ClinicalTrials.gg
RecruitingNCT07908381RESOLVEUpdated Nov 2, 2026

A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease

A Phase 2/3 interventional study of zelicapavir and Placebo in RSV, sponsored by Enanta Pharmaceuticals, Inc. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Enanta Pharmaceuticals, Inc · Phase 2/3, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
860
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,277 studies in Pulmonary Disease, Chronic Obstructive with a site in United States — 137 open to participants now, 171 under way, 20 of them phase 3. Pulmonary Disease, Chronic Obstructive · United States.

Planned enrollment
133rd of 1,036
860 · median 100
Started
2026
with 36 others
Phase 2/3
12 of 1,277
3 open now
Primary completion
2029-07
later than 141 of 170 live
Registered
1,276th of 1,277
by date

Among the 1,277 studies in Pulmonary Disease, Chronic Obstructive with a site in United States, this one is the 133rd largest by planned enrollment of the 1,036 interventional ones that give a count, is one of 37 that started in 2026, is one of 12 in phase 2/3, reaches primary completion later than 141 of the 170 other live ones, and was the 1,276th registered.

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

137 of the 1,277 studies in Pulmonary Disease, Chronic Obstructive with a site in United States are open now. Recruiting first, the newest first:

131 more — sign in →

All 137 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Zelicapavir is a novel orally administered non-fusion replication inhibitor of RSV that is being developed for the treatment of patients with RSV infection. This phase 2b/3 study will evaluate the efficacy and safety of zelicapavir compared with placebo in adults with RSV who are at high risk for severe disease. High-risk participants include those who are either ≥75 years of age or ≥18 years of age with COPD and/or CHF. Participants will be non-hospitalized adults who have up to 72 hours of respiratory tract infection symptoms and test positive for RSV.

03

Conditions studied

  • RSV

Keywords

  • High Risk
  • Respiratory Syncytial Virus
  • EDP-938
  • COPD
  • CHF
  • Elderly
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥75 years at the time of enrollment, or, age ≥18 at the time of enrollment and has at least one of the following conditions that predispose them to complications of RSV infection:

    1. CHF
  • New onset or worsening of preexisting symptoms consistent with respiratory tract infection no more than 72 hours before administration of the first dose of study intervention: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
  • Reports at least 2 of the following symptoms, one of which must be reported by the participant as at least moderate in severity using the RiiQ™: cough, cough with phlegm, wheezing, or short of breath.
  • Tested positive for RSV infection defined as a positive nucleic acid amplification test (PCR or other) or rapid-antigen viral detection test performed on a nasal swab specimen collected no more than 72 hours before administration of the first dose of study intervention.
  • A woman of who is sexually active with a male must agree to use two effective methods of from the date of Screening until 30 days after her last dose of study drug.
  • A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  • Reported history of respiratory infection (other than RSV) within 7 days prior to signing the ICF.
  • Anticipated need for hospitalization within 24 hours of signing the ICF.
  • Receiving dialysis or have known severe renal impairment.
  • Reported history of chronic liver disease, including cirrhosis, hepatitis, end stage liver disease, history of hepatocellular carcinoma, or decompensated liver failure.
  • Prior receipt of or waiting to receive a bone marrow, stem cell, or solid organ transplant. Currently taking, or has taken within 7 days prior to randomization, or is anticipated to receive during the study, systemic medications that are known to cause . Note: Chronic use of immunomodulators such as dupilumab and omalizumab is permitted.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
860 participants (estimated)

Study arms

  • Experimental
    zelicapavir

    Zelicapavir 800 mg, orally

    Drug: zelicapavir

  • Placebo comparator
    Placebo

    Matching placebo, orally

    Drug: Placebo

Interventions

  • Zelicapavir 800mg, once daily for 7 days

  • DrugPlacebo

    Participants will take matching placebo, once daily for 7 days

06

What researchers measure

Primary outcomes

  1. Time to complete resolution of all 13 RSV symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ) symptom scale

    Time frame: Day 1 through Day 21

Secondary outcomes

  1. Number of participants with hospitalization due to RSV

    Time frame: Day 1 through Day 35

  2. Number of participants with hospitalization or death due to any cause

    Time frame: Day 1 through Day 35

  3. Number of participants who died

    Time frame: Day 1 through Day 35

  4. Number of participants with non-protocol defined medical visits for any cause

    Time frame: Day 1 through Day 35

  5. Time to complete resolution of RSV LRTD symptoms by RiiQ

    Time frame: Day 1 through Day 21

  6. Time to complete resolution of all 29 RSV parameters as assessed by RiiQ symptom scale score

    Time frame: Day 1 through Day 21

  7. Time to alleviation of LRTD symptoms by RiiQ

    Time frame: Day 1 through Day 21

  8. Time to alleviation of all 13 RSV symptoms as assessed by RiiQ

    Time frame: Day 1 through day 21

  9. Time to alleviation of all 29 RSV parameters as assessed by RiiQ

    Time frame: Day 1 through Day 21

  10. Time to complete resolution of RSV infection symptoms as assessed by PGI-S scale

    Time frame: Day 1 through Day 35

  11. Time to resolution to pre-existing symptoms

    Time frame: Day 1 through Day 21

  12. Number of participants requiring mechanical ventilation

    Time frame: Day 1 through Day 35

  13. Number of participants requiring supplemental oxygen in hospital

    Time frame: Day 1 through Day 35

  14. Number of participants requiring ICU admission

    Time frame: Day 1 through Day 35

  15. Change from baseline in RSV viral load

    Time frame: Up to Day 35

  16. Percentage of participants with RSV RNA viral load TND

    Time frame: Up to Day 35

  17. Time to RSV RNA viral load TND

    Time frame: Up to Day 35

  18. Safety as measured by frequency of adverse events (AEs)

    Time frame: Day 1 through Day 35

  19. Plasma Concentrations of zelicapavir

    Time frame: At Day 7

07

Study locations

4 of 4 sites recruiting
  • C&A Clinical Trials Corp
    Cape Coral, Florida 33990, United States
    Recruiting
  • Continental Clinical Research, LLC
    Miami, Florida 33144, United States
    Recruiting
  • PanAmerican Clinical Research
    Bluffton, South Carolina 29910, United States
    Recruiting
  • PanAmerican Clinical Research - Brownville
    Brownsville, Texas 78520, United States
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Jul 2029, 33 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartActual
Oct 19, 2026
Primary completionEst.
Jul 2029
CompletionEst.
Jul 2029
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07908381
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Oct 19, 2026
Primary completion
Jul 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Nov 2, 2026

Study contacts

Chris Harris, MD
Contact
charris@enanta.com
617-607-0800
Enanta Pharmaceuticals, Inc
study director · Enanta Pharmaceuticals, Inc

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: EDP-938

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