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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 days 3, 5, 9, and 14

Awards & highlights

RSVHR Trial Summary

This trial is testing a new drug to see if it can help people with RSV who are at high risk for complications.

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.Check my eligibility

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).See study design

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.

RSVHR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3, 5, 9, and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 3, 5, 9, and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3, 5, 9, and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Respiratory Tract Diseases

Secondary outcome measures

Perinatal death

Change from Baseline for Health-Related Quality of Life

Change from Baseline for impact scale

+15 more

Side effects data

From 2022 Phase 2 trial • 82 Patients • NCT04196101

Diarrhoea

Urinary tract infection

Urine ketone body present

Blood chloride decreased

Anaemia

Alanine aminotransferase increased

Dyspepsia

Protein total decreased

Blood creatine phosphokinase increased

Blood cholesterol increased

Hepatic function abnormal

Leukocytosis

Blood sodium decreased

Headache

Haemoptysis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

EDP-938

RSVHR 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

~420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Enanta Pharmaceuticals, IncLead Sponsor

39 Previous Clinical Trials

2,804 Total Patients Enrolled

Media Library

EDP-938 (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05568706 — Phase 2

Respiratory Syncytial Virus Research Study Groups: Placebo, EDP-938

Respiratory Syncytial Virus Clinical Trial 2023: EDP-938 Highlights & Side Effects. Trial Name: NCT05568706 — Phase 2

EDP-938 (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05568706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical care centers is this research being conducted?

"Currently, this trial is taking place in 9 locations. The sites are situated in Spartanburg, Ormond Beach and Miami as well other cities. To make the process more convenient for patients, it is best to enroll at a location nearest to them."

Answered by AI

When will EDP-938 be available for public consumption?

"EDP-938 is in Phase 2 of clinical trials, meaning that while there is some evidence supporting its safety, none yet exists for efficacy. Therefore, it received a score of 2."

Answered by AI

Are we still enrolling patients for this clinical trial?

"That is correct. The clinical trial in question, as indicated by information on clinicaltrials.gov, is still recruiting participants. This study was originally posted on October 1st, 2022 and was edited recently on the 14th of the same month. There are 9 locations across which the 180 necessary participants will be recruited."

Answered by AI

How many patients will be taking part in this experiment at most?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as actively recruiting new patients. This particular study was first posted on October 1st, 2022 and last updated two weeks ago on October 14th, 2022. A total of 180 individuals are being sought for participation across 9 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

2022. "A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05568706.

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