A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 Covid-19

NCT04742712 | Completed

• 1 other identifier: PHT/2020/57
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Point of care testing is urgently required to enable the immediate detection of SARS-CoV-2 infection to allow effective transmission prevention precautions to succeed.

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• Presence of SARS-CoV-2 infection in those with high clinical suspicion and/or a positive RT-PCR swab.

  Measured using the CoronaCheck device

  through study completion, an average of 1 year

Interventions

CoronaCheck Device DEVICE

All participants breath normally into the device for up to 6 minutes

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cross-sectional study including four groups at different stages of the diagnostic and screening process for potential SARS-CoV-2 infection, utilising RT-PCR from nasopharyngeal swab as the current gold standard: 1. Participants with clinically suspected SARS-CoV-2 confirmed with a positive RT-PCR swab (inpatient or outpatient testing) 2. Participants with clinically suspected SARS-CoV-2 but a negative RT-PCR swab (inpatient or outpatient testing) 3. Asymptomatic participants with a low clinical suspicion of SARS-CoV-2 but a positive RT-PCR swab 4. Asymptomatic participants with a low clinical suspicion of SARS-CoV-2 and a negative RT-PCR swab

You may qualify if:

• o Any adult (≥ 16 years of age) who is:
• undergoing a swab for possible SARS-CoV-2 infection
• willing and able to give informed consent for participation in the study
• unlikely to suffer harm as a result of testing in the opinion of the investigator

You may not qualify if:

• o Participants receiving:
• invasive ventilation, non-invasive ventilation or nasal high flow oxygen
• supplementary oxygen with symptomatic hypoxia or oxygen saturations ≤92% (≤88% in COPD) despite 4L oxygen via nasal cannulae
• unable to comprehend the study or provide informed consent

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

RT-PCR swab

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: February 8, 2021
• Study Start: October 27, 2020
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)