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

NCT04750720 | Completed

• 1 other identifier: CHRO-2020-12
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV-2

Keywords

Covid19; SARS-CoV-2

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (15)

• Presence of specific anti-SARS-CoV-2 antibodies

  Month 12

• Presence of specific anti-SARS-CoV-2 antibodies in subgroups

  Month 12

• Presence of specific anti-SARS-CoV-2 antibodies in subgroups

  Month 24

• Neutralizing capacity of anti-SARS-CoV-2 antibodies

  Month 6

• Neutralizing capacity of anti-SARS-CoV-2 antibodies

  Month 12

Study Arms (1)

Group with biological samples

EXPERIMENTAL

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)

Interventions

Sampling by venipuncture (and eventually by nasopharyngeal swab) OTHER

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

Group with biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead
• Institut Pasteur: collaborator

Study Sites (1)

CHU Orléans

Orléans, 45067, France

Location

Related Publications (6)

• 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.

  PMID: 31992387 BACKGROUND

• 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.

  PMID: 32113704 BACKGROUND

• 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.

  PMID: 32747185 BACKGROUND

• Bolland W, Michel V, Planas D, Hubert M, Staropoli I, Guivel-Benhassine F, Porrot F, N'Debi M, Rodriguez C, Fourati S, Prot M, Planchais C, Hocqueloux L, Simon-Loriere E, Mouquet H, Prazuck T, Pawlotsky J-M, Bruel T, Schwartz O, Buchrieser J. High fusion and cytopathy of SARS-CoV-2 variant B.1.640.1. J Virol. 2024 Jan 23;98(1):e0135123. doi: 10.1128/jvi.01351-23. Epub 2023 Dec 13.

  PMID: 38088562 DERIVED

• Clairon Q, Prague M, Planas D, Bruel T, Hocqueloux L, Prazuck T, Schwartz O, Thiebaut R, Guedj J. Modeling the kinetics of the neutralizing antibody response against SARS-CoV-2 variants after several administrations of Bnt162b2. PLoS Comput Biol. 2023 Aug 7;19(8):e1011282. doi: 10.1371/journal.pcbi.1011282. eCollection 2023 Aug.

  PMID: 37549192 DERIVED

• 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.

  PMID: 35891471 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thierry PRAZUCK, MD

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 11, 2021
• Study Start: August 27, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)