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Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection (ABCOVID)

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ClinicalTrials.gov Identifier: NCT04750720
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : March 17, 2022
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:
The main objective of the study is to describe the temporal curve of COVID-19 IgG and neutralizing antibodies over 24 months in an identified population of patients who presented with SARS-CoV-2 virus infection. The secondary objectives are to characterize the kinetics of the antibodies according to the severity of the clinical presentation and patient's characteristics and to determine if the anti-SARS-CoV-2 antibodies retain their neutralizing capacity over time. A sub-study aims to describe the kinetic of neutralizing antibodies (in blood and nasal mucosa) after vaccination.

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV-2 Other: Sampling by venipuncture (and eventually by nasopharyngeal swab) Not Applicable

Detailed Description:

Given the seriousness of the global health consequences of the COVID-19 pandemic and the difficulty of covering the world population with effective vaccination, several questions arise:

  • Are the antibodies made by a patient neutralizing and do they protect the individual from further contamination?
  • What is the persistence of the antibodies over time according to the clinical presentation, knowing that the very symptomatic forms have developed a much higher level of antibodies than the forms followed only on an outpatient basis and no less severe?
  • What is the impact of vaccination (against wild-type virus and emerging variants) ? The investigators propose a single-center, observational study including 300 patients to answer the two questions, by selecting from the file of all the patients having had a positive RT-PCR 3 distinct groups: severe (hospitalized), pauci-symptomatic to moderate (followed in ambulatory only). Note: people living with HIV can be included in each of the groups.

MAIN EVALUATION

> Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at M24 at each of the sampling times (M0, M3, M6, M9, M12, M15, M18, M24)

SECONDARY EVALUATION CRITERIA

  • Presence of specific anti-SARS-CoV-2 antibodies in the different groups of the study at M12 and in each of the subgroups at M12 and M24
  • Neutralizing capacity of anti-SARS-CoV-2 antibodies to M6, M12 and M24 on the classical strain and the new variants, before and after a possible vaccination against COVID-19
  • Measurement of CD8 (CD38 + DR +), CD4 and activated B lymphocytes in culture This will make it possible to answer the question of the persistence or not of an immune response over 24 months, an essential element in the event of seasonal circulation of the virus in the years to come, and of the persistence or not of the neutralizing capacities of these antibodies in the over time, especially when the title approaches the detection threshold.

These information will be decisive in the event of successive waves of the SARS-CoV-2 epidemic given a low level of collective immunity (<10% in France at the end of 2020) in order to know whether previously affected patients are durably protected.

In the context of a lack of vaccine, results from this study would make it possible to select candidates for vaccination from the truly non-immune population.

Vaccine sub-study :

Study of the kinetic of neutralizing antibodies after vaccination :

Volunteers participants, provided they give a special agreement for the vaccine sub-study, will undergo an additional grid of samples to accurately study the kinetic of neutralizing antibodies before and monthly after (up to 6 months) receiving anti-SARS-CoV-2 vaccine (whatever the product used). A special attention will be given to the capacity of their antibodies to neutralize emerging variants. Samples will include blood and possibly nasopharyngeal swabs (not mandatory).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Collection of biological samples (M0, M3, M6, M9, M12, M15, M18, M24) with associated data for the study of the kinetics of antibodies anti COVID-19 in subjects with documented SARS-CoV-2 infection (PCR and/or positive specific serology)
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection According to the Clinical Severity of the Infection.
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group with biological samples
Collection of biological samples (M0, M3, M6, M9, M12, M15, M18, M24) with associated data for the study of the kinetics of antibodies anti COVID-19 in subjects with documented SARS-CoV-2 infection (PCR and/or positive specific serology). In the vaccine sub-study: additional blood and nasopharyngeal samples before and after vaccination, up to 6 months.
Other: Sampling by venipuncture (and eventually by nasopharyngeal swab)

Biological samples :

