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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT06008860
Eligibility Criteria:
Inclusion Criteria (Primary Cohort):
* 18 and up
* Ability to consent
* Have a Covid-19 positive saliva sample prior to the start of treatment; or positive rapid antigen test at home confirmed via first COVID-19 positive saliva sample
* Ability to follow the study instructions and adhere to the study procedures
* Ability to provide every other day saliva samples throughout the study period 10 days, and report symptoms
* Subjects that have been vaccinated for Covid-19
* Does not have any symptoms or only experiencing mild symptoms of Covid-19 (e.g., such as fever below a threshold or no fever, or without severe cough, among others).
Inclusion Criteria (Close Contacts):
* Ability to consent
* Ability to follow the study instructions and report side effects
* Ability to provide saliva samples throughout the study period
* Subjects that have been vaccinated for Covid-19.
Exclusion Criteria (Primary Cohort):
* Women who are breastfeeding, pregnant, or who plan to become pregnant
* Contradictions to intranasal azelastine (known hypersensitivity)
* Use of other Covid-19 treatments (steroids, convalescent plasma, therapeutic antibodies, etc.)
* Intranasal, corticosteroid, immunomodulator, or other medication use which can change the effect of Astepro.
* Prior Covid infection greater than 5 and less than 30 days before enrollment
* Subjects who have been involved with any other research study within the last 30 days.
* A prior hypersensitivity to olopatadine (Patanase), diphenhydramine, hydroxyzine.
Subjects that have not been vaccinated for Covid-19. Subjects that have moderate to severe COVID-19 symptoms, or signs of meeting indications (e.g.
Shortness of Breath, chest pains) for urgent or emergent therapy (these subjects will be advised to seek emergency medical assistance).
Exclusion Criteria (Close Contacts)
* Prior Covid infection less than 30 days or greater 5 days prior to enrollment in study
* Use of other Covid-19 treatments
* Having a positive rapid home or PCR COVID test prior to the positive test for the primary cohort subject they're associated with
* Involved with any other research study within the last 30 days
* Subjects that have not been vaccinated for Covid-19.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06008860
Study Brief:
Protocol Section:
NCT06008860