Respiratory Syncytial VirusPhase 2RSVPNCT04196101
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus, run by Enanta Pharmaceuticals, Inc at 29 sites in 7 countries.
Trial summary
This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- EDP-938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 22 Jan 2020to 4 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An informed consent document must be signed and dated by the subject
- Male or female individuals aged 18 to 75 years, inclusive.
- Up to 48 hours of URTI symptoms with at least one of the following symptoms:
- Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, and/or symptoms of fever.
- Positive for RSV infection and negative for influenza virus based on rapid diagnostic.
- Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol.
Who cannot join
- SARS-CoV-2 positive within 28 days of Screening or at Screening following signature of full ICF.
- Clinical evidence of a lower respiratory tract infection, as determined by the Investigator.
- Anticipated need for hospitalization or emergency room care within 24 hours of Screening.
- Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening and for the duration of the study
- Awareness of concomitant respiratory infections that are viral (other than RSV), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days of Screening.
- Frailty scale score ≥4 at Screening.
Show all 23Show fewer
- History of chronic liver disease (eg, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or alcoholic liver disease); a history of biliary disease (eg, primary sclerosing cholangitis, cholecystitis, choledocholithiasis); or a history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver) is not exclusionary.
- Heart disease: any congenital heart disease, acute or chronic heart failure, ischemic heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation.
- Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury).
- Malignant tumor or history of malignancy that may interfere with the aims of the study or a subject completing the study.
- Prior receipt or the subject is waiting to receive a bone marrow, stem cell, or solid organ transplantation.
- Diagnosis of cystic fibrosis.
- Known positive human immunodeficiency virus, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection.
- Prior or planned ileal resection or bariatric surgery.
- Pregnant or nursing female subjects.
- History of alcohol addiction or current heavy alcohol use defined as: >14 standard drinks per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per week and/or ≥3 standard drinks per occasion for females. A standard drink is 12 oz of beer (5% alcohol), 5 oz table wine (12% alcohol), or 1.5 oz of spirits (40% alcohol).
- Known or suspected, in the opinion of the Investigator, renal disease or renal impairment.
- Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged by the Investigator at Screening.
- Use of or intention to use excluded or contraindicated medication(s) or supplements, including any medication known to be a moderate or potent inducer or inhibitor of the cytochrome P450 3A4 enzyme, within 14 days prior to Screening and for the duration of the study.
- Receipt of ≥14 days of systemic immunomodulator therapy (eg, oral corticosteroids) within 3 months of Screening.
- Prior to the first dose of study drug and during study participation, the subject has received any vaccine, investigational agent, or biological product within 30 days or 5 times the half-life, whichever is longer. Note: Influenza vaccination within 7 days of Screening is allowed.
- Use of St John's wort within 28 days prior to the first dose of study drug and for the duration of the study.
- History of or currently experiencing a medical condition or any other finding (including laboratory test results) that, in the opinion of the Investigator, might confound the results of the study; pose an additional risk in administering study drug to the subject; could prevent, limit, or confound the protocol-specified assessments; or deems the subject unsuitable for the study.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
United States12 sites
Saint Joseph's Clinical Research
Anaheim, California, 92804
Pioneer Clinical Research LLC
Bellevue, Nebraska, 68005
Central Alabama Research
Birmingham, Alabama, 35209
FMC Science
Lampasas, Texas, 76550
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Torrance Clinical Research Institute
Lomita, California, 90717
Miami Clinical Research - ClinEdge - PPDS
Miami, Florida, 33155
Meridian Clinical Research
Norfolk, Nebraska, 68701
Cahaba Research Inc. - Birmingham
Pelham, Alabama, 35124
Carolina Research Center
Shelby, North Carolina, 28150
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Bulgaria6 sites
Multiprofile Hospital for Active Treatment Puls
Blagoevgrad, 2700
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
Haskovo, 6300
Medical Center Zdrave-1 OOD
Kozloduy, 3320
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431
Medical Center Hera
Sofia, Sofia-Grad, 1510
Medical Center Tara OOD
Veliko Tarnovo, 5000
Ukraine5 sites
Communal Non-Profit Enterprise City Clinical Hospital #1 of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014
City Outpatient Clinic #9
Kyiv, 3035
Medical Center of LLC Preventclinic
Kyiv, 3035
Limited Liability Company Medical Center Consilium Medical
Kyiv, 4050
Municipal Enterprise The 1st City Clinical Hospital of Poltava City Council
Poltava, Poltava Oblast, 36039
New Zealand2 sites
Lakeland Clinical Trials - Waikato
Hamilton, 3200
Lakeland Clinical Trials
Rotorua, 3010
Poland2 sites
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota
Ostróda, 14-100
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, Lesser Poland Voivodeship, 33-100
South Africa1 site
Clinical Projects Research SA pty Ltd
Worcester, Western Cape, 6850
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)
This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.
