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Virus Therapy

EDP-938 for RSV Infection (RSVTx 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 49
Awards & highlights

RSVTx Trial Summary

This trial is testing a potential new treatment for people who have had a stem cell transplant and who have developed symptoms of a respiratory infection caused by the RSV virus.

Who is the study for?
This trial is for hematopoietic cell transplant recipients with a low lymphocyte count who have an acute upper respiratory tract infection caused by RSV. Participants must show symptoms like cough or sore throat, have no severe lung issues on recent chest imaging, and agree to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of EDP-938 compared to a placebo in managing RSV infections. It's randomized and double-blind, meaning participants are put into groups by chance and neither they nor the doctors know who gets the real drug or placebo.See study design
What are the potential side effects?
While specific side effects of EDP-938 aren't listed here, similar antiviral drugs can cause headaches, nausea, diarrhea, fatigue, and sometimes more serious reactions affecting blood counts or liver function.

RSVTx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 49
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 49 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who develop Lower Respiratory Tract (LRTC) complication
Secondary outcome measures
Change from baseline in RSV RNA viral load
Plasma PK Concentrations of EDP-938
Proportion of Subjects Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or all-cause mortality
+1 more

Side effects data

From 2022 Phase 2 trial • 82 Patients • NCT04196101
5%
Urinary tract infection
5%
Diarrhoea
3%
Hepatic function abnormal
3%
Alanine aminotransferase increased
3%
Dyspepsia
3%
Urine ketone body present
3%
Protein total decreased
3%
Blood cholesterol increased
3%
Headache
3%
Blood creatine phosphokinase increased
3%
Haemoptysis
3%
Blood sodium decreased
3%
Leukocytosis
3%
Blood chloride decreased
3%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
EDP-938

RSVTx Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-938Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-938
2021
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,339 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
39 Previous Clinical Trials
2,975 Total Patients Enrolled

Media Library

EDP-938 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04633187 — Phase 2
Respiratory Syncytial Virus Research Study Groups: EDP-938, Placebo
Respiratory Syncytial Virus Clinical Trial 2023: EDP-938 Highlights & Side Effects. Trial Name: NCT04633187 — Phase 2
EDP-938 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633187 — Phase 2
~2 spots leftby May 2025
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