COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
Primary Purpose
Infection Viral
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood, salivary and nasopharyngeal samples.
Sponsored by
About this trial
This is an interventional other trial for Infection Viral
Eligibility Criteria
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
Sites / Locations
- Service épidémiologie, Hopital édouard Herriot
- hopital Edouard Herriot
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
RT-PCR confirmed COVID-19 patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
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
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04637867
First Posted
November 16, 2020
Last Updated
June 3, 2021
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT04637867
Brief Title
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
Official Title
Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Viral
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RT-PCR confirmed COVID-19 patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of blood, salivary and nasopharyngeal samples.
Intervention Description
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
Primary Outcome Measure Information:
Title
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
Description
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
Time Frame
Month 6
Title
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
Description
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
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe VANHEMS, MD
Organizational Affiliation
Lyon, France, 69003
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service épidémiologie, Hopital édouard Herriot
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69003
Country
France
Facility Name
hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
Learn more about this trial
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
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