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AzTrials

Covid19ABCOVIDNCT04750720

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

A study testing Sampling by venipuncture (and eventually by nasopharyngeal swab) in people with Covid19 and SARS-CoV-2, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, SARS-CoV-2
What is being tested?
Sampling by venipuncture (and eventually by nasopharyngeal swab)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteFrance
Study dates
27 Aug 2020to 7 Mar 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Orléans

    Orléans, 45067

Other trials in France

About this study

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.

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.

Read the 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).

Conditions
Covid19, SARS-CoV-2
Being tested
Sampling by venipuncture (and eventually by nasopharyngeal swab)
Keywords
Covid19, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT04750720
Study groupRoleWhat they receive
Group with biological samplesExperimentalCollection 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.
Receives: Other: Sampling by venipuncture (and eventually by nasopharyngeal swab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Month 0

  2. 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

    Measured: Month 3

  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

    Measured: Month 6

  4. 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

    Measured: Month 9

  5. 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

    Measured: Month 12

  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

    Measured: Month 15

  7. 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

    Measured: Month 18

  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

    Measured: Month 24

Secondary outcomes (15)
  1. Presence of specific anti-SARS-CoV-2 antibodies

    Presence of specific anti-SARS-CoV-2 antibodies in the different study groups

    Measured: Month 12

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

    Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups

    Measured: Month 12

  3. Presence of specific anti-SARS-CoV-2 antibodies in subgroups

    Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups

    Measured: Month 24

  4. 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

    Measured: Month 6

  5. 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.

    Measured: Month 12

  6. 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.

    Measured: Month 24

  7. Measurement of activated CD8 (CD38+DR+) in culture

    Measurement of activated CD8 (CD38+DR+) in culture

    Measured: Month 6

  8. Measurement of activated CD8 (CD38+DR+) in culture

    Measurement of activated CD8 (CD38+DR+) in culture

    Measured: Month 12

  9. Measurement of activated CD8 (CD38+DR+) in culture

    Measurement of activated CD8 (CD38+DR+) in culture

    Measured: Month 24

  10. Measurement of activated CD4 in culture

    Measurement of activated CD4 in culture

    Measured: Month 6

  11. Measurement of activated CD4 in culture

    Measurement of activated CD4 in culture

    Measured: Month 12

  12. Measurement of activated CD4 in culture

    Measurement of activated CD4 in culture

    Measured: Month 24

  13. Measurement of activated B lymphocytes in culture

    Measurement of activated B lymphocytes in culture

    Measured: Month 6

  14. Measurement of activated B lymphocytes in culture

    Measurement of activated B lymphocytes in culture

    Measured: Month 12

  15. Measurement of activated B lymphocytes in culture

    Measurement of activated B lymphocytes in culture

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start27 Aug 2020
  3. Primary completion7 Mar 2022
  4. Study completion7 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750720
Sponsor's protocol ID
CHRO-2020-12
Acronym
ABCOVID
Status last verified
Dec 2025
First submitted
9 Feb 2021
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31992387
  • 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.

    PubMed 32113704
  • 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.

    PubMed 32747185
  • 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.

    PubMed 38088562
  • 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.

    PubMed 37549192
  • 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.

    PubMed 35891471

Questions about this trial

What is this clinical trial studying?

A study testing Sampling by venipuncture (and eventually by nasopharyngeal swab) in people with Covid19 and SARS-CoV-2, run by Centre Hospitalier Régional d'Orléans 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 6 inclusion and 3 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 30 Dec 2025. 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?

Presence of specific anti-SARS-CoV-2 antibodies (time frame: Month 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04750720, which also lists 6 linked publications.

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 30 Dec 2025.

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