COVIDSOCRATESNCT04403906
Somerset and South Essex Coronavirus Antigen Testing
A study testing PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) in people with COVID and SARS-CoV 2, run by Somerset NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation and holds a European CE marking for in vitro diagnostic devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV 2
- What is being tested?
- PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2020to Aug 2021
- 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
- Participant has clinical indication for a COVID diagnostic test and a clinical blood sample from which whole blood or plasma will be leftover for storage
Who cannot join
- Inability to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Justin Pepperell, MD, justin.pepperell@tst.nhs.uk
Caitlin Morgan, MBBS, caitlin.morgan@tst.nhs.uk
About this study
Official title: Evaluation of the PCL Rapid Point of Care Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2
This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation and holds a European CE marking for in vitro diagnostic devices. These tests have been made available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology Partnership). They have been widely used in South Korea.
This study will test the practical delivery of the test in terms of time constraints and error rates. We will also compare the objective performance to the current standard diagnostic test for COVID-19 and against a proven serological antibody test when a suitable reference testing becomes available.
Read more
We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them with the PCL antigen test in parallel. We aim to study 200 patients split across three sites; Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The results will not be used to guide clinical decision making. Patients having a COVID PCR test will be asked to read the patient information sheet and asked if they would like to participate. The patients will be asked to have a second nasal/throat swab taken shortly after their swab for the PCR test.
Written informed consent will be taken for whole blood or plasma left over from any routine clinical sample to be stored as anonymised samples for future testing once a reference test becomes available.
We will report results of the onsite clinical diagnostic test and the PCL antigen test with the number of the kit used, and test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of onset, symptoms and immunodeficiency status or significant conditions.
Read the detailed description
Participants will be identified as they attend assessment areas or testing facilities hosted by the recruiting NHS centres. They will be screened by clinical staff and identified to the research team.
Consent will be taken by a clinical staff member or research staff member with the aim of reducing the number of contacts with the patients and minimising the usage of personal protective equipment.
The consent form gives the patient the opportunity to ask further questions. Only those that are able to consent for themselves will be recruited for this trial.
We want to allow patients as long as possible to make a decision to participate but we feel it is important if possible that the swab samples are taken during the same patient contact (reducing PPE usage and minimising additional staff exposures). However there should not be undue delay to clinical testing therefore we propose if due to clinical urgency potential participants do not have sufficient time to consider the patient information sheet and discuss the trial prior to the PCR swab being taken they can have up to 24 hours to consider this information and participate if they wish to.
Consent will be taken by a clinical staff member or research staff member reducing the number of contacts with the patients. They will then be assigned a trial number used to identify them during the trial. The consent form that will be photocopied and reprinted on clean paper, with the original staying with the patient. The clean copy will be stored in the patient's notes and the case record file.
The current standard COVID PCR swab will be taken and a second swab taken immediately after for use in the rapid antigen test. As the swab process can be uncomfortable after the first swab is taken for the standard clinical test (PCR) the participant's consent will be confirmed again prior to taking the second swab required for the antigen test. After consent the research team will complete an anonymised data case record form from the notes and clinical management database. Participant's year of birth and date of onset of symptoms if symptomatic will be documented.
From routine blood samples taken by phlebotomy or clinical staff consent will be sort to store a leftover sample. This will be processed and stored by research laboratory staff. This will be stored in an anonymised secure research freezer.
In the laboratory their swab for the PCL COVID19 Ag rapid FIA will be run on the test platform. Following the test the swab will be destroyed as per local guidelines for contaminated items. This will performed by dedicated research laboratory scientists. Participant's results from this antigen test will not be used to make clinical decisions. We will not be able to feedback participants' individual results.
Participants are expected to be in the study for total of 20 minutes total although this will be spread over their patient journey so they have sufficient time to read the information leaflet and ask questions.
- Conditions
- COVID, SARS-CoV 2
- Being tested
- PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)
- Keywords
- Anitgen testing, Coronavirus
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)Diagnostic test
The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea.
| Study group | Role | What they receive |
|---|---|---|
| PCL Rapid Antigen Test arm | Experimental | Single arm trial design. Only patients undergoing standard clinical testing (SARS-CoV-2 PCR test) and consenting for additional testing with the PCL rapid antigen test will be included Receives: Diagnostic Test: PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the result of SARS-COV2 PCR test to PCL rapid antigen test
Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test
Measured: within 24 hours
Secondary outcomes (2)
Number of technically failed samples due to test issues.
