Thymic Function in Patients With COVID-19

NCT ID: NCT04716907

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case : COVID-19 positive patients

patients hospitalized for COVID-19 infection

Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region

Intervention Type GENETIC

DNA extraction from blood samples, PCR and Sequencing

Blood sample

Intervention Type BIOLOGICAL

Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.

CT Scan

Intervention Type DIAGNOSTIC_TEST

Thymus and lung imaging

Bronchial fibroscopy

Intervention Type BIOLOGICAL

Bronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs

Control : COVID-19 negative patients

patients hospitalized for other reasons

Blood sample

Intervention Type BIOLOGICAL

Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.

CT Scan

Intervention Type DIAGNOSTIC_TEST

Thymus and lung imaging

Interventions

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Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region

DNA extraction from blood samples, PCR and Sequencing

Intervention Type GENETIC

Blood sample

Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.

Intervention Type BIOLOGICAL

CT Scan

Thymus and lung imaging

Intervention Type DIAGNOSTIC_TEST

Bronchial fibroscopy

Bronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMC Ambroise Paré

Neuilly-sur-Seine, , France

Site Status

Countries

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France

Other Identifiers

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2020/06

Identifier Type: -

Identifier Source: org_study_id

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