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Clinical Trials/NCT04648709
NCT04648709
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country73 target enrollmentMarch 9, 2021
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
73
Locations
1
Primary Endpoint
T cell immune response
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
December 11, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

T cell immune response

Time Frame: from baseline to 18 months

Characterize T-cell immune response in patient with COVID 19 infection

Secondary Outcomes

  • B cell immune response(from baseline to 18 months)
  • Immune response and chronic forms(from baseline to 18 months)
  • Platelet immune response(from baseline to 18 months)

Study Sites (1)

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