Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)

NCT04329507 | Completed

• 1 other identifier: 282014
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

On Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help. This study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.

Conditions

COVID-19; Respiratory Disease

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without.

  breath sample collection

  up to daily during hospital admission

Secondary Outcomes (4)

• Detection of markers of Covid-19 pneumonia in non-invasive breath samples.

  multiple samples up to 60 days

• Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs.

  multiple samples up to 60 days

• Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored

  multiple samples up to 60 days

• In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden .

  multiple samples up to 60 days

Interventions

Breath test DIAGNOSTIC_TEST

collection of an exhaled breath sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to hospital with respiratory signs and tested for SARS-CoV-2

You may qualify if:

• ≥18 years old with clinical features consistent with pneumonia or chest infection due to SARS-CoV-2 AND
• presenting to the Royal Infirmary of Edinburgh where they are swabbed and triaged for Covid-19.

You may not qualify if:

• Inability to provide informed consent
• Age 17 years or less

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders

Interventions

Breath Tests

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)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: March 25, 2020
• Primary Completion: January 31, 2021
• Study Completion: May 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

GB (1)