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 (RSVPEDs)

Status: Open to Recruitment

Population: Paediatric   

Disease Group: Respiratory Syncytial Virus (RSV) 

Funder: Enanta Pharmaceuticals, Inc. 

Sponsor: Enanta Pharmaceuticals, Inc. 

Principal Investigator: Dr. Simon Drysdale 


Study Aims

RSV can cause a variety of respiratory tract symptoms and is one of the most frequent causes of hospitalisation in babies and young children. The symptoms of RSV include: runny nose, fever, cough, trouble eating and drinking. In some babies and young children, the illness may move into the lungs and cause wheezing and difficulty breathing. In some instances, severe respiratory disease may require hospitalisation for support, such as oxygen.  

This study is investigating a new medicine called EDP-938 (study medicine) to see if it will help in the treatment of RSV infections in children, including collecting more information on the dose that should be used and it’s safety profile. The study compares the EDP-938 with placebo, or ‘dummy’ medicine. EDP-938 is an oral medication that targets RSV and prevents it from replicating in the body, so hopefully reducing severe RSV infections in children and babies. The study will consist of 2 parts: the purpose of part 1 is mostly to obtain information on dosage and safety of the study medicine, the 2nd part is mostly looking at how effective it is against RSV in children.  

What does participating in the study involve?

This study will enroll young children and infants who are unwell with an RSV infection and who would like to volunteer to take part. Before the study, we review the medical history and complete some procedures including a physical examination, electrocardiogram (ECG), taking a nose swab sample, a blood sample and a urine sample. Then participants will be randomly assigned (like flipping a coin) to take either study medicine or placebo (a ‘dummy’ medicine with no active ingredients) by mouth for 5 days, either in hospital or at home. Participants have a higher chance of getting study medicine rather than placebo.  

The study follow-up period continues up to day 29. During this period, we will be regularly in contact with families. The child will have regular blood tests to check the levels of the medication and other safety tests, as well as nose swabs for RSV and check-ups by the study doctor and nurse. Families are asked to complete an electronic study diary (eDiary) each day for the first 14 days after dosing. After 29 days the study is finished and the data is submitted to the study team.  

This study is happening all over the world in different countries. As with all our research studies, taking part is voluntary and families can change their mind at any time. We’re proud to be taking part in this exciting study, looking at a new medicine for RSV because there are no treatments available at the moment. If you would like to know more about this study please feel free to read the patient information sheet or get in touch on the email below.  

For more information about the study, please contact the study email address: rsvstudy@sgul.ac.uk