Evaluating Astepro® Nasal Spray for Early COVID-19 Management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) in Adults

  This study tests and compares the immune responses and tolerability of the latest COVID-19 vaccines from Novavax and Pfizer/BioNTech in adults at risk for severe COVID-19.

  Recruiting Phase 4 Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland · NCT07287137

• Omicron-based COVID-19 vaccine with Matrix-M given as a single dose in older adults and high-risk individuals

  A single-dose Omicron-subvariant vaccine with Matrix-M is tested to see if it is safe and can induce an immune response in adults 65+ and in younger adults with conditions that raise the risk of severe COVID-19, who were previously vaccinated.

  Recruiting at 20 sites Phase 4 Sanofi · Fair Oaks, California and 19 other locations · NCT07861542

• Secutrelvir for nonhospitalized COVID-19 in teens and adults

  This study tests whether secutrelvir can help nonhospitalized people with COVID-19 see faster symptom relief compared with a placebo.

  Recruiting Phase 3 Shionogi Inc. · Multiple Locations · NCT07746544

• Virological Monitoring of Seasonal Respiratory Infections in France

  This project tests how often common respiratory viruses show up in patients seen by primary care doctors in metropolitan France during the fall and winter.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Paris · NCT07599449

• COVID-19 Registry at San Matteo (SMACORE) - patient-matching observational registry

  This registry tests how COVID-19 patients are being treated and progress across San Matteo in Pavia to understand patterns and outcomes.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia · NCT07597876

• MDX2301 in healthy adults and adults at higher risk for severe COVID-19

  This study will try single and repeat doses of MDX2301 given by IV, IM, or SC to see if they are safe and trigger neutralizing activity in healthy adults and adults at higher risk for severe COVID-19.

  Recruiting at 2 sites Phase 1 ModeX Therapeutics, An OPKO Health Company · Las Vegas, Nevada and 1 other locations · NCT07445971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.