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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
Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received a type of stem cell transplant called autologous HCT within the past 6 months, or a different type called allogeneic HCT at any time.

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%
Urine ketone body present
3%
Blood chloride decreased
3%
Dyspepsia
3%
Blood creatine phosphokinase increased
3%
Anaemia
3%
Alanine aminotransferase increased
3%
Protein total decreased
3%
Blood cholesterol increased
3%
Hepatic function abnormal
3%
Leukocytosis
3%
Blood sodium decreased
3%
Headache
3%
Haemoptysis
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

Frequently Asked Questions

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

What is the status of EDP-938's FDA approval process?

"EDP-938 is still in Phase 2 clinical trials, so there is only limited data supporting its safety."

Answered by AI

Are we recruiting individuals who are above the age of 50 for this trial?

"For this particular study, investigators are only recruiting patients that fall between the ages of 16-75. Out of the 939 total clinical trials, 244 were for patients under 18 years old and 695 were for seniors over the age of 65."

Answered by AI

Are there still open slots for people who want to participate in this clinical trial?

"That is correct, the online registry shows that this research is currently looking for participants. The trial was originally advertised on July 7th, 2021 and has since been updated October 12th, 2022. They are seeking 200 individuals from 3 different locations."

Answered by AI

Is there a limit to the number of people who can join this research project?

"The sponsor, Enanta Pharmaceuticals, Inc. needs to recruit 200 eligible patients from various locations, including Augusta University Medical Center in Augusta, Georgia and Toronto General Hospital in Toronto, Ontario."

Answered by AI

Could I take part in this experiment if I qualify?

"This clinical trial is recruiting 200 participants, within the ages of 16 and 75 who currently have respiratory syncytial virus infections. It is important that participants also meet the following criteria: Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen, Absolute lymphocyte count (ALC) <500 cells/ µL in allogeneic HCT recipients. Absolute lymphocyte count (ALC) <300 cells/ µL in autologous HCT recipients., Laboratory confirmed RSV diagnosis from a respiratory sample obtained within 3 days"

Answered by AI
~2 spots leftby Mar 2025