A Pilot Clinical Evaluation of Astepro4 Nasal Spray for Management of Early SARS-CoV-2 Infection

What this Trial Is About

Researchers are evaluating the use of Astepro4 0.15 nasal spray to manage early SARS-CoV-2 infection in vaccinated adults. This pilot clinical trial aims to confirm whether this medication can reduce viral load, lessen symptoms, lower infectivity, and improve quality of life in people recently diagnosed with mild Covid-19. The study is conducted at the University of Chicago and involves participants who test positive by home antigen or PCR tests. Participants will be randomly assigned to receive either the Astepro nasal spray or a placebo, both provided with instructions for proper use. The study is double-blind, meaning neither participants nor researchers know who receives the medication or placebo. Treatment follows standard dosing for allergic rhinitis, and supportive care recommendations are standardized for all. If severe disease develops, participants will be guided on how to seek further care. During the study, participants will provide saliva samples every other day over a 10-day period to measure viral load and report symptoms using validated surveys. Researchers will also collect data on side effects, patient satisfaction, and tolerability through contactless methods. The primary outcome focuses on viral load changes from baseline to day 10, while secondary outcomes evaluate infectivity rates among close contacts and changes in respiratory symptoms and quality of life.

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