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NCT04467112
Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols
trial testing Breath Biopsy face masks with removable filters and fitted PVA strip in COVID in 8 participants. Completed in 19 December 2020.
19 December 2020
Quick facts
| Lead sponsor | Owlstone Ltd |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8 |
| Start date | 30 July 2020 |
| Primary completion | 19 December 2020 |
| Estimated completion | 19 December 2020 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Breath Biopsy face masks with removable filters and fitted PVA strip
Conditions studied
- COVID — all drugs for COVID →
Sponsor
Owlstone Ltd
Who can join
16 and older, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The SARS-CoV-2 viral load in COVID-19 patients is lower on face mask filters than on nasopharyngeal swabs.
Smolinska A, Jessop DS, Pappan KL, De Saedeleer A, et al · · 2021 · cited 12× · PMID 34188082 · DOI 10.1038/s41598-021-92665-3
Verify or expand the search:
- PubMed search for NCT04467112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Breath Biopsy face masks with removable filters and fitted PVA strip
Trials testing the same drug.
- NCT04508556 — Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study · completed
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- NCT04351347 — The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment · Phase 2, PHASE3 · recruiting
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Other Owlstone Ltd trials
Trials by the same sponsor.
- NCT06193239 — Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2) · Phase 2 · recruiting
- NCT05510674 — Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution) · Phase 1 · completed
- NCT04508556 — Performance Assessment of SARS-CoV-2 Detection Breath Biopsy - SARS-CoV-2 Study · completed
- NCT03756597 — PAN-study: Pan-Cancer Early Detection Study (PAN) · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04467112 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Owlstone Ltd
- Last refreshed: 30 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04467112.
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