SARS-CoV2 InfectionNCT06175611
Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
An observational study of SARS-CoV2 Infection and Influenza A, run by EDAN Instruments Inc. at 3 sites in Spain.
Trial summary
The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of: 1. ClariLight Influenza A/B \& SARS-CoV-2 test kits and 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV2 Infection, Influenza A, Influenza B
- What is being tested?
- COVID-19/Flu A/Flu B/RSV Test Kit
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesSpain
- Study dates
- 10 Dec 2023to Apr 2024
- How long will I take part?
- 1 Day
- 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
- Child, Adult, Older adult
Study population: The study population comprises of subjects suspected of respiratory infection by their healthcare provider who meet the all the inclusion criteria and none of the exclusion criteria detailed in the CPSP.
Who may be able to join
- Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
- Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
- Subjects able to provide anterior nasal swabs and oropharyngeal swabs for testing on the study device according to the instructions for use of that device.
- Subjects able to provide comparator samples according to the instructions for use of the comparator device.
- Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
- Subjects or their legal guardians willing and able to provide written informed consent.
Who cannot join
- Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study.
- Subjects who have undergone anterior nasal, or oropharyngeal sampling within the past 30 minutes (i.e. a minimum wait of 30 minutes is required before collecting swabs for the study device if previous anterior nasal or oropharyngeal samples were collected from the same subject).
- Subjects or their legal guardians unwilling and unable to provide informed consent.
- Subjects who have had a nasal wash or aspirate procedure within the past 24 hours.
- Women who are pregnant or currently breastfeeding.
Trial locations and contacts
3 sites in 1 country.
MARIA SORIA contact
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis de Alicante
Alicante, 03010
Juan Carlos Rodríguez Díaz, MD, 605 104 019, rodriguez_juadia@gva.es
- Not yet recruiting
Laboratorio Central Health Diagnostics Quirónsalud
Madrid, 28108
Miguel Ochando Gómez, MD, 608 541 857, miguel.ochando@quironsalud.es
Maria del Carmen Garma Lopez, PhD, 619 97 97 15, carmina.garma@quironsalud.es
- Not yet recruiting
Hospital Universitario de Getafe
Madrid, 28905
Roberto Vates Gómez, MD, 665 223 827, roberto_vates@hotmail.com
About this study
The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:
- ClariLight Influenza A/B \& SARS-CoV-2 test kits and
- ClariLight Influenza A/B \& RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.
Read the detailed description
Prospective, non-randomized, observational, post-market, multicenter, clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection for evaluating the clinical performance of ClariLight Influenza A/B \& SARS-CoV-2 Cartridge and the ClariLight Influenza A/B \& RSV Cartridge by comparing them against a reference standard of care, CE marked, comparator device.
This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.
This clinical performance study:
- Does not involve surgically invasive sample-taking
- Is not interventional as test results will not influence patient management decisions neither they will be used to guide treatment
- There are no additional invasive procedures or other risks for the subjects. The device is being used within the scope of its CE marked intended purpose and for the specimen types claimed which include standard of care specimen collection procedures.
No specific follow-up of subjects providing swabs is required following termination, temporary suspension or early termination of the study, or withdrawal of the subject's informed consent. The participation of each subject for the total duration of the study will amount to 1 hour, finishing the participation in day 1. Subjects will be provided with the Investigator's contact information and be instructed to contact the Investigator if they experience any complications from the specimen collection procedures within twenty-four (24) hours of the visit".
- Being tested
- COVID-19/Flu A/Flu B/RSV Test Kit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19/Flu A/Flu B/RSV Test KitDevice
The performance characteristics of EDAN's Test Kit will be evaluated in a prospective, non-randomized, observational, post-market, multicenter, comparison clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection.
Samples will be obtained fresh, collected prospectively and will be tested with the study device COVID- 19/Flu A/Flu B/RSV Test Kit. The results will be compared against a reference, CE marked, in-vitro diagnostic device, used in the standard of care.
This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Site 1. Laboratorio Central Health Diagnostics Quirónsalud | COVID-19/Flu A/Flu B/RSV Test Kit Receives: Device: COVID-19/Flu A/Flu B/RSV Test Kit | |
| SIte 2. Hospital General Universitario Dr. Balmis de Alicante | COVID-19/Flu A/Flu B/RSV Test Kit Receives: Device: COVID-19/Flu A/Flu B/RSV Test Kit | |
| Site 3. Hospital Universitario de Getafe | COVID-19/Flu A/Flu B/RSV Test Kit Receives: Device: COVID-19/Flu A/Flu B/RSV Test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percentage Agreement (PPA)
The PPA is defined as the proportion of positive results from the comparator or reference method that are correctly identified as positive by study device. PPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
Measured: Day 1. No follow-up is required for this study.
Negative Percentage Agreement (NPA).
The NPA is defined as the as the proportion of negative results from the comparator or reference method that are correctly identified as negative by the study device.
NPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
Measured: Day 1. No follow-up is required for this study.
Secondary outcomes (1)
Rate of adverse events, serious adverse events and device deficiencies leading to a serious adverse event.
