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RECRUITING

NCT06008860

PHASE4

A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection

Sponsor: University of Chicago

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2023-07-01

Completion Date

2026-12

Last Updated

2025-11-10

Healthy Volunteers

Yes

Conditions

COVID-19

Interventions

DRUG

Experimental: Primary Cohort

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.

OTHER

Placebo Comparator: Primary Cohort - Placebo

A Placebo will be provided by Bayer which features similar color and packaging as azelastine.

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.

Locations (1)

University of Chicago

Chicago, Illinois, United States