Clinical trial NCT04739020: 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
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Infection
Covid19
Keywords: COVID-19
Aerosol
SARS-CoV-2
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Palas GmbH
First posted: 2021-02-04
Enrollment: 525
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
timeFrame: Each patient visit will take about 1-2 hours.
Secondary outcomes:
measure: Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants
timeFrame: 7 days
measure: Aerosol concentration in children and adults
timeFrame: Each patient visit will take about 1-2 hours.
measure: Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.
timeFrame: Each patient visit will take about 1-2 hours.
measure: Cofounder Analysis
timeFrame: Each patient visit will take about 1-2 hours.
measure: Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants
timeFrame: Each patient visit will take about 1-2 hours.
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University Hospital
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Stefan Zielen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.