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

NCT04467112 | Completed

• 1 other identifier: COVID-Breath
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Independent Patient use of face mask

  1 year

Interventions

Breath Biopsy face masks with removable filters and fitted PVA strip DEVICE

Device developed for collection of breath samples

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Owlstone Ltd: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospital NHS

Cambridge, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The face mask will be placed onto the subject's face, covering his/her nose and mouth, head straps will be used to ensure that the face mask is kept in place for the duration of the test. This mask will contain a material designed to capture exhaled respiratory droplets and/or aerosols. Several iterations of these impaction and filtration devices may be used to optimize functional attributes of the material for capture of COVID. These materials will always have a proven safety for use with humans. Subjects can talk, cough and sneeze in the mask or can temporarily remove the mask if uncomfortable, to drink some water etc if required. Total collection time spread across two masks will not exceed one hour

Study Officials

• Stefan Marciniak

  Cambridge Institute for Medical Research

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 10, 2020
• Study Start: July 30, 2020
• Primary Completion: December 19, 2020
• Study Completion: December 19, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)