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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Treatments: Azelastine

Criteria

Inclusion Criteria:

• • 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

• Willing to abstain from any other COVID specific treatment during the duration of the study period.

• 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.