Covid19INFORMNCT04782336

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

An observational study of Covid19 and RSV Infection, run by LumiraDx UK Limited at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Covid19, RSV Infection, Influenza Type A
What is being tested?: Sample Collection
How many people: 79 participants
Where: 6 sitesUnited Kingdom
Study dates: 30 Jun 2021to 10 Aug 2021
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Influenza or RSV or SARS-CoV-2 suspected adult and paediatric patients. Participants should be suspected of either Influenza A/B, RSV or COVID-19 when presenting at their designated care or testing facility. Participants may be of any age, there will be no upper or lower age limit.

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United Kingdom6 sites

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

Other trials in United Kingdom

About this study

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)

Read the 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.

Conditions: Covid19, RSV Infection, Influenza Type A, Influenza Type B
Being tested: Sample Collection
Keywords: POC, SARS-CoV-2, Antigen, Paediatric, Flu
Medical subject headings: COVID-19, Respiratory Syncytial Virus Infections, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sample CollectionOther
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

Study groups in NCT04782336
Study group	Role	What they receive
Sample Collection - Symptomatic Patients-Suspected Influenza/RSV		The participant must have a fever of 38°C (or greater), with the onset of the fever being within the past three (3) days and/or present at the time the visit. The participant must have presented with respiratory symptoms and a documented positive Flu or RSV Test in the past forty-eight (48) hours. Receives: Other: Sample Collection
Sample Collection - Symptomatic Patients-Suspected COVID-19		The participant must have a fever of 38°C (or greater), with the onset of the fever being within the past three (3) days and/or present at the time the visit. The participant must have presented with respiratory symptoms and a documented positive Flu or RSV Test in the past forty-eight (48) hours. Receives: Other: Sample Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202110 Aug 2021

First posted4 Mar 2021
Study start30 Jun 2021
Primary completion10 Aug 2021
Study completion10 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04782336
Sponsor's protocol ID: S-CLIN-PROT-00018
Acronym: INFORM
Status last verified: Jun 2026
First submitted: 17 Feb 2021
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
RecruitingObservational study
Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH)
Mental Health
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All Covid19 trials