SARS-CoV 2CoviDiagMSNCT04460638
SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling
An observational study of SARS-CoV 2, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Saliva collection and Clinical assessment
- How many people
- 779 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2020to 13 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients and caregivers infected and uninfected with CoV2-SARS.
Who may be able to join
- 18 years of age;
- screened for SARS-CoV2 by RT-PCR from a nasopharyngeal swab within 96 hours prior to inclusion.
Who cannot join
- Patient admitted to intensive care;
- Pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Saliva collection, Clinical assessment
- Keywords
- MALDI-TOF MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionBiological
Saliva samples are regularly collected over a period of up to 30 consecutive days.
Clinical assessmentOther
The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Covid+ hospitalization group | Patients hospitalized with SARS-CoV2 infection Receives: Biological: Saliva collection; Other: Clinical assessment | |
| Covid+ outpatient group | Patients or caregivers followed on an outpatient basis for an SARS-CoV2 infection Receives: Biological: Saliva collection; Other: Clinical assessment | |
| Covid- group | Caregivers not infected with an SARS-CoV2 Receives: 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 Receives: Biological: Saliva collection; Other: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (5)
Rate of correct classification by the test (MALDI-TOF MS profiling) from saliva sample
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%.
Measured: Day 30
Rate of correct classification by RT-PCR from saliva sample
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.
Measured: Day 30
Identification of proteins specific to the SARS-CoV2 infection
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.
Measured: Day 30
Presence of a positive anti-SARS-CoV2 antibody response by RT-PCR
On each SARS-CoV2 infected saliva sample, the presence of anti-SARS-CoV2 antibodies, by RT-PCR, will be determined.
Measured: Day 30
Correlation between the identified protein markers and the clinical course of the participants.
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start23 Jul 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460638
- Sponsor's protocol ID
- 2020-COVID19-15
- Other IDs
- 2020-A01249-30
- Acronym
- CoviDiagMS
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling
- ClinicalTrials.gov ID
- NCT04460638
- Acronym / sponsor ID
- CoviDiagMS / 2020-COVID19-15
- Conditions
- SARS-CoV 2
- Keywords
- MALDI-TOF MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Covid+ hospitalization group | – | Biological: Saliva collection, Other: Clinical assessmentPatients hospitalized with SARS-CoV2 infection |
| Covid+ outpatient group | – | Biological: Saliva collection, Other: Clinical assessmentPatients or caregivers followed on an outpatient basis for an SARS-CoV2 infection |
| Covid- group | – | Biological: Saliva collection, Other: Clinical assessmentCaregivers not infected with an SARS-CoV2 |
| Non-SARS pathology group | – | Biological: Saliva collection, Other: Clinical assessmentIndividuals not infected with SARS-CoV2 but with another acute and/or infectious non-SARS pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients and caregivers infected and uninfected with CoV2-SARS.
Key inclusion criteria (2 listed)
- 18 years of age;
- screened for SARS-CoV2 by RT-PCR from a nasopharyngeal swab within 96 hours prior to inclusion.
Key exclusion criteria (2 listed)
- Patient admitted to intensive care;
- Pregnant woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collectionSaliva samples are regularly collected over a period of up to 30 consecutive days. | Biological | Covid+ hospitalization group, Covid+ outpatient group, Covid- group, Non-SARS pathology group |
| Clinical assessmentThe participant's clinical data will be collected regularly over a period of up to 30 consecutive days. | Other | Covid+ hospitalization group, Covid+ outpatient group, Covid- group, Non-SARS pathology group |
Primary outcome
Development of a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.
Time frame: Day 30
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.
5 secondary outcomes
Rate of correct classification by the test (MALDI-TOF MS profiling) from saliva sample
Time frame: Day 30
Rate of correct classification by RT-PCR from saliva sample
Time frame: Day 30
Identification of proteins specific to the SARS-CoV2 infection
Time frame: Day 30
Presence of a positive anti-SARS-CoV2 antibody response by RT-PCR
Time frame: Day 30
Correlation between the identified protein markers and the clinical course of the participants.
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample. (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.