NCT04637867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

September 5, 2025

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

November 16, 2020

Last Update Submit

August 29, 2025

Conditions

Infection Viral

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

RT-PCR confirmed COVID-19 patients

OTHER

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.

Other: Collection of blood, salivary and nasopharyngeal samples.

Interventions

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

RT-PCR confirmed COVID-19 patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SARS-CoV-2 confirmed by RT-PCR
  • Adults \> 18 years
  • Signed consent form
  • Affiliated to the French health system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service épidémiologie, Hopital édouard Herriot

Lyon, Rhone, 69003, France

Location

hopital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (1)

  • Khanafer N, Henaff L, Bennia S, Termoz A, Chapurlat R, Escuret V, Proriol M, Duvert F, Mena C, Planckaert C, Trehet-Mandez N, Saadatian-Elahi M, Vanhems P. Factors Associated with Long COVID-19 in a French Multicentric Prospective Cohort Study. Int J Environ Res Public Health. 2023 Aug 29;20(17):6678. doi: 10.3390/ijerph20176678.

    PMID: 37681818RESULT

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Philippe VANHEMS, MD

    Lyon, France, 69003

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

November 23, 2020

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

September 5, 2025

Record last verified: 2021-06

Locations

FR(2)