Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT06008860

A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection

Led by University of Chicago · Updated on 2025-11-10

280

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Ability to provide consent
  • Positive Covid-19 saliva test or positive home rapid antigen test confirmed by saliva sample
  • Ability to follow study instructions and procedures
  • Willingness to provide saliva samples every other day for 10 days and report symptoms
  • Vaccinated against Covid-19
  • Having no symptoms or only mild symptoms of Covid-19
  • Ability to provide consent (close contacts)
  • Ability to follow study instructions and report side effects (close contacts)
  • Ability to provide saliva samples throughout the study (close contacts)
  • Vaccinated against Covid-19 (close contacts)
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy
  • Known allergy or hypersensitivity to intranasal azelastine
  • Use of other Covid-19 treatments like steroids, plasma, or antibodies
  • Use of intranasal corticosteroids, immunomodulators, or medications that affect Astepro
  • Previous Covid-19 infection more than 5 and less than 30 days before enrollment
  • Participation in another research study within the last 30 days
  • Allergic reaction to olopatadine, diphenhydramine, or hydroxyzine
  • Not vaccinated against Covid-19
  • Moderate to severe Covid-19 symptoms or urgent/emergency signs such as shortness of breath or chest pain
  • Prior Covid infection less than 30 days or more than 5 days before enrollment (close contacts)
  • Positive Covid-19 test before the primary cohort subject's positive test (close contacts)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

B

Brandon Baird

CONTACT

S

Shalitha Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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