NCT06008860 · University of Chicago
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
(COVID-19)
What this study is about
The study team proposes to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Primary Cohort):
- 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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations