NCT04337424

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

April 13, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2020

Completed
Last Updated

November 4, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 5, 2020

Last Update Submit

November 3, 2020

Conditions

SARS-CoV-2

Keywords

Diagnosis testSalivary sampling

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Secondary Outcomes (3)

  • Analytical sensitivity of the LAMP test.

    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.

    1 day

  • Evaluation of the use of saliva samples compared to nasopharyngeal samples

    1 day

Study Arms (4)

Participants with active infection test to SARS-COV2

Sampling of saliva (1 to 2 ml)

Diagnostic Test: Sampling salivary

Convalescent participants for SARS-COV2

Sampling of saliva (1 to 2 ml)

Diagnostic Test: Sampling salivary

Participants cured to SARS-COV2

Sampling of saliva (1 to 2 ml)

Diagnostic Test: Sampling salivary

Participants with negative test to SARS-COV2

Sampling of saliva (1 to 2 ml)

Diagnostic Test: Sampling salivary

Interventions

Sampling salivaryDIAGNOSTIC_TEST

Collection of 1 to 2 ml of saliva

Convalescent participants for SARS-COV2Participants cured to SARS-COV2Participants with active infection test to SARS-COV2Participants with negative test to SARS-COV2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The samples size is 90 samples with active infection to SARS-COV2 and at least 90 with no active infection

You may qualify if:

  • \- 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.

You may not qualify if:

  • Eligibility Criteria:
  • \- 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
  • Not affiliated with a French Social Security Systemscheme or equivalent system
  • Persons deprived of their liberty, adult protected under guardianship or vulnerable persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCH Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary sampling (1 to 2 ml of salivary)

Study Officials

  • REYNES Jacques, PU PH

    Montpellier Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 7, 2020

Study Start

April 13, 2020

Primary Completion

October 7, 2020

Study Completion

October 7, 2020

Last Updated

November 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)