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OpenTrials
Completed

NCT Number: NCT04716907

Thymic Function in Patients With COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, 92200, France

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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

Genetic

DNA extraction from blood samples, PCR and Sequencing

Blood sample

Biological

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

CT Scan

Diagnostic Test

Thymus and lung imaging

Bronchial fibroscopy

Biological

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

Primary outcomes

  1. Genetic Predisposition to severe forms of COVID-19

    Time frame: through study completion, average 1 year

    Test of association between single-nucleotide polymorphisms (SNP) within the TCRA/D region known to influence the level of thymopoiesis (Clave et al., Sci Transl Med., 2018) and CT scan classification of COVID-associated pneumopathy (0=Absent or minor pulmonary parenchymal changes ; 1=Limited ground-glass opacities ; 2=Bilateral ground-glass opacities < 50% of pulmonary parenchyma ; 3=Idem 2, with superimposed inter/intra lobular septal thickening, i.e. 'crazy paving' ; 4=Bilateral ground-glass opacities > 50% of pulmonary parenchyma ; 5=Idem 4, with superimposed 'crazy paving' ; 6=Idem 5, with pulmonary fibrosis).

Secondary outcomes

  1. Genetic Predisposition to thymic enlargement observed during COVID-19 infection

    Time frame: through study completion, average 1 year

    Test of association between single-nucleotide polymorphisms (SNP) within the TCRA/D region known to influence the level of thymopoiesis (Clave et al., Sci Transl Med., 2018) and CT scan classification of thymus aspects (0=Fatty thymus atrophy (the most common in middle aged adults) ; A=Homogeneous non-fatty thymus (common in young adults) or Fat in the thymus area associated with micronodules or Moderate infiltration of the thymus area ; B=Hyperplasia, marked infiltration, micronodules or Hyperplasia with well-defined contours or Nodular hyperplasia without a tumour mass or Pseudo-tumoral mass with well-defined contours).

  2. Genetic Predisposition to enhanced thymic function during COVID-19 infection

    Time frame: through study completion, average 1 year

    Test of association between single-nucleotide polymorphisms (SNP) within the TCRA/D region known to influence the level of thymopoiesis (Clave et al., Sci Transl Med., 2018) and sj/βTREC ratio.

  3. Genetic Predisposition to severity of COVID-19 pathology

    Time frame: through study completion, average 1 year

    Test of association between single-nucleotide polymorphisms (SNP) within the TCRA/D region known to influence the level of thymopoiesis (Clave et al., Sci Transl Med., 2018) and ICU length of stay.

  4. Basal thymic function in COVID patients

    Time frame: through study completion, average 1 year

    Analysis of sj/βTREC ratio during infection and away from infection (> 6 months).

  5. Thymic function in COVID patients

    Time frame: through study completion, average 1 year

    Analysis of sj/βTREC ratio in COVID positive patients and in COVID negative patients

  6. Immune response in COVID patients

    Time frame: through study completion, average 1 year

    Analysis of lymphocytes in COVID positive patients and in COVID negative patients

  7. Immune response in lungs of COVID patients

    Time frame: through study completion, average 1 year

    Analysis of recent thymic emigrants in the bronchoalveolar fluid of COVID positive patients

  8. Inflammatory response in COVID patients

    Time frame: through study completion, average 1 year

    Analysis of serum concentrations of cytokines and chemokines in pg/ml (composite : IFNα, IFNβ, IL-17A, IL17F, IL21, IL22, IL23, IL27, IL29, TSLP, GM-CSF, IL10, IL12p70, IL1β, IL4, IL6, TNFα, VEGF, IL15, IL17E, IL33, IL8, MDC, Mip1α, Mip1β, Mip3α, SDF1), in COVID positive patients and in COVID negative patients

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: COVITHYM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Apr 8, 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.

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