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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in France

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.

  1. 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)
  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.

  1. First posted8 Mar 2021
  2. Study start10 Aug 2021
  3. Primary completion10 Sep 2021
  4. Study completion31 Dec 2023 (estimated)

Resources

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)
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

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.

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