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

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

Sponsors

Lead Sponsor: Hospices Civils de Lyon

Source 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.

Overall Status Not yet recruiting
Start Date November 23, 2020
Completion Date November 1, 2021
Primary Completion Date November 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients Month 6
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients Month 12
Enrollment 200
Condition
Intervention

Intervention Type: Other

Intervention Name: Collection of blood, salivary and nasopharyngeal samples.

Description: 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

Arm Group Label: RT-PCR confirmed COVID-19 patients

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Philippe VANHEMS, MD Principal Investigator Lyon, France, 69003
Overall Contact

Last Name: Philippe VANHEMS, MD

Phone: 04 72 11 07 20

Phone Ext.: +33

Email: [email protected]

Verification Date

November 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: RT-PCR confirmed COVID-19 patients

Type: Other

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov