Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols

This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19.

These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab.

The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment.

Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected.

Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Device: Breath Biopsy face masks with removable filters and fitted PVA strip

Detailed Description

Subjects will be recruited for the study during their scheduled appointments per clinical practice to the site, no separate study visit is required.

The participant's involvement in the study will be limited to one visit (per routine practice) only. No additional follow up is required.

For the purpose of the study a breath sample will be collected using the Breath Biopsy face masks. Collection of exhaled breath aerosols using these single use, disposable face masks will require subjects to breath normally into these face masks, the total collection time will not exceed one hour. It is expected to reduce collection times after initial validation steps to the shortest time providing sufficient diagnostic accuracy.

Given the non-invasive nature of these breath collections subjects can immediately provide up to two samples using the Breath Biopsy face masks. The breath collection should occur within 24 hours of the diagnostic sample.

Collected samples will be either frozen or shipped for rtPCR analysis of the presence of nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to validate different storage conditions.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospital NHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.

Description

Inclusion Criteria:

• Provide written informed consent
• Be 16 years or older
• Suspected or confirmed nCOVID-19 infection

Exclusion Criteria:

• Subjects unable to provide written informed consent

• Ineligible subjects will specifically include subjects:

  • deemed unlikely to be able to maintain oxygen saturation of greater than 90% while breathing room air for 30 seconds Require non-invasive ventilation or high flow nasal oxygen
  • who require inotropic medication to maintain adequate organ perfusion
  • communication barrier and / or unable to comply with the instructions to use the Breath Biopsy face masks

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of nCOVID-19 using a face mask	The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent Patient use of face mask	The secondary objective is to assess the feasibility of independent use of the Breath Biopsy face masks. This will be measured by means of patient reported feedback on their level of comfort in performing the breath collection	1 year

Collaborators and Investigators

• Sponsor: Owlstone Ltd
• Collaborators: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Study Chair: Stefan Marciniak, Cambridge Institute for Medical Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ACTUAL): December 19, 2020
• Study Completion (ACTUAL): December 19, 2020

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (ACTUAL): July 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: COVID-Breath

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No