Immune Response and Risk of Serious Infection to SARS-Cov2

NCT04410432 | Completed

• 1 other identifier: GHESQUIERE AOIc 2020
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of circulating Th1 lymphocytes

  Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

  Until the end of the study, about 12 months.

Secondary Outcomes (1)

• Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11

  Until the end of the study, about 12 months.

Study Arms (1)

Patient

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

Biological: Blood sample collection

Interventions

Blood sample collection 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

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for SARS-Cov-2 infection

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• Samson M, Nicolas B, Ciudad M, Greigert H, Guilhem A, Cladiere C, Straub C, Blot M, Piroth L, Rogier T, Devilliers H, Manckoundia P, Ghesquiere T, Francois S, Lakomy D, Audia S, Bonnotte B. T-cell immune response predicts the risk of critical SARS-Cov2 infection in hospitalized COVID-19 patients. Eur J Intern Med. 2022 Aug;102:104-109. doi: 10.1016/j.ejim.2022.06.001. Epub 2022 Jun 3.

  PMID: 35690570 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 1, 2020
• Study Start: September 29, 2020
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

FR (1)