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

Civil Hospices of Lyon

Status: Completed

Conditions: Infection Viral

Treatments: Other: Collection of blood, salivary and nasopharyngeal samples.

Study type: Interventional

Funder types: Other

Identifiers

NCT04637867

69HCL20_0761

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 1 patient group

RT-PCR confirmed COVID-19 patients

Other group

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.

Treatment:

Other: Collection of blood, salivary and nasopharyngeal samples.