Clinical trial NCT04716907: Thymic Function in Patients With COVID-19
Official title: Thymic Function in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Thymic function
Genetic polymorphism
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 50 cases and 50 control subjects

Brief summary: The main clinical manifestation associated with SARS-CoV-2 infection is an influenza-like illness that follows the infection of the respiratory tract. In a few percent of infected people, inflammation of the lungs leads to severe pneumonia that requires hospitalization, in intensive care units for the more severe cases. Despite intensive care, a fatal outcome occurs in 6% and 12% of women and men over 80 years of age hospitalized for severe COVID, respectively.

Factors associated with a higher risk of death in patients with SARS-CoV-2 include age and low circulating lymphocyte counts. Significant lymphopenia is indeed frequently observed in patients with severe COVID-19 and both phenotypic and functional changes in antiviral T cells have been correlated with the severity of COVID-19.

The thymus, the organ that produces T lymphocytes, undergoes progressive physiological involution with age. However, in the elderly, rare cases of thymic hyperplasia are reported in autoimmune diseases or cancers, or are observed in response to deep lymphopenia, whether or not associated with sepsis.

This cohort of patients treated for a SARS-CoV-2 infection could allow to better understand the role of the thymus in this pathology.


Eligibility criteria: Inclusion Criteria:

Cases :

* Patients with confirmed COVID-19 infection
* Hospitalized for COVID-19 infection
* Having signed a written informed consent form
* Affiliation to the social security system

Controls :

* Non-COVID-19 patients
* Hospitalized for other reasons
* Age and sex-matched controls
* Having signed a written informed consent form,
* Affiliation to the social security system

Exclusion Criteria:

* Autoimmune disease
* HIV, Hepatitis B or Hepatitis C
* Pregnant or breastfeeding women
* A mental or linguistic inability to understand the study
* Patient under protection of the adults (guardianship, curators or safeguard of justice)

Primary outcomes:
measure: Genetic Predisposition to severe forms of COVID-19
timeFrame: through study completion, average 1 year
Secondary outcomes:
measure: Genetic Predisposition to thymic enlargement observed during COVID-19 infection
timeFrame: through study completion, average 1 year
measure: Genetic Predisposition to enhanced thymic function during COVID-19 infection
timeFrame: through study completion, average 1 year
measure: Genetic Predisposition to severity of COVID-19 pathology
timeFrame: through study completion, average 1 year
measure: Basal thymic function in COVID patients
timeFrame: through study completion, average 1 year
measure: Thymic function in COVID patients
timeFrame: through study completion, average 1 year
measure: Immune response in COVID patients
timeFrame: through study completion, average 1 year
measure: Immune response in lungs of COVID patients
timeFrame: through study completion, average 1 year
measure: Inflammatory response in COVID patients
timeFrame: through study completion, average 1 year
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
Study officials:
References: