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

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.