CLINICAL TRIAL / NCT06008860
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
- Interventional
- Recruiting
- NCT06008860
Contact Information
- Carlisa Dixon
A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
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.
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:
1. Compare the trajectories of SARS-CoV-2 viral load in the upper airway of adults with
new onset Covid-19 randomized to receive azelastine at standard rhinitis dosing
(n=70) or placebo (n=70) over 10 days. The study team will target early disease
(immediately upon diagnosis), mild severity in outpatients (facilitating study
participation and self-sample collection), and pragmatic, receptive target
populations (volunteers living nearby).
2. Determine if there is a decrease in R0 in Covid-19 positive patients and their
closest contacts The study team hypothesizes that less new covid infections will be
observed among close contacts who co-habitate with subjects randomized to the
Astepro (azelastine) arm.
3. Determine whether treatment with azelastine improves pertinent clinical parameters
in these subjects. Rates, durations, and intensities of key symptoms will be
captured using existing, low burden data collection instruments that meet FDA
guidelines. All sample and data collection, including validated, objective olfactory
testing, will be contactless, minimizing risk.
4. Assess and quantitate side effects, subject satisfaction, and tolerability of
azelastine in this setting. Given the heterogeneous nature of Covid-19, the study
team will assess the feasibility of this treatment from the patient standpoint,
including qualitative and quantitative feedback, to inform future trials and
scaling.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
Accepts Healthy Volunteers
Inclusion Criteria:
- • 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
- Willing to abstain from any other COVID specific treatment during the duration
of the study period.
- 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).
Inclusion Criteria (Close Contacts):
- 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.
Exclusion Criteria (Primary Cohort):
- Women who are breastfeeding, pregnant, or who plan to become pregnant
- Contradictions to intranasal azelastine (known hypersensitivity)
- Use of other Covid-19 treatments (steroids, convalescent plasma, therapeutic
antibodies, etc.)
- Intranasal, corticosteroid, immunomodulator, or other medication use which can
change the effect of Astepro.
- Prior Covid infection greater than 5 and less than 30 days before enrollment
- Subjects who have been involved with any other research study within the last 30
days.
- A prior hypersensitivity to olopatadine (Patanase), diphenhydramine, hydroxyzine.
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)
- Prior Covid infection less than 30 days or greater 5 days prior to enrollment in
study
- Use of other Covid-19 treatments
- Having a positive rapid home or PCR COVID test prior to the positive test for the
primary cohort subject they're associated with
- Involved with any other research study within the last 30 days
- Subjects that have not been vaccinated for Covid-19.