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OpenTrials
Completed

NCT Number: NCT04410432

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of circulating Th1 lymphocytes

    Time frame: Until the end of the study, about 12 months.

    Flow cytometry measurement of the percentage of circulating Th1 lymphocytes

Secondary outcomes

  1. Serum IFN concentrations-γ, CXCL9, CXCL10, CXCL11

    Time frame: Until the end of the study, about 12 months.

    Immunofluorimetric measurement of serum concentrations of IFN-γ, CXCL9, CXCL10, CXCL11

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.