Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (SALICOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04578509
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).

Condition or disease Intervention/treatment
SARS-CoV-2 Infection COVID-19 Diagnostic Test: Nasopharyngeal swab Diagnostic Test: Saliva sample Diagnostic Test: axillary sweat sample Other: Data collection

Detailed Description:

Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS).

However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results.

New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care.

Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used.

Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times.

The main objective of the study is to evaluate, for the detection of SARS-CoV-2 infection, the performance of various alternative virological diagnostic strategies on saliva samples, in comparison with the reference technique (RT-PCR on NPS).

The primary endpoint of the study is positivity of the standard technique (RT-PCR on NPS) for the SARS-CoV-2 virus. The result of the alternative strategies on a saliva sample will be considered as positive or negative according to criteria specific to each of them and compared to the result of the reference technique to estimate their respective sensitivity.

The secondary objectives are to compare the diagnostic performances of RT-PCR on saliva versus RT-PCR on NPS, the diagnostic performances of alternative techniques on saliva versus RT-PCR on saliva, to evaluate the acceptability of the saliva self-sampling and the cost-effectiveness of new diagnostic strategies compared to the reference technique.

The study will include adults and children in whom a NPS is performed for SARS-CoV-2 screening. After informed consent, participants will be asked to provide a saliva sample before nasopharyngeal sampling. Both samples will be analyzed in parallel. The analytical performance of each technique will be assessed, centrally or delocalised, depending on the feasibility of the techniques and according to the advice of the scientific board. The analyzes will be carried out by a team of technicians specifically recruited for the study. All samples collected will be stored in a centralized in a biobank.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Diagnostic Test: Nasopharyngeal swab
Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test

Diagnostic Test: Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach

Diagnostic Test: axillary sweat sample
Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.

Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected

SalicovII (ancillary study)
Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected.
Diagnostic Test: Saliva sample
Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach

Other: Data collection
Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected




Primary Outcome Measures :
  1. Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus [ Time Frame: At diagnosis ]
    RT-PCR on nasopharyngeal is considered as gold standard


Secondary Outcome Measures :
  1. Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus [ Time Frame: At diagnosis ]
  2. Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus [ Time Frame: At diagnosis ]
  3. Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus [ Time Frame: At diagnosis ]
  4. Practicability to samples [ Time Frame: At diagnosis ]
    Number of samples tested in a day for each test

  5. Practicability to premises [ Time Frame: At diagnosis ]
    Quantity of premises required for each test

  6. Practicability to interpretation [ Time Frame: At diagnosis ]
    Feasibly Reading and interpretation For each test

  7. Practicability to render time [ Time Frame: At diagnosis ]
    Render times for each test

  8. IgG Antibody detection in saliva [ Time Frame: At diagnosis ]
    Research of IgG by ELISA and RDT

  9. IgM Antibody detection in saliva [ Time Frame: At diagnosis ]
    Research of IgM by ELISA and RDT

  10. IgA Antibody detection in saliva [ Time Frame: At diagnosis ]
    Research of IgA by ELISA and RDT

  11. Positivity of canine olfactory detection of SARS-CoV-2 [ Time Frame: At diagnosis ]
  12. Patient tolerance of the salivary self-sampling [ Time Frame: At diagnosis ]
    Evaluation by questionnaire of the patient tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions are about pain, discomfort, speed of performance)

  13. Operator tolerance of the salivary self-sampling [ Time Frame: At diagnosis ]
    Evaluation by questionnaire of the operator tolerance of the salivary self-sampling compared to the nasopharyngeal swab (questions is about pain, discomfort, speed of performance)

  14. Cost of each approach [ Time Frame: At diagnosis ]
    Including sampling, transport, technique (consumables, reagents, machine), human resources


Biospecimen Retention:   Samples Without DNA
Saliva,axillary sweat


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
Criteria

Inclusion Criteria:

  • Adult or child subject able to receive nasopharyngeal swab, regardless of age
  • Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP
  • Subject or parent not opposed to saliva sampling and data collection as part of this research

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578509


Contacts
Layout table for location contacts
Contact: Solen Kernéis, Doctor +33 1 58 41 19 08 solen.kerneis@aphp.fr
Contact: Laure Choupeaux, Master +33 1 44 38 17 11 laure.choupeaux@aphp.fr

Locations
Layout table for location information
France
SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP) Recruiting
Paris, France, 75001
Contact: Solen Kernéis, MD, PhD    +33 1 58.41.19.08    solen.kerneis@aphp.fr   
Contact: Laure Choupeaux, Master    +33 1 44 38 17 11    laure.choupeaux@aphp.fr   
Sub-Investigator: LE GOFF Jérôme, Professor         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Study Director: Jérôme Le Goff, Professor Assistance Publique - Hôpitaux de Paris
Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04578509    
Other Study ID Numbers: APHP200960
2020-A02431-38 ( Other Identifier: APHP )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Screening program
SARS-CoV-2 infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases