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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06008860
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Experimental: Primary Cohort — DRUG
    Astepro (azelastine) is a second generation antihistamine, as well as an anti-inflammatory and mast cell stabilizer8. It is available as a 0.1% and 0.15% nasal spray by prescription in the USA and over-the-counter in the European Union (EU). Dosing for adults and adolescents 12 years and older is 1 or 2 sprays per nostril twice daily (0.1%) or 2 sprays per nostril once daily (0.15%)9. It is approved by the FDA for treatment of seasonal allergic rhinitis symptoms (rhinorrhea, sneezing, and nasal pruritus) in adults and children 2 years and older, perennial allergic rhinitis in adults and children ages 6 months and older, and the symptoms of vasomotor rhinitis (rhinorrhea, nasal congestion and postnasal drip) in adults and adolescents 12 years and older9.
  • Placebo Comparator: Primary Cohort - Placebo — OTHER
    A Placebo will be provided by Bayer which features similar color and packaging as azelastine.

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Astepro for use in managing Covid-19 symptoms and assessing viral load in participants.. [ Time Frame: Baseline (Day -1) through Day 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Brandon Baird
[email protected]
773-702-6143
Brandon Baird (PRINCIPAL_INVESTIGATOR)
Jayant Pinto (SUB_INVESTIGATOR)
David Meltzer (SUB_INVESTIGATOR)
Julian Solway (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Chicago· Chicago, IL

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