Using face masks to detect COVID-19 in breath samples
The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19
This study tests if wearing special masks that collect breath samples can help diagnose COVID-19 better than the usual nose swab test for hospitalized patients and healthcare workers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 630 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT04481646 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of mask-based sampling for diagnosing COVID-19 by comparing it to the standard nasopharyngeal swab test. Participants, including hospitalized patients and healthcare workers, will wear modified masks that collect breath samples for analysis. The study aims to assess the amount of COVID-19 detected in breath and its implications for public health. Data on demographics and microbiological results will be collected to evaluate the method's utility in a healthcare setting.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients with suspected COVID-19 and healthcare workers at University Hospitals of Leicester.
Not a fit: Patients requiring oxygen by face mask or those with respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a non-invasive and efficient way to diagnose COVID-19, improving screening processes.
How similar studies have performed: Previous studies have shown the utility of mask-based sampling for other respiratory infections, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Not requiring oxygen by face mask * Either: o Patients admitted to hospital with suspected COVID-19 * Or o Healthcare workers working within University Hospitals of Leicester, including those with and without symptoms suspicious of COVID-19. Exclusion Criteria: * Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe) * Participants with respiratory failure * Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the study * Individuals who are unable to provide informed consent for themselves (i.e., individuals who lack capacity).
Where this trial is running
Leicester
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Manish Pareek, MBChB PhD
- Email: manish.pareek@leicester.ac.uk
- Phone: 01162541414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.