What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) that inhibit viral replication, such as ribavirin, can have side effects including hemolytic anemia, rash, and respiratory complications. Other antiviral treatments may cause gastrointestinal symptoms like nausea and vomiting, as well as potential neuropsychiatric effects such as irritability and confusion. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved antiviral treatments specifically targeting RSV replication like EDP-938. The primary approach to managing RSV infections has been supportive care, as no curative therapies exist. Palivizumab, a monoclonal antibody, is approved for the prevention of severe RSV infection in high-risk infants but does not treat active infections. Research is ongoing to develop effective antiviral treatments for RSV, including agents like EDP-938 that inhibit viral replication.

What other types of research exist?

Promising novel alternatives to EDP-938 for RSV treatment include monoclonal antibodies like nirsevimab, which has shown efficacy in preventing RSV in infants, and antiviral agents such as remdesivir, which has been used off-label for severe RSV cases. Additionally, new RSV vaccines under development may provide preventive options.

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EDP-938 for Children with RSV (RSVPEDs Trial)

Phase 2

Waitlist Available

Research Sponsored by Enanta Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects diagnosed with RSV infection

Be younger than 18 years old

Must not have

Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness

Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medicine called EDP-938 in young children with RSV. The goal is to see if EDP-938 can safely help these children by stopping the virus from multiplying and causing illness. EDP-938 has shown strong antiviral activities in laboratory and animal studies.

Who is the study for?

This trial is for children with RSV infection. It includes kids aged 6 months to less than 3 years, and infants from about a month old to under 6 months who were born after at least 29 weeks of pregnancy. Caregivers must understand the study's needs and ensure the child can complete it. Children on certain life support, with recent transplants or cancer treatments, chronic oxygen therapy, immune deficiencies, or recent RSV medications are excluded.

What is being tested?

The study tests EDP-938 against a placebo in two parts to check its safety and effectiveness in treating RSV in children. The first part will focus on how well the drug works and if it's safe; the second part will look into how much of the drug gets into the bloodstream and how long it stays there.

What are the potential side effects?

While specific side effects for EDP-938 aren't listed here, common side effects for antiviral drugs like this may include nausea, vomiting, diarrhea, headache, dizziness, fatigue or allergic reactions. Each child's experience could vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an RSV infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not need life support treatments and am expected to survive my current illness.

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I have not had, nor am I waiting for, any transplant or received chemotherapy or radiation in the last year.

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I use oxygen at home regularly before being admitted.

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I have an immune deficiency not including IgA deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 82 Patients • NCT04196101

Urinary tract infection

Diarrhoea

Alanine aminotransferase increased

Blood creatine phosphokinase increased

Dyspepsia

Anaemia

Hepatic function abnormal

Blood chloride decreased

Blood cholesterol increased

Urine ketone body present

Headache

Blood sodium decreased

Protein total decreased

Haemoptysis

Leukocytosis

100%

80%

60%

40%

20%

Study treatment Arm

EDP-938

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EDP-938Experimental Treatment1 Intervention

EDP-938, oral suspension, once daily for 5 days

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo, orally, once daily for 5 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EDP-938

2021

Completed Phase 2

~510

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Respiratory Syncytial Virus (RSV) focus on inhibiting viral replication. Agents like EDP-938 work by targeting specific proteins or enzymes essential for the virus to replicate within the host cells. By blocking these critical components, these treatments prevent the virus from multiplying, thereby reducing the viral load and severity of the infection. This is particularly important for RSV patients, as it can lead to faster recovery, reduce the risk of severe complications, and limit the spread of the virus to others.

Pharmacological targets and emerging treatments for respiratory syncytial virus bronchiolitis.New therapies for acute RSV infections: where are we?