Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults with Acute Respiratory Syncytial Virus Infection who are at High Risk for Complications

This study is looking at a new medicine called EDP-938 for adults who have an RSV infection and are managing their symptoms at home, but are considered at risk of developing more serious problems. The main goal is to find out if EDP-938 helps people recover more quickly from common RSV symptoms such as coughing, feeling short of breath, and wheezing. Researchers will also check if the medicine is safe to use. Half the participants will get the actual medicine, while the other half will get a dummy pill (placebo) to fairly compare the effects. This will help doctors understand if EDP-938 could be a helpful treatment for RSV.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Enanta Pharmaceuticals Inc.

Enrolment target

Start

05 Jul 2024

Respiratory syncytial virus (RSV)

What is this study about?

You might have heard of RSV (Respiratory Syncytial Virus), which is a common virus that can cause cold-like symptoms. For most healthy people, it's a mild illness. However, for some individuals, especially older adults or those with certain health conditions, RSV can lead to more serious breathing problems, sometimes affecting the lower parts of their lungs. This study is for people who have RSV and are being treated at home, but are considered to be at a higher chance of developing these more serious complications.

The study is testing a new medicine called EDP-938. The main things researchers want to find out are whether this medicine helps people with RSV feel better sooner, particularly from symptoms like coughing, feeling breathless, wheezing, and coughing up phlegm. They will also be carefully watching to see if the medicine is safe and if it causes any unwanted side effects. To make sure the results are fair, some participants will receive the actual medicine, while others will receive a 'dummy' pill that looks the same but contains no active medicine. This is a common and important way to study new treatments.

By taking part, you would be helping doctors and scientists learn more about how to treat RSV and potentially prevent more serious illness in those who are at higher risk. This information could lead to better treatments for many people in the future.

Key takeaways

This study is testing a new medicine (EDP-938) for RSV.
It's for adults with RSV who are at home but at higher risk of complications.
The main goal is to see if it helps people recover faster from RSV symptoms.
Some participants will get the new medicine, others a dummy pill.
Participation involves taking the medicine and regularly reporting symptoms.
You can leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. The study is open to both men and women. Importantly, you would need to have been diagnosed with an acute RSV infection and be managing your symptoms from home, rather than needing to be in hospital.

The researchers are specifically looking for people who are at a higher risk of developing complications from RSV. This might include those with certain underlying health conditions, but the detailed criteria would be explained to you by the study team.

There will also be other specific health requirements and checks to make sure the study is safe and suitable for you. If you're interested, the study team will go through all the detailed rules with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with RSV?
Are you currently managing your RSV symptoms at home (not in hospital)?
Are you considered by a doctor to be at higher risk for RSV complications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the study medicine (EDP-938) or a dummy pill (placebo) to take. You wouldn't know which one you are receiving. The study will involve regular check-ups, which might include clinic visits, phone calls, or questionnaires to assess your symptoms and how you are feeling. You would also be asked to complete questionnaires about your symptoms, daily activities, and general well-being throughout the study period.

The main part of the study will involve monitoring your symptoms for just over a month, up to Day 33, but the exact total duration of your involvement, including initial screening and follow-up, would be fully explained by the study team. You'll need to answer questions about your cough, breathlessness, and other symptoms, and report if you need any other medicines. There will also be assessments to check how the medicine is affecting your body and to ensure your safety.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the new medicine, EDP-938, might help you recover faster from your RSV symptoms. However, as it's a new medicine, there's also a chance it might not help you, or you might receive the dummy pill. Potential risks include experiencing side effects from the medicine, which will be carefully monitored. The study team will provide you with all known information about side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovakia
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Unverified
Spain
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Unverified
Poland
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Unverified
Czechia
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Unverified
Netherlands
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Unverified
Bulgaria

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but it can sometimes lead to more serious breathing problems, especially in certain individuals.

What is EDP-938?

EDP-938 is a new medicine being tested to see if it can help adults with RSV recover more quickly and prevent serious illness.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the actual medicine or the dummy pill. This helps ensure the study results are fair and unbiased.

Why a 'dummy pill' (placebo)?

A dummy pill (placebo) is used to compare against the active medicine. This helps researchers work out if any changes in your symptoms are due to the new medicine or other factors.

How long will I be in the study?

The main part of the study involves monitoring your symptoms for just over a month (up to Day 33), but the full commitment, including initial checks and follow-up, will be clearly explained by the research team.