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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

University of Chicago
Chicago, Illinois, United States