COVID-19: A POC Test Under Research & Evaluation

Not Applicable

Suspended

• Conditions: COVID-19
• Interventions: Diagnostic Test: Sample Collection/Performance Evaluation (A); Diagnostic Test: Sample Collection/Performance Evaluation (B)

• Registration Number: NCT04408066
• Lead Sponsor: LumiraDx UK Limited

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.

Study Timeline

• Study Start: 2020-04-30
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A:Suspected COVID-19 patients	Sample Collection/Performance Evaluation (A)	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	Sample Collection/Performance Evaluation (B)	Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.

Primary Outcome Measures

Name	Time	Method
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.	1 Year approx	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.

Trial Locations

Locations (3)

Homerton University Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom