Back to resultsCOVID-19: A POC Test Under Research & Evaluation (CAPTURE)
Primary Purpose
COVID-19
Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sample Collection/Performance Evaluation (A)
Sample Collection/Performance Evaluation (B)
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring POC, IVD, SARS-CoV-2, IgG, IgM, Antigen, Antibody
Eligibility Criteria
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.
Sites / Locations
- Barts Health NHS Trust
- Homerton University Hospital NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A:Suspected COVID-19 patients
Arm B: Previously positive COVID-19 patients
Arm Description
Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM
Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04408066
Brief Title
COVID-19: A POC Test Under Research & Evaluation
Acronym
CAPTURE
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Number of required participants met
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LumiraDx UK Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
POC, IVD, SARS-CoV-2, IgG, IgM, Antigen, Antibody
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Sample Collection & Performance Evaluation Study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A:Suspected COVID-19 patients
Arm Type
Experimental
Arm Description
Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM
Arm Title
Arm B: Previously positive COVID-19 patients
Arm Type
Experimental
Arm Description
Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sample Collection/Performance Evaluation (A)
Intervention Description
This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
Sample types include:
Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab
Whole Venous Blood
Intervention Type
Diagnostic Test
Intervention Name(s)
Sample Collection/Performance Evaluation (B)
Intervention Description
This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
Sample types include:
Whole Venous Blood
Fingerstick Capillary Sample
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 Year approx
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer Elkhodair
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19: A POC Test Under Research & Evaluation
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