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Astepro® Nasal Spray for COVID-19 (COVID-19 Trial)

Phase 4

Recruiting

Led By Brandon Baird

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Subjects that have been vaccinated for Covid-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up primary cohort: baseline (day -1) through day 10, close contact cohort: day 1 and day 11

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if a nasal spray can help treat adults with SARS-CoV-2 infection.

Who is the study for?

This trial is for adults with a positive COVID-19 test who can provide saliva samples every other day for 10 days and report symptoms. Participants should have mild or no symptoms, be able to follow study instructions, and not use other COVID treatments during the study. Vaccinated individuals are eligible.

What is being tested?

The University of Chicago is testing Astepro® 0.15% nasal spray's effectiveness against early SARS-CoV-2 infection in adults compared to a placebo. The goal is to see if this treatment can manage the virus effectively.

What are the potential side effects?

While specific side effects of Astepro® nasal spray in treating COVID-19 aren't detailed here, common side effects may include nosebleeds, nasal discomfort, sneezing, or an unpleasant taste/smell.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild or no symptoms of Covid-19.

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I have been vaccinated for Covid-19.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ primary cohort: baseline (day -1) through day 10, close contact cohort: day 1 and day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~primary cohort: baseline (day -1) through day 10, close contact cohort: day 1 and day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and primary cohort: baseline (day -1) through day 10, close contact cohort: day 1 and day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..

Secondary study objectives

Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey

Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey

Rate of Covid-19 infectivity in primary cohorts close contacts

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Primary Cohort - AzelastineExperimental Treatment1 Intervention

This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.

Group II: Primary Cohort - PlaceboPlacebo Group1 Intervention

This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care.

0 / 3Eligibility criteria met