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

Primary Purpose

Covid19, RSV Infection, Influenza Type A

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sample Collection
Sponsored by
LumiraDx UK Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring POC, SARS-CoV-2, Antigen, Paediatric, Flu

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

N.B. Inclusions 1 & 2 are not applicable to Group B sites.

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.

N.B. Paediatric participants may only enrol at Group A sites, in which enrolment is limited to once/week.

Sites / Locations

  • Cambridge University Hospitals NHS Foundation Trust
  • NHS Lothian - Royal Hospital for Children & Young People
  • Leicester Royal Infirmary
  • Barts Health NHS Trust
  • University College London Hospitals NHS Foundation Trust
  • St George's University Hospitals NHS Foundation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sample Collection - Symptomatic Patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2021
Last Updated
February 6, 2023
Sponsor
LumiraDx UK Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04782336
Brief Title
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Acronym
INFORM
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment Pause
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LumiraDx UK Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, RSV Infection, Influenza Type A, Influenza Type B
Keywords
POC, SARS-CoV-2, Antigen, Paediatric, Flu

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sample Collection - Symptomatic Patients
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Sample Collection
Intervention Description
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
Primary Outcome Measure Information:
Title
Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.
Description
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.
Time Frame
1-3 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer Elkhodair
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian - Royal Hospital for Children & Young People
City
Edinburgh
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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