Rate of adverse events that occur during the clinical performance study and that are critical to the evaluation of the study results.
Rate of serious adverse events that have a causal relationship with the device, the comparator, or the study procedure or where such causal relationship is reasonably possible.
Rate of device deficiencies that occur during the clinical performance study, which might have led to a serious adverse event, if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate.
Measured: Day 1. No follow-up is required for this study. Nevertheless, subjects who have undergone sample collection can contact the study's Principal Investigator throughout the whole clinical performance study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start10 Dec 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- EDAN Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175611
- Sponsor's protocol ID
- CL30_2023_08
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
- ClinicalTrials.gov ID
- NCT06175611
- Acronym / sponsor ID
- CL30_2023_08
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- EDAN Instruments Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:
- ClariLight Influenza A/B \& SARS-CoV-2 test kits and
- ClariLight Influenza A/B \& RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.
Detailed description
Prospective, non-randomized, observational, post-market, multicenter, clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection for evaluating the clinical performance of ClariLight Influenza A/B \& SARS-CoV-2 Cartridge and the ClariLight Influenza A/B \& RSV Cartridge by comparing them against a reference standard of care, CE marked, comparator device.
This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.
This clinical performance study:
- Does not involve surgically invasive sample-taking
- Is not interventional as test results will not influence patient management decisions neither they will be used to guide treatment
- There are no additional invasive procedures or other risks for the subjects. The device is being used within the scope of its CE marked intended purpose and for the specimen types claimed which include standard of care specimen collection procedures.
No specific follow-up of subjects providing swabs is required following termination, temporary suspension or early termination of the study, or withdrawal of the subject's informed consent. The participation of each subject for the total duration of the study will amount to 1 hour, finishing the participation in day 1. Subjects will be provided with the Investigator's contact information and be instructed to contact the Investigator if they experience any complications from the specimen collection procedures within twenty-four (24) hours of the visit".
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Site 1. Laboratorio Central Health Diagnostics Quirónsalud | – | Device: COVID-19/Flu A/Flu B/RSV Test KitCOVID-19/Flu A/Flu B/RSV Test Kit |
| SIte 2. Hospital General Universitario Dr. Balmis de Alicante | – | Device: COVID-19/Flu A/Flu B/RSV Test KitCOVID-19/Flu A/Flu B/RSV Test Kit |
| Site 3. Hospital Universitario de Getafe | – | Device: COVID-19/Flu A/Flu B/RSV Test KitCOVID-19/Flu A/Flu B/RSV Test Kit |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises of subjects suspected of respiratory infection by their healthcare provider who meet the all the inclusion criteria and none of the exclusion criteria detailed in the CPSP.
Key inclusion criteria (6 listed)
- Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
- Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
- Subjects able to provide anterior nasal swabs and oropharyngeal swabs for testing on the study device according to the instructions for use of that device.
- Subjects able to provide comparator samples according to the instructions for use of the comparator device.
- Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
Key exclusion criteria (5 listed)
- Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study.
- Subjects who have undergone anterior nasal, or oropharyngeal sampling within the past 30 minutes (i.e. a minimum wait of 30 minutes is required before collecting swabs for the study device if previous anterior nasal or oropharyngeal samples were collected from the same subject).
- Subjects or their legal guardians unwilling and unable to provide informed consent.
- Subjects who have had a nasal wash or aspirate procedure within the past 24 hours.
- Women who are pregnant or currently breastfeeding.
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 |
|---|---|---|
| COVID-19/Flu A/Flu B/RSV Test KitThe performance characteristics of EDAN's Test Kit will be evaluated in a prospective, non-randomized, observational, post-market, multicenter, comparison clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection. Samples will be obtained fresh, collected prospectively and will be tested with the study device COVID- 19/Flu A/Flu B/RSV Test Kit. The results will be compared against a reference, CE marked, in-vitro diagnostic device, used in the standard of care. This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants. | Device | SIte 2. Hospital General Universitario Dr. Balmis de Alicante, Site 1. Laboratorio Central Health Diagnostics Quirónsalud, Site 3. Hospital Universitario de Getafe |
Primary outcome
Positive Percentage Agreement (PPA)
Time frame: Day 1. No follow-up is required for this study.
The PPA is defined as the proportion of positive results from the comparator or reference method that are correctly identified as positive by study device. PPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
Negative Percentage Agreement (NPA).
Time frame: Day 1. No follow-up is required for this study.
The NPA is defined as the as the proportion of negative results from the comparator or reference method that are correctly identified as negative by the study device. NPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
1 secondary outcome
Rate of adverse events, serious adverse events and device deficiencies leading to a serious adverse event.
Time frame: Day 1. No follow-up is required for this study. Nevertheless, subjects who have undergone sample collection can contact the study's Principal Investigator throughout the whole clinical performance study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
MARIA SORIA contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and Influenza A, run by EDAN Instruments Inc. at 3 sites in Spain.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAVID TOMÉ (34 93 609 62 69, david.tome@medivd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percentage Agreement (PPA) (time frame: Day 1. No follow-up is required for this study.). The study lists 2 primary outcomes in all. 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 11 Jan 2024.