• Eudract number

  2018-001010-15

• Clinicaltrials.gov Identifier

  NCT04225897

• Research summary

  Respiratory syncytial virus (RSV) causes infections of the respiratory tract. Very severe disease can occur in the very young, especially premature infants, older adults, people with heart/lung disease, or anyone with a weak immune system. RSV spreads easily through the air in respiratory droplets and through other secretions from infected people, entering the body through the eyes, nose or mouth. Virtually all children will have been infected by the age of 2 years. The majority of children with RSV infection develop upper respiratory tract disease, but about a third can go on to develop bronchiolitis or pneumonia. Evidence suggests RSV bronchiolitis may create a long-term risk for developing asthma. Visits to GPs and hospitalisation due to RSV infection are a major and significant burden on health-care providers and hospitals during RSV outbreaks.
  In the northern hemisphere, RSV usually appears in October, peaks early January and ends in April. The virus then appears in the Southern hemisphere causing a similar epidemic during the winter season. Consequently, RSV is a worldwide issue. The burden of illness and mortality due to RSV is highest in children in the developing world. There is a large unmet need for effective therapy as current RSV treatments demonstrate limited benefit. Only two approved therapeutic agents exist, one a preventative treatment licensed for infants at high risk of developing severe disease and another which has limited potency.
  RV521 is being developed to treat RSV infection and disease in young children up to 3 years old.
  This is a 3-part study; Part A has already been successfully completed. Part B will continue to evaluate how safe/well tolerated RV521 is; the levels of drug in the blood and antiviral effect of RV521. Part C will explore the clinical effect compared to placebo on the course of infection.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0776

• Date of REC Opinion

  30 Nov 2021

• REC opinion

  Further Information Favourable Opinion