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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008860
• Other study ID #: IRB22-1144
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Brandon Baird
• Phone: 7737026143
• Email: bbaird[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. 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).

2. 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.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (15)

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Reznikov LR, Norris MH, Vashisht R, Bluhm AP, Li D, Liao YJ, Brown A, Butte AJ, Ostrov DA. Identification of antiviral antihistamines for COVID-19 repurposing. Biochem Biophys Res Commun. 2021 Jan 29;538:173-179. doi: 10.1016/j.bbrc.2020.11.095. Epub 2020 Dec 3. — View Citation

Rogosnitzky M, Berkowitz E, Jadad AR. Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. JMIR Public Health Surveill. 2020 May 13;6(2):e19199. doi: 10.2196/19199. — View Citation

To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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