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Trial record 1 of 1 for:    NCT04369066
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COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur (Curie-O-SA)

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ClinicalTrials.gov Identifier: NCT04369066
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE April 28, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2021)
  • Antibodies against the SARS-CoV-2 virus in serum at inclusion [ Time Frame: 1 day ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 1 month [ Time Frame: 1 month ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 3 months [ Time Frame: 3 months ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 6 months [ Time Frame: 6 months ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 12 months [ Time Frame: 12 months ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Antibodies against the SARS-CoV-2 virus in serum at inclusion [ Time Frame: 1 day ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 1 month [ Time Frame: 1 month ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 3 months [ Time Frame: 3 months ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
  • Antibodies against the SARS-CoV-2 virus in serum at 6 months [ Time Frame: 6 months ]
    Detection of antibodies against the SARS-CoV-2 virus with serological tests
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Comparative performance of anti-SARS-CoV-2 antibody detection techniques [ Time Frame: 9 months ]
    Comparative performance of anti-SARS-CoV-2 antibody detection techniques (sensitivity and specificity of serological tests)
  • Prevalence of immune subjects for SARS-CoV-2 [ Time Frame: 3 months ]
    Prevalence of immune subjects for SARS-CoV-2 in a well-defined active healthy population, working at the hospital or not, leading to variable exposure levels
  • Nature and quantity of anti-SARS-CoV-2 antibodies [ Time Frame: 3 months ]
    Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
  • Evolution of the different antibodies against the SARS-CoV-2 virus over time. [ Time Frame: 6 months ]
    The analysis of the evolution of serology results over time will be done by a mixed model taking into account the repeated framework of the data of a subject
  • Prevalence of Anti-covid IgA response in the nasal mucosa [ Time Frame: 6 months ]
    Prevalence of Anti-covid IgA in volonteers RT/PCR+ and/or presence of antibodies at the 95 % threshold and/or COVID symptoms
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Comparative performance of anti-SARS-CoV-2 antibody detection techniques [ Time Frame: 9 months ]
    Comparative performance of anti-SARS-CoV-2 antibody detection techniques (sensitivity and specificity of serological tests)
  • Prevalence of immune subjects for SARS-CoV-2 [ Time Frame: 3 months ]
    Prevalence of immune subjects for SARS-CoV-2 in a well-defined active healthy population, working at the hospital or not, leading to variable exposure levels
  • Nature and quantity of anti-SARS-CoV-2 antibodies [ Time Frame: 3 months ]
    Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
  • Evolution of the different antibodies against the SARS-CoV-2 virus over time. [ Time Frame: 6 months ]
    The analysis of the evolution of serology results over time will be done by a mixed model taking into account the repeated framework of the data of a subject
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
Official Title  ICMJE COVID-19 Study of the Serological Response Against the SARS-CoV-2 Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
Brief Summary

This research proposes to study a large healthy population active for the presence of antibodies directed against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus and this over time.

After verification of the inclusion criteria and information by the coordinating investigative doctor, the volunteers sign a written consent. A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data.

The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0 (day of inclusion), between 6 weeks and 3 months ,6 months and 12 months post-inclusion.

Each blood sample consists of a collection of 5 mL of blood in a dry tube. The serum samples will be extracted and collected prospectively from the blood samples.

The nasopharyngeal swabs will be performed at 3 times: , between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff who have had at least one of the following four criteria on the sample or questionnaire carried out at T0:

  • have had RT-PCR+
  • and/or presence of antibodies at the 95% threshold
  • and/or anosmia/ageusia
  • and/or digestive syndrome with associated respiratory signs. In case of infection between sampling times, if the volunteer meets one of the four criteria above, a nasopharyngeal swab will be performed during the following visits.

The nasopharyngeal swab shall also be proposed to volunteers not meeting the 4 above listed criteria in order to have a control group (about 100 volunteers) for future statistical analyses.

If the volunteers accept, naso-pharyngeal swab shall be performed between 6 weeks and 3 months, 6 months and 12 months after inclusion.

For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples and nasopharyngeal swabs shall be performed.

Those shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.

The blood samplings and nasopharyngeal swabs will be performed at 4 times for Institute Pasteur personnel: at T0 (inclusion day), between 6 weeks and 3 months, at 6 months and 12 months post-inclusion

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection
Intervention  ICMJE
  • Diagnostic Test: Blood samples (collection of 5 mL of blood in a dry tube)

    A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data.

    The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0, between 6 weeks and 3 months ,6 months and 12 months post-inclusion.

    For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples shall be performed, if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.

    The serum samples will be extracted and collected prospectively from the blood samples.

    For each blood sample, a sample number will be assigned by the laboratory management system of the Department of Biology at Institut Curie.

  • Diagnostic Test: Nasopharyngeal swabs

    The nasopharyngeal swabs will be performed between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff with at least one of the following criteria: have had RT-PCR+, and/or presence of antibodies at the 95% threshold, and/or anosmia/ageusia, and/or digestive syndrome with associated respiratory signs.

    The nasopharyngeal swab shall also be proposed to volunteers not meeting the above listed criteria to have a control group (about 100 volunteers).

    For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) infection between 2 sampling times, nasopharyngeal swabs shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.

    The nasopharyngeal swabs will be performed at T0 for Institute Pasteur staff so 4 times in total.

Study Arms  ICMJE Subjects who are not showing active SARS-Cov2 infection
Interventions:
  • Diagnostic Test: Blood samples (collection of 5 mL of blood in a dry tube)
  • Diagnostic Test: Nasopharyngeal swabs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 18, 2021)
1971
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2020)
2500
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Person, adult volunteer outside of any acute infectious episode with SARS-CoV-2* (see paragraph indication), working at the Institute Curie and able to exercise their professional activity on one of the 3 sites of the Institute Curie: Paris, Orsay or Saint Cloud, or on the Campus of the Institute Pasteur.
  2. Person aged 18 or over.
  3. Information and consent of the person to the procedures related to the study (cf. information note / consent).

From November 2020, person having presented at least one of the following criteria since January 2020:

  • A positive diagnostic test for SARS-COV-2 by PCR on a nasopharyngeal sample or antigenic test,
  • A positive SARS-CoV-2 serology,
  • An anosmia or / and an ageusia,
  • A respiratory infection ** associated with digestive signs **

whatever the working methods during confinement * Subjects who are not showing active SARS-CoV-2 infection are considered volunteers at the time of inclusion: people with no clinical signs ** suggestive of SARS-CoV-2 infection at the time of collection or having had an end of symptoms for more than 7 days [1].

** fever, fatigue, cough, shortness of breath, difficulty to breath, loss of taste or smell, headache, body aches, conjunctivitis or cold, digestive problems (vomiting, diarrhea), whether or not the signs led to sick leave, treatment and / or hospitalization [2].

Exclusion Criteria:

  • Declaration by the subject of signs suggestive of Coronavirus Infectious Disease 2019 (COVID-19) infection with SARS-CoV-2 in progress or for which the end of symptoms dates from less than 7 days
  • Inability to submit to study monitoring for geographic, social or psychological reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369066
Other Study ID Numbers  ICMJE IC 2020-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Curie
Study Sponsor  ICMJE Institut Curie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pierre Fumoleau, PhD Institut Curie
PRS Account Institut Curie
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP