Respiratory Aerosols in Patients With COVID-19 and Healthy Controls
NCT ID: NCT04739020
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
525 participants
INTERVENTIONAL
2021-01-18
2021-12-31
Brief Summary
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Detailed Description
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In the proposed investigation, measurement of the particle size and concentration in respiratory aerosols will be conducted via the Resp-Aer-Meter (Palas GmbH). First step will be to establish the measurements with this new device. Thereafter, a comparison between PCR SARS-CoV-2 positive and negative participants, as well as between children and adults, will be conducted. In addition to the measurement of aerosols, the clinical symptoms suggestive of COVID-19, lung function (FEV1) and laboratory inflammatory markers, if available, will be analyzed.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PCR SARS-CoV-2 Negative Adults
Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers.
Resp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (\>5000/L).
PCR SARS-CoV-2 Positive Adults
Adults with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic parents that are in the hospital with their children and symptomatic adults that are admitted to the infectious disease ward.
Resp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (\>5000/L).
PCR SARS-CoV-2 Negative Children
Children with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of children admitted to the Children's Hospital or presenting for planned diagnostic testing or follow up.
Resp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (\>5000/L).
PCR SARS-CoV-2 Positive Children
Children with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic children that are admitted to the Children's Hospital for reasons other than COVID-19 and symptomatic children.
Resp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (\>5000/L).
Interventions
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Resp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (\>5000/L).
Eligibility Criteria
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Inclusion Criteria
* SARS-CoV-2 PCR testing within the last 3 days
* Ability to capture extend and consequences of the study
* Written informed consent of patient and, if applicable, of caregiver
Exclusion Criteria
* Inability to participate in aerosol measurement
* Inability to participate in Spirometry
* Inability to capture extend and consequences of the study
* Only for arm 1 (PCR SARS-CoV-2 negative adults): chronic disease with immunosuppressive therapy
6 Years
ALL
Yes
Sponsors
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Palas GmbH
UNKNOWN
Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Stefan Zielen
Professor Stefan Zielen
Principal Investigators
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Stefan Zielen, Professor
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital
Locations
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Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Desiree Gutmann, MD
Role: primary
Stefan Zielen, Professor
Role: backup
References
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Gutmann D, Donath H, Herrlich L, Lehmkuhler T, Landeis A, Ume ER, Hutter M, Gossmann AK, Weis F, Weiss M, Rabenau HF, Zielen S. Exhaled Aerosols in SARS-CoV-2 Polymerase Chain Reaction-Positive Children and Age-Matched-Negative Controls. Front Pediatr. 2022 Jul 18;10:941785. doi: 10.3389/fped.2022.941785. eCollection 2022.
Other Identifiers
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20-1001
Identifier Type: -
Identifier Source: org_study_id