COVIDMolCOVIDNCT04367545
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
A study testing Saliva collection in people with COVID and RT-ddPCR Multiplex, run by University Hospital, Rouen at 1 site in France.
Trial summary
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to : 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, RT-ddPCR Multiplex
- What is being tested?
- Saliva collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2020to 17 May 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
- Person affiliated to a social security scheme
Who cannot join
- Person objecting to participation in the research after reading information
- Person under the protection of justice,
- Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
- to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
- to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
- and to have a method compatible with screening extended to populations at risk.
- Conditions
- COVID, RT-ddPCR Multiplex
- Being tested
- Saliva collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionDiagnostic test
Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID-19 infection suspicion | Experimental | Patient with COVID-19 infection suspicion are tested using standard diagnosis method Receives: Diagnostic Test: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive patient using saliva method compared to number of positive patient using standard method
Measured: One hour
Number of negative patient using saliva method compared to number of negative patient using standard method
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start16 Apr 2020
- Primary completion17 May 2020
- Study completion17 May 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 COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry FREBOURG, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367545
- Sponsor's protocol ID
- 2020/0094/OB
- Acronym
- MolCOVID
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cassinari K, Alessandri-Gradt E, Chambon P, Charbonnier F, Gracias S, Beaussire L, Alexandre K, Sarafan-Vasseur N, Houdayer C, Etienne M, Caron F, Plantier JC, Frebourg T. Assessment of Multiplex Digital Droplet RT-PCR as a Diagnostic Tool for SARS-CoV-2 Detection in Nasopharyngeal Swabs and Saliva Samples. Clin Chem. 2021 Apr 29;67(5):736-741. doi: 10.1093/clinchem/hvaa323.
PubMed 33331864
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04367545
- Acronym / sponsor ID
- MolCOVID / 2020/0094/OB
- Conditions
- COVID, RT-ddPCR Multiplex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 17 May 2020 (actual)
- Study completion
- 17 May 2020 (actual)
- First posted
- 29 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.
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
- to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
- to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
- and to have a method compatible with screening extended to populations at risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID-19 infection suspicion | Experimental | Diagnostic Test: Saliva collectionPatient with COVID-19 infection suspicion are tested using standard diagnosis method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
- Person affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Person objecting to participation in the research after reading information
- Person under the protection of justice,
- Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
- Patient under guardianship or curatorship
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 collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab) | Diagnostic test | Patient with COVID-19 infection suspicion |
Primary outcome
Number of positive patient using saliva method compared to number of positive patient using standard method
Time frame: One hour
Number of negative patient using saliva method compared to number of negative patient using standard method
Time frame: One hour
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 17 Apr 2026.
- Results publication: PubMed 33331864Cassinari K, Alessandri-Gradt E, Chambon P, Charbonnier F, Gracias S, Beaussire L, Alexandre K, Sarafan-Vasseur N, Houdayer C, Etienne M, Caron F, Plantier JC, Frebourg T. Assessment of Multiplex Digital Droplet RT-PCR as a Diagnostic Tool for SARS-CoV-2 Detection in Nasopharyngeal Swabs and Saliva Samples. Clin Chem. 2021 Apr 29;67(5):736-741. doi: 10.1093/clinchem/hvaa323.
- 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.
Thierry FREBOURG, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva collection in people with COVID and RT-ddPCR Multiplex, run by University Hospital, Rouen 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 4 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 17 Apr 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?
Number of positive patient using saliva method compared to number of positive patient using standard method (time frame: One hour). The study lists 2 primary outcomes in all. 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 NCT04367545, 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 17 Apr 2026.