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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Experimental: Primary Cohort
  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
• Другое Placebo Comparator: Primary Cohort - Placebo
  A Placebo will be provided by Bayer which features similar color and packaging as azelastine.

Первичные конечные точки

• Astepro for use in managing Covid-19 symptoms and assessing viral load in participants.. [Срок оценки: Baseline (Day -1) through Day 10]

Вторичные конечные точки (3)

• Rate of Covid-19 infectivity in primary cohorts close contacts [Срок оценки: Day 1, Day 11]
• Change from baseline in upper respiratory symptoms and Quality of Life, as measured by the WURSS44 survey [Срок оценки: 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 [Срок оценки: Primary Cohort: Baseline (Day -1) through Day 10, Close Contact Cohort: Day 1 and Day 11]

Критерии участия

Inclusion 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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839. PMID 32648899
• Johns Hopkins University & Medicine. Coronavirus Resource Center. https://coronavirus.jhu.edu/. Accessed 01/26/2021.
• 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 PMID 33059771
• 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
• 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, Bonnet PMID 32445440
• 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.
• 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
• 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.

Идентификаторы

NCT: NCT06008860 · IRB22-1144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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