- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408066
COVID-19: A POC Test Under Research & Evaluation (CAPTURE)
Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19
Study Overview
Status
Conditions
Detailed Description
CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.
Stage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays.
Stage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, E1 1BB
- Barts Health NHS Trust
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London, United Kingdom, NW1 2PG
- University College London Hospitals NHS Foundation Trust
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London, United Kingdom, E9 6SR
- Homerton University Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient is at least 18 years of age.
Patient meets either of the below categories:
- Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)
- Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)
Exclusion Criteria:
- The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).
- The patient is deemed to be unsuitable for research at the research teams' discretion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A:Suspected COVID-19 patients
Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM
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This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include:
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Experimental: Arm B: Previously positive COVID-19 patients
Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample.
Capillary fingerstick samples will additionally be collected in Stage 2.
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This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
Time Frame: 1 Year approx
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Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test.
Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
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1 Year approx
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samer Elkhodair, University College London Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-CLIN-PROT-00028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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