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

NCT06008860 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB22-1144
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Astepro for use in managing Covid-19 symptoms and assessing viral load in participants..

  The primary cohort will be followed while utilizing study drug or placebo to evaluate the outcomes and saliva collection to follow viral load.

  Baseline (Day -1) through Day 10

Secondary Outcomes (3)

• Rate of Covid-19 infectivity in primary cohorts close contacts

  Day 1, Day 11

• Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey

  Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11

• Change from baseline symptoms and quality of life utilizing the All of Us Research Program Covid-19 Participant Experience (COPE) survey

  Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11

Study Arms (2)

Primary Cohort - Azelastine

OTHER

This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.

Drug: Experimental: Primary Cohort

Primary Cohort - Placebo

PLACEBO COMPARATOR

This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care.

Other: Placebo Comparator: Primary Cohort - Placebo

Interventions

Experimental: Primary Cohort DRUG

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.

Also known as: azelastine

Primary Cohort - Azelastine

Placebo Comparator: Primary Cohort - Placebo OTHER

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

Primary Cohort - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (15)

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  PMID: 32648899 BACKGROUND

• Johns Hopkins University & Medicine. Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed 01/26/2021.

  BACKGROUND

• Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.

  PMID: 33059771 BACKGROUND

• Rogosnitzky M, Berkowitz E, Jadad AR. Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. JMIR Public Health Surveill. 2020 May 13;6(2):e19199. doi: 10.2196/19199.

  PMID: 32374264 BACKGROUND

• Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.

  PMID: 32445440 BACKGROUND

• World Health Organization. An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care. https://www.who.int/publications/m/item/an-international-randomised-trial-of-additional-treatments-for-covid-19-in-hospitalised-patients-who-are-all-receiving-the-local-standard-of-care.

  BACKGROUND

• Bernstein JA. Azelastine hydrochloride: a review of pharmacology, pharmacokinetics, clinical efficacy and tolerability. Curr Med Res Opin. 2007 Oct;23(10):2441-52. doi: 10.1185/030079907X226302.

  PMID: 17723160 BACKGROUND

• U.S. Food & Drug Administration. Astelin Nasal Spray Full Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf. Accessed 01/26/2021.

  BACKGROUND

• Reznikov LR, Norris MH, Vashisht R, Bluhm AP, Li D, Liao YJ, Brown A, Butte AJ, Ostrov DA. Identification of antiviral antihistamines for COVID-19 repurposing. Biochem Biophys Res Commun. 2021 Jan 29;538:173-179. doi: 10.1016/j.bbrc.2020.11.095. Epub 2020 Dec 3.

  PMID: 33309272 BACKGROUND

• Freedberg DE, Conigliaro J, Wang TC, Tracey KJ, Callahan MV, Abrams JA; Famotidine Research Group. Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study. Gastroenterology. 2020 Sep;159(3):1129-1131.e3. doi: 10.1053/j.gastro.2020.05.053. Epub 2020 May 22. No abstract available.

  PMID: 32446698 BACKGROUND

• Ghosh R, Chatterjee S, Dubey S, Lavie CJ. Famotidine Against SARS-CoV2: A Hope or Hype? Mayo Clin Proc. 2020 Aug;95(8):1797-1799. doi: 10.1016/j.mayocp.2020.05.027. Epub 2020 Jun 6. No abstract available.

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• Ennis M, Tiligada K. Histamine receptors and COVID-19. Inflamm Res. 2021 Jan;70(1):67-75. doi: 10.1007/s00011-020-01422-1. Epub 2020 Nov 18.

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• Hedeker D. Multilevel Models for Ordinal and Nominal Variables. In: Leeuw Jd, Meijer E, eds. Handbook of Multilevel Analysis. New York, NY: Springer New York; 2008:237-274.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

azelastine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Brandon Baird

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon Baird

CONTACT

7737026143; bbaird@bsd.uchicago.edu

Shalitha Johnson

CONTACT

7738348758; sjohnson28@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind clinical trial. Randomization schedules will be generated and stratified by age (18-30, 31--40, 41-50, and ≥50 years) and sex, using computer-generated random numbers and alternating block sizes. Only the study statistician will have access to the randomization lists. The assigned treatment for each study subject will be obtained via REDCap. The Investigational Drug Service (IDS) pharmacy will be used to distribute the drug or placebo as provided by Bayer. The pharmacy will also help to coordinate and track randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)