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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
- Experimental: Primary Cohort (drug)
- Placebo Comparator: Primary Cohort - Placebo (other)
Sponsor: University of Chicago · Participants: 280 · Started: Jul 1, 2023
Contact the study team
- Brandon Baird · Phone: 7737026143
- Shalitha Johnson · Phone: 7738348758
Official record on ClinicalTrials.gov — NCT06008860
Locations in the U.S.
| Illinois | University 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.