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New treatment option for COVID-19
Official title A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection
ClinicalTrials.gov ID: NCT06008860
What this study is testing
What is Experimental: Primary Cohort?
Experimental: Primary Cohort is an investigational medicine, given as an once-daily, being studied as a potential treatment for covid-19.
Also referred to as azelastine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- (Primary Cohort):
- 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...
- Ability to follow the study instructions and adhere to the study procedures
You likely can't join if
- (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
See the full eligibility criteria
- (Primary Cohort):
- 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
- people 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). (Close Contacts):
- Ability to consent
- Ability to follow the study instructions and report side effects
- Ability to provide saliva samples throughout the study period
- people that have been vaccinated for Covid-19.
- (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
- people who have been involved with any other research study within the last 30 days.
- A prior hypersensitivity to olopatadine (Patanase), diphenhydramine, hydroxyzine. people that have not been vaccinated for Covid-19. people that have moderate to severe COVID-19 symptoms, or signs of meeting indications...
- 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
- people that have not been vaccinated for Covid-19.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.