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

Enanta Pharmaceuticals, Inc187 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

187

Conditions

RSV Infection

Interventions

EDP-938DRUG

Subjects took EDP-938 once daily for 5 days

PlaceboDRUG

Subjects took matching placebo, once daily for 5 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least one of the following conditions that predispose them to complications after RSV infection: 1. Age ≥65 years 2. Congestive heart failure (CHF) 3. Asthma 4. 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

Locations (84)

Outcomes

Primary Outcomes

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

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.

Time frame: Day 1 through Day 33

Time to Complete Resolution of LRTD Symptoms for the mITT Population

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.

Time frame: Day 1 through Day 33

Time to Complete Resolution of LRTD Symptoms for the HR3 Population

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.

Time frame: Day 1 through Day 33

Secondary Outcomes

Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms

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.

Data from ClinicalTrials.gov

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Voyage Medical

Tempe, Arizona, United States

UCSF Fresno

Fresno, California, United States

Torrance Clinical Research Institute

Lomita, California, United States

Downtown LA Research Center Inc - ClinEdge - PPDS

Los Angeles, California, United States

Allianz Research Institute Inc

Westminster, California, United States

Allianz Research Institute - Colorado

Aurora, Colorado, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

C&A Clinical Trials Corp

Cape Coral, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Dinamo Research & Diagnostic center, LLC

Hialeah, Florida, United States

...and 74 more locations

Time frame: Day 1 through Day 33

Time to Resolution of All RSV Symptoms

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.

Time frame: Day 1 through Day 33

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

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.

Time frame: Day 1 through Day 33

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

Time frame: Day 1 through Day 33

Change From Baseline in Severity of RSV LRTD Symptoms

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.

Time frame: Day 1 through Day 33

Change From Baseline for Impact Scale

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.

Time frame: Day 1 through Day 33

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

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.

Time frame: Day 1 through Day 33

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

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.

Time frame: Day 1 through Day 33

Percentage of Participants With Post-baseline RSV-related Complications

Time frame: Day 1 through Day 33

Time to Improvement in RSV Disease

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.

Time frame: Day 1 through Day 33

Change From Baseline for Health-Related Quality of Life

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.

Time frame: Day 1 through Day 33

Time to Return to Usual Health

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'.

Time frame: Day 1 through Day 33

Time to Return to Usual Activities

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'.

Time frame: Day 1 through Day 33

Percentage of Subjects Requiring Hospitalization for RSV or Other Causes

Time frame: Day 1 through Day 33

Duration of Hospitalization for RSV or Other Causes

Time frame: Day 1 through Day 33

All-cause Mortality

Time frame: Day 1 through Day 33

RSV RNA Viral Load Change From Baseline for the mITT Population

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

Change in Infectious RSV Viral Load Over Time

Time frame: Up to Day 14

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

Time to RSV RNA Viral Load TND for the mITT Population

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.

Time frame: Day 1 through Day 14

Plasma PK Concentrations of EDP-938

Time frame: Up to Day 5

Safety as Measured by Frequency of Adverse Events (AEs)

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

Time frame: Up to Day 33

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

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.

Time frame: Day 1 through Day 33

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

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

Time frame: Day 1 through Day 33

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

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

Time frame: Day 1 through Day 33