Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER (COVID-SER)

May 21, 2024 updated by: Hospices Civils de Lyon
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite cedex, France, 69495
        • Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
  • Age: ≥ 18 years old
  • Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
  • Persons affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

  • Pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serological tests will be applied on patients blood sampling
Diagnostic test: Serological tests will be applied on patients blood sampling
Application of tests on patients' serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The positivity (Yes/No) of the serological test.
Time Frame: Day 0
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 0
The positivity (Yes/No) of the serological test.
Time Frame: Day 3
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 3
The positivity (Yes/No) of the serological test.
Time Frame: Day 7
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 7
The positivity (Yes/No) of the serological test.
Time Frame: Day 14
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 14
The positivity (Yes/No) of the serological test.
Time Frame: Day 21
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 21
The positivity (Yes/No) of the serological test.
Time Frame: Day 28
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 28
The positivity (Yes/No) of the serological test.
Time Frame: Day 35
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 35
The positivity (Yes/No) of the serological test.
Time Frame: Day 42
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of IgM and IgG antibody titer at each sampling of weekly and monthly visits of covid-19+ patients and implementation of the kinetics of mean appearance.
Time Frame: Day 42
Day 42
- Among the symptomatic PCR negative patients recruited into the study at the first visit, the measurement of the IgM antibody and IgG titer will be performed in serum at D28, and the positive results will then constitute the false-negative PCR results.
Time Frame: Day 28
Day 28
- Measurement of IgM and IgG antibody titer at each sampling of late patient visits.
Time Frame: Day 42
Day 42
- The neutralizing capacity of the antibodies will be determined by in vitro serum neutralization tests on seropositive serum. A group of 50 patients made up of seropositive and asymptomatic caregivers at the time of infection will represent this group.
Time Frame: Day 42
Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

April 10, 2023

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL20_0329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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