1 in every 100 children up to 6 months may be hospitalized yearly due to respiratory syncytial virus (RSV).
Introducing a clinical study for infants and toddlers (ages 28 days to 36 months) diagnosed with RSV.
Respiratory syncytial virus (RSV) is a common yet very contagious virus that infects the respiratory tract of most children before their second birthday. Some cases of RSV cause nothing more than cold symptoms. But there are extreme cases that can result in severe respiratory disease that may require hospitalization or other more aggressive treatments. The common symptoms of RSV infection include:
- Runny nose
- Nasal congestion
- Rapid breathing
- Shortness of breath
Researchers are working to find a treatment for RSV, and the purpose of this study is to see if an investigational drug, EDP-938, will help. The RSVPEDs Study will evaluate the safety and efficacy of the experimental drug EDP-938 in children, and determine the dose of EDP-938 that works best. EDP-938 has been tested in healthy adults in studies and has shown a favorable safety profile to date.
Your child may be eligible to participate in the RSVPEDs Study if they are:
- Between the ages of 28 days and 36 months
- Diagnosed with respiratory syncytial virus (RSV)
- Experiencing symptoms of RSV
- Either hospitalized or not hospitalized for this condition
If your child is eligible to participate, they will have up to 7 visits with the study doctor and be enrolled in the study for 29 days. During this time, they will:
- Take the study drug for 5 days
- Receive standard-of-care treatment for RSV
- Complete study procedures and tests
- Be closely monitored by our team of medical professionals
There are no costs associated with participating in this clinical study. The following items will be provided to you and your child free of charge:
- The study medicine
- All study-related visits, procedures and tests
- Reimbursements for any reasonable expenses incurred by taking part in the study. This may include:
- Travel to and from study visits
- Parking for study visits
To see if the RSVPEDs Study is right for your child, please find a local study center from the list below. Then contact a member of the study team to schedule a screening visit. To find more, please go to https://clinicaltrials.gov/ct2/show/NCT04816721.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment is safe and effective in people. (Definition from National Institutes of Health website, www.nia.nih.gov)
Clinical studies play an important role in the development of new medical treatments. By choosing to enroll your child in the RSVPEDs Study, you are helping us better understand the investigational drug and how it can potentially improve the symptoms resulting from an RSV infection. Participation in a clinical study is completely voluntary. Your decision to have your child participate or not participate will have no effect on the medical care he/she receives, either now or in the future.