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 :
Completed
First Posted : February 11, 2021
Last Update Posted : March 20, 2023
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Condition or disease | Intervention/treatment | Phase |
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Covid19 SARS-CoV-2 | Other: Sampling by venipuncture (and eventually by nasopharyngeal swab) | Not Applicable |
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 187 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 |
Actual Primary Completion Date : | March 7, 2022 |
Actual Study Completion Date : | March 7, 2022 |

Arm | Intervention/treatment |
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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.
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Other: Sampling by venipuncture (and eventually by nasopharyngeal swab)
Biological samples :
Associated data :
Blood Fractioning
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- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 6 ]Measurement of activated CD8 (CD38+DR+) in culture
- Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 12 ]Measurement of activated CD8 (CD38+DR+) in culture
- Measurement of activated CD8 (CD38+DR+) in culture [ Time Frame: Month 24 ]Measurement of activated CD8 (CD38+DR+) in culture
- Measurement of activated CD4 in culture [ Time Frame: Month 6 ]Measurement of activated CD4 in culture
- Measurement of activated CD4 in culture [ Time Frame: Month 12 ]Measurement of activated CD4 in culture
- Measurement of activated CD4 in culture [ Time Frame: Month 24 ]Measurement of activated CD4 in culture
- Measurement of activated B lymphocytes in culture [ Time Frame: Month 6 ]Measurement of activated B lymphocytes in culture
- Measurement of activated B lymphocytes in culture [ Time Frame: Month 12 ]Measurement of activated B lymphocytes in culture
- Measurement of activated B lymphocytes in culture [ Time Frame: Month 24 ]Measurement of activated B lymphocytes in culture

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

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
France | |
Centre Hospitalier Régional d'Orléans, France | |
Orléans, France, 45000 |
Principal Investigator: | Thierry PRAZUCK, MD | CHR ORLEANS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 20, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Covid19 SARS-CoV-2 |
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 |