Status:
RECRUITING
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
Lead Sponsor:
University of Chicago
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06008860
Start Date
July 1 2023
End Date
December 1 2026
Last Update
November 10 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637