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.
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
- Are there results?
- None posted in the registry
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.
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
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)
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samer Elkhodair, Principal investigator, University College London Hospitals
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04782336
- Acronym / sponsor ID
- INFORM / S-CLIN-PROT-00018
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Keywords
- POC, SARS-CoV-2, Antigen, Paediatric, Flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sample Collection - Symptomatic Patients-Suspected Influenza/RSV | – | Other: Sample CollectionThe 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. |
| Sample Collection - Symptomatic Patients-Suspected COVID-19 | – | Other: Sample CollectionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample CollectionSample 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 | Other | Sample Collection - Symptomatic Patients-Suspected COVID-19, Sample Collection - Symptomatic Patients-Suspected Influenza/RSV |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samer Elkhodair principal investigator
University College London Hospitals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and RSV Infection, run by LumiraDx UK Limited at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics. (time frame: 1-3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.