Clinical trial NCT04460638: SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling
Official title: SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Keywords: MALDI-TOF MS
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 779
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients and caregivers infected and uninfected with CoV2-SARS.

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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age;
* screened for SARS-CoV2 by RT-PCR from a nasopharyngeal swab within 96 hours prior to inclusion.

Exclusion Criteria:

* Patient admitted to intensive care;
* Pregnant woman.

Primary outcomes:
measure: Development of a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.
timeFrame: Day 30
Secondary outcomes:
measure: Rate of correct classification by the test (MALDI-TOF MS profiling) from saliva sample
timeFrame: Day 30
measure: Rate of correct classification by RT-PCR from saliva sample
timeFrame: Day 30
measure: Identification of proteins specific to the SARS-CoV2 infection
timeFrame: Day 30
measure: Presence of a positive anti-SARS-CoV2 antibody response by RT-PCR
timeFrame: Day 30
measure: Correlation between the identified protein markers and the clinical course of the participants.
timeFrame: Day 30
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
Study officials:
References: