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

Not Applicable

Completed

• Conditions: Infection Viral
• Interventions: Other: Collection of blood, salivary and nasopharyngeal samples.

• Registration Number: NCT04637867
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Study Start: 2020-11-23
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

SARS-CoV-2 confirmed by RT-PCR

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RT-PCR confirmed COVID-19 patients	Collection of blood, salivary and nasopharyngeal samples.	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.

Primary Outcome Measures

Name	Time	Method
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients	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

Trial Locations

Locations (2)

hopital Edouard Herriot; 🇫🇷 Lyon, France

Service épidémiologie, Hopital édouard Herriot; 🇫🇷 Lyon, Rhone, France