Allergic Rhinitis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

• 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.

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Contact Information
Primary
Brandon Baird
bbaird@bsd.uchicago.edu
7737026143
Backup
Shalitha Johnson
sjohnson28@bsd.uchicago.edu
7738348758
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 280
Treatments
Other: Primary Cohort - Azelastine
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.
Placebo_comparator: Primary Cohort - Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov