Evaluating Astepro® Nasal Spray for Early COVID-19 Management
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
This study is testing if Astepro® nasal spray can help vaccinated adults with early COVID-19 by reducing the virus in their bodies compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06008860 on ClinicalTrials.gov |
What this trial studies
This pilot clinical evaluation aims to assess the efficacy of Astepro® 0.15% nasal spray in treating early SARS-CoV-2 infection in adults. The study will recruit vaccinated individuals diagnosed with COVID-19 and randomize them to receive either Astepro® or a placebo. Participants will provide saliva samples to monitor viral load over a 10-day period, allowing researchers to compare the effectiveness of the treatment against standard care. The study seeks to determine if Astepro® can reduce viral load and potentially decrease the spread of infection among close contacts.
Who should consider this trial
Good fit: Ideal candidates are vaccinated adults aged 18 and older who have a positive COVID-19 diagnosis and are experiencing mild or no symptoms.
Not a fit: Patients who are unvaccinated, pregnant, breastfeeding, or experiencing moderate to severe COVID-19 symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for managing early COVID-19 infections and improving patient outcomes.
How similar studies have performed: While this approach is novel in the context of COVID-19, previous studies have explored nasal sprays for respiratory infections, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Brandon Baird — University of Chicago
- Study coordinator: Brandon Baird
- Email: bbaird@bsd.uchicago.edu
- Phone: 7737026143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.