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Completed

NCT Number: NCT04637867

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

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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Key information

Conditions

Infection Viral Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service épidémiologie, Hopital édouard Herriot, Lyon, Rhone, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of blood, salivary and nasopharyngeal samples.

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

Primary outcomes

  1. Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients

    Time frame: Month 6

    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

  2. Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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