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

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, the study team aims to re-confirm the utility of this medication for use in Covid-19 to decrease the significant impact on quality of life, symptoms, infectivity, and occupation. plan to recruit vaccinated adults immediately upon Covid-19 diagnosis at one major Chicago University and follow viral load as a primary outcome in those randomized to receive Astepro® vs. placebo. Subjects who have a home antigen test or polymerase chain reaction (PCR) positive diagnosis of Covid-19 will be enrolled in the study. Viral load will be assessed at Day -1, day of presentation, followed by self-collected saliva over the subsequent 10 days in patients getting either azelastine or placebo. Specific Aims To address this hypothesis, the study team is investigating the following specific aims: Compare the trajectories of SARS-CoV-2 viral load in the upper airway of adults with new onset Covid-19 randomized to receive azelastine at standard rhinitis dosing (n=70) or placebo (n=70) over 10 days. The study team will target early disease (immediately upon diagnosis), mild severity in outpatients (facilitating study participation and self-sample collection), and pragmatic, receptive target populations (volunteers living nearby). Determine if there is a decrease in R0 in Covid-19 positive patients and their closest contacts The study team hypothesizes that less new covid infections will be observed among close contacts who co-habitate with subjects randomized to the Astepro (azelastine) arm. Determine whether treatment with azelastine improves pertinent clinical parameters in these subjects. Rates, durations, and intensities of key symptoms will be captured using existing, low burden data collection instruments that meet FDA guidelines. All sample and data collection, including validated, objective olfactory testing, will be contactless, minimizing risk. Assess and quantitate side effects, subject satisfaction, and tolerability of azelastine in this setting. Given the heterogeneous nature of Covid-19, the study team will assess the feasibility of this treatment from the patient standpoint, including qualitative and quantitative feedback, to inform future trials and scaling.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Experimental: Primary Cohort
* Other: Placebo Comparator: Primary Cohort - Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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 Willing to abstain from any other COVID specific treatment during the duration of the study period. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary Cohort - Azelastine<br>This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray. | Drug: Experimental: Primary Cohort<br>* 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.<br>* Other names: azelastine;|
| Placebo Comparator: Primary Cohort - Placebo<br>This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care. | Other: Placebo Comparator: Primary Cohort - Placebo<br>* A Placebo will be provided by Bayer which features similar color and packaging as azelastine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Astepro for use in managing Covid-19 symptoms and assessing viral load in participants.. | The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load. | Baseline (Day -1) through Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey | All of Us Research Program Covid-19 Participant Experience (COPE) survey is utilized to assess the health impact of Covid-19. | Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 | 
| Rate of Covid-19 infectivity in primary cohorts close contacts | Saliva will be collected from close contacts to assess any changes in Covid-19 infectivity. | Day 1, Day 11 | 
| Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey | WURSS44 is illness-specific quality of life instrument, designed to assess the negative impact of viral acute upper respiratory infection. | Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 |