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NCT04550390: SAMILCOV

Study of the Analytical Performance of Different Salivary Self-collection Methods for the Detection of COVID-19

Completed Last updated 10 March 2021
What this trial tests

trial testing Saliva collection in SARS-CoV Infection in 329 participants. Completed in 19 October 2020.

Timeline
15 September 2020
Primary endpoint
19 October 2020
19 October 2020

Quick facts

Lead sponsorDirection Centrale du Service de Santé des Armées
StatusCompleted
Study typeOBSERVATIONAL
Enrollment329
Start date15 September 2020
Primary completion19 October 2020
Estimated completion19 October 2020
Sites4 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Direction Centrale du Service de Santé des Armées — full company profile →

Who can join

18 and older, any sex, with SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Performances, feasibility and acceptability of nasopharyngeal swab, saliva and oral-self sampling swab for the detection of severe acute respiratory syndrome coronavirus 2.
    Plantamura J, Bousquet A, Otto MP, Bigaillon C, et al · · 2021 · cited 16× · PMID 33987804 · DOI 10.1007/s10096-021-04269-4

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Other trials of Saliva collection

Trials testing the same drug.

Other recruiting trials for SARS-CoV Infection

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Other Direction Centrale du Service de Santé des Armées trials

Trials by the same sponsor.

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Data sources for this page

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