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

Terminated

• Conditions: Covid19

• Registration Number: NCT04648709
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-01
• Study Start: 2021-03-09
• Primary Completion: 2022-09-26
• Status Verified: 2023-02
• Study Completion: 2023-12-11
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T cell immune response	from baseline to 18 months	Characterize T-cell immune response in patient with COVID 19 infection

Secondary Outcome Measures

Name	Time	Method
B cell immune response	from baseline to 18 months	Characterize B-cell immune response in patient with COVID 19 infection
Immune response and chronic forms	from baseline to 18 months	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.
Platelet immune response	from baseline to 18 months	Characterize platelet immune response in patient with COVID 19 infection

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France