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Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen (SeroCOV)

Primary Purpose

Corona Virus Infection

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Serological testing for COVID-19 infection

About this trial

This is an interventional diagnostic trial for Corona Virus Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :

Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020)
Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus)
Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen.

The criteria for inclusion in the "acute point infection" group are as follows:

Patients screened by a positive RT-PCR for an SARS-CoV-2 infection
Patients aged ≥ 18 years old
Patients taken in charge in the emergency room / in a unit / in COVID resuscitation at the Rouen University Hospital.
Patients having read and understood the briefing note
Non-opposition to participation in the study

The criteria for inclusion in the "Sequential acute infection" group are as follows:

Patients with positive RT-PCR for CoV-2-SARS infection
Patients aged ≥ 18 years old
Taken care of in a COVID unit at the Rouen University Hospital
Having read and understood the briefing note and signed the informed consent form

The criteria for inclusion in the "Convalescent" group are as follows:

Caregivers working at the UH of Rouen
Screened by positive RT-PCR for SARS-CoV-2 infection,
Healed for at least one month at the time of inclusion
Having read and understood the briefing note and signed the informed consent form

Exclusion Criteria:

Minor person
Known Pregnancy
Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
Person not affiliated with social security
Person who does not understand and speak French

Sites / Locations

Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient infected or cured from covid19

Arm Description

Patients with an acute SARS-CoV-2 infection confirmed by a positive RT-PCR, hospitalized in COVID units or in COVID resuscitations, Nurses at the Rouen University Hospital infected with COVID 19, and cured, Patients with a high suggestive clinic for COVID-19 infection but with negative COVID-19 RT-PCR

Outcomes

Primary Outcome Measures

Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay

Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )

Secondary Outcome Measures

Evaluation of immunological of EUROIMMUN SARS-CoV-2(IgA) ELISA, EUROIMMUN SARS-CoV-2 (IgG) ELISA, WANTAI SARS-CoV-2 Ab ELISA, WANTAI SARS-CoV-2 IgM ELISA, Diasorin LIAISON SARS CoV-2 S1/S2 IgG, Roche ECL anti-SARS-Cov-2 (combined IgG IgA)

Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )

Full Information

NCT ID

NCT04707833

First Posted

December 29, 2020

Last Updated

January 12, 2021

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT04707833

Brief Title

Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

Acronym

SeroCOV

Official Title

Protocol for the Collection of Clinical Samples for Evaluation and Implementation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 26, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months. In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corona Virus Infection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient infected or cured from covid19

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Serological testing for COVID-19 infection

Intervention Description

The tests used will be the following: EUROIMMUN SARS-CoV-2(IgA) ELISA ELISA SARS-CoV-2 (IgG) EUROIMMUN WANTAI SARS-CoV-2 Ab ELISA WANTAI SARS-CoV-2 IgM ELISA Abbott Architect SARS-CoV-2 IgG Diasorin SARS LINK CoV-2 S1/S2 IgG Roche ECL anti-SARS-Cov-2 (combined IgG IgM IgA)

Primary Outcome Measure Information:

Title

Evaluation of immunological Abbott Architect SARS-CoV-2 IgG Assay

Description

Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Description

Measurement of antibodies against COVID-19 infection (Sensitivity and specificity )

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows : Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020) Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus) Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen. The criteria for inclusion in the "acute point infection" group are as follows: Patients screened by a positive RT-PCR for an SARS-CoV-2 infection Patients aged ≥ 18 years old Patients taken in charge in the emergency room / in a unit / in COVID resuscitation at the Rouen University Hospital. Patients having read and understood the briefing note Non-opposition to participation in the study The criteria for inclusion in the "Sequential acute infection" group are as follows: Patients with positive RT-PCR for CoV-2-SARS infection Patients aged ≥ 18 years old Taken care of in a COVID unit at the Rouen University Hospital Having read and understood the briefing note and signed the informed consent form The criteria for inclusion in the "Convalescent" group are as follows: Caregivers working at the UH of Rouen Screened by positive RT-PCR for SARS-CoV-2 infection, Healed for at least one month at the time of inclusion Having read and understood the briefing note and signed the informed consent form Exclusion Criteria: Minor person Known Pregnancy Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship Person not affiliated with social security Person who does not understand and speak French

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Christophe Plantier, Professor

Phone

02 32 88 66 72

Jc.plantier@chu-rouen.fr

Facility Information:

Facility Name

Rouen University Hospital

City

Rouen

ZIP/Postal Code

760031

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Mallet

secretariat.dcr@chu-rouen.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

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