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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
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
December 29, 2020
Last Updated
January 12, 2021
Sponsor
University Hospital, Rouen
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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
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
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)
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
No
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
Email
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
Email
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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