SARS-CoV-2EasyCoVNCT04337424
Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
An observational study of SARS-CoV-2, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Sampling salivary
- How many people
- 627 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2020to 7 Oct 2020
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The samples size is 90 samples with active infection to SARS-COV2 and at least 90 with no active infection
Who may be able to join
- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2
- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.
- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2
- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR
Who cannot join
- Eligibility Criteria:
- Not affiliated with a French Social Security Systemscheme or equivalent system
- Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
Trial locations and contacts
1 site in 1 country.
About this study
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.
Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.
We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).
Read the detailed description
Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)
- Conditions
- SARS-CoV-2
- Being tested
- Sampling salivary
- Keywords
- Diagnosis test, Salivary sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling salivaryDiagnostic test
Collection of 1 to 2 ml of saliva
| Study group | Role | What they receive |
|---|---|---|
| Participants with active infection test to SARS-COV2 | Sampling of saliva (1 to 2 ml) Receives: Diagnostic Test: Sampling salivary | |
| Convalescent participants for SARS-COV2 | Sampling of saliva (1 to 2 ml) Receives: Diagnostic Test: Sampling salivary | |
| Participants cured to SARS-COV2 | Sampling of saliva (1 to 2 ml) Receives: Diagnostic Test: Sampling salivary | |
| Participants with negative test to SARS-COV2 | Sampling of saliva (1 to 2 ml) Receives: Diagnostic Test: Sampling salivary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific detection of SARS-CoV-2 specific RNA
Detection by the LAMP method is to be corroborated with the reference method, RT-PCR on the same salivary sample. Only one sample is taken per subject participating in the study. The sample is divided into two aliquots which will be analyzed by LAMP and RT-PCR
Measured: 1 day
Secondary outcomes (3)
Analytical sensitivity of the LAMP test.
This test developed by SYS2DIAG / SKILLCELL must be able to detect a minimum viral load equivalent to that of the standard method on the same salivary sample.
Measured: 1 day
The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.
A correlation between the viral loads measured on the same sample by RT-PCR and by LAMP will be carried out.
Measured: 1 day
Evaluation of the use of saliva samples compared to nasopharyngeal samples
The RT-PCR results on these 2 types of samples and the LAMP results for the saliva samples will be compared with the patient diagnosis to assess the feasibility and performance of the saliva samples for the molecular diagnosis of SARS-CoV-2.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start13 Apr 2020
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- societe SkillCell - 97198 Jarry, CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier
- Responsible party
- Sponsor
- Investigators
- REYNES Jacques, PU PH, Principal investigator, Montpellier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337424
- Sponsor's protocol ID
- RECHMPL20_0170
- Acronym
- EasyCoV
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider FS, Molina L, Picot MC, L'Helgoualch N, Espeut J, Champigneux P, Alali M, Baptiste J, Cardeur L, Carniel C, Davy M, Dedisse D, Dubuc B, Fenech H, Foulongne V, Gaillard CF, Galtier F, Makinson A, Marin G, Santos RM, Morquin D, Ouedraogo A, Lejeune AP, Quenot M, Keiflin P, Robles FC, Rego CR, Salvetat N, Trento C, Vetter D, Molina F, Reynes J. Performances of rapid and connected salivary RT-LAMP diagnostic test for SARS-CoV-2 infection in ambulatory screening. Sci Rep. 2022 Feb 18;12(1):2843. doi: 10.1038/s41598-022-04826-7.
PubMed 35181680
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04337424
- Acronym / sponsor ID
- EasyCoV / RECHMPL20_0170
- Conditions
- SARS-CoV-2
- Keywords
- Diagnosis test, Salivary sampling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- societe SkillCell - 97198 Jarry, CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 7 Apr 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.
Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.
Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.
We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).
Detailed description
Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with active infection test to SARS-COV2 | – | Diagnostic Test: Sampling salivarySampling of saliva (1 to 2 ml) |
| Convalescent participants for SARS-COV2 | – | Diagnostic Test: Sampling salivarySampling of saliva (1 to 2 ml) |
| Participants cured to SARS-COV2 | – | Diagnostic Test: Sampling salivarySampling of saliva (1 to 2 ml) |
| Participants with negative test to SARS-COV2 | – | Diagnostic Test: Sampling salivarySampling of saliva (1 to 2 ml) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The samples size is 90 samples with active infection to SARS-COV2 and at least 90 with no active infection
Key inclusion criteria (4 listed)
- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2
- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.
- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2
- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR
Key exclusion criteria (3 listed)
- Eligibility Criteria:
- Not affiliated with a French Social Security Systemscheme or equivalent system
- Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
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 |
|---|---|---|
| Sampling salivaryCollection of 1 to 2 ml of saliva | Diagnostic test | Convalescent participants for SARS-COV2, Participants cured to SARS-COV2, Participants with active infection test to SARS-COV2, Participants with negative test to SARS-COV2 |
Primary outcome
Specific detection of SARS-CoV-2 specific RNA
Time frame: 1 day
Detection by the LAMP method is to be corroborated with the reference method, RT-PCR on the same salivary sample. Only one sample is taken per subject participating in the study. The sample is divided into two aliquots which will be analyzed by LAMP and RT-PCR
3 secondary outcomes
Analytical sensitivity of the LAMP test.
Time frame: 1 day
The correlation between the measurement of the assayed viral load (CT value) by the standard method and by the LAMP developed by SYS2DIAG / SKILLCELL.
Time frame: 1 day
Evaluation of the use of saliva samples compared to nasopharyngeal samples
Time frame: 1 day
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 12 Jun 2026.
- Results publication: PubMed 35181680Schneider FS, Molina L, Picot MC, L'Helgoualch N, Espeut J, Champigneux P, Alali M, Baptiste J, Cardeur L, Carniel C, Davy M, Dedisse D, Dubuc B, Fenech H, Foulongne V, Gaillard CF, Galtier F, Makinson A, Marin G, Santos RM, Morquin D, Ouedraogo A, Lejeune AP, Quenot M, Keiflin P, Robles FC, Rego CR, Salvetat N, Trento C, Vetter D, Molina F, Reynes J. Performances of rapid and connected salivary RT-LAMP diagnostic test for SARS-CoV-2 infection in ambulatory screening. Sci Rep. 2022 Feb 18;12(1):2843. doi: 10.1038/s41598-022-04826-7.
- Individual participant dataSharing planned: No
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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.
REYNES Jacques, PU PH principal investigator
Montpellier Hospital
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 University Hospital, Montpellier 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 4 inclusion and 3 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 12 Jun 2026. 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?
Specific detection of SARS-CoV-2 specific RNA (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337424, which also lists 1 linked publication.
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 12 Jun 2026.