Respiratory Aerosols in Patients With COVID-19 and Healthy Controls
Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults
1 other identifier
interventional
525
1 country
1
Brief Summary
The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe Acute Respiratory Syndrome Corona Virus 2) positive and negative children and adults with the Resp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratory aerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established. Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive and negative participants (children and adults) will be conducted. In addition to the measurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratory inflammatory markers will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2021
CompletedFirst Submitted
Initial submission to the registry
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 15, 2021
December 1, 2021
12 months
February 1, 2021
December 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
Distinction between PCR SARS-CoV-2 positive and negative participants via aerosol measurement. Especially participants with high aerosol concentrations should be detected.
Each patient visit will take about 1-2 hours.
Secondary Outcomes (5)
Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
7 days
Aerosol concentration in children and adults
Each patient visit will take about 1-2 hours.
Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.
Each patient visit will take about 1-2 hours.
Cofounder Analysis
Each patient visit will take about 1-2 hours.
Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants
Each patient visit will take about 1-2 hours.
Study Arms (4)
PCR SARS-CoV-2 Negative Adults
ACTIVE COMPARATORHealthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers.
PCR SARS-CoV-2 Positive Adults
ACTIVE COMPARATORAdults 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.
PCR SARS-CoV-2 Negative Children
ACTIVE COMPARATORChildren 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.
PCR SARS-CoV-2 Positive Children
ACTIVE COMPARATORChildren 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.
Interventions
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
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
You may qualify if:
- Age 6 years or older
- 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
You may not qualify if:
- Age under 6 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johann Wolfgang Goethe University Hospitallead
- Palas GmbHcollaborator
Study Sites (1)
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
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.
PMID: 35923787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zielen, Professor
Johann Wolfgang Goethe University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Stefan Zielen
Study Record Dates
First Submitted
February 1, 2021
First Posted
February 4, 2021
Study Start
January 18, 2021
Primary Completion
December 30, 2021
Study Completion
December 31, 2021
Last Updated
December 15, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After end of study, anticipated between June and December 2021
- Access Criteria
- The data will be available after the end of study and successful publication of the results (anticipated June 2022) for 10 years
Anonymized data will be provided of the investigated cohort