  • Serum and plasma from each donor for the purpose of performing (if applicable) the SARS-CoV-2 serologic test
  • PBMC (peripheral blood mononuclear cells)
  • Nasopharyngeal samples (not mandatory)

Associated data :

  • Demographic data
  • Description of clinical manifestations related to SARS-CoV-2 infection
  • Notion of hospitalization/ambulatory follow-up

Blood Fractioning

  • Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
  • Separation of PBMC on Lymphoprep and freezing in liquid nitrogen for subsequent analysis of immune system cells




Primary Outcome Measures :
  1. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 0 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  2. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 3 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  3. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 6 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  4. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 9 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  5. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 12 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  6. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 15 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  7. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 18 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time

  8. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 24 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time


Secondary Outcome Measures :
  1. Presence of specific anti-SARS-CoV-2 antibodies [ Time Frame: Month 12 ]
    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups

  2. Presence of specific anti-SARS-CoV-2 antibodies in subgroups [ Time Frame: Month 12 ]
    Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups

  3. Presence of specific anti-SARS-CoV-2 antibodies in subgroups [ Time Frame: Month 24 ]
    Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups

  4. Neutralizing capacity of anti-SARS-CoV-2 antibodies [ Time Frame: Month 6 ]
    Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19

  5. Neutralizing capacity of anti-SARS-CoV-2 antibodies [ Time Frame: Month 12 ]
    Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19.

  6. Neutralizing capacity of anti-SARS-CoV-2 antibodies [ Time Frame: Month 24 ]
    Neutralizing capacity of anti-SARS-CoV-2 antibodies on the classical strain and the new variants, before and after a possible vaccination against COVID-19.

  7. Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 6 ]
    Measurement of activated CD8 (CD38+DR+) in culture

  8. Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 12 ]
    Measurement of activated CD8 (CD38+DR+) in culture

  9. Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 24 ]
    Measurement of activated CD8 (CD38+DR+) in culture

  10. Measurement of activated CD4 in culture [ Time Frame: Month 6 ]
    Measurement of activated CD4 in culture

  11. Measurement of activated CD4 in culture [ Time Frame: Month 12 ]
    Measurement of activated CD4 in culture

  12. Measurement of activated CD4 in culture [ Time Frame: Month 24 ]
    Measurement of activated CD4 in culture

  13. Measurement of activated B lymphocytes in culture [ Time Frame: Month 6 ]
    Measurement of activated B lymphocytes in culture

  14. Measurement of activated B lymphocytes in culture [ Time Frame: Month 12 ]
    Measurement of activated B lymphocytes in culture

  15. Measurement of activated B lymphocytes in culture [ Time Frame: Month 24 ]
    Measurement of activated B lymphocytes in culture



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Having had a confirmed infection with CoV-2-SARS by RT-PCR and/or serology (IgM and/or IgG specific as significant)
  • Being vaccinated against anti-SARS-CoV-2 (vaccine sub-study)
  • Benefiting from a Social Security system
  • Having consented to participate in the study
  • Accepting regular follow-up for 24 months

Exclusion Criteria:

  • Protected person (under guardianship or trusteeship)
  • Person under the protection of justice
  • Person unable to express consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750720


Contacts
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Contact: Aurélie DESPUJOLS +33238744071 aurelie.despujols@chr-orleans.fr
Contact: Elodie POUGOUE TOUKO +33238744086 elodie.pougoue-touko@chr-orleans.fr

Locations
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France
Centre Hospitalier Régional d'Orléans, France Recruiting
Orléans, France, 45000
Contact: Thierry PRAZUCK, MD       thierry.prazuck@chr-orleans.fr   
Principal Investigator: Thierry PRAZUCK, MD         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Institut Pasteur
Investigators
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Principal Investigator: Thierry PRAZUCK, MD CHR ORLEANS
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04750720    
Other Study ID Numbers: CHRO-2020-12
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Covid19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases