What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) include supportive care and antiviral agents. Supportive care typically involves hydration, oxygen therapy, and mechanical ventilation if necessary. Antiviral agents, such as ribavirin, have been used to target RSV replication. Known side effects of ribavirin include hemolytic anemia, rash, and respiratory complications. Newer antiviral agents like EDP-938 are being studied, and while specific side effects for EDP-938 are not detailed, similar agents may cause gastrointestinal disturbances, headache, and potential liver enzyme elevations. It is important to consult with a healthcare provider for the most current and personalized information.

What prior FDA approvals exist?

As of now, there are no FDA-approved antiviral agents specifically targeting RSV replication similar to EDP-938. The primary treatment for RSV has been supportive care, including oxygen therapy and hydration. 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 therapies for RSV, including agents like EDP-938.

What other types of research exist?

Promising novel alternatives to EDP-938 for RSV treatment in 2024 include: 1) Remdesivir, which has shown broad-spectrum antiviral activity and efficacy in treating various viral infections, including RSV. 2) Monoclonal antibodies like Palivizumab, which are used for prophylaxis in high-risk infants and may have therapeutic potential. 3) Newer agents in clinical trials, such as Nirsevimab, a long-acting monoclonal antibody designed for RSV prevention in infants, which may also be explored for therapeutic use in adults.

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Antiviral

EDP-938 for Respiratory Syncytial Virus (RSVHR Trial)

Phase 2

Recruiting

Research Sponsored by Enanta Pharmaceuticals, Inc

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests an oral medication called EDP-938 for adults with RSV who are at high risk of severe illness. The goal is to help fight the virus or reduce its impact.

Who is the study for?

Adults over 65 or those with heart failure, asthma, COPD at high risk for RSV complications can join. They must have recent respiratory symptoms and a positive RSV test. Participants need to use contraception if of childbearing potential. Exclusions include recent COVID-19 infection, severe lung function impairment, certain heart conditions, living in care facilities receiving acute respiratory management, imminent hospitalization need, recent systemic anti-infective therapy or active viral hepatitis/HIV.

What is being tested?

The trial is testing EDP-938 against a placebo in non-hospitalized adults with confirmed RSV who are at high risk for complications. It's a Phase 2b study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).

What are the potential side effects?

While specific side effects of EDP-938 aren't listed here, common side effects from antiviral drugs may include nausea, diarrhea, headache and rarely more serious reactions like allergic responses or liver problems.

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-938 800 mg, once daily

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo, once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EDP-938

2021

Completed Phase 2

~510

Do I qualify?Apply below to find out

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 antiviral agents that inhibit the virus's replication. For example, EDP-938, an antiviral agent under study, targets the replication process of RSV, thereby reducing the viral load in the patient's body. This mechanism is crucial for patients, particularly those at high risk for complications, as it can lead to faster recovery and fewer severe outcomes. While antiviral agents are being developed and studied, supportive care remains the primary treatment recommendation, emphasizing the need for effective antiviral therapies to improve patient outcomes.

New therapies for acute RSV infections: where are we?