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

Covid19 Clinical Trial

— COVIMMUNITY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04648709
• Other study ID #: 20CH207
• Secondary ID: 2020-A02943-36
• Status: Terminated
• Start date: March 9, 2021
• Est. completion date: December 11, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: December 11, 2023
• Est. primary completion date: September 26, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• ELISPOT
measure of immune response by ELISPOT
• QUANTIFERON
measure of immune response by QUANTIFERON

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell immune response	Characterize T-cell immune response in patient with COVID 19 infection	from baseline to 18 months
Secondary	B cell immune response	Characterize B-cell immune response in patient with COVID 19 infection	from baseline to 18 months
Secondary	Platelet immune response	Characterize platelet immune response in patient with COVID 19 infection	from baseline to 18 months
Secondary	Immune response and chronic forms	Determine 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.	from baseline to 18 months