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Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Primary Purpose

SARS-CoV-2 Infection, Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Resp-Aer-Meter
Spirometry
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for SARS-CoV-2 Infection focused on measuring COVID-19, Aerosol, SARS-CoV-2

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johann Wolfgang Goethe University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

PCR SARS-CoV-2 Negative Adults

PCR SARS-CoV-2 Positive Adults

PCR SARS-CoV-2 Negative Children

PCR SARS-CoV-2 Positive Children

Arm Description

Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients.
Aerosol concentration in children and adults
Distinction between children and adults via aerosol measurement.
Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.
Quantitative and qualitative virus PCR measurements of respiratory secretions in participants with aerosol concentrations > 5000/L.
Cofounder Analysis
Investigation of change in aerosol concentration due to confounders, such as age, sex, other viral illness, lung function, height, weight, BMI and smoking status.
Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants
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.

Full Information

First Posted
February 1, 2021
Last Updated
December 14, 2021
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Palas GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04739020
Brief Title
Respiratory Aerosols in Patients With COVID-19 and Healthy Controls
Official Title
Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Palas GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, Covid19
Keywords
COVID-19, Aerosol, SARS-CoV-2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCR SARS-CoV-2 Negative Adults
Arm Type
Active Comparator
Arm Description
Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers.
Arm Title
PCR SARS-CoV-2 Positive Adults
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PCR SARS-CoV-2 Negative Children
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PCR SARS-CoV-2 Positive Children
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Resp-Aer-Meter
Intervention Description
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spirometry
Intervention Description
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
Intervention Type
Diagnostic Test
Intervention Name(s)
Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
Intervention Description
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).
Primary Outcome Measure Information:
Title
Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
Description
Distinction between PCR SARS-CoV-2 positive and negative participants via aerosol measurement. Especially participants with high aerosol concentrations should be detected.
Time Frame
Each patient visit will take about 1-2 hours.
Secondary Outcome Measure Information:
Title
Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
Description
Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients.
Time Frame
7 days
Title
Aerosol concentration in children and adults
Description
Distinction between children and adults via aerosol measurement.
Time Frame
Each patient visit will take about 1-2 hours.
Title
Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.
Description
Quantitative and qualitative virus PCR measurements of respiratory secretions in participants with aerosol concentrations > 5000/L.
Time Frame
Each patient visit will take about 1-2 hours.
Title
Cofounder Analysis
Description
Investigation of change in aerosol concentration due to confounders, such as age, sex, other viral illness, lung function, height, weight, BMI and smoking status.
Time Frame
Each patient visit will take about 1-2 hours.
Title
Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants
Description
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.
Time Frame
Each patient visit will take about 1-2 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Desiree Gutmann, MD
Phone
004915117190498
Email
desiree.gutmann@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Zielen, Professor
Phone
0049696301
Ext
83349
Email
stefan.zielen@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zielen, Professor
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johann Wolfgang Goethe University Hospital
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desiree Gutmann, MD
Phone
004915117190498
Email
desiree.gutmann@kgu.de
First Name & Middle Initial & Last Name & Degree
Stefan Zielen, Professor
Phone
0049696301
Ext
83349
Email
stefan.zielen@kgu.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35923787
Citation
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.
Results Reference
derived

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Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

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