Read the detailed description
Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study.
Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects.
For each subject, the duration of study participation was approximately 2 weeks and consisted of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).
- Conditions
- Respiratory Syncytial Virus
- Being tested
- EDP-938, Placebo
- Keywords
- RSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-938Drug
Four tablets daily for 5 days
PlaceboDrug
Four tablets daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 | Experimental | Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days Receives: Drug: EDP-938 |
| Placebo | Placebo comparator | Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Score (TSS) Area Under the Curve (AUC)
Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analysis.
Measured: Day 1 through Day 14
Secondary outcomes (3)
RSV RNA Viral Load Area Under the Curve (AUC)
RSV RNA viral load as measured in nasopharyngeal swab samples by RT-qPCR on Days 1 (Baseline, time 0), 3, 5, 9, and 14 to generate curve for analysis.
Measured: Day 1 through Day 14
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)
Proportion of patients that have undetectable RSV RNA by qRT-PCR at Days 3, 5, 9 and 14.
Measured: Days 3, 5, 9 and 14
Number of Participants With Adverse Events
Measured: Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start22 Jan 2020
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Scott Rottinghaus, MD, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196101
- Sponsor's protocol ID
- EDP 938-102
- Acronym
- RSVP
- Status last verified
- Sep 2023
- First submitted
- 3 Dec 2019
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)
- ClinicalTrials.gov ID
- NCT04196101
- Acronym / sponsor ID
- RSVP / EDP 938-102
- Conditions
- Respiratory Syncytial Virus
- Keywords
- RSV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 30 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.
Detailed description
Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study.
Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind, placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of acute URTI with confirmed RSV infection in ambulatory adult subjects.
For each subject, the duration of study participation was approximately 2 weeks and consisted of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDP-938 | Experimental | Drug: EDP-938Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take EDP-938 matching placebo tablets once a day orally for 5 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An informed consent document must be signed and dated by the subject
- Male or female individuals aged 18 to 75 years, inclusive.
- Up to 48 hours of URTI symptoms with at least one of the following symptoms:
- Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, and/or symptoms of fever.
- Positive for RSV infection and negative for influenza virus based on rapid diagnostic.
Key exclusion criteria (23 listed)
- SARS-CoV-2 positive within 28 days of Screening or at Screening following signature of full ICF.
- Clinical evidence of a lower respiratory tract infection, as determined by the Investigator.
- Anticipated need for hospitalization or emergency room care within 24 hours of Screening.
- Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening and for the duration of the study
- Awareness of concomitant respiratory infections that are viral (other than RSV), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-938Four tablets daily for 5 days | Drug | EDP-938 |
| PlaceboFour tablets daily for 5 days | Drug | Placebo |
Primary outcome
Total Symptom Score (TSS) Area Under the Curve (AUC)
Time frame: Day 1 through Day 14
Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analysis.
3 secondary outcomes
RSV RNA Viral Load Area Under the Curve (AUC)
Time frame: Day 1 through Day 14
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD)
Time frame: Days 3, 5, 9 and 14
Number of Participants With Adverse Events
Time frame: Day 1 through Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Rottinghaus, MD study director
Enanta Pharmaceuticals, Inc
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus, run by Enanta Pharmaceuticals, Inc at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Bulgaria, Ukraine, New Zealand, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Symptom Score (TSS) Area Under the Curve (AUC) (time frame: Day 1 through Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.