Sars-CoV2IMMUNO-COVIDNCT04408001
Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff
An observational study of Sars-CoV2, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Clinical interview, Blood collection and Saliva collection
- How many people
- 499 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2020to 15 Mar 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Percy hospital staff having (symptomatic individuals group) or not (asymptomatic individuals group) presented COVID-19 infection symptoms.
Who may be able to join
- 18 years of age or older;
- Military or civilian or contactual volunteer on duty at Percy hospital during the COVID-19 pandemic.
Who cannot join
- Individuals who have displayed a severe form of early-onset COVID-19 who required intensive care management or hospitalization;
- Presence of factors modulating immunity with congenital or acquired immunosuppression:
- Medication: cancer chemotherapy, immunosuppressive drugs, biotherapy, corticosteroids
- Uncontrolled HIV infection or CD4 <200/mm3 infection
- History of solid organ or hematopoietic stem cell transplants
Trial locations and contacts
1 site in 1 country.
About this study
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.
A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.
Read more
Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.
Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.
The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
- Conditions
- Sars-CoV2
- Being tested
- Clinical interview, Blood collection, Saliva collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical interviewOther
At each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19.
Blood collectionBiological
At each study visit,
- 1 EDTA tube for complete blood count
- 3 dry tubes with gel for serology, serum neutralisation test and serum library
- 1 cell preparation tube for the separation of immune cells within the circulating blood will be collected.
Saliva collectionBiological
At each study visit, a saliva sample will be collected for the determination of IgA antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic individuals | Hospital staff identified by the COVID-19 case census cell :
* who have been infected (confirmed by a positive RT-PCR result on a nasopharyngeal swab)
* OR who have displayed clinical signs compatible with COVID-19 despite a negative RT-PCR result. Receives: Other: Clinical interview; Biological: Blood collection; Biological: Saliva collection | |
| Asymptomatic individuals | Hospital staff who have not been identified by the COVID-19 case census cell. Receives: Other: Clinical interview; Biological: Blood collection; Biological: Saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induced SARS-CoV2 immunity
The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.
Measured: At day 21 (compared to enrollment [Day 0])
Long-term protection of induced SARS-CoV2 immunity at 6 months
The presence of induced immunity will be identified on serology analysis at 6 months.
Measured: 6 months following enrollment
Long-term protection of induced SARS-CoV2 immunity at 1 year
The presence of induced immunity will be identified on serology analysis at 1 year.
Measured: 1 year following enrollment
Anti-SARS-CoV2 antibodies kinetics in blood throughout the study
Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement
Measured: From enrollment (Day 0) to 1 year after enrollement
Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study
Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement
Measured: From enrollment (Day 0) to 1 year after enrollement
Kinetics of serum neutralization in blood throughout the study
Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.
Measured: From enrollment (Day 0) to 1 year after enrollement
Secondary outcomes (2)
Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0
Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 0.
Measured: At enrollment (Day 0)
Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21
Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 21.
Measured: At Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start4 Jun 2020
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- 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
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408001
- Sponsor's protocol ID
- 2020-COVID19-04
- Other IDs
- 2020-A01019-30
- Acronym
- IMMUNO-COVID
- Status last verified
- Apr 2023
- First submitted
- 28 May 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff
- ClinicalTrials.gov ID
- NCT04408001
- Acronym / sponsor ID
- IMMUNO-COVID / 2020-COVID19-04
- Conditions
- Sars-CoV2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 29 May 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.
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.
A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.
Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.
Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.
The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic individuals | – | Other: Clinical interview, Biological: Blood collection, Biological: Saliva collectionHospital staff identified by the COVID-19 case census cell : * who have been infected (confirmed by a positive RT-PCR result on a nasopharyngeal swab) * OR who have displayed clinical signs compatible with COVID-19 despite a negative RT-PCR result. |
| Asymptomatic individuals | – | Other: Clinical interview, Biological: Blood collection, Biological: Saliva collectionHospital staff who have not been identified by the COVID-19 case census cell. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Percy hospital staff having (symptomatic individuals group) or not (asymptomatic individuals group) presented COVID-19 infection symptoms.
Key inclusion criteria (2 listed)
- 18 years of age or older;
- Military or civilian or contactual volunteer on duty at Percy hospital during the COVID-19 pandemic.
Key exclusion criteria (5 listed)
- Individuals who have displayed a severe form of early-onset COVID-19 who required intensive care management or hospitalization;
- Presence of factors modulating immunity with congenital or acquired immunosuppression:
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 |
|---|---|---|
| Clinical interviewAt each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19. | Other | Asymptomatic individuals, Symptomatic individuals |
| Blood collectionAt each study visit, * 1 EDTA tube for complete blood count * 3 dry tubes with gel for serology, serum neutralisation test and serum library * 1 cell preparation tube for the separation of immune cells within the circulating blood will be collected. | Biological | Asymptomatic individuals, Symptomatic individuals |
| Saliva collectionAt each study visit, a saliva sample will be collected for the determination of IgA antibodies. | Biological | Asymptomatic individuals, Symptomatic individuals |
Primary outcome
Induced SARS-CoV2 immunity
Time frame: At day 21 (compared to enrollment [Day 0])
The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.
Long-term protection of induced SARS-CoV2 immunity at 6 months
Time frame: 6 months following enrollment
The presence of induced immunity will be identified on serology analysis at 6 months.
Long-term protection of induced SARS-CoV2 immunity at 1 year
Time frame: 1 year following enrollment
The presence of induced immunity will be identified on serology analysis at 1 year.
Anti-SARS-CoV2 antibodies kinetics in blood throughout the study
Time frame: From enrollment (Day 0) to 1 year after enrollement
Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement
Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study
Time frame: From enrollment (Day 0) to 1 year after enrollement
Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement
Kinetics of serum neutralization in blood throughout the study
Time frame: From enrollment (Day 0) to 1 year after enrollement
Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.
2 secondary outcomes
Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0
Time frame: At enrollment (Day 0)
Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21
Time frame: At Day 21
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 28 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2, run by Direction Centrale du Service de Santé des Armées at 1 site 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 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Induced SARS-CoV2 immunity (time frame: At day 21 (compared to enrollment [Day 0])). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2023.