Thymic Function in Patients With COVID-19
COVITHYM
1 other identifier
observational
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedStudy Start
First participant enrolled
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2022
CompletedApril 8, 2026
April 1, 2026
1 year
January 16, 2021
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genetic Predisposition to severe forms of COVID-19
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).
through study completion, average 1 year
Secondary Outcomes (8)
Genetic Predisposition to thymic enlargement observed during COVID-19 infection
through study completion, average 1 year
Genetic Predisposition to enhanced thymic function during COVID-19 infection
through study completion, average 1 year
Genetic Predisposition to severity of COVID-19 pathology
through study completion, average 1 year
Basal thymic function in COVID patients
through study completion, average 1 year
Thymic function in COVID patients
through study completion, average 1 year
- +3 more secondary outcomes
Study Arms (2)
Case : COVID-19 positive patients
patients hospitalized for COVID-19 infection
Control : COVID-19 negative patients
patients hospitalized for other reasons
Interventions
Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.
Thymus and lung imaging
Bronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs
DNA extraction from blood samples, PCR and Sequencing
Eligibility Criteria
A total of 50 cases and 50 control subjects
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMC Ambroise Paré
Neuilly-sur-Seine, 92200, France
Related Publications (1)
Roux HM, Marouf A, Dutrieux J, Charmeteau-De Muylder B, Figueiredo-Morgado S, Avettand-Fenoel V, Cuvelier P, Naudin C, Bouaziz F, Geri G, Couedel-Courteille A, Squara P, Marullo S, Cheynier R. Genetically determined thymic function affects strength and duration of immune response in COVID patients with pneumonia. Sci Adv. 2023 Sep 22;9(38):eadh7969. doi: 10.1126/sciadv.adh7969. Epub 2023 Sep 22.
PMID: 37738336RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2021
First Posted
January 20, 2021
Study Start
March 19, 2021
Primary Completion
April 2, 2022
Study Completion
April 2, 2022
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share