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

January 25, 2024 updated by: LumiraDx UK Limited

Sample Collection to Facilitate the Performance Evaluation of the LumiraDx Point of Care Device for the Detection of Influenza A/B, Respiratory Syncytial Virus (RSV) & COVID-19 (SARS-COV-2 Virus)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

INFORM is a sample collection study targeting a population of patients attending their designated care or testing facility, suspected of having a respiratory illness typical of Influenza, RSV or COVID-19 and undergoing a Standard of Care (SOC) test on the day. Or those who have been in recent contact with SARS-CoV-2 positive patients. Participants may be of any age, there is no upper or lower age limit.

Depending on the facility's viability and agreed contracting, the following study samples will be collected per patient:

Adult Population: Two (2) Nasal, AND/OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample

Paediatric Population: Two (2) Nasal, OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample

Once required samples and data have been collected, participation is complete. No follow-up or subsequent patient involvement is required.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Edinburgh, United Kingdom
        • NHS Lothian - Royal Hospital for Children & Young People
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals Nhs Foundation Trust
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sample Collection - Symptomatic Patients
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.
Time Frame: 1-3 Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LumiraDx UK Limited

Investigators

  • Principal Investigator: Samer Elkhodair, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-CLIN-PROT-00018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Sample Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe