COVID-19CERAbTc-19NCT05298462
Clinical Evaluation of Rapid Antibody Test for Covid-19
A study testing Livzon Rapid Antibody Test for COVID-19 in people with COVID-19, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Livzon Rapid Antibody Test for COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2020to 24 Jul 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient or patient in the "virtual hospital" with confirmed Covid-19 infection on PCR OR with history of clinically suspected Covid-19 but no PCR test OR hospital staff with clinical suspicion of past Covid-19 infection.
- Age 18 or over
- At least 7 days since onset of symptoms
- Willing and able to give written informed consent
Who cannot join
- Symptom duration <7 days.
- Lack of written consent
- Age under 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Watford General Hospital
Watford, Hertfordshire, WD18 0HB
About this study
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported.
Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team would like to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody.
Read more
In this study we aim to evaluate the accuracy of this new test, in three groups of patients. Firstly those with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). The second group of 250 patients will be those hospital staff who report symptoms possibly caused by Covid-19 and are receiving a standard antibody test.
The third group of patients will be those followed up in a "virtual hospital" for clinically suspected Covid-19 who had never been tested with a standard PCR test.
As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient.
This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.
- Conditions
- COVID-19
- Being tested
- Livzon Rapid Antibody Test for COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livzon Rapid Antibody Test for COVID-19Diagnostic test
Point-of-care Rapid Antibody Test for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Not described Receives: Diagnostic Test: Livzon Rapid Antibody Test for COVID-19 |
| Hospital staff | Other | Not described Receives: Diagnostic Test: Livzon Rapid Antibody Test for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Sensitivity and specificity compared to standard PCR and/or venous antibody test.
Measured: At least 7 days after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start17 May 2020
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this study we aim to evaluate the accuracy of this new test, in patients and in hospital staff with a history of COVID-19 symptoms
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- West Hertfordshire Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Michael Moore, FRCGP, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298462
- Sponsor's protocol ID
- 56480
- Other IDs
- 283264
- Acronym
- CERAbTc-19
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vancheeswaran R, Willcox ML, Stuart B, Knight M, Kandil H, Barlow A, Patel MH, Stockham J, O'Neill A, Clark TW, Wilkinson T, Little P, Francis N, Griffiths G, Moore M. Accuracy of rapid point-of-care antibody test in patients with suspected or confirmed COVID-19. J Infect. 2022 Jan;84(1):94-118. doi: 10.1016/j.jinf.2021.07.006. Epub 2021 Jul 14. No abstract available.
PubMed 34273411
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Rapid Antibody Test for Covid-19
- ClinicalTrials.gov ID
- NCT05298462
- Acronym / sponsor ID
- CERAbTc-19 / 56480
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- West Hertfordshire Hospitals NHS Trust
- Study start
- 17 May 2020 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 28 Mar 2022 (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.
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported.
Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team would like to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody.
In this study we aim to evaluate the accuracy of this new test, in three groups of patients. Firstly those with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). The second group of 250 patients will be those hospital staff who report symptoms possibly caused by Covid-19 and are receiving a standard antibody test.
The third group of patients will be those followed up in a "virtual hospital" for clinically suspected Covid-19 who had never been tested with a standard PCR test.
As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient.
This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study we aim to evaluate the accuracy of this new test, in patients and in hospital staff with a history of COVID-19 symptoms
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Diagnostic Test: Livzon Rapid Antibody Test for COVID-19 |
| Hospital staff | Other | Diagnostic Test: Livzon Rapid Antibody Test for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient or patient in the "virtual hospital" with confirmed Covid-19 infection on PCR OR with history of clinically suspected Covid-19 but no PCR test OR hospital staff with clinical suspicion of past Covid-19 infection.
- Age 18 or over
- At least 7 days since onset of symptoms
- Willing and able to give written informed consent
Key exclusion criteria (3 listed)
- Symptom duration <7 days.
- Lack of written consent
- Age under 18
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 |
|---|---|---|
| Livzon Rapid Antibody Test for COVID-19Point-of-care Rapid Antibody Test for COVID-19 | Diagnostic test | Hospital staff, Patients |
Primary outcome
Sensitivity and Specificity
Time frame: At least 7 days after onset of symptoms
Sensitivity and specificity compared to standard PCR and/or venous antibody test.
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 28 Mar 2022.
- Results publication: PubMed 34273411Vancheeswaran R, Willcox ML, Stuart B, Knight M, Kandil H, Barlow A, Patel MH, Stockham J, O'Neill A, Clark TW, Wilkinson T, Little P, Francis N, Griffiths G, Moore M. Accuracy of rapid point-of-care antibody test in patients with suspected or confirmed COVID-19. J Infect. 2022 Jan;84(1):94-118. doi: 10.1016/j.jinf.2021.07.006. Epub 2021 Jul 14. No abstract available.
- Pre-printLink provided by the sponsor.
- 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.
Michael Moore, FRCGP principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livzon Rapid Antibody Test for COVID-19 in people with COVID-19, run by University of Southampton 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 3 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 28 Mar 2022. 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?
Sensitivity and Specificity (time frame: At least 7 days after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298462, which also lists 1 linked publication.
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 28 Mar 2022.