Infection ViralNCT04637867
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
A study testing Collection of blood, salivary and nasopharyngeal samples. in people with Infection Viral, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection Viral
- What is being tested?
- Collection of blood, salivary and nasopharyngeal samples.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Nov 2020to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SARS-CoV-2 confirmed by RT-PCR
- Adults > 18 years
- Signed consent form
- Affiliated to the French health system
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service épidémiologie, Hopital édouard Herriot
Lyon, Rhone, 69003
hopital Edouard Herriot
Lyon, 69003
About this study
Official title: Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study
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.
- Conditions
- Infection Viral
- Being tested
- Collection of blood, salivary and nasopharyngeal samples.
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of blood, salivary and nasopharyngeal samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start23 Nov 2020
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe VANHEMS, MD, Principal investigator, Lyon, France, 69003
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637867
- Sponsor's protocol ID
- 69HCL20_0761
- Status last verified
- Jun 2021
- First submitted
- 16 Nov 2020
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37681818
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study
- ClinicalTrials.gov ID
- NCT04637867
- Acronym / sponsor ID
- 69HCL20_0761
- Conditions
- Infection Viral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT-PCR confirmed COVID-19 patients | Other | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SARS-CoV-2 confirmed by RT-PCR
- Adults > 18 years
- Signed consent form
- Affiliated to the French health system
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | RT-PCR confirmed COVID-19 patients |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 37681818Khanafer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe VANHEMS, MD principal investigator
Lyon, France, 69003
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of blood, salivary and nasopharyngeal samples. in people with Infection Viral, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.