Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Supportive Care
Participants needed
280 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for adults with a positive COVID-19 test who can safely use Astepro® nasal spray. Participants will take samples of their saliva and report any symptoms during the study period.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I can give my consent to participate
I have a positive saliva sample for COVID-19 before treatment
I can follow study instructions and procedures
I can provide saliva samples every other day for 10 days
I have been vaccinated for COVID-19
I have mild or no COVID-19 symptoms
You may not be able to join if
I am pregnant, breastfeeding, or planning to become pregnant
I have a known allergy to intranasal azelastine
I am using other COVID-19 treatments
I have had a prior COVID-19 infection within the last 30 days
I have taken part in another research study within the last 30 days
I have an allergy to olopatadine, diphenhydramine, or hydroxyzine
I have moderate to severe COVID-19 symptoms
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
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 stu…
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.
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