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Study on the Effectiveness and Safety of EDP-938 for Adults with High-Risk Respiratory Syncytial Virus (RSV) Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a drug called EDP-938 on adults who have an infection caused by the Respiratory Syncytial Virus (RSV). RSV is a virus that affects the respiratory system, which includes the lungs and airways. The study is particularly interested in adults who are not hospitalized but are at high risk for complications from this infection. The purpose of the study is to evaluate how well EDP-938 works in treating RSV and to assess its safety. Participants in the study will receive either the drug EDP-938 or a placebo, which is a tablet that looks like the drug but does not contain the active ingredient.

During the study, participants will take the medication in the form of a coated tablet by mouth. The study will monitor the progression of RSV infection by looking at clinical symptoms, which are the signs and feelings of illness that participants experience. The study will last for a period of time, and participants will be asked to report on their symptoms and any changes they notice. The study aims to understand how quickly symptoms of RSV improve and how the drug affects the overall health and daily activities of the participants.

The study will also look at the safety of EDP-938 by monitoring any side effects or adverse events that participants may experience. This includes checking vital signs, which are basic measures of health like heart rate and blood pressure, and conducting laboratory tests. The information gathered from this study will help determine if EDP-938 is an effective and safe treatment option for people with RSV who are at high risk for complications.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of respiratory syncytial virus (RSV) infection through a nasal swab test and reviewing medical history to ensure the participant meets the criteria for high risk of complications.

  3. Step 3

    Randomization and medication

    Participants will be randomly assigned to receive either the study drug EDP-938 or a placebo. The medication is administered orally in the form of coated tablets. The dosage and frequency will be determined by the study protocol.

  4. Step 4

    Treatment period

    During the treatment period, participants will take the assigned medication as directed. Regular monitoring will occur to assess the progression of RSV symptoms and any side effects.

  5. Step 5

    Follow-up assessments

    Follow-up assessments will be conducted to evaluate the resolution of RSV symptoms. This includes using questionnaires to measure symptom severity and impact on daily activities.

  6. Step 6

    End of study participation

    At the end of the study, participants will undergo a final assessment to determine the overall effect of the treatment. This includes reviewing any changes in health status and completing final questionnaires.

Who can join the trial?

14 criteria

  • The person must have signed and dated the informed consent forms, which means they agree to participate in the study.
  • The person must be an adult, at least 18 years old, and have one of the following conditions that could lead to complications after a **Respiratory Syncytial Virus (RSV)** infection:
    • Age 65 years or older
    • **Congestive Heart Failure (CHF)**, which is a condition where the heart doesn't pump blood as well as it should
    • **Asthma**, a condition that makes it hard to breathe
    • **Chronic Obstructive Pulmonary Disease (COPD)**, a lung disease that makes it hard to breathe
    • The person must have new or worsening symptoms of a respiratory tract infection, like feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or shortness of breath, within 72 hours before the first dose of the study drug.
    • The person must report at least two symptoms, such as cough, cough with phlegm, wheezing, or shortness of breath, with at least one being of moderate severity.
    • The person must have tested positive for **RSV** infection using a test called **NAAT** (like a **PCR** test) on a nasal swab sample.
    • The person must have a **Body Mass Index (BMI)** between 18 and 40. BMI is a measure of body fat based on height and weight.
    • A sexually active female must agree to use two effective birth control methods during the study and for 30 days after the last dose of the study drug, or be surgically sterile or postmenopausal.
    • A sexually active male and their female partner(s) must agree to use two effective birth control methods during the study and for 90 days after the last dose of the study drug.
    • Female participants must agree not to donate eggs from the screening date until 30 days after their last dose of the study drug.
    • Male participants must agree not to donate sperm from the screening date until 90 days after their last dose of the study drug.
    • The person must be willing and able to follow the study's assessments, visit schedule, and any rules or restrictions.

Who cannot join the trial?

7 criteria

  • Individuals with a known allergy or adverse reaction to the study medication or its ingredients.
  • Participants who have received another investigational drug within a certain period before the study.
  • People with a history of severe or uncontrolled medical conditions that could interfere with the study.
  • Individuals who are pregnant or breastfeeding.
  • Participants with a history of drug or alcohol abuse that could affect their ability to follow the study procedures.
  • People who have been diagnosed with another respiratory illness that could interfere with the study results.
  • Individuals who are unable to comply with the study requirements or follow-up visits.
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Investigated drugs

EDP-938 is a medication being studied for its potential to treat respiratory syncytial virus (RSV) infection in adults who are not hospitalized but are at high risk for complications. The trial aims to determine how effective and safe EDP-938 is in reducing the symptoms and progression of RSV infection.

What is already known about the treatment

EDP-938 – EDP-938 is an investigational medication administered orally, currently being studied in clinical trials for its potential to treat respiratory syncytial virus (RSV) infections. It is in the Phase 2b stage of clinical trials, focusing on non-hospitalized adults at high risk for complications from RSV. The main therapeutic indication for EDP-938 is to prevent the progression of RSV infection by alleviating clinical symptoms. At the molecular level, EDP-938 works by inhibiting the replication of the RSV virus, thereby reducing the viral load in the body. It is classified pharmacologically as an antiviral agent.

Investigated diseases

Respiratory Syncytial Virus (RSV) Infection – This is a common respiratory virus that usually causes mild, cold-like symptoms. It can affect people of all ages but is particularly serious for infants and older adults. The virus primarily infects the respiratory tract, leading to symptoms such as coughing, wheezing, and difficulty breathing. In some cases, it can progress to more severe respiratory illnesses like bronchiolitis or pneumonia. The infection typically spreads through respiratory droplets when an infected person coughs or sneezes. Most people recover in a week or two, but the virus can cause significant discomfort and complications in vulnerable populations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513861-38-00Protocol codeEDP 938-104Estimated enrolment111 patientsSponsorEnanta Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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