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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection Viral

Intervention / Treatment
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* Other: Collection of blood, salivary and nasopharyngeal samples.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RT-PCR confirmed COVID-19 patients<br>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.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 6 | 
| 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 | Month 12 |