Number of PCL antigen tests that are invalid (no control testing line)
Measured: At time of testing (within 30 minutes)
Time taken for PCL Antigen test result
Time from swab being taken to result being read by point of care analyser, manufacturer anticipates 10-15 minutes
Measured: within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of diagnostic test - point of care
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somerset NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403906
- Sponsor's protocol ID
- IRAS283137
- Acronym
- SOCRATES
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymised individual data would be available to be shared on request from other research teams/public health bodies but no formal plans in place at time of submission
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PCL Rapid Point of Care Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2
- ClinicalTrials.gov ID
- NCT04403906
- Acronym / sponsor ID
- SOCRATES / IRAS283137
- Conditions
- COVID, SARS-CoV 2
- Keywords
- Anitgen testing, Coronavirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Somerset NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 27 May 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.
This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation and holds a European CE marking for in vitro diagnostic devices. These tests have been made available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology Partnership). They have been widely used in South Korea.
This study will test the practical delivery of the test in terms of time constraints and error rates. We will also compare the objective performance to the current standard diagnostic test for COVID-19 and against a proven serological antibody test when a suitable reference testing becomes available.
We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them with the PCL antigen test in parallel. We aim to study 200 patients split across three sites; Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The results will not be used to guide clinical decision making. Patients having a COVID PCR test will be asked to read the patient information sheet and asked if they would like to participate. The patients will be asked to have a second nasal/throat swab taken shortly after their swab for the PCR test.
Written informed consent will be taken for whole blood or plasma left over from any routine clinical sample to be stored as anonymised samples for future testing once a reference test becomes available.
We will report results of the onsite clinical diagnostic test and the PCL antigen test with the number of the kit used, and test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of onset, symptoms and immunodeficiency status or significant conditions.
Detailed description
Participants will be identified as they attend assessment areas or testing facilities hosted by the recruiting NHS centres. They will be screened by clinical staff and identified to the research team.
Consent will be taken by a clinical staff member or research staff member with the aim of reducing the number of contacts with the patients and minimising the usage of personal protective equipment.
The consent form gives the patient the opportunity to ask further questions. Only those that are able to consent for themselves will be recruited for this trial.
We want to allow patients as long as possible to make a decision to participate but we feel it is important if possible that the swab samples are taken during the same patient contact (reducing PPE usage and minimising additional staff exposures). However there should not be undue delay to clinical testing therefore we propose if due to clinical urgency potential participants do not have sufficient time to consider the patient information sheet and discuss the trial prior to the PCR swab being taken they can have up to 24 hours to consider this information and participate if they wish to.
Consent will be taken by a clinical staff member or research staff member reducing the number of contacts with the patients. They will then be assigned a trial number used to identify them during the trial. The consent form that will be photocopied and reprinted on clean paper, with the original staying with the patient. The clean copy will be stored in the patient's notes and the case record file.
The current standard COVID PCR swab will be taken and a second swab taken immediately after for use in the rapid antigen test. As the swab process can be uncomfortable after the first swab is taken for the standard clinical test (PCR) the participant's consent will be confirmed again prior to taking the second swab required for the antigen test. After consent the research team will complete an anonymised data case record form from the notes and clinical management database. Participant's year of birth and date of onset of symptoms if symptomatic will be documented.
From routine blood samples taken by phlebotomy or clinical staff consent will be sort to store a leftover sample. This will be processed and stored by research laboratory staff. This will be stored in an anonymised secure research freezer.
In the laboratory their swab for the PCL COVID19 Ag rapid FIA will be run on the test platform. Following the test the swab will be destroyed as per local guidelines for contaminated items. This will performed by dedicated research laboratory scientists. Participant's results from this antigen test will not be used to make clinical decisions. We will not be able to feedback participants' individual results.
Participants are expected to be in the study for total of 20 minutes total although this will be spread over their patient journey so they have sufficient time to read the information leaflet and ask questions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of diagnostic test - point of care
| Arm | Type | Receives |
|---|---|---|
| PCL Rapid Antigen Test arm | Experimental | Diagnostic Test: PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)Single arm trial design. Only patients undergoing standard clinical testing (SARS-CoV-2 PCR test) and consenting for additional testing with the PCL rapid antigen test will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant has clinical indication for a COVID diagnostic test and a clinical blood sample from which whole blood or plasma will be leftover for storage
Key exclusion criteria (1 listed)
- Inability to give written 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 |
|---|---|---|
| PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea. | Diagnostic test | PCL Rapid Antigen Test arm |
Primary outcome
To compare the result of SARS-COV2 PCR test to PCL rapid antigen test
Time frame: within 24 hours
Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test
2 secondary outcomes
Number of technically failed samples due to test issues.
Time frame: At time of testing (within 30 minutes)
Time taken for PCL Antigen test result
Time frame: within 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Yes. anonymised individual data would be available to be shared on request from other research teams/public health bodies but no formal plans in place at time of submission
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) in people with COVID and SARS-CoV 2, run by Somerset NHS Foundation 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the result of SARS-COV2 PCR test to PCL rapid antigen test (time frame: within 24 hours). 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 27 May 2020.