Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06585150
Eligibility Criteria:
Key Inclusion Criteria:
* Exhibits at least 1 of the following risk factors for severe RSV disease:
1. Age ≥ 60 years
2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
4. One or more of the following chronic lung diseases:
* i) Bronchiectasis
* ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
* iii) Pulmonary hypertension
5. Chronic cardiovascular disease exclusive of hypertension
* RSV infection confirmed ≤ 3 days before randomization
* New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization.
* RSV vaccine status:
* Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.
Key Exclusion Criteria:
* Currently requiring or expected to require hospitalization within 48 hours after randomization.
* Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
* Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
* Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
* Individuals with a history of cystic fibrosis.
* Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
* Pregnant at screening.
* Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
* Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06585150
Study Brief:
Protocol Section:
NCT06585150