COVID-19: A POC Test Under Research & Evaluation

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04408066
• Other study ID #: S-CLIN-PROT-00028
• Status: Suspended
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: LumiraDx UK Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2000
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Patient meets either of the below categories:

1. 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)

2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)

Exclusion Criteria:

1. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).

2. The patient is deemed to be unsuitable for research at the research teams' discretion.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Sample Collection/Performance Evaluation (A)
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
• Sample Collection/Performance Evaluation (B)
This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: Whole Venous Blood Fingerstick Capillary Sample

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Homerton University Hospital NHS Foundation Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
LumiraDx UK Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Year approx