A study to learn how well the drug EDP 938 works and how safe it is for non hospitalized Adults with Acute Respiratory Syncytial Virus Infection, who are at High Risk for Complications
- Conditions
- Respiratory syncytial virus (RSV)MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2022-002215-29-SK
- Lead Sponsor
- Enanta Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
Each subject must meet all of the following criteria to be enrolled into this study:
1. The subject has signed and dated the informed consent forms (ICFs).
2. The subject is a male or female adult at least 18 years of age, who has at least one of the following conditions that predispose them to complications after RSV infection:
a. Age =65 years;
b. CHF (New York Heart Association [NYHA] Class I to IV) [New York Heart Association Criteria Committee, 1994];
c. Asthma;
d. COPD
Note: Subjects with COPD and a diagnosis of alpha-1 anti-trypsin deficiency must have a transient elastography indicating no evidence of significant liver fibrosis (i.e., >7 kPa) or cirrhosis (i.e., >11 kPa).
3. The subject has a new onset of any of the following symptom(s) or worsening of preexisting 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.
Note: The duration of new onset of symptom(s) or worsening of pre-existing symptom(s) is to be measured from the estimated time of onset of the first symptom to the anticipated time of dosing with investigational drug.
4. The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity by the subject using the RiiQ: cough, cough with phlegm, wheezing, or short of breath.
5. The subject has tested positive for RSV infection using a nucleic acid amplification test (NAAT; polymerase chain reaction [PCR] or other) on a nasal swab sample.
6. The subject has a body mass index =18 kg/m2 and =40 kg/m2.
7. A heterosexually active female subject must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study drug or be surgically sterile for at least 6 months or postmenopausal; subjects who are <2 years postmenopausal will require a confirmatory serum follicle-stimulating hormone (FSH) levels >35 IU/mL.
Note: Effective birth control methods include male or female condom (may not be used together), intrauterine device (IUD), or systemic hormonal (i.e., oral, injectable, implantable, transdermal, or intravaginal) contraception associated with the inhibition of ovulation started a minimum of 2 weeks prior to signing the Study ICF:
a. A heterosexually active female subject with a single male partner who has been vasectomized is not required to use another effective birth control method.
b. A female subject who practices sexual abstinence is not required to use another effective birth control method.
8. A heterosexually active male subject and their female partner(s) of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study drug.
Note: Effective birth control methods include male or female condom (may not be used together), systemic hormonal contraception associated with the inhibition of ovulation started a minimum of 2 weeks prior to signing the Study ICF, or IUD:
a. A vasectomized heterosexually active male subject with a single female partner is not required to use another effective birth control method;
b. Male subjects who practice sexual abstinence are not required to use another effective birth control method.
9. Male subject must agree to refrain
A subject will not be eligible to participate in the study if they meet any of the following criteria:
1. The subject has an anticipated need for hospitalization within 24 hours of signing the Study ICF;
Note: Emergency room or hospital observation status for an anticipated duration of less than <24 hours is not considered as hospitalization.
2. 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;
3. The subject has a SARS-CoV-2 test result that is positive within 28 days prior to signing the Study ICF;
4. The subject is pregnant or nursing;
5. The subject has COPD GOLD Class IV [Venkatesan P., 2022];
6. The subject has a malignant tumor or history of malignancy that may interfere with the aims of the study or a subject completing the study;
7. The subject has prior receipt of or is waiting to receive a bone marrow, stem cell, or solid organ transplantation;
8. The subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis A 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.
9.The subject has a history of chronic liver disease (e.g., hemochromatosis, Wilson’s disease, cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or alcoholic liver disease); a history of active biliary disease (e.g., primary sclerosing cholangitis); or a history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver) is not exclusionary;
10.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;
11.The subject has 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 CYP450 3A4 enzyme, within 14 days prior to signing the Study ICF;
12.The subject has received an RSV vaccine within 12 months prior to signing the study ICF.
13. The subject has received any investigational agent, within 30 days (or 5 half-lives of that investigational agent, whichever is longer) prior to the first dose of study drug.
14.The subject has a history of or is 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.
15.Known hypersensitivity to the investigational product or any of its excipients.
16.Receiving dialysis or have known severe renal impairment (i.e., eGFR <30 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms.;Secondary Objective: - To evaluate the clinical efficacy of EDP-938 compared with placebo;<br> - To evaluate the antiviral activity of EDP-938 compared with placebo;<br> - To evaluate the PK of EDP-938;<br> - To evaluate the safety of EDP-938 compared with placebo.<br><br>;Primary end point(s): Time to resolution of RSV Lower Respiratory Tract Disease (LRTD) symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) symptom scale through Day 33.;Timepoint(s) of evaluation of this end point: Day 33
- Secondary Outcome Measures
Name Time Method