Skip to content

Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19

Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04648709
Acronym
COVIMMUNITY
Enrollment
73
Registered
2020-12-01
Start date
2021-03-09
Completion date
2023-12-11
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

T cells, B cells, immune response, SARS-CoV-2

Brief summary

Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection. To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.

Interventions

DIAGNOSTIC_TESTELISPOT

measure of immune response by ELISPOT

DIAGNOSTIC_TESTQUANTIFERON

measure of immune response by QUANTIFERON

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Social security affiliation * Signed informed consent * Patients with COVID infection documented by PCR and/or antigenic testing * Patients belonging to the following groups: * asymptomatic patients with PCR-positive PCR * patients with mild symptoms and PCR positive * seriously symptomatic patients with PCR positive * patients in resuscitation with positive PCR * Healthy individuals as controls

Exclusion criteria

* haemoglobin \< 8g/dL * Pregnancy, breastfeeding woman * Patient vaccinated within 15 days prior to inclusion

Design outcomes

Primary

MeasureTime frameDescription
T cell immune responsefrom baseline to 18 monthsCharacterize T-cell immune response in patient with COVID 19 infection

Secondary

MeasureTime frameDescription
B cell immune responsefrom baseline to 18 monthsCharacterize B-cell immune response in patient with COVID 19 infection
Platelet immune responsefrom baseline to 18 monthsCharacterize platelet immune response in patient with COVID 19 infection
Immune response and chronic formsfrom baseline to 18 monthsDetermine if there is a correlation between the pattern of immune response and the risk of reinfection or with persistence of symptoms in chronic forms of COVID-19.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026