NCT04739020

Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 525 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2 Infection
• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Spirometry	Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
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).

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-12-30
• Completion: 2021-12-31
• First posted: 2021-02-04
• Last updated: 2021-12-15

Locations

1 site across 1 country: Germany