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

Sponsor

LumiraDx UK Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04782336

Collaborator

(none)

3,500

Enrollment

Locations

Arms

24.6

Anticipated Duration (Months)

583.3

Patients Per Site

23.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 RSV Infection Influenza Type A Influenza Type B	Other: Group A (Sample Collection) Other: Group B (Sample Collection) Diagnostic Test: On-Site Testing (LumiraDx)	N/A

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.

An additional Group (B), has been incorporated into the study, enabling collection from the asymptomatic population, in order to acquire negative samples (when required), to further aid the development and on-going calibration of the LumiraDx assays. This group will be considered for new site's, who do not routinely provide SOC Testing. Inclusions 1 & 2 will therefore not be applicable to this group. Paediatric participants will not be recruited into Group B.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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)

Actual Study Start Date :

Dec 12, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (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: Group A (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 Diagnostic Test: On-Site Testing (LumiraDx) Collected samples may be tested using a LumiraDx POC assay at a selection of sites, prior to being transferred to LumiraDx or one of its approved designees for in-house use, in the development and performance testing of the LumiraDx Influenza A/B, SARS-CoV-2 & RSV assays.
Experimental: Group B (Sample Collection - Asymptomatic Patients) To enable the participation of site's who do not routinely providing SOC testing.	Other: Group B (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 Diagnostic Test: On-Site Testing (LumiraDx) Collected samples may be tested using a LumiraDx POC assay at a selection of sites, prior to being transferred to LumiraDx or one of its approved designees for in-house use, in the development and performance testing of the LumiraDx Influenza A/B, SARS-CoV-2 & RSV assays.

Arm

Intervention/Treatment

Experimental: Group A (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: Group A (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

Diagnostic Test: On-Site Testing (LumiraDx)

Collected samples may be tested using a LumiraDx POC assay at a selection of sites, prior to being transferred to LumiraDx or one of its approved designees for in-house use, in the development and performance testing of the LumiraDx Influenza A/B, SARS-CoV-2 & RSV assays.

Experimental: Group B (Sample Collection - Asymptomatic Patients)

To enable the participation of site's who do not routinely providing SOC testing.

Other: Group B (Sample Collection)

Diagnostic Test: On-Site Testing (LumiraDx)

Outcome Measures

Primary Outcome Measures

Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics. [1-2 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cambridge University Hospitals NHS Foundation Trust	Cambridge	United Kingdom	CB2 0QQ
2	NHS Lothian - Royal Hospital for Children & Young People	Edinburgh	United Kingdom
3	Leicester Royal Infirmary	Leicester	United Kingdom	LE1 5WW
4	Barts Health NHS Trust	London	United Kingdom	E1 1BB
5	University College London Hospitals NHS Foundation Trust	London	United Kingdom	NW1 2PG
6	St George's University Hospitals NHS Foundation	London	United Kingdom	SW17 0QT