Immune Response and Risk of Serious Infection to SARS-Cov2

January 15, 2021 updated by: Centre Hospitalier Universitaire Dijon

To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for SARS-Cov-2 infection

Description

Inclusion Criteria:

  • Person having given his or her non-opposition
  • Patient hospitalized with an SARS-Cov2 infection proven by virological sampling (nasopharyngeal or sputum PCR) less than 8 days old.

Exclusion Criteria:

  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a safeguard measure of justice
  • Pregnant, parturient or breastfeeding woman
  • Major incapable or incapable of giving consent
  • Minor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Patient hospitalized with SARS-Cov2 infection proven by virological sampling.
Biological: Blood sample collection

Additional blood volumes taken during a routine care blood test:

  • 1 dry tube 5 mL for isolation and freezing of serum
  • 1 x 5 mL EDTA tube to isolate and freeze plasma
  • 8 heparinized 6 mL tubes for flow cytometry study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of circulating Th1 lymphocytes
Time Frame: Until the end of the study, about 12 months.
Flow cytometry measurement of the percentage of circulating Th1 lymphocytes
Until the end of the study, about 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11
Time Frame: Until the end of the study, about 12 months.
Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11
Until the end of the study, about 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 29, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (ACTUAL)

June 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHESQUIERE AOIc 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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