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

Covid19 Clinical Trial

— ABCOVID  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750720
• Other study ID #: CHRO-2020-12
• Status: Completed
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: March 7, 2022

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Régional d'Orléans, France	Orléans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans	Institut Pasteur

Country where clinical trial is conducted

France, 

References & Publications (3)

Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. Erratum In: Euro Surveill. 2020 Apr;25(14): Euro Surveill. 2020 Jul;25(30): Euro Surveill. 2021 Feb;26(5): — View Citation

Fafi-Kremer S, Bruel T, Madec Y, Grant R, Tondeur L, Grzelak L, Staropoli I, Anna F, Souque P, Fernandes-Pellerin S, Jolly N, Renaudat C, Ungeheuer MN, Schmidt-Mutter C, Collongues N, Bolle A, Velay A, Lefebvre N, Mielcarek M, Meyer N, Rey D, Charneau P, Hoen B, De Seze J, Schwartz O, Fontanet A. Serologic responses to SARS-CoV-2 infection among hospital staff with mild disease in eastern France. EBioMedicine. 2020 Sep;59:102915. doi: 10.1016/j.ebiom.2020.102915. Epub 2020 Jul 31. — View Citation

Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 0
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 3
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 6
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 9
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 12
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 15
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 18
Primary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time	Month 24
Secondary	Presence of specific anti-SARS-CoV-2 antibodies	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups	Month 12
Secondary	Presence of specific anti-SARS-CoV-2 antibodies in subgroups	Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups	Month 12
Secondary	Presence of specific anti-SARS-CoV-2 antibodies in subgroups	Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups	Month 24
Secondary	Neutralizing capacity of anti-SARS-CoV-2 antibodies	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	Month 6
Secondary	Neutralizing capacity of anti-SARS-CoV-2 antibodies	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.	Month 12
Secondary	Neutralizing capacity of anti-SARS-CoV-2 antibodies	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.	Month 24
Secondary	Measurement of activated CD8 (CD38+DR+) in culture	Measurement of activated CD8 (CD38+DR+) in culture	Month 6
Secondary	Measurement of activated CD8 (CD38+DR+) in culture	Measurement of activated CD8 (CD38+DR+) in culture	Month 12
Secondary	Measurement of activated CD8 (CD38+DR+) in culture	Measurement of activated CD8 (CD38+DR+) in culture	Month 24
Secondary	Measurement of activated CD4 in culture	Measurement of activated CD4 in culture	Month 6
Secondary	Measurement of activated CD4 in culture	Measurement of activated CD4 in culture	Month 12
Secondary	Measurement of activated CD4 in culture	Measurement of activated CD4 in culture	Month 24
Secondary	Measurement of activated B lymphocytes in culture	Measurement of activated B lymphocytes in culture	Month 6
Secondary	Measurement of activated B lymphocytes in culture	Measurement of activated B lymphocytes in culture	Month 12
Secondary	Measurement of activated B lymphocytes in culture	Measurement of activated B lymphocytes in culture	Month 24