Covid19Kaïssa CovidNCT04786197
Detection of SARS-CoV-2 (COVID-19) by SERS Spectroscopy Combined With Artificial Intelligence
An observational study of Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
SARS-CoV-2 infection was identified as responsible for several cases of pneumonia and acute respiratory distress syndromes described in Wuhan, Hubei Province, China in December 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 712 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care
Who may be able to join
- Patient aged ≥ 18 years
- Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care
- French-speaking patient.
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research.
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: Detection of SARS-CoV-2 by SERS Spectroscopy
SARS-CoV-2 infection was identified as responsible for several cases of pneumonia and acute respiratory distress syndromes described in Wuhan, Hubei Province, China in December 2019. A global epidemic has spread since and the Director General of the World Health Organization (WHO) declared in March 2020 the state of a global pandemic.
As the spread of the virus accelerates, several countries are implementing containment strategies to stem the epidemic.
The context of an influx of patients and congestion in healthcare establishments requires rapid and reliable diagnostic solutions for SARS-CoV-2 infection in order to enable patients to be properly referred. These solutions will represent fundamental tools in the management of new epidemic waves, both in terms of health and economics.
Read the detailed description
Spectroscopy is the discipline of studying the interactions between light and matter, in order to perform analyzes unmatched in terms of the speed of data acquisition. Depending on the spectral ranges used by the sensors, it is possible to carry out molecular (molecular and vibrational spectroscopy) or elementary (atomic spectroscopy) analyzes.
As part of this project, GreenTropism has selected Surface Enhanced Raman Scattering (SERS) technology as a spectral technique. The scientific literature reports several cases of use of SERS technology for virus analysis, under variable conditions: variable viral loads, after amplification, use of substrates enriched in antigens.
The SERS allows an analysis of a sample deposited on a substrate on average (from fifteen seconds to 10 minutes depending on the devices and the presence of complementary imaging). Already proven for the identification of viruses on strains pathogenic for humans and animals, its deployment is slowed down by the complexity of the data to be processed.
These spectra acquisition technologies require the joint use of statistical tools and multivariate analyzes to allow sample discrimination (classification) and / or quantification. Until recently, the capacity and performance of statistical tools were limited by the available computational capacities. The lifting of this technological lock allowed the advent and democratization of Artificial Intelligence (AI) techniques theorized in the 1960s and applied today.
GreenTropism's Kaïssa, AI tool, in addition to processing big data, has been designed and trained specifically for processing spectral data and automating all of the algorithmic chains needed to go from spectrum support to its interpretation, and the presentation of the final answer.
The analysis of chemometric data, for the purpose of classification, implements several types of algorithms that Kaïssa uses, combining them automatically to obtain the best possible analyzes of these data. These algorithms are divided into two large groups: mathematical preprocessing and classification models.
The combination of photonic technologies (here SERS) and AI allows real-time analyzes of multiple substrates, without a priori knowledge of the user on the sample and without prior expertise. These characteristics make it a valuable tool for diagnosing SARS-CoV-2 infection in the context of Point Of Care.
In a work carried out between the months of March and June 2020, several models showed, on test databases not integrated in the learning, performance of discrimination between positive and negative patients for SARS-CoV-2 according to RT-PCR equivalent to Youden indices of 0.6 to 0.92. On the other hand, these models have highlighted a variability in the use of samples which results in a drop in performance during tests on statistically independent databases requiring additional spectral acquisitions, leading today to the presentation of this report project.
- Conditions
- Covid19
- Keywords
- artificial intelligence
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance in terms of sensitivity and specificity of the technique by spectral analysis combined with artificial intelligence for the SARS-CoV-2 virus versus to the reference technique by RT-qPCR
Detection of the SARS-CoV-2 virus with the technique by spectral analysis combined with artificial intelligence and with the reference technique by RT-qPCR (Xpert Xpress SARS-CoV-2 or Simplexa™ COVID-19 Direct assay)
Measured: Day 1
Secondary outcomes (1)
Evaluate the detection limit of the technique by spectral analysis combined with artificial intelligence
Detection limit of the technique by spectral analysis combined with artificial intelligence compared to the CTs of RT-qPCR (Xpert Xpress SARS-CoV-2 or 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 start10 Aug 2021
- Primary completion10 Sep 2021
- Study completion31 Dec 2023 (estimated)
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
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alban Le Monnier, Pr, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786197
- Sponsor's protocol ID
- Kaïssa Covid
- Acronym
- Kaïssa Covid
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2021
- Last updated
- 27 Apr 2023
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of SARS-CoV-2 by SERS Spectroscopy
- ClinicalTrials.gov ID
- NCT04786197
- Acronym / sponsor ID
- Kaïssa Covid / Kaïssa Covid
- Conditions
- Covid19
- Keywords
- artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- 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.
