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

PHASE4RecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
COVID-19
Interventions
DRUG

Experimental: Primary Cohort

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.

OTHER

Placebo Comparator: Primary Cohort - Placebo

A Placebo will be provided by Bayer which features similar color and packaging as azelastine.

Trial Locations (1)

60637

RECRUITING

University of Chicago, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER