COVID-19: A POC Test Under Research & Evaluation

NCT04408066 | Suspended

• 1 other identifier: S-CLIN-PROT-00028
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

POC; IVD; SARS-CoV-2; IgG; IgM; Antigen; Antibody

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm A:Suspected COVID-19 patients

EXPERIMENTAL

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

Diagnostic Test: Sample Collection/Performance Evaluation (A)

Arm B: Previously positive COVID-19 patients

EXPERIMENTAL

Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.

Diagnostic Test: Sample Collection/Performance Evaluation (B)

Interventions

Sample Collection/Performance Evaluation (A) 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 A:Suspected COVID-19 patients

Sample Collection/Performance Evaluation (B) 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

Arm B: Previously positive COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (3)

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Samer Elkhodair

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Sample Collection \& Performance Evaluation Study.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 29, 2020
• Study Start: April 30, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)