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

Covid19 Clinical Trial

— 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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04782336
• Other study ID #: S-CLIN-PROT-00018
• Status: Suspended
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: LumiraDx UK Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2500
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Influenza Type A
• Influenza Type B
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	NHS Lothian - Royal Hospital for Children & Young People	Edinburgh
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	St George's University Hospitals NHS Foundation	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
LumiraDx UK Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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