CHU Orléans
Orléans, 45067, France
NCT Number: NCT04750720
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Orléans, 45067, France
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:
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
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biological samples :
Associated data :
Blood Fractioning
Time frame: Month 0
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 3
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 6
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 9
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 12
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 15
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 18
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 24
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
Time frame: Month 12
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups
Time frame: Month 12
Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups
Time frame: Month 24
Presence of specific anti-SARS-CoV-2 antibodies in each of the subgroups
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
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.
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.
Time frame: Month 6
Measurement of activated CD8 (CD38+DR+) in culture
Time frame: Month 12
Measurement of activated CD8 (CD38+DR+) in culture
Time frame: Month 24
Measurement of activated CD8 (CD38+DR+) in culture
Time frame: Month 6
Measurement of activated CD4 in culture
Time frame: Month 12
Measurement of activated CD4 in culture
Time frame: Month 24
Measurement of activated CD4 in culture
Time frame: Month 6
Measurement of activated B lymphocytes in culture
Time frame: Month 12
Measurement of activated B lymphocytes in culture
Time frame: Month 24
Measurement of activated B lymphocytes in culture
Centre Hospitalier Régional d'Orléans
Other
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.
Acronym: ABCOVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04703114
COVID-19, Coronaviridae Infections
Paris, Île-de-France Region, France
View Trial DetailsNCT04466982
Anosmia, COVID-19
Cambridge, United Kingdom
View Trial DetailsNCT04913948
COVID-19, Corona Virus Infection
Hamilton, Ontario, Canada
View Trial DetailsNCT04652102
COVID-19, Coronaviridae Infections
Buenos Aires, Argentina
View Trial Details