Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

NCT ID: NCT04739020

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Infection Covid19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COVID-19 Aerosol SARS-CoV-2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Resp-Aer-Meter

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Group Type ACTIVE_COMPARATOR

Resp-Aer-Meter

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Group Type ACTIVE_COMPARATOR

Resp-Aer-Meter

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Group Type ACTIVE_COMPARATOR

Resp-Aer-Meter

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Spirometry

Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Palas GmbH

UNKNOWN

Sponsor Role collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stefan Zielen

Professor Stefan Zielen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Zielen, Professor

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Desiree Gutmann, MD

Role: CONTACT

Phone: 004915117190498

Email: [email protected]

Stefan Zielen, Professor

Role: CONTACT

Phone: 0049696301

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Desiree Gutmann, MD

Role: primary

Stefan Zielen, Professor

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35923787 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-1001

Identifier Type: -

Identifier Source: org_study_id