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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-05-12

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.

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Detailed Description

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Conditions

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Infection Viral

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Collection of blood, salivary and nasopharyngeal samples.

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes