Immune Response and Risk of Serious Infection to SARS-Cov2

NCT ID: NCT04410432

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2021-08-31

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.

Conditions

SARS Cov2, Immune Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

Patient hospitalized with SARS-Cov2 infection proven by virological sampling.

Blood sample collection

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thibault GHESQUIERE

Role: CONTACT

thibault.squiere@chu-dijon.fr

0380293857 ext. +33

Facility Contacts

Thibault GHESQUIERE

Role: primary

thibault.ghesquiere@chu-dijon.fr

0380293857 ext. +33

Other Identifiers

GHESQUIERE AOIc 2020

Identifier Type: -

Identifier Source: org_study_id