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

RecruitingPhase 4Healthy volunteers welcome

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of Chicago · Participants: 280 · Started: Jul 1, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06008860

Locations in the U.S.

IllinoisUniversity of Chicago, Chicago

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.