Covid19NCT04529460
Healthy Volunteer COVID-19 Antibody Testing Study
An observational study of Covid19, run by Royal Free Hospital NHS Foundation Trust.
Trial summary
The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government. Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 antibody point of care test kit
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Apr 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Adult (aged ≥ 18 years) healthy volunteers.
- For the positive group: PCR confirmed COVID-19 infection and/or positive antibodies test in the past six months,
- For the negative group: Never had symptoms of COVID-19
- Able to attend hospital for a blood and finger-prick test
Who cannot join
- Current symptoms of COVID-19
- Positive COVID-19 test result in the last 14 days
- Receiving or have received immunosuppression (including systemic corticosteroids) in the last 12 months
- Children (aged < 18years)
- Pregnancy
- Prisoners
About this study
Official title: Post Market Clinical Study of a Point of Care COVID-19 IgG-IgM Rapid Test in Healthy Volunteers
The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government.
Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Immunoglobulins (Ig) to the SARS-CoV-2 develop during the second and third week of COVID-19 disease and can be detected by analyses conducted using laboratory tests. Accurate and scalable point-of-care testing (POCT) for the diagnosis of COVID-19 immunity would allow community diagnostic to be upscaled enormously. POCT for COVID-19 antibodies is possible using small disposable kits. POCT immunity testing using disposable kits will be imperative for effective surveillance and vaccinations programmes.
The study aims to test a novel, rapid antibody testing kit (IgG and IgM) in order to confirm its accuracy in a healthy volunteer population. The antibody testing kit intended for use in the study has already been CE marked for this purpose.
Read the detailed description
This is a commercially funded prospective observational, cohort study of healthy volunteers to assess the sensitivity and specificity of a point of care antibody assay for COVID-19 (the ARIA COVID-19 IgG/IgM Rapid Test. The test is a disposable lateral flow chromatographic cassette (CTK Biotech, Inc., USA). The kit is CE approved for its intended purpose.
200 healthy volunteers will be enrolled into one of two cohorts:100 who have been confirmed to have had COVID-19 in the past (either by previous positive PCR swab or positive antibody test) and 100 thought not to have been affected by COVID-19. Once they have provided written informed consent to participate, volunteers will be invited to attend a 30 minutes appointment for testing. Prior to testing they will be asked to complete a short questionnaire to collect demographic information and details about previous symptoms of COVID-19.
A finger prick blood sample will be taken from the patient and then tested in the ARIA antibody kit. Afterwards, a routine blood sample (10 ml) will then be taken from the participant. The blood sample will be used in three separate ways:
- A small sample of blood will be immediately removed from the sample bottle and placed into an ARIA antibody test kit.
- One blood tube will be immediately centrifuged and a sample of plasma removed for use in the ARIA antibody testing kit.
- One tube will be sent to the designated laboratory for formal COVID-19 ELISA antibody testing.
The ARIA antibody kit will be used to identify the presence of COVID-19 antibodies. The results will be compared to a laboratory enzyme-linked immunosorbent assay (ELISA) for COVID-19 antibodies. Once samples have arrived at the designated study laboratory they will undergo a specified ELSIA test for COVID-19 antibodies conducted according to the laboratory standard operating procedure for that test. For each sample type analysed (finger prick blood, venous blood, and plasma) the sensitivity and specificity of the test will be calculated against the results of the laboratory ELISA test.
Afterwards a brief exit questionnaire will be completed by the participant to document their experience of the study.
Recruitment is expected to be completed within six months of commencing the study.
- Conditions
- Covid19
- Being tested
- COVID-19 antibody point of care test kit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 antibody point of care test kitDiagnostic test
A disponible point of care test that identifies the presence of antibodies to COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Previously COVID-19 positive | Previously confirmed PCR positive for COVID-19 And/or positive COVID-19 antibody test in the past six months Receives: Diagnostic Test: COVID-19 antibody point of care test kit | |
| Previously COVID19 negative | No previous symptoms of COVID-19 Receives: Diagnostic Test: COVID-19 antibody point of care test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the COVID-19 antibody testing kit
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion29 Jan 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Martin, MB ChB, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529460
- Sponsor's protocol ID
- 134035
- Status last verified
- Oct 2021
- First submitted
- 26 Aug 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Study of a Point of Care COVID-19 IgG-IgM Rapid Test in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04529460
- Acronym / sponsor ID
- 134035
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 29 Jan 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 27 Aug 2020 (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.
