COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)

June 3, 2021 updated by: Hospices Civils de Lyon

Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study

There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.

Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

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
      • Lyon, France, 69003
        • Hôpital Edouard Herriot
    • Rhone
      • Lyon, Rhone, France, 69003
        • Service épidémiologie, Hopital édouard Herriot

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

SARS-CoV-2 confirmed by RT-PCR

  • Adults > 18 years
  • Signed consent form
  • Affiliated to the French health system

Exclusion Criteria:

  • Pregnant women
  • Hospitalized patients
  • Individuals subject to legal protection
  • Imprisoned individuals
  • Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: RT-PCR confirmed COVID-19 patients
RT-PCR confirmed patients included in the NOSO-COR study are invited six and 12 months after the initial infection to provide blood (41.5mL in total), salivary and nasopharyngeal samples and to complete a questionnaire. Each visit is expected to take about one hour.
Other: Collection of blood, salivary and nasopharyngeal samples.

Each visit M6 and M12

  • Blood: 1 PAXgene tube (2.5mL) 1 EDTA tube (4mL), 1 dry tube with gel (5mL), 3 EDTA tubes (10mL each)
  • Salivary sample
  • Nasopharyngeal sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
Time Frame: Month 6
To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients six months after laboratory-confirmed diagnosis of SARS-CoV-2
Month 6
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
Time Frame: Month 12
To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients 12 months after laboratory-confirmed diagnosis of SARS-CoV-2
Month 12

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Philippe VANHEMS, MD, Lyon, France, 69003

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)

November 23, 2020

Primary Completion (ACTUAL)

May 12, 2021

Study Completion (ACTUAL)

May 12, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0761

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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