Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test

NCT04782336 | Suspended

• 1 other identifier: S-CLIN-PROT-00018
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 6

Brief Summary

Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who have been in recent contact with SARS-CoV-2 positive patients. Collected samples will aid the development, calibration and performance evaluation of the LumiraDx POC Test.

Conditions

Covid19; RSV Infection; Influenza Type A; Influenza Type B

Keywords

POC; SARS-CoV-2; Antigen; Paediatric; Flu

Outcome Measures

Primary Outcomes (1)

• Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.

  The collection of Nasal Swabs, Throat Swabs and Saliva Samples positive for Influenza A, Influenza B, RSV or SARS-CoV-2 across a range of demographics to help determine the accuracy of the LumiraDx Point of Care (POC) Influenza A/B + RSV and SARS-CoV-2 tests.

  1-3 Years

Study Arms (1)

Sample Collection - Symptomatic Patients

OTHER

The patient will be completing or has completed a SOC Influenza A/B and/or COVID-19 and/or RSV test on the day of study

Other: Sample Collection

Interventions

Sample Collection OTHER

Sample Collection - Adult Population: * Two (2) Nasal AND/OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample Sample Collection - Paediatric Population: * Two (2) Nasal OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample

Sample Collection - Symptomatic Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preliminary assessment of the patient by the Investigator/Designee should be suggestive of Influenza and/or COVID-19 and/or RSV at the time of the study visit. This may include referral to a testing facility.
• The patient will be completing or has completed a Standard of Care (SOC) Influenza A/B, COVID-19 and/or an RSV test on the day of study. This SOC sampling can be conducted prior or post the patient consenting to this study.
• Written Informed Consent must be obtained prior to study enrolment:
• A participant who is 16 years or older must be willing to give written informed consent and must agree to comply with study procedures.
• The Legal Guardian or Legal Authorised Representative of a participant who is under the age of 16 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as determined by the consent taker in accordance with GCP).

You may not qualify if:

• The patient underwent a nasal wash/aspirate as part of standard of care testing during their current visit.
• The patient is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
• The patient is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
• The patient is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
• The patient does not have the capacity to consent as determined by the Research Team.
• The patient is deemed to be unsuitable for research at the Research Team's discretion.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (6)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

NHS Lothian - Royal Hospital for Children & Young People

Edinburgh, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

St George's University Hospitals NHS Foundation

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Respiratory Syncytial Virus Infections; Influenza, Human

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; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections

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: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 4, 2021
• Study Start: December 12, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

GB (6)