SARS-CoV InfectionNCT04742712
A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 Covid-19
An observational study of SARS-CoV Infection, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- CoronaCheck Device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2020to 2 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 - FIND SARS CoV-2 Covid-19
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.
Read the detailed description
The Coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of EBC. It provides an automated platform for the detection of SARS-CoV-2 using an existing sensor repurposed with immobilised recombinant ACE-2 to bind the virus. This produces a measurable signal indicating whether SARS-CoV-2 is present or not.
EBC is collected by the CoronaCheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. Previous studies using Inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. The full test cycle including sample collection and test assay typically occurs in less than 5 minutes.
Given the risk of infection, this CoronaCheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. It is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of SARS-CoV-2 it is felt unavoidable at present.
Using the CoronaCheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. This could potentially be applied to screening for SARS-CoV-2 in a wide variety of environments for example: GP practices, drive-thru centres, colleges, universities, airports and sports arenas.
Any person undergoing a swab for a possible SARS CoV-2 infection is eligible for inclusion, participants will not be assigned an intervention.
The participants will breathe into the CoronaCheck device. This involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. This disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. The CoronaCheck device then provides a reading reflecting EBC ACE2 binding which will be documented on the eCRF. This result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study.
- Conditions
- SARS-CoV Infection
- Being tested
- CoronaCheck Device
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaCheck DeviceDevice
All participants breath normally into the device for up to 6 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of SARS-CoV-2 infection in those with high clinical suspicion and/or a positive RT-PCR swab.
Measured using the CoronaCheck device
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start27 Oct 2020
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742712
- Sponsor's protocol ID
- PHT/2020/57
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 - FIND SARS CoV-2 Covid-19
- ClinicalTrials.gov ID
- NCT04742712
- Acronym / sponsor ID
- PHT/2020/57
- Conditions
- SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of EBC. It provides an automated platform for the detection of SARS-CoV-2 using an existing sensor repurposed with immobilised recombinant ACE-2 to bind the virus. This produces a measurable signal indicating whether SARS-CoV-2 is present or not.
EBC is collected by the CoronaCheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. Previous studies using Inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. The full test cycle including sample collection and test assay typically occurs in less than 5 minutes.
Given the risk of infection, this CoronaCheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. It is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of SARS-CoV-2 it is felt unavoidable at present.
Using the CoronaCheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. This could potentially be applied to screening for SARS-CoV-2 in a wide variety of environments for example: GP practices, drive-thru centres, colleges, universities, airports and sports arenas.
Any person undergoing a swab for a possible SARS CoV-2 infection is eligible for inclusion, participants will not be assigned an intervention.
The participants will breathe into the CoronaCheck device. This involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. This disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. The CoronaCheck device then provides a reading reflecting EBC ACE2 binding which will be documented on the eCRF. This result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoronaCheck DeviceAll participants breath normally into the device for up to 6 minutes | Device | – |
Primary outcome
Presence of SARS-CoV-2 infection in those with high clinical suspicion and/or a positive RT-PCR swab.
Time frame: through study completion, an average of 1 year
Measured using the CoronaCheck device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of SARS-CoV-2 infection in those with high clinical suspicion and/or a positive RT-PCR swab. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.