Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID06008860

A Pilot Clinical Evaluation of Astepro4 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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Astepro4 0.15% nasal spray to manage early SARS-CoV-2 infection in vaccinated adults. This pilot clinical trial aims to confirm whether this medication can reduce viral load, lessen symptoms, lower infectivity, and improve quality of life in people recently diagnosed with mild Covid-19. The study is conducted at the University of Chicago and involves participants who test positive by home antigen or PCR tests. Participants will be randomly assigned to receive either the Astepro nasal spray or a placebo, both provided with instructions for proper use. The study is double-blind, meaning neither participants nor researchers know who receives the medication or placebo. Treatment follows standard dosing for allergic rhinitis, and supportive care recommendations are standardized for all. If severe disease develops, participants will be guided on how to seek further care. During the study, participants will provide saliva samples every other day over a 10-day period to measure viral load and report symptoms using validated surveys. Researchers will also collect data on side effects, patient satisfaction, and tolerability through contactless methods. The primary outcome focuses on viral load changes from baseline to day 10, while secondary outcomes evaluate infectivity rates among close contacts and changes in respiratory symptoms and quality of life.

CONDITIONS

Brief 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 consent to participate
  • Positive Covid-19 saliva sample or positive rapid antigen test confirmed by saliva test
  • Ability to follow study instructions and procedures
  • Ability to provide saliva samples every other day for 10 days and report symptoms
  • Vaccinated against Covid-19
  • Mild or no symptoms of Covid-19 at enrollment
Not Eligible

You will not qualify if you...

  • Women who are pregnant, breastfeeding, or planning to become pregnant
  • Known allergy or hypersensitivity to intranasal azelastine or related medications
  • Current use of other Covid-19 treatments such as steroids, convalescent plasma, or therapeutic antibodies
  • Use of intranasal corticosteroids, immunomodulators, or other medications that could affect Astepro
  • Prior Covid-19 infection between 5 and 30 days before enrollment
  • Participation in another research study within the last 30 days
  • Moderate to severe Covid-19 symptoms or signs needing urgent care
  • Unvaccinated against Covid-19 (primary and close contact cohorts)
  • For close contacts: positive Covid-19 test before the primary subject's positive test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - 10 days

Participants receive either Astepro nasal spray or placebo and self-collect saliva samples to monitor viral load and symptoms for early Covid-19 management.

Self-collected saliva samples every other day for 10 days with remote symptom reporting

Follow-up

Duration - Up to 11 days including baseline and final assessments

Participants report symptoms and quality of life outcomes to assess treatment impact and side effects after the treatment period.

Symptom and quality of life surveys at baseline, daily during treatment, and at end of study

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

S

Shalitha Johnson

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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