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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

COVID-19 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.Check my eligibility

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.See study design

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.

COVID-19 Trial 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.

COVID-19 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Side effects data

From 2014 Phase 4 trial • 191 Patients • NCT01880840

pyrexia

cough

epistaxis

sneezing

rhinalgia

upper respiratory tract infection

vomiting

dysgusia

exacerbation of asthma

100%

80%

60%

40%

20%

Study treatment Arm

Astepro 0.15% Nasal Spray

Astepro 0.1% Nasal Spray

COVID-19 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

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,497 Total Patients Enrolled

11 Trials studying COVID-19

34,828 Patients Enrolled for COVID-19

Brandon BairdPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA validated Primary Cohort - Azelastine?

"Assigning a score of 3, our team at Power estimates that the safety profile for Primary Cohort - Azelastine is excellent due to its status as an approved Phase 4 treatment."

Answered by AI

Is the research team in need of participants for this experiment?

"Unfortunately, clinicaltrials.gov indicates that this medical trial is not presently looking for participants. This study was first listed on July 1st 2023 and the latest update was registered on August 24th 2023. Nonetheless, there are 725 other studies actively recruiting volunteers across many different sites in the US right now."

Answered by AI

Recent research and studies

BiostatisticsJournal

A Bayesian Approach to Functional-based Multilevel Modeling of Longitudinal Data: Applications to Environmental Epidemiology

Berhane, K., and N.-T. Molitor. 2008. “A Bayesian Approach to Functional-based Multilevel Modeling of Longitudinal Data: Applications to Environmental Epidemiology”. Biostatistics. Oxford University Press (OUP). doi:10.1093/biostatistics/kxm059.

The Lancet Infectious DiseasesJournal

Temporal Profiles of Viral Load in Posterior Oropharyngeal Saliva Samples and Serum Antibody Responses During Infection by Sars-cov-2: An Observational Cohort Study

To, Kelvin Kai-Wang, Owen Tak-Yin Tsang, Wai-Shing Leung, Anthony Raymond Tam, Tak-Chiu Wu, David Christopher Lung, Cyril Chik-Yan Yip, et al.. 2020. “Temporal Profiles of Viral Load in Posterior Oropharyngeal Saliva Samples and Serum Antibody Responses During Infection by Sars-cov-2: An Observational Cohort Study”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(20)30196-1.

clinicaltrials.govStudy

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

2023. "A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008860.

All > Covid 19