SARS-CoV-2 InfectionNCT04739020
Respiratory Aerosols in Patients With COVID-19 and Healthy Controls
A study testing Resp-Aer-Meter, Spirometry and Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations in people with SARS-CoV-2 Infection and Covid19, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- What is being tested?
- Resp-Aer-Meter, Spirometry and Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590
Desiree Gutmann, MD, 004915117190498, desiree.gutmann@kgu.de
Stefan Zielen, Professor, 0049696301 ext. 83349, stefan.zielen@kgu.de
About this study
Official title: 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.
Read the 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.
- Conditions
- SARS-CoV-2 Infection, Covid19
- Being tested
- Resp-Aer-Meter, Spirometry, Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
- Keywords
- COVID-19, Aerosol, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resp-Aer-MeterDiagnostic test
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
SpirometryDiagnostic 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 concentrationsDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| PCR SARS-CoV-2 Negative Adults | Active comparator | Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers. Receives: Diagnostic Test: Resp-Aer-Meter; Diagnostic Test: Spirometry; Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations |
| PCR SARS-CoV-2 Positive Adults | Active comparator | 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. Receives: Diagnostic Test: Resp-Aer-Meter; Diagnostic Test: Spirometry; Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations |
| PCR SARS-CoV-2 Negative Children | Active comparator | 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. Receives: Diagnostic Test: Resp-Aer-Meter; Diagnostic Test: Spirometry; Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations |
| PCR SARS-CoV-2 Positive Children | Active comparator | 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. Receives: Diagnostic Test: Resp-Aer-Meter; Diagnostic Test: Spirometry; Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients.
Measured: 7 days
Aerosol concentration in children and adults
Distinction between children and adults via aerosol measurement.
Measured: Each patient visit will take about 1-2 hours.
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.
Measured: Each patient visit will take about 1-2 hours.
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.
Measured: Each patient visit will take about 1-2 hours.
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.
Measured: Each patient visit will take about 1-2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start18 Jan 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Palas GmbH
- Responsible party
- Principal investigator, Stefan Zielen, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Professor, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739020
- Sponsor's protocol ID
- 20-1001
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be provided of the investigated cohort
Publications
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.
PubMed 35923787
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults
- ClinicalTrials.gov ID
- NCT04739020
- Acronym / sponsor ID
- 20-1001
- Conditions
- SARS-CoV-2 Infection, Covid19
- Keywords
- COVID-19, Aerosol, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Palas GmbH
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PCR SARS-CoV-2 Negative Adults | Active comparator | Diagnostic Test: Resp-Aer-Meter, Diagnostic Test: Spirometry, Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrationsHealthy 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 comparator | Diagnostic Test: Resp-Aer-Meter, Diagnostic Test: Spirometry, Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrationsAdults 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 comparator | Diagnostic Test: Resp-Aer-Meter, Diagnostic Test: Spirometry, Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrationsChildren 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 comparator | Diagnostic Test: Resp-Aer-Meter, Diagnostic Test: Spirometry, Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrationsChildren 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resp-Aer-MeterMeasurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups. | Diagnostic test | PCR SARS-CoV-2 Negative Adults, PCR SARS-CoV-2 Negative Children, PCR SARS-CoV-2 Positive Adults, PCR SARS-CoV-2 Positive Children |
| SpirometryComparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups. | Diagnostic test | PCR SARS-CoV-2 Negative Adults, PCR SARS-CoV-2 Negative Children, PCR SARS-CoV-2 Positive Adults, PCR SARS-CoV-2 Positive Children |
| Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrationsComparison 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). | Diagnostic test | PCR SARS-CoV-2 Negative Adults, PCR SARS-CoV-2 Negative Children, PCR SARS-CoV-2 Positive Adults, PCR SARS-CoV-2 Positive Children |
Primary outcome
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.
5 secondary outcomes
Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
Time frame: 7 days
Aerosol concentration in children and adults
Time frame: 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.
Cofounder Analysis
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Derived from this study: PubMed 35923787Gutmann 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be provided of the investigated cohort
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Professor principal investigator
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resp-Aer-Meter, Spirometry and Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations in people with SARS-CoV-2 Infection and Covid19, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desiree Gutmann, MD (004915117190498, desiree.gutmann@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerosol concentration in PCR SARS-CoV-2 positive and negative participants (time frame: Each patient visit will take about 1-2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.