Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: SARS-CoV-2 Infection; Covid19

Treatments: Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations; Diagnostic Test: Spirometry; Diagnostic Test: Resp-Aer-Meter

Study type: Interventional

Funder types: Other

Identifiers

NCT04739020

20-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 525 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 4 patient groups

PCR SARS-CoV-2 Negative Adults

Active Comparator group

Description:

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

Treatment:

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 group

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.

Treatment:

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 group

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.

Treatment:

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 group

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.

Treatment:

Diagnostic Test: Resp-Aer-Meter

Diagnostic Test: Spirometry

Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations