Covid19COVID-IDNowNCT04785898
Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay
A study testing ID Now™ COVID-19 Screening Test in people with Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), first appeared in China, and then spread around the world. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei province, China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- ID Now™ COVID-19 Screening Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,265 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2020to 9 May 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- Patient presenting to the emergency room of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient
- French-speaking patient
- Patient affiliated with social security or, failing that, with another health insurance system
- Patient capable of giving free, informed and express consent.
Who cannot join
- Pregnant or breastfeeding patient.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay in Off-site Biology in Emergency Rooms for COVID-19 Screenin
Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), first appeared in China, and then spread around the world. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the entire virus genome was sequenced. This new coronavirus, named SARS-CoV-2 for its genetic homology with SARS-CoV, has shown worldwide spread. Thus, on January 30, 2020, the World Health Organization (WHO) announced the COVID-19 epidemic as a threat to public health at the international level, then, in March 2020, the global situation degenerated into a pandemic. Johns Hopkins University has reported more than 7,600,000 cases of infections and more than 427,000 deaths as of June 13, 20203. Due to the rapid progression of the COVID-19 pandemic and the limited capacity of molecular laboratory tests, the concept of delocalized molecular tests appears to be relevant. Indeed, the urgent need to increase testing for COVID-19 has been clearly identified as an essential part of the strategy to combat the coronavirus worldwide. In fact, COVID-19 represents a major public health problem currently causing a rapidly increasing number of infections and significant morbidity and mortality worldwide. As of July 1, 2020, more than 10 million people worldwide have been infected with SARS-CoV-211. As of August 25, 2020, this tally is 23,741,562 cases of contamination and 813,820 deaths following Johns Hopkins University.
Read the detailed description
Early detection with a sensitive technique of COVID-19 is essential to ensure rapid and appropriate patient management, to contain the epidemic and to better understand the global epidemiology of the virus. This detection will intensify in the coming months due to the start of the school year and university as well as the economic recovery.
Until now, laboratory diagnostics have relied primarily on the amplification and detection of viral gene sequences in upper respiratory tract samples performed in a centralized laboratory. A new test (ID NowTM COVID-19 developed by the Abbott laboratory) is available on the market. This test is the first in France to be able to be carried out in a medical examination of delocalized biology (MEDB) and makes it possible to return a result in 15 min directly in the clinical department. This speed will allow faster care, isolation and filiarisation of COVID-19 patients. The speed of this technique is based on the use of isothermal gene amplification. The investigators will be the first to evaluate it in France in MEDB in the context of urgent care. This evaluation of diagnostic performance will be performed during a comparison with that of our routine PCR microbiology laboratory test Simplexa ™ COVID-19 Direct assay marketed by the company DiaSorin.
This speed of obtaining results should lead to better efficiency of medical management, faster isolation and organization for COVID-19 positive patients.
The objective of this work is to assess diagnostic performance in relocated biology in a real situation and to validate this rapid strategy for the benefit of patients consulting the emergency department.
- Conditions
- Covid19
- Being tested
- ID Now™ COVID-19 Screening Test
- Keywords
- Covid19, SARS-CoV2, Diagnosis performance
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID Now™ COVID-19 Screening TestDiagnostic test
Patients, meeting the eligibility criteria, are selected consecutively in the emergency room. The investigating doctor delivers the written information note, answers the patient's questions and obtains his free, informed and express consent. The patient has sufficient time to reflect to make the decision to participate in the study. His oral, free, informed and express consent will be traced in the computerized medical file on the day of its inclusion in the "COVID-IDNow" protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Screening patients COVID-19 test | Other | As part of the patient's management, two nasopharyngeal swabs will be taken from the same nostril:
* The first swab will be sent to the microbiology laboratory for analysis with the Simplexa ™ COVID-19 Direct assay so as not to impact the patient's diagnostic result.
* The second swab taken as part of the research will be analyzed with the ID NowTM COVID-19 test located in the UAS by one of the nurses trained and authorized to use it. The choice to perform the ID Now ™ COVID-19 test in the emergency room and not in the laboratory is based on the supplier's instructions. Indeed, the nasopharyngeal swab is intended to be analyzed directly and not to be transported in a container which could hinder the quality of the sample.
The discomfort or pain felt by the patient during the first sample can possibly influence the quality of the second. This could induce a bias. To minimize this bias, staff will be specifically trained in sampling. Receives: Diagnostic Test: ID Now™ COVID-19 Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic performance of the ID Now ™ COVID-19 test carried out by nurses in an emergency department in comparison with the reference PCR test: Simplexa ™ COVID-19 Direct
Sensitivity of the ID Now ™ COVID-19 Test Compared to the Simplexa ™ COVID-19 Direct Assay
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start9 Nov 2020
- Primary completion22 Dec 2020
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a diagnostic cohort study.
- Masking
- None (open label)
- Enrolment
- 1,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude NGUYEN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785898
- Sponsor's protocol ID
- COVID-IDNow
- Acronym
- COVID-IDNow
- Status last verified
- May 2022
- First submitted
- 1 Mar 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
NguyenVan JC, Gerlier C, Pilmis B, Mizrahi A, Pean de Ponfilly G, Khaterchi A, Enouf V, Ganansia O, Le Monnier A. Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department. J Clin Virol. 2021 Dec;145:105021. doi: 10.1016/j.jcv.2021.105021. Epub 2021 Oct 30.
PubMed 34768231
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the ID Now™ COVID-19 Screening Test Versus Simplexa™ COVID-19 Direct Assay in Off-site Biology in Emergency Rooms for COVID-19 Screenin
- ClinicalTrials.gov ID
- NCT04785898
- Acronym / sponsor ID
- COVID-IDNow / COVID-IDNow
- Conditions
- Covid19
- Keywords
- Covid19, SARS-CoV2, Diagnosis performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,265 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 8 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.
Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), first appeared in China, and then spread around the world. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the entire virus genome was sequenced. This new coronavirus, named SARS-CoV-2 for its genetic homology with SARS-CoV, has shown worldwide spread. Thus, on January 30, 2020, the World Health Organization (WHO) announced the COVID-19 epidemic as a threat to public health at the international level, then, in March 2020, the global situation degenerated into a pandemic. Johns Hopkins University has reported more than 7,600,000 cases of infections and more than 427,000 deaths as of June 13, 20203. Due to the rapid progression of the COVID-19 pandemic and the limited capacity of molecular laboratory tests, the concept of delocalized molecular tests appears to be relevant. Indeed, the urgent need to increase testing for COVID-19 has been clearly identified as an essential part of the strategy to combat the coronavirus worldwide. In fact, COVID-19 represents a major public health problem currently causing a rapidly increasing number of infections and significant morbidity and mortality worldwide. As of July 1, 2020, more than 10 million people worldwide have been infected with SARS-CoV-211. As of August 25, 2020, this tally is 23,741,562 cases of contamination and 813,820 deaths following Johns Hopkins University.
Detailed description
Early detection with a sensitive technique of COVID-19 is essential to ensure rapid and appropriate patient management, to contain the epidemic and to better understand the global epidemiology of the virus. This detection will intensify in the coming months due to the start of the school year and university as well as the economic recovery.
Until now, laboratory diagnostics have relied primarily on the amplification and detection of viral gene sequences in upper respiratory tract samples performed in a centralized laboratory. A new test (ID NowTM COVID-19 developed by the Abbott laboratory) is available on the market. This test is the first in France to be able to be carried out in a medical examination of delocalized biology (MEDB) and makes it possible to return a result in 15 min directly in the clinical department. This speed will allow faster care, isolation and filiarisation of COVID-19 patients. The speed of this technique is based on the use of isothermal gene amplification. The investigators will be the first to evaluate it in France in MEDB in the context of urgent care. This evaluation of diagnostic performance will be performed during a comparison with that of our routine PCR microbiology laboratory test Simplexa ™ COVID-19 Direct assay marketed by the company DiaSorin.
This speed of obtaining results should lead to better efficiency of medical management, faster isolation and organization for COVID-19 positive patients.
The objective of this work is to assess diagnostic performance in relocated biology in a real situation and to validate this rapid strategy for the benefit of patients consulting the emergency department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a diagnostic cohort study.
| Arm | Type | Receives |
|---|---|---|
| Screening patients COVID-19 test | Other | Diagnostic Test: ID Now™ COVID-19 Screening TestAs part of the patient's management, two nasopharyngeal swabs will be taken from the same nostril: * The first swab will be sent to the microbiology laboratory for analysis with the Simplexa ™ COVID-19 Direct assay so as not to impact the patient's diagnostic result. * The second swab taken as part of the research will be analyzed with the ID NowTM COVID-19 test located in the UAS by one of the nurses trained and authorized to use it. The choice to perform the ID Now ™ COVID-19 test in the emergency room and not in the laboratory is based on the supplier's instructions. Indeed, the nasopharyngeal swab is intended to be analyzed directly and not to be transported in a container which could hinder the quality of the sample. The discomfort or pain felt by the patient during the first sample can possibly influence the quality of the second. This could induce a bias. To minimize this bias, staff will be specifically trained in sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥ 18 years
- Patient presenting to the emergency room of the GhPSJ and for whom a PCR examination is prescribed by the emergency doctor in charge of the patient
- French-speaking patient
- Patient affiliated with social security or, failing that, with another health insurance system
- Patient capable of giving free, informed and express consent.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding patient.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection.
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 |
|---|---|---|
| ID Now™ COVID-19 Screening TestPatients, meeting the eligibility criteria, are selected consecutively in the emergency room. The investigating doctor delivers the written information note, answers the patient's questions and obtains his free, informed and express consent. The patient has sufficient time to reflect to make the decision to participate in the study. His oral, free, informed and express consent will be traced in the computerized medical file on the day of its inclusion in the "COVID-IDNow" protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol. | Diagnostic test | Screening patients COVID-19 test |
Primary outcome
Evaluate the diagnostic performance of the ID Now ™ COVID-19 test carried out by nurses in an emergency department in comparison with the reference PCR test: Simplexa ™ COVID-19 Direct
Time frame: Day 1
Sensitivity of the ID Now ™ COVID-19 Test Compared to the Simplexa ™ COVID-19 Direct Assay
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 13 May 2022.
- Results publication: PubMed 34768231NguyenVan JC, Gerlier C, Pilmis B, Mizrahi A, Pean de Ponfilly G, Khaterchi A, Enouf V, Ganansia O, Le Monnier A. Prospective evaluation of ID NOW COVID-19 assay used as point-of-care test in an emergency department. J Clin Virol. 2021 Dec;145:105021. doi: 10.1016/j.jcv.2021.105021. Epub 2021 Oct 30.
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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.
Jean-Claude NGUYEN, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID Now™ COVID-19 Screening Test in people with Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Evaluate the diagnostic performance of the ID Now ™ COVID-19 test carried out by nurses in an emergency department in comparison with the reference PCR test: Simplexa ™ COVID-19 Direct (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785898, which also lists 1 linked publication.
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 13 May 2022.