COVID-19: A POC Test Under Research & Evaluation (CAPTURE)

LumiraDx

Status: Suspended

Conditions: COVID-19

Treatments: Diagnostic Test: Sample Collection/Performance Evaluation (A); Diagnostic Test: Sample Collection/Performance Evaluation (B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04408066

S-CLIN-PROT-00028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Arm A:Suspected COVID-19 patients

Experimental group

Description:

Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM

Treatment:

Diagnostic Test: Sample Collection/Performance Evaluation (A)

Arm B: Previously positive COVID-19 patients

Experimental group

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.

Treatment:

Diagnostic Test: Sample Collection/Performance Evaluation (B)