SARS (Severe Acute Respiratory Syndrome)CORSERNCT04325646
Sero-epidemiological Study of the SARS-CoV-2 Virus Responsible for COVID-19 in France
An observational study of SARS (Severe Acute Respiratory Syndrome) and COVID-19, run by Institut Pasteur at 21 sites in France.
Trial summary
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome), COVID-19
- What is being tested?
- Human Biological samples
- Type of treatment
- Vaccines
- How many people
- 5,000 participants
- Where
- 21 sitesFrance
- Study dates
- 13 Mar 2020to 31 May 2023
- Phase
- Observational
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults (≥ 18 years old) at the time of collection (including minors for group 2c) CORSER-1 : subjects who were in China between 08/2019 and 01/2020 and who have not been diagnosed with an SARS-CoV-2 infection; CORSER-2 : Sub-group 2a: suspected SARS-CoV-2 infection with a negative result of RT-PCR virus test on respiratory sample. Sub-group 2b: contact or co-exposure with confirmed cases of SARS-CoV-2-infection. Subgroup 2c: exposed to a risk of infection with SARS-CoV-2 in a geographic area of SARS-CoV-2 circulation. Subgroup 2d : Staff of health care institutions Subgroup 2e : hospitalized or residing in health care facilities Subgroup 2f : Subjects with two symptomatic episodes of SARS-CoV-2- infection CORSER 3 : returning from a humanitarian mission that started before the epidemic circulation of the virus in France CORSER 4 : being vaccinated against COVID-19 CORSER 5 : with acute SARS-CoV-2 infection and controls
Who may be able to join
- Affiliated with or benefiting from a Social Security system
- State of health compatible with a blood sample as defined in the protocol
Who cannot join
- Person benefiting from a legal protection measure or unable to express informed consent to participation
- Have had an infectious episode and/or respiratory signs in the 14 days prior to the scheduled visit (CORSER 1 and 2a, 2b)
- Have been in contact with a confirmed case of SARS-CoV-2 infection within 14 days prior to the date of the visit.(CORSER 1 and 2a, 2b)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CHU Amiens-Picardie
Amiens
EHPAD Villa Concorde
Asnières-sur-Seine
CHU François Mitterand
Dijon
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon
CHU Limoges
Limoges
Hôpital de la Croix Rousse
Lyon
EHPAD Les Etangs
Mennecy
CHRU de Nancy
Nancy
Hôpitaux de Brabois
Nancy
CHR Orléans
Orléans
Institut Mutualiste
Paris, 75014
Centre Médical de l'Institut Pasteur
Paris, 75015
Institut Pasteur
Paris, 75015
EHPAD Villa Lecourbe
Paris
Hôpital la Pitié Salpetrière
Paris
CHU Poitiers
Poitiers
Hôpital Pontchaillou
Rennes
CHU Saint-Etienne
Saint-Etienne
CHRU de Strasbourg
Strasbourg
CH de Tourcoing
Tourcoing
Hôpital Bretonneau
Tours
About this study
Official title: Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
Read more
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
Read the detailed description
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). This new virus is presented as the causative agent of pneumonias. Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the transition from animal to human occur, the beginning of viral circulation in humans, the period of contagiousness, the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
- Conditions
- SARS (Severe Acute Respiratory Syndrome), COVID-19
- Being tested
- Human Biological samples
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Biological samplesOther
Blood samples for serological tests
Human Biological samplesOther
Blood samples, saliva, nasopharyngeal swab for serological tests
| Study group | Role | What they receive |
|---|---|---|
| CORSER-1a | Subjects who had been to China in the weeks before the outbreak began Receives: Other: Human Biological samples | |
| CORSER-1b | Subject who had a clinical profile compatible with an SARS-CoV-2 infection between August 1, 2019 and February 29, 2020 Receives: Other: Human Biological samples | |
| CORSER-2a | Subjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens Receives: Other: Human Biological samples | |
| CORSER-2b | Contacts or co-exposures of confirmed CoV-2-SARS infection cases, or who have worked or stayed in a hospital where confirmed CoV-2-SARS infection has been managed Receives: Other: Human Biological samples | |
| CORSER-2c | Subjects who have been exposed to a risk of infection with SARS-CoV-2 in a geographical area of SARS-CoV-2 circulation.
* study among pupils, their parents and siblings, as well as teachers and non-teaching staff of a high-school located in Oise
* study among pupils from 5 to 12 and their parents in elementary schools located in Oise
* study among choir members Receives: Other: Human Biological samples | |
| CORSER-2d | Staff of health care institutions Receives: Other: Human Biological samples | |
| CORSER-2e | Subjects in care, hospitalized or residing in health care facilities Receives: Other: Human Biological samples | |
| CORSER-3 | Subjects returning from a humanitarian mission that started before 31/01/2020 Receives: Other: Human Biological samples | |
| CORSER-2f | Subjects with two symptomatic episodes of SARS-CoV-2 infection Receives: Other: Human Biological samples | |
| CORSER-4 | Subjects being vaccinated against COVID-19 Receives: Other: Human Biological samples | |
| CORSER-5 | Subjects with acute SARS-CoV-2 infection and uninfected controls Receives: Other: Human Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
Description of the serological status of individuals by different detection tests
Measured: One year
Secondary outcomes (1)
Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies
Proportion of asymptomatic subjects into seropositive population
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start13 Mar 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno HOEN, Pr, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325646
- Sponsor's protocol ID
- 2020-007
- Acronym
- CORSER
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2020
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.
