COVID-19: A POC Test Under Research & Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A Sample Collection \& Performance Evaluation Study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sample Collection/Performance Evaluation (A)

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type EXPERIMENTAL

Sample Collection/Performance Evaluation (B)

Intervention Type DIAGNOSTIC_TEST

This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.

Sample types include:

* Whole Venous Blood
* Fingerstick Capillary Sample

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No