The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government.
Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Immunoglobulins (Ig) to the SARS-CoV-2 develop during the second and third week of COVID-19 disease and can be detected by analyses conducted using laboratory tests. Accurate and scalable point-of-care testing (POCT) for the diagnosis of COVID-19 immunity would allow community diagnostic to be upscaled enormously. POCT for COVID-19 antibodies is possible using small disposable kits. POCT immunity testing using disposable kits will be imperative for effective surveillance and vaccinations programmes.
The study aims to test a novel, rapid antibody testing kit (IgG and IgM) in order to confirm its accuracy in a healthy volunteer population. The antibody testing kit intended for use in the study has already been CE marked for this purpose.
Detailed description
This is a commercially funded prospective observational, cohort study of healthy volunteers to assess the sensitivity and specificity of a point of care antibody assay for COVID-19 (the ARIA COVID-19 IgG/IgM Rapid Test. The test is a disposable lateral flow chromatographic cassette (CTK Biotech, Inc., USA). The kit is CE approved for its intended purpose.
200 healthy volunteers will be enrolled into one of two cohorts:100 who have been confirmed to have had COVID-19 in the past (either by previous positive PCR swab or positive antibody test) and 100 thought not to have been affected by COVID-19. Once they have provided written informed consent to participate, volunteers will be invited to attend a 30 minutes appointment for testing. Prior to testing they will be asked to complete a short questionnaire to collect demographic information and details about previous symptoms of COVID-19.
A finger prick blood sample will be taken from the patient and then tested in the ARIA antibody kit. Afterwards, a routine blood sample (10 ml) will then be taken from the participant. The blood sample will be used in three separate ways:
- A small sample of blood will be immediately removed from the sample bottle and placed into an ARIA antibody test kit.
- One blood tube will be immediately centrifuged and a sample of plasma removed for use in the ARIA antibody testing kit.
- One tube will be sent to the designated laboratory for formal COVID-19 ELISA antibody testing.
The ARIA antibody kit will be used to identify the presence of COVID-19 antibodies. The results will be compared to a laboratory enzyme-linked immunosorbent assay (ELISA) for COVID-19 antibodies. Once samples have arrived at the designated study laboratory they will undergo a specified ELSIA test for COVID-19 antibodies conducted according to the laboratory standard operating procedure for that test. For each sample type analysed (finger prick blood, venous blood, and plasma) the sensitivity and specificity of the test will be calculated against the results of the laboratory ELISA test.
Afterwards a brief exit questionnaire will be completed by the participant to document their experience of the study.
Recruitment is expected to be completed within six months of commencing the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously COVID-19 positive | – | Diagnostic Test: COVID-19 antibody point of care test kitPreviously confirmed PCR positive for COVID-19 And/or positive COVID-19 antibody test in the past six months |
| Previously COVID19 negative | – | Diagnostic Test: COVID-19 antibody point of care test kitNo previous symptoms of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Adult (aged ≥ 18 years) healthy volunteers.
- For the positive group: PCR confirmed COVID-19 infection and/or positive antibodies test in the past six months,
- For the negative group: Never had symptoms of COVID-19
- Able to attend hospital for a blood and finger-prick test
Key exclusion criteria (6 listed)
- Current symptoms of COVID-19
- Positive COVID-19 test result in the last 14 days
- Receiving or have received immunosuppression (including systemic corticosteroids) in the last 12 months
- Children (aged < 18years)
- Pregnancy
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 |
|---|---|---|
| COVID-19 antibody point of care test kitA disponible point of care test that identifies the presence of antibodies to COVID-19 | Diagnostic test | Previously COVID-19 positive, Previously COVID19 negative |
Primary outcome
Sensitivity and specificity of the COVID-19 antibody testing kit
Time frame: Immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- 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.
Daniel Martin, MB ChB principal investigator
Royal Free Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Royal Free Hospital NHS Foundation Trust.
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 6 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: withdrawn, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 of the COVID-19 antibody testing kit (time frame: Immediate). 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 14 Oct 2021.