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

NCT04556318 | Completed

• 1 other identifier: HC-N-H-2004
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 related volatile organic compounds (VOC)

  1 hour after breath gas sampling

Secondary Outcomes (1)

• To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings

  Within 3 days

Interventions

Ion Mobility Spectrometry (IMS) DEVICE

Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (2)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

Location

Technical University of Munich, Klinikum rechts der Isar

Munich, Germany

Location

Related Publications (1)

• Voit F, Erber J, Feuerherd M, Fries H, Bitterlich N, Diehl-Wiesenecker E, Gladis S, Lieb J, Protzer U, Schneider J, Geisler F, Somasundaram R, Schmid RM, Bauer W, Spinner CD. Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study. Eur J Med Res. 2023 Sep 2;28(1):318. doi: 10.1186/s40001-023-01284-3.

  PMID: 37660038 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ion Mobility Spectrometry

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Christoph Spinner, PD Dr.

  Technical University of Munich, Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 21, 2020
• Study Start: September 23, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

DE (2)