Recruiting

Astepro®

Sponsor:

University of Chicago

Code:

NCT06008860

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Experimental: Primary Cohort

Placebo Comparator: Primary Cohort - Placebo

Study Details

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.

Conditions

COVID-19

Study ID

NCT06008860

Start date

Jul 1, 2023

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: 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.

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.

Interventions

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.

Placebo Comparator: Primary Cohort - Placebo

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

Primary outcome measure

  • Astepro for use in managing Covid-19 symptoms and assessing viral load in participants.. [ Time Frame: Baseline (Day -1) through Day 10 ]

Central Contacts and Locations

Central contacts

Brandon Baird

7737026143bbaird@bsd.uchicago.edu

Shalitha Johnson

7738348758sjohnson28@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Brandon Baird

773-702-6143bbaird@bsd.uchicago.edu

Principal Investigator:

Brandon Baird

More Information

Sponsor

University of Chicago

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-10.