SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling

NCT04460638 | Completed

• 2 other identifiers: 2020-COVID19-152020-A01249-30
• Study Type: observational
• Target: 779
• Locations: 1 country
• Sites: 1

Brief Summary

Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables). In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR. The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.

Conditions

SARS-CoV 2

Keywords

MALDI-TOF MS

Outcome Measures

Primary Outcomes (1)

• Development of a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.

  The development of this test is based on machine learning techniques, which involve "training" a mathematical model, in which the results of the mass spectrometry analysis of saliva samples and clinical data will be used to determine the information needed to distinguish a saliva sample from a SARS-CoV2-infected participant from a healthy saliva sample.

  Day 30

Secondary Outcomes (5)

• Rate of correct classification by the test (MALDI-TOF MS profiling) from saliva sample

  Day 30

• Rate of correct classification by RT-PCR from saliva sample

  Day 30

• Identification of proteins specific to the SARS-CoV2 infection

  Day 30

• Presence of a positive anti-SARS-CoV2 antibody response by RT-PCR

  Day 30

• Correlation between the identified protein markers and the clinical course of the participants.

  Day 30

Study Arms (4)

Covid+ hospitalization group

Patients hospitalized with SARS-CoV2 infection

Biological: Saliva collection; Other: Clinical assessment

Covid+ outpatient group

Patients or caregivers followed on an outpatient basis for an SARS-CoV2 infection

Biological: Saliva collection; Other: Clinical assessment

Covid- group

Caregivers not infected with an SARS-CoV2

Biological: Saliva collection; Other: Clinical assessment

Non-SARS pathology group

Individuals not infected with SARS-CoV2 but with another acute and/or infectious non-SARS pathology

Biological: Saliva collection; Other: Clinical assessment

Interventions

Saliva collection BIOLOGICAL

Saliva samples are regularly collected over a period of up to 30 consecutive days.

Covid+ hospitalization group; Covid+ outpatient group; Covid- group; Non-SARS pathology group

Clinical assessment OTHER

The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.

Covid+ hospitalization group; Covid+ outpatient group; Covid- group; Non-SARS pathology group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients and caregivers infected and uninfected with CoV2-SARS.

You may qualify if:

• years of age;

You may not qualify if:

• Patient admitted to intensive care;
• Pregnant woman.

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instruction des Armées Laveran

Marseille, 13013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples

Study Design

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

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 7, 2020
• Study Start: July 23, 2020
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

FR (1)