SARS-CoV-2 infection was identified as responsible for several cases of pneumonia and acute respiratory distress syndromes described in Wuhan, Hubei Province, China in December 2019. A global epidemic has spread since and the Director General of the World Health Organization (WHO) declared in March 2020 the state of a global pandemic.
As the spread of the virus accelerates, several countries are implementing containment strategies to stem the epidemic.
The context of an influx of patients and congestion in healthcare establishments requires rapid and reliable diagnostic solutions for SARS-CoV-2 infection in order to enable patients to be properly referred. These solutions will represent fundamental tools in the management of new epidemic waves, both in terms of health and economics.
Detailed description
Spectroscopy is the discipline of studying the interactions between light and matter, in order to perform analyzes unmatched in terms of the speed of data acquisition. Depending on the spectral ranges used by the sensors, it is possible to carry out molecular (molecular and vibrational spectroscopy) or elementary (atomic spectroscopy) analyzes.
As part of this project, GreenTropism has selected Surface Enhanced Raman Scattering (SERS) technology as a spectral technique. The scientific literature reports several cases of use of SERS technology for virus analysis, under variable conditions: variable viral loads, after amplification, use of substrates enriched in antigens.
The SERS allows an analysis of a sample deposited on a substrate on average (from fifteen seconds to 10 minutes depending on the devices and the presence of complementary imaging). Already proven for the identification of viruses on strains pathogenic for humans and animals, its deployment is slowed down by the complexity of the data to be processed.
These spectra acquisition technologies require the joint use of statistical tools and multivariate analyzes to allow sample discrimination (classification) and / or quantification. Until recently, the capacity and performance of statistical tools were limited by the available computational capacities. The lifting of this technological lock allowed the advent and democratization of Artificial Intelligence (AI) techniques theorized in the 1960s and applied today.
GreenTropism's Kaïssa, AI tool, in addition to processing big data, has been designed and trained specifically for processing spectral data and automating all of the algorithmic chains needed to go from spectrum support to its interpretation, and the presentation of the final answer.
The analysis of chemometric data, for the purpose of classification, implements several types of algorithms that Kaïssa uses, combining them automatically to obtain the best possible analyzes of these data. These algorithms are divided into two large groups: mathematical preprocessing and classification models.
The combination of photonic technologies (here SERS) and AI allows real-time analyzes of multiple substrates, without a priori knowledge of the user on the sample and without prior expertise. These characteristics make it a valuable tool for diagnosing SARS-CoV-2 infection in the context of Point Of Care.
In a work carried out between the months of March and June 2020, several models showed, on test databases not integrated in the learning, performance of discrimination between positive and negative patients for SARS-CoV-2 according to RT-PCR equivalent to Youden indices of 0.6 to 0.92. On the other hand, these models have highlighted a variability in the use of samples which results in a drop in performance during tests on statistically independent databases requiring additional spectral acquisitions, leading today to the presentation of this report project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care
Key inclusion criteria (3 listed)
- Patient aged ≥ 18 years
- Patient presenting to the GhPSJ for a consultation or hospitalization and for whom a PCR test for SARS-CoV-2 is prescribed as part of his care
- French-speaking patient.
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the performance in terms of sensitivity and specificity of the technique by spectral analysis combined with artificial intelligence for the SARS-CoV-2 virus versus to the reference technique by RT-qPCR
Time frame: Day 1
Detection of the SARS-CoV-2 virus with the technique by spectral analysis combined with artificial intelligence and with the reference technique by RT-qPCR (Xpert Xpress SARS-CoV-2 or Simplexa™ COVID-19 Direct assay)
1 secondary outcome
Evaluate the detection limit of the technique by spectral analysis combined with artificial intelligence
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Alban Le Monnier, Pr 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?
An observational study of 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 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Results are not available in the source record.
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 performance in terms of sensitivity and specificity of the technique by spectral analysis combined with artificial intelligence for the SARS-CoV-2 virus versus to the reference technique by RT-qPCR (time frame: Day 1). 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 27 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.