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Immune Response and Risk of Serious Infection to SARS-Cov2

Immune Response and Risk of Serious Infection to SARS-Cov2

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04410432
Enrollment
39
Registered
2020-06-01
Start date
2020-09-29
Completion date
2021-01-21
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS Cov2, Immune Response

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.

Interventions

BIOLOGICALBlood 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

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of circulating Th1 lymphocytesUntil the end of the study, about 12 months.Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

Secondary

MeasureTime frameDescription
Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11Until the end of the study, about 12 months.Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026