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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.
Full description
In this study, the study team aims to re-confirm the utility of this medication for use in Covid-19 to decrease the significant impact on quality of life, symptoms, infectivity, and occupation. plan to recruit vaccinated adults immediately upon Covid-19 diagnosis at one major Chicago University and follow viral load as a primary outcome in those randomized to receive Astepro® vs. placebo. Subjects who have a home antigen test or polymerase chain reaction (PCR) positive diagnosis of Covid-19 will be enrolled in the study. Viral load will be assessed at Day -1, day of presentation, followed by self-collected saliva over the subsequent 10 days in patients getting either azelastine or placebo.
Specific Aims
To address this hypothesis, the study team is investigating the following specific aims:
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Inclusion and exclusion criteria
Inclusion Criteria (Primary Cohort):
Inclusion Criteria (Close Contacts):
Exclusion Criteria (Primary Cohort):
Subjects that have not been vaccinated for Covid-19. Subjects that have moderate to severe COVID-19 symptoms, or signs of meeting indications (e.g.
Shortness of Breath, chest pains) for urgent or emergent therapy (these subjects will be advised to seek emergency medical assistance).
Exclusion Criteria (Close Contacts)
Primary purpose
Allocation
Interventional model
Masking
280 participants in 2 patient groups, including a placebo group
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Central trial contact
Brandon Baird; Shalitha Johnson
Data sourced from clinicaltrials.gov
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