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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05314933
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female volunteers, age ≥ 18 years old at screening
* Females must be post-menopausal (\> 1 year since last menstruation)
* Able to comprehend and to give informed consent
* Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
* Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health)
Exclusion Criteria:
* Frequent epistaxis (equal to or greater than 1/month)
* Hypo- or anosmia
* Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation
* Medical history of diabetes mellitus of any type
* Clinically relevant abnormal findings at screening
* Preceding nasal surgery or sinus surgery
* Medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening
* SARS-CoV-2 infection positive by PCR test at screening
* Vulnerable subjects as defined by GCP
* Subjects in a dependency relationship towards the investigators, e.g. as employees
* Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures
* Use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results
* Concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
* Scheduled vaccination appointments during the study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05314933
Study Brief:
Protocol Section:
NCT05314933