Immune Response and Risk of Serious Infection to SARS-Cov2

• Conditions: SARS Cov2, Immune Response
• Interventions: Biological: Blood sample collection

• Registration Number: NCT04410432
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Study Start: 2020-09-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Blood sample collection	Patient hospitalized with SARS-Cov2 infection proven by virological sampling.

Primary Outcome Measures

Name	Time	Method
Percentage of circulating Th1 lymphocytes	Until the end of the study, about 12 months.	Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

Secondary Outcome Measures

Name	Time	Method
Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11	Until the end of the study, about 12 months.	Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France