SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling
NCT ID: NCT04460638
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
779 participants
OBSERVATIONAL
2020-07-23
2021-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Saliva for COVID-19 Diagnosis
NCT04953039
The Salivary Raman COVID-19 Fingerprint
NCT04583306
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
NCT04367545
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
NCT04547114
Transmissibility and Viral Load of SARS-CoV-2 in Oral Secretions
NCT04348240
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Covid+ hospitalization group
Patients hospitalized with SARS-CoV2 infection
Saliva collection
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessment
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
Covid+ outpatient group
Patients or caregivers followed on an outpatient basis for an SARS-CoV2 infection
Saliva collection
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessment
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
Covid- group
Caregivers not infected with an SARS-CoV2
Saliva collection
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessment
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
Non-SARS pathology group
Individuals not infected with SARS-CoV2 but with another acute and/or infectious non-SARS pathology
Saliva collection
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessment
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saliva collection
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessment
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* screened for SARS-CoV2 by RT-PCR from a nasopharyngeal swab within 96 hours prior to inclusion.
Exclusion Criteria
* Pregnant woman.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital d'Instruction des Armées Laveran
Marseille, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A01249-30
Identifier Type: OTHER
Identifier Source: secondary_id
2020-COVID19-15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.