NCT06008860 A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
| NCT ID | NCT06008860 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Chicago |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 280 participants in total. It began in 2023-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Brandon Baird
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06008860 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06008860 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06008860 currently recruiting?
Yes, NCT06008860 is actively recruiting participants. Contact the research team at bbaird@bsd.uchicago.edu for enrollment information.
Where is the NCT06008860 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06008860 clinical trial?
NCT06008860 is sponsored by University of Chicago. The principal investigator is Brandon Baird at University of Chicago. The trial plans to enroll 280 participants.
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