SARS-CoV InfectionSAMILCOVNCT04550390
Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19
An observational study of SARS-CoV Infection, run by Direction Centrale du Service de Santé des Armées at 4 sites in France.
Trial summary
Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. 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 Infection
- What is being tested?
- Saliva collection
- How many people
- 329 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Sep 2020to 19 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is composed of people coming for COVID-19 screening to one of the four military training hospitals involved,either spontaneously or during cluster investigations. Patients hospitalized in these hospitals with non-severe illness and symptoms related to COVID-19 for less than 7 days will also be eligible to the study.
Who may be able to join
- To be at least 18 years of age
- To come at hospital for SARS-CoV-2 screening
- To be able to receive a nasopharyngeal swab
Who cannot join
- People under 18 years of age
- Inpatient in intensive care
- Pregnant or breastfeeding woman
- Individual with dry syndrome (Gougerot-Sjögren syndrome)
- Taking treatments that reduce salivary volume (anticholinergic activity)
- People with a COVID-19 diagnosis confirmed by a molecular biology method >7 days ago
- Contraindication to oral swabbing
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital d'Instruction des Armées Percy
Clamart, 92141
Hôpital d'Instruction des Armées Laveran
Marseille, 13384
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
About this study
Official title: Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19.
Since March 2020, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).
Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.
Read more
In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.
An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.
- Conditions
- SARS-CoV Infection
- Being tested
- Saliva collection
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionDiagnostic test
2 saliva samples are self-collected by participants
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative result of molecular tests for the SARS-CoV-2 virus.
Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.
Measured: At enrollment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 Sep 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies 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
- 329 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
- NCT04550390
- Sponsor's protocol ID
- 2020-COVID19-36
- Other IDs
- 2020-A02536-33
- Acronym
- SAMILCOV
- Status last verified
- Mar 2021
- First submitted
- 14 Sep 2020
- Last updated
- 10 Mar 2021
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19.
- ClinicalTrials.gov ID
- NCT04550390
- Acronym / sponsor ID
- SAMILCOV / 2020-COVID19-36
- Conditions
- SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 16 Sep 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, the SARS-CoV type coronavirus infection (SARS-CoV-2; nCoV19; COVID-19) is considered pandemic. As early as April 2020, the World Health Organization recommended the implementation of mass screening of populations, with the aim of identifying cases and contacts and controlling viral spread. Since the end of lock-down on May 11, 2020,the screening policy has been intensified to fight against COVID-19. Virological tests by RT-PCR are thus accessible to all, without a prescription and reimbursed by health insurance. The French government has also set a quantitative target of 1 million tests per week. In order to meet this target, the number of sampling centers has been increased (mobile structures, etc.).
Screening tests are currently carried out using a nasopharyngeal swab analyzed by RT-PCR for the detection of viral RNA. This type of sample has several technical and logistic constraints. It must be carried out by personnel who are authorized and trained in this procedure and in appropriate hospital hygiene practices. It exposes the sampling personnel to possible contamination through nasopharyngeal secretions or coughing that may occur during sampling. With the increase in screening, there are sometimes insufficient numbers of sampling personnel and there is significant market pressure for swabs and virological transport media.
In addition, these swabs are uncomfortable or even painful for the patient, which could imply a reluctance to be screened. They are also complicated in children, whether they are rhino- or oropharyngeal.
An alternative to the nasopharyngeal swab, which is the subject of this project, would be to have one or more reliable sampling methods that are less restrictive than the nasopharyngeal swab ("gold standard"). Thus, we propose to test and compare the results obtained by molecular biology techniques on nasopharyngeal, salivary and buccal swabs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of people coming for COVID-19 screening to one of the four military training hospitals involved,either spontaneously or during cluster investigations. Patients hospitalized in these hospitals with non-severe illness and symptoms related to COVID-19 for less than 7 days will also be eligible to the study.
Key inclusion criteria (3 listed)
- To be at least 18 years of age
- To come at hospital for SARS-CoV-2 screening
- To be able to receive a nasopharyngeal swab
Key exclusion criteria (7 listed)
- People under 18 years of age
- Inpatient in intensive care
- Pregnant or breastfeeding woman
- Individual with dry syndrome (Gougerot-Sjögren syndrome)
- Taking treatments that reduce salivary volume (anticholinergic activity)
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 collection2 saliva samples are self-collected by participants | Diagnostic test | – |
Primary outcome
Qualitative result of molecular tests for the SARS-CoV-2 virus.
Time frame: At enrollment (day 1)
Qualitative result may be : "positive", "negative" or "invalid". The test results will be compared between the two types of collection method.
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 10 Mar 2021.
- 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.
4 sites 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 Infection, run by Direction Centrale du Service de Santé des Armées at 4 sites 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 3 inclusion and 7 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Qualitative result of molecular tests for the SARS-CoV-2 virus. (time frame: At enrollment (day 1)). 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 10 Mar 2021.