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

Infection Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637867
• Other study ID #: 69HCL20_0761
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection Viral
• Virus Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	hopital Edouard Herriot	Lyon
France	Service épidémiologie, Hopital édouard Herriot	Lyon	Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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