A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
University of Chicago
280 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
Summary
The study team proposes to evaluate the efficacy of Astepro® 0.15% nasal spray in treating SARS-CoV-2 infection in adults through a pilot and feasibility clinical trial at the University of Chicago.
Eligibility
Inclusion Criteria11
- 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).
- 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 Criteria14
- 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).
- 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.
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Interventions
Astepro (azelastine) is a second generation antihistamine, as well as an anti-inflammatory and mast cell stabilizer8. It is available as a 0.1% and 0.15% nasal spray by prescription in the USA and over-the-counter in the European Union (EU). Dosing for adults and adolescents 12 years and older is 1 or 2 sprays per nostril twice daily (0.1%) or 2 sprays per nostril once daily (0.15%)9. It is approved by the FDA for treatment of seasonal allergic rhinitis symptoms (rhinorrhea, sneezing, and nasal pruritus) in adults and children 2 years and older, perennial allergic rhinitis in adults and children ages 6 months and older, and the symptoms of vasomotor rhinitis (rhinorrhea, nasal congestion and postnasal drip) in adults and adolescents 12 years and older9.
A Placebo will be provided by Bayer which features similar color and packaging as azelastine.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06008860