Evaluation of EDP-938 in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV)
- 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] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001966-13-DE
- Lead Sponsor
- Enanta Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. Male or female who is either =6 months to =36 months (for Age Group 1) or =28 days to <6 months, (for Age Group 2), defined at the time of randomization (Subjects in Age Group 2 must have been born =29 weeks of gestation to be eligible. If a subject was born <29 weeks of gestation the subject can only be enrolled in Age Group 1)
2. Subjects diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2. If RSV infection is not confirmed, caregivers may be asked to sign a RSV Diagnostic Test ICF allowing a rapid antigen RSV test to be performed;
3. Subjects with signs of an acute respiratory illness (e.g., fever [or symptoms of fever], cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset =7 days for Part 1 and =5 days for Part 2 before the time of signing the informed consent form (ICF)
Note: Time of onset of signs is defined as the caregiver(s) estimated time of awareness of the first sign of respiratory infection or worsening
from the subject's pre-existing respiratory signs.
4. Have a calculated creatinine clearance rate not below the lower limit of normal (LLN) for the subject’s age as determined by the Schwartz equation (Schwartz & Work, 2009) at Screening
5. In the Investigator’s opinion, the subject’s caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
Additional inclusion criterion for Part 1 Cohort 1, Age Groups 2
6. Subject is currently or is planned to be hospitalized as a consequence of RSV infection and is not anticipated to be discharged in less than 24 hours after enrollment
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
3. Subjects who are considered unable to take study drug orally, by mouth, nasogastric tube, or orogastric tube (e.g., as a consequence of acute respiratory distress, or unable to absorb study drug enterally)
4. Subjects who have received blood products within 6 months of study drug administration
5. Subjects with underlying immune deficiency, e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
6. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
7. Subjects who have had major surgery in the 6 weeks before randomization
8. Subject receiving chronic oxygen therapy at home before admission
9. Subjects who are being breastfed by a mother taking any of the excluded medications
10. Subjects whose mother received a RSV vaccination while pregnant with the subject if they were born at term (=37 weeks of gestation) and
are less than 12 months of age;
11. Receipt of systemic antiviral, antifungal, or antimycobacterial therapy within 7 days of Screening
12. Subjects who received systemic medications other than corticosteroids (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies. Systemic
corticosteroids are not prohibited in Part 1
13. In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug:
• ribavirin: 35 days,
• palivizumab: 100 days,
• nirsevimab: 350 days,
• other RSV-specific monoclonal antibody: 5 half-lives of specific antibody,
• RSV vaccines: 12 months.
14. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug
15. Subjects who are enrolled in another investigational drug or vaccine study
16. Known allergy/hypersensitivity or intolerance to EDP-938, placebo or their excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method