Status:

SUSPENDED

COVID-19: A POC Test Under Research & Evaluation

Lead Sponsor:

LumiraDx UK Limited

Conditions:

COVID-19

Eligibility:

All Genders

18+ years

Phase:

NA

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 tho...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2024

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT04408066

Start Date

April 30 2020

End Date

July 1 2024

Last Update

January 12 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Barts Health NHS Trust

London, United Kingdom, E1 1BB

2

Homerton University Hospital NHS Foundation Trust

London, United Kingdom, E9 6SR

3

University College London Hospitals NHS Foundation Trust

London, United Kingdom, NW1 2PG