PubMed 35891471Benetos A, Lai TP, Toupance S, Labat C, Verhulst S, Gautier S, Ungeheuer MN, Perret-Guillaume C, Levy D, Susser E, Aviv A. The Nexus Between Telomere Length and Lymphocyte Count in Seniors Hospitalized With COVID-19. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):e97-e101. doi: 10.1093/gerona/glab026.
PubMed 33528568
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
- ClinicalTrials.gov ID
- NCT04325646
- Acronym / sponsor ID
- CORSER / 2020-007
- Conditions
- SARS (Severe Acute Respiratory Syndrome), COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 Mar 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.
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
Detailed description
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). This new virus is presented as the causative agent of pneumonias. Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the transition from animal to human occur, the beginning of viral circulation in humans, the period of contagiousness, the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| CORSER-1a | – | Other: Human Biological samplesSubjects who had been to China in the weeks before the outbreak began |
| CORSER-1b | – | Other: Human Biological samplesSubject who had a clinical profile compatible with an SARS-CoV-2 infection between August 1, 2019 and February 29, 2020 |
| CORSER-2a | – | Other: Human Biological samplesSubjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens |
| CORSER-2b | – | Other: Human Biological samplesContacts or co-exposures of confirmed CoV-2-SARS infection cases, or who have worked or stayed in a hospital where confirmed CoV-2-SARS infection has been managed |
| CORSER-2c | – | Other: Human Biological samplesSubjects who have been exposed to a risk of infection with SARS-CoV-2 in a geographical area of SARS-CoV-2 circulation. * study among pupils, their parents and siblings, as well as teachers and non-teaching staff of a high-school located in Oise * study among pupils from 5 to 12 and their parents in elementary schools located in Oise * study among choir members |
| CORSER-2d | – | Other: Human Biological samplesStaff of health care institutions |
| CORSER-2e | – | Other: Human Biological samplesSubjects in care, hospitalized or residing in health care facilities |
| CORSER-3 | – | Other: Human Biological samplesSubjects returning from a humanitarian mission that started before 31/01/2020 |
| CORSER-2f | – | Other: Human Biological samplesSubjects with two symptomatic episodes of SARS-CoV-2 infection |
| CORSER-4 | – | Other: Human Biological samplesSubjects being vaccinated against COVID-19 |
| CORSER-5 | – | Other: Human Biological samplesSubjects with acute SARS-CoV-2 infection and uninfected controls |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults (≥ 18 years old) at the time of collection (including minors for group 2c) CORSER-1 : subjects who were in China between 08/2019 and 01/2020 and who have not been diagnosed with an SARS-CoV-2 infection; CORSER-2 : Sub-group 2a: suspected SARS-CoV-2 infection with a negative result of RT-PCR virus test on respiratory sample. Sub-group 2b: contact or co-exposure with confirmed cases of SARS-CoV-2-infection. Subgroup 2c: exposed to a risk of infection with SARS-CoV-2 in a geographic area of SARS-CoV-2 circulation. Subgroup 2d : Staff of health care institutions Subgroup 2e : hospitalized or residing in health care facilities Subgroup 2f : Subjects with two symptomatic episodes of SARS-CoV-2- infection CORSER 3 : returning from a humanitarian mission that started before the epidemic circulation of the virus in France CORSER 4 : being vaccinated against COVID-19 CORSER 5 : with acute SARS-CoV-2 infection and controls
Key inclusion criteria (2 listed)
- Affiliated with or benefiting from a Social Security system
- State of health compatible with a blood sample as defined in the protocol
Key exclusion criteria (3 listed)
- Person benefiting from a legal protection measure or unable to express informed consent to participation
- Have had an infectious episode and/or respiratory signs in the 14 days prior to the scheduled visit (CORSER 1 and 2a, 2b)
- Have been in contact with a confirmed case of SARS-CoV-2 infection within 14 days prior to the date of the visit.(CORSER 1 and 2a, 2b)
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 |
|---|---|---|
| Human Biological samplesBlood samples for serological tests | Other | CORSER-1a, CORSER-1b, CORSER-2a, CORSER-2b, CORSER-2c, CORSER-2d, CORSER-2e, CORSER-3 |
| Human Biological samplesBlood samples, saliva, nasopharyngeal swab for serological tests | Other | CORSER-2f, CORSER-4, CORSER-5 |
Primary outcome
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
Time frame: One year
Description of the serological status of individuals by different detection tests
1 secondary outcome
Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies
Time frame: One year
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 7 Jul 2023.
- Derived from this study: PubMed 35891471Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.
- Derived from this study: PubMed 33528568Benetos A, Lai TP, Toupance S, Labat C, Verhulst S, Gautier S, Ungeheuer MN, Perret-Guillaume C, Levy D, Susser E, Aviv A. The Nexus Between Telomere Length and Lymphocyte Count in Seniors Hospitalized With COVID-19. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):e97-e101. doi: 10.1093/gerona/glab026.
- Individual participant dataSharing planned: Undecided
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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.
Bruno HOEN, Pr principal investigator
Institut Pasteur
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS (Severe Acute Respiratory Syndrome) and COVID-19, run by Institut Pasteur at 21 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 2 inclusion and 3 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. (time frame: One year). 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 NCT04325646, which also lists 2 linked publications.
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 7 Jul 2023.