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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07482657
Eligibility Criteria:
Inclusion Criteria:
* Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza
* Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization
* In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.
Exclusion Criteria:
* Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.
* Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.
* Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.
* Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for \>5 days.
* Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
36 Months
Study:
NCT07482657
Study Brief:
Protocol Section:
NCT07482657