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Astepro Nasal Spray for Early COVID-19 Infection

This study is looking at whether Astepro® (azelastine) nasal spray can help adults who have recently tested positive for COVID-19. Astepro is an antihistamine that also has anti-inflammatory properties. You would be given either Astepro nasal spray or a placebo (an inactive spray that looks similar) to use. Researchers will compare how well Astepro helps manage COVID-19 symptoms and reduces the amount of virus in your body (viral load) over 10 days. To join, you must be 18 or older, have a recent positive COVID-19 test, and be able to provide saliva samples. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 280 participants. It compares Astepro nasal spray to a placebo in adults with new onset COVID-19.
What's involved
You would need to provide saliva samples every other day for 10 days. You would also need to follow study instructions and procedures.
Compensation
Not stated in the trial record.
Follow-up
Your viral load will be assessed from baseline (Day -1) through Day 10.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06008860

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

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Chicago
~280 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Experimental: Primary CohortPlacebo Comparator: Primary Cohort - Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..
Measured over Baseline (Day -1) through Day 10

Conditions

COVID-19

Explore related trials

COVID-19 Infection

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Brandon Baird · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Brandon Baird
[email protected]
7737026143
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
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

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.
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.

What this trial measures

  • Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..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.