Evaluation of EDP-938 in subjects aged 28 days to 36 months with RSV.

• Research type

  Research Study

• Full title

  A phase 2, randomized, double-blind, placebo-controlled, 2 part study to evaluate EDP-938 regimens in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV).

• IRAS ID

  1003504

• Contact name

  Maria Gawryl

• Sponsor organisation

  Enanta Pharmaceuticals, Inc.

• Eudract number

  2020-001966-13

• Research summary

  This is a multicentre, phase 2, randomised, double-blind, placebo-controlled, 2-part study.

  This study is being conducted to evaluate whether the experimental medication, EDP-938, is effective at treating Respiratory Syncytial Virus (RSV) infection. RSV infections can cause a variety of respiratory tract symptoms. RSV infection is the most common cause of hospitalisations among babies and young children because of trouble breathing caused by pneumonia or bronchiolitis (inflammation of the small airways in the lungs). Symptoms start about 2 to 5 days after the child is infected with the virus. The early phase of RSV in babies and young children is often mild and similar to a cold.

  The study is planned to involve about 90 hospitalised and non-hospitalised children from the age of 28 days to 24 months, who have been diagnosed with RSV infection. Children will be enrolled in 1 of 4 age groups (Group 1: 12 to 24 months, Group 2: 6 to less than 12 months, Group 3: 3 to less than 6 months and Group 4: 28 days to less than 3 months). The study will consist of 2 parts and in each part children will receive either EDP-938 or a placebo once a day by mouth for 5 days.

  The study will start with Part 1 Group 1 and enrolment for the subsequent groups will only start once the Study Steering Committee (SSC) has reviewed available safety data and has recommended progression to another dose or age group. The same applies to Part 2. Each child will have a 2 out of 3 chance of receiving the EDP-938 in Part 1 and a 4 out of 5 chance in Part 2. Children will receive treatment with the Study Medicine for 5 days and at the end of treatment the study doctor will continue to monitor the child for another 23 days.

  Each child will take part in this study for around 29 days. The study will consist of Screening, Treatment, and Follow up periods. Each child will complete study procedures such as blood sample collection, nose swab samples, physical examinations and ECGs.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  21/EE/0081

• Date of REC Opinion

  8 Jun 2021

• REC opinion

  Further Information Favourable Opinion