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Completed

NCT Number: NCT05568706

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

This was a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who were at high risk for complications after RSV infection.

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Key information

Conditions

RSV Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Medico Platense, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one of the following conditions that predispose them to complications after RSV infection:
  • Age ≥65 years
  • Congestive heart failure (CHF)
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: 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.
  • The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
  • The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
  • A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception 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

  • The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF
  • The subject has concomitant respiratory infections that are viral (other than RSV but including influenza), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days prior to signing the Study ICF
  • The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF
  • The subject has COPD with spirometry results (obtained within 1 year prior to signing the Study ICF) FEV1 ≤35%
  • The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled.
  • The subject has any of the following cardiac conditions: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation
  • The subject has immunocompromised status
  • The subject is living in institutional care or assisted living facility and is also receiving acute care management for any respiratory condition; Note: Independent living apartments are not considered institutional care or assisted living facility

Treatment and study plan

EDP-938

Drug

Subjects took EDP-938 once daily for 5 days

Placebo

Drug

Subjects took matching placebo, once daily for 5 days

Primary outcomes

  1. Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms

    Time frame: Day 1 through Day 33

    Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  2. Time to Complete Resolution of LRTD Symptoms for the mITT Population

    Time frame: Day 1 through Day 33

    Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

  3. Time to Complete Resolution of LRTD Symptoms for the HR3 Population

    Time frame: Day 1 through Day 33

    Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

Secondary outcomes

  1. Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms

    Time frame: Day 1 through Day 33

    Resolution of LRTD and 2 Systemic Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) and each of the 2 systemic symptoms (feeling fever and fatigue/tiredness) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero or 1; Higher scores indicate worse outcomes (greater symptom intensity and greater impact on daily functioning). Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  2. Time to Resolution of All RSV Symptoms

    Time frame: Day 1 through Day 33

    Resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQ Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  3. Time to Complete Resolution of All RSV Symptoms for the mITT Population

    Time frame: Day 1 through Day 33

    Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero. Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

  4. Time to Complete Resolution of All RSV Symptoms for the HR3 Population

    Time frame: Day 1 through Day 33

    Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero. Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.

  5. Change From Baseline in Severity of RSV LRTD Symptoms

    Time frame: Day 1 through Day 33

    The RiiQ Infection Intensity Scale assesses 4 symptoms of LRTD (cough, shortness of breath, wheezing, and expectoration) on a scale from 0 (absent) to 3 (severe). The composite LRTD Score is the average of all 4 individual item scores.

  6. Change From Baseline for Impact Scale

    Time frame: Day 1 through Day 33

    The RiiQ Impact Scale assesses daily activities (7 items), emotions (4 items), and social relationships (5 items) on a scale of 0 (no impact) to 3 (extreme impact). The composite Impact Score is the average of all 16 individual item scores.

  7. Time to Resolution of Upper Respiratory Tract Disease Congestion, LRTD, and 2 Systemic Symptoms

    Time frame: Day 1 through Day 33

    Resolution of Symptoms is defined as the first of two consecutive timepoints where each of the RSV symptoms (4 LRTD symptoms [cough, short of breath, wheezing, coughing up phlegm [sputum]], 2 URTD symptoms [nasal congestion and sore throat], 2 Systemic symptoms [feeling feverish and fatigue[tiredness]]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  8. Time to no or Mild Impact of RSV Disease on Daily Activities, Emotions, and Social Relationships

    Time frame: Day 1 through Day 33

    Resolution of No or Mild Impact of RSV is defined as the first of two consecutive timepoints where each of the 3 impact Scale Scores (daily activities, emotions and social relationships) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  9. Percentage of Participants With Post-baseline RSV-related Complications

    Time frame: Day 1 through Day 33

  10. Time to Improvement in RSV Disease

    Time frame: Day 1 through Day 33

    Time to Improvement is defined as the time from first dose to first timepoint where the response assessed by PGI-C is 'Much better'. Time to Improvement is calculated as: date/time of Improvement - date/time of first timepoint.

  11. Change From Baseline for Health-Related Quality of Life

    Time frame: Day 1 through Day 33

    Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire; 5 dimensions (mobility, taking care of yourself, usual activities, pain/discomfort, and anxiety/depression) are scored on 5 levels from 1 (full health) to 5 (extreme disability). An index score is derived based on the 5 reported levels where 1.0 represents full health and 0.0 the worst possible health.

  12. Time to Return to Usual Health

    Time frame: Day 1 through Day 33

    Time to return to usual health is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Health is 'Yes'. Time to return to usual health is calculated as: date/time of return to usual health - date/time of response to 'Yes'.

  13. Time to Return to Usual Activities

    Time frame: Day 1 through Day 33

    Time to return to usual activities is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Activities is 'Yes'. Time to return to usual activities is calculated as: date/time of return to usual activities - date/time of first response to 'Yes'.

  14. Percentage of Subjects Requiring Hospitalization for RSV or Other Causes

    Time frame: Day 1 through Day 33

  15. Duration of Hospitalization for RSV or Other Causes

    Time frame: Day 1 through Day 33

  16. All-cause Mortality

    Time frame: Day 1 through Day 33

  17. RSV RNA Viral Load Change From Baseline for the mITT Population

    Time frame: Days 3, 5, 9, and 14

  18. Change in Infectious RSV Viral Load Over Time

    Time frame: Up to Day 14

  19. Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population

    Time frame: Days 1, 3, 5, 9 and 14

  20. Time to RSV RNA Viral Load TND for the mITT Population

    Time frame: Day 1 through Day 14

    Time to RSV viral load TND is defined as the time between the date of first dose to the first date of achieving viral load TND.

  21. Plasma PK Concentrations of EDP-938

    Time frame: Up to Day 5

  22. Safety as Measured by Frequency of Adverse Events (AEs)

    Time frame: Up to Day 33

    Number of subjects experiencing any Treatment-Emergent Adverse Events (TEAEs)

  23. Time to Resolution of RSV Infection Symptoms by Patient Global Impression of Severity (PGI-S) Scale Score for the mITT Population

    Time frame: Day 1 through Day 33

    PGI-S is a 7-point patient-reported scale ranging from 1 (normal/none) to 7 (among the most extremely ill); lower scores indicate less severe disease.

    Time to resolution is defined as time from the first dose to first of two consecutive timepoints where the response assessed by PGI-S is 'None'. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.

  24. Incidence of New Antibiotic Use, or New or Increased Use of Bronchodilators, Systemic or Inhaled Corticosteroids, or Oxygen Supplementation for the mITT Population

    Time frame: Day 1 through Day 33

    Incidence was defined as the number of subjects with new antibiotic, bronchodilators, inhaled corticosteroids or oxygen use

  25. Incidence of Unscheduled Medically Attended Visits for RSV Infection or Other Causes for the mITT Population

    Time frame: Day 1 through Day 33

    Incidence was defined as the number of subjects with unscheduled medically attended visits for RSV infection or other causes.

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults With Acute Respiratory Syncytial Virus Infection Who Are at High Risk for Complications

Acronym: RSVHR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2022
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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