Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

December 14, 2021 updated by: Stefan Zielen, Johann Wolfgang Goethe University Hospital

Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Corona virus disease 2019 (COVID-19) is a viral illness caused by SARS-CoV-2. Current research suggests that the SARS-CoV-2 infection is primarily spread through droplets and aerosols. As per current literature, the spread through asymptomatic carriers, as well as highly contagious carriers ('super spreader') play an important role in the infectiousness of the virus. It is currently unclear, if the contagiousness of children differs from adults.

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.

Study Type

Interventional

Enrollment (Anticipated)

525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Johann Wolfgang Goethe University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Diagnostic test: 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.
Diagnostic test: Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Diagnostic test: 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).
Active Comparator: 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.
Diagnostic test: 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.
Diagnostic test: Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Diagnostic test: 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).
Active Comparator: 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.
Diagnostic test: 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.
Diagnostic test: Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Diagnostic test: 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).
Active Comparator: 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.
Diagnostic test: 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.
Diagnostic test: Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Diagnostic test: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
Time Frame: Each patient visit will take about 1-2 hours.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
Time Frame: 7 days
Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients.
7 days
Aerosol concentration in children and adults
Time Frame: Each patient visit will take about 1-2 hours.
Distinction between children and adults via aerosol measurement.
Each patient visit will take about 1-2 hours.
Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.
Time Frame: Each patient visit will take about 1-2 hours.
Quantitative and qualitative virus PCR measurements of respiratory secretions in participants with aerosol concentrations > 5000/L.
Each patient visit will take about 1-2 hours.
Cofounder Analysis
Time Frame: Each patient visit will take about 1-2 hours.
Investigation of change in aerosol concentration due to confounders, such as age, sex, other viral illness, lung function, height, weight, BMI and smoking status.
Each patient visit will take about 1-2 hours.
Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants
Time Frame: Each patient visit will take about 1-2 hours.
Correlation between clinical symptoms and results of aerosol measurement in PCR SARS-CoV-2 positive participants. Determination if more symptoms lead to higher aerosol concentrations.
Each patient visit will take about 1-2 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

Palas GmbH

Investigators

  • Principal Investigator: Stefan Zielen, Professor, Johann Wolfgang Goethe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized data will be provided of the investigated cohort

IPD Sharing Time Frame

After end of study, anticipated between June and December 2021

IPD Sharing Access Criteria

The data will be available after the end of study and successful publication of the results (anticipated June 2022) for 10 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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