SARS Cov2, Immune Response Clinical Trial
Official title:
Immune Response and Risk of Serious Infection to SARS-Cov2
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.
| Status | Recruiting |
| Enrollment | 63 |
| Est. completion date | August 2021 |
| Est. primary completion date | August 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Dijon Bourogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Serum IFN concentrations-?, CXCL9, CXCL10, CXCL11 | Immunofluorimetric measurement of serum concentrations of IFN-?, CXCL9, CXCL10, CXCL11 | Until the end of the study, about 12 months. |