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A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection (COVID-19)

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ClinicalTrials.gov Identifier: NCT06008860
Recruitment Status : Recruiting
First Posted : August 24, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE August 21, 2023
First Posted Date  ICMJE August 24, 2023
Last Update Posted Date January 5, 2024
Actual Study Start Date  ICMJE July 1, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2023)		 Astepro for use in managing Covid-19 symptoms and assessing viral load in participants.. [ Time Frame: Baseline (Day -1) through Day 10 ]
The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2023)		 Utility of Astepro for use in managing Covid-19 symptoms and assessing viral load. [ Time Frame: Baseline (Day -1) through Day 10 ]
The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2023)
  • Rate of Covid-19 infectivity in primary cohorts close contacts [ Time Frame: Day 1, Day 11 ]
    Saliva will be collected from close contacts to assess any changes in Covid-19 infectivity.
  • Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey [ Time Frame: Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 ]
    WURSS44 is illness-specific quality of life instrument, designed to assess the negative impact of viral acute upper respiratory infection.
  • Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey [ Time Frame: Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 ]
    All of Us Research Program Covid-19 Participant Experience (COPE) survey is utilized to assess the health impact of Covid-19.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2023)
  • Change of Covid-19 infectivity in primary cohorts close contacts [ Time Frame: Day 1, Day 11 ]
    Saliva will be collected from close contacts to assess any changes in Covid-19 infectivity.
  • Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey [ Time Frame: Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 ]
    WURSS44 is illness-specific quality of life instrument, designed to assess the negative impact of viral acute upper respiratory infection.
  • Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey [ Time Frame: Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11 ]
    All of Us Research Program Covid-19 Participant Experience (COPE) survey is utilized to assess the health impact of Covid-19.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
Official Title  ICMJE A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is a double-blind clinical trial. Randomization schedules will be generated and stratified by age (18-30, 31--40, 41-50, and ≥50 years) and sex, using computer-generated random numbers and alternating block sizes. Only the study statistician will have access to the randomization lists. The assigned treatment for each study subject will be obtained via REDCap. The Investigational Drug Service (IDS) pharmacy will be used to distribute the drug or placebo as provided by Bayer. The pharmacy will also help to coordinate and track randomization.
Primary Purpose: Supportive Care
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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 Name: azelastine
  • Other: Placebo Comparator: Primary Cohort - Placebo
    A Placebo will be provided by Bayer which features similar color and packaging as azelastine.
Study Arms  ICMJE
  • Primary Cohort - Azelastine
    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.
    Intervention: Drug: Experimental: Primary Cohort
  • Placebo Comparator: Primary Cohort - Placebo
    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.
    Intervention: Other: Placebo Comparator: Primary Cohort - Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2023)		 280
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brandon Baird 7737026143 bbaird@bsd.uchicago.edu
Contact: Shalitha Johnson 7738348758 sjohnson28@bsd.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06008860
Other Study ID Numbers  ICMJE IRB22-1144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brandon Baird University of Chicago
PRS Account University of Chicago
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP