Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)

B. Braun

Status: Completed

Conditions: Covid19

Treatments: Device: Ion Mobility Spectrometry (IMS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04556318

HC-N-H-2004

Details and patient eligibility

About

Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.

In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
• Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
• Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

Exclusion criteria

• History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
• Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis