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:
- Cough
- Runny nose
- Nasal congestion
- Fever
- Rapid breathing
- Shortness of breath
- Wheezing
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:
- Food
- 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.
Frequently Asked Questions
The investigational drug, EDP-938, is being studied as a potential treatment for respiratory syncytial virus (RSV) infections in infants and toddlers. The investigational drug comes in an oral suspension that is given by mouth for 5 days.
If your child is eligible to participate, he/she will receive their assigned study medicine, either the investigational drug or placebo, once daily for five days. Your child will also have procedures and assessments that are necessary to monitor safety and collect the required information about the study medicine. All patients who agree to participate in the study are closely monitored by clinic staff and the medical team to ensure their safety.
A placebo looks like the investigational drug being tested, but it doesn’t have any active ingredients and is not expected to have any effect. In placebo-controlled research, one group is given the placebo, while another group is given the investigational drug. This is the best way to find out if the treatment being tested works better than the placebo.
During Part 1 of the study, your child will have a 2 out of 3 chance of receiving the investigational drug. During Part 2, your child will have a 4 out of 5 chance of receiving the investigational drug.
Participation in any clinical study is completely voluntary. Your decision to have your child participate – or not participate – in this clinical study will have no effect on the medical care that he/she receives now or in the future. You may leave the clinical study at any time, and for any reason.
Study participants will be reimbursed for any reasonable study-related expenses.
There are many reasons to participate in clinical research. Study participants play an important role in helping to bring new treatment options to market. Being a participant in a clinical study can help thousands of people who have viruses, diseases and other conditions.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you and your child have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
Enanta Pharmaceuticals, Inc. is responsible for conducting this clinical study.
