Detection of SARS-CoV-2 (COVID-19) by SERS Spectroscopy Combined With Artificial Intelligence

NCT04786197 | Unknown

• 1 other identifier: Kaïssa Covid
• Study Type: observational
• Target: 712
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid19

Keywords

artificial intelligence

Outcome Measures

Primary Outcomes (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)

  Day 1

Secondary Outcomes (1)

• Evaluate the detection limit of the technique by spectral analysis combined with artificial intelligence

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of their data for this research.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alban Le Monnier, Pr

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 8, 2021
• Study Start: August 10, 2021
• Primary Completion: September 10, 2021
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)