CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Clinical assessmentWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2187 Saliva collection Wiki 0.45
drug852 Enoxaparin Wiki 0.33

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D020141 Hemostatic Disorders NIH 0.30
D001778 Blood Coagulation Disorders NIH 0.30
D011024 Pneumonia, Viral NIH 0.13
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001928 Abnormality of coagulation HPO 0.30
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

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

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.

NCT04460638 SARS-CoV 2 Biological: Saliva collection Other: Clinical assessment

Primary Outcomes

Description: 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.

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

Time: Day 30

Secondary Outcomes

Description: For each saliva sample, the status ("correct" or "incorrect") of the classification of the sample ("infected" or "not infected") by the test (MALDI-TOF MS profiling) will be determined. Then the rate of correct classification will be calculated. The test will be considered efficient when it has reached a correct classification rate of more than 95%.

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

Time: Day 30

Description: For each saliva sample, the status ("correct" or "incorrect") of the classification of the sample ("infected" or "not infected") by RT-PCR will be determined. Then the rate of correct classification by RT-PCR will be calculated.

Measure: Rate of correct classification by RT-PCR from saliva sample

Time: Day 30

Description: On each saliva sample, the expression of proteins will be determined using mass spectrometry. By comparison between SARS-CoV2 infected saliva samples and non-infected saliva samples, the presence of proteins that are specifically expressed in SARS-CoV2 infected saliva samples will be determined.

Measure: Identification of proteins specific to the SARS-CoV2 infection

Time: Day 30

Description: On each SARS-CoV2 infected saliva sample, the presence of anti-SARS-CoV2 antibodies, by RT-PCR, will be determined.

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

Time: Day 30

Description: In SARS-CoV2 infected participants (Covid+ hospitalization group and Covid+ outpatient group), the presence of a correlation between the presence of proteins specific to the SARS-CoV2 infection and the clinical evolution of patients will be determined.

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

Time: Day 30

No related HPO nodes (Using clinical trials)