Covid19COVITHYMNCT04716907
Thymic Function in Patients With COVID-19
An observational study of Covid19, run by CMC Ambroise Paré at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region, Blood sample and CT Scan
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2021to 2 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 cases and 50 control subjects
Who may be able to join
- 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 :
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Covid19
- Being tested
- Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region, Blood sample, CT Scan, Bronchial fibroscopy
- Keywords
- Covid19, Thymic function, Genetic polymorphism
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Nucleotide Polymorphisms (SNP) within the TCRA/D regionGenetic
DNA extraction from blood samples, PCR and Sequencing
Blood sampleBiological
Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.
CT ScanDiagnostic test
Thymus and lung imaging
Bronchial fibroscopyBiological
Bronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs
| Study group | Role | What they receive |
|---|---|---|
| Case : COVID-19 positive patients | patients hospitalized for COVID-19 infection Receives: Genetic: Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region; Biological: Blood sample; Diagnostic Test: CT Scan; Biological: Bronchial fibroscopy | |
| Control : COVID-19 negative patients | patients hospitalized for other reasons Receives: Biological: Blood sample; Diagnostic Test: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, average 1 year
Secondary outcomes (8)
Genetic Predisposition to thymic enlargement observed during COVID-19 infection
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).
Measured: through study completion, average 1 year
Genetic Predisposition to enhanced thymic function during COVID-19 infection
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.
Measured: through study completion, average 1 year
Genetic Predisposition to severity of COVID-19 pathology
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.
Measured: through study completion, average 1 year
Basal thymic function in COVID patients
Analysis of sj/βTREC ratio during infection and away from infection (> 6 months).
Measured: through study completion, average 1 year
Thymic function in COVID patients
Analysis of sj/βTREC ratio in COVID positive patients and in COVID negative patients
Measured: through study completion, average 1 year
Immune response in COVID patients
Analysis of lymphocytes in COVID positive patients and in COVID negative patients
Measured: through study completion, average 1 year
Immune response in lungs of COVID patients
Analysis of recent thymic emigrants in the bronchoalveolar fluid of COVID positive patients
Measured: through study completion, average 1 year
Inflammatory response in COVID patients
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
Measured: through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start19 Mar 2021
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716907
- Sponsor's protocol ID
- 2020/06
- Acronym
- COVITHYM
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37738336
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymic Function in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04716907
- Acronym / sponsor ID
- COVITHYM / 2020/06
- Conditions
- Covid19
- Keywords
- Covid19, Thymic function, Genetic polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case : COVID-19 positive patients | – | Genetic: Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region, Biological: Blood sample, Diagnostic Test: CT Scan, Biological: Bronchial fibroscopypatients hospitalized for COVID-19 infection |
| Control : COVID-19 negative patients | – | Biological: Blood sample, Diagnostic Test: CT Scanpatients hospitalized for other reasons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 cases and 50 control subjects
Key inclusion criteria (11 listed)
- Patients with confirmed COVID-19 infection
- Hospitalized for COVID-19 infection
- Having signed a written informed consent form
- Affiliation to the social security system
- Non-COVID-19 patients
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Nucleotide Polymorphisms (SNP) within the TCRA/D regionDNA extraction from blood samples, PCR and Sequencing | Genetic | Case : COVID-19 positive patients |
| Blood sampleDosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines. | Biological | Case : COVID-19 positive patients, Control : COVID-19 negative patients |
| CT ScanThymus and lung imaging | Diagnostic test | Case : COVID-19 positive patients, Control : COVID-19 negative patients |
| Bronchial fibroscopyBronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs | Biological | Case : COVID-19 positive patients |
Primary outcome
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).
8 secondary outcomes
Genetic Predisposition to thymic enlargement observed during COVID-19 infection
Time frame: through study completion, average 1 year
Genetic Predisposition to enhanced thymic function during COVID-19 infection
Time frame: through study completion, average 1 year
Genetic Predisposition to severity of COVID-19 pathology
Time frame: through study completion, average 1 year
Basal thymic function in COVID patients
Time frame: through study completion, average 1 year
Thymic function in COVID patients
Time frame: through study completion, average 1 year
Immune response in COVID patients
Time frame: through study completion, average 1 year
Immune response in lungs of COVID patients
Time frame: through study completion, average 1 year
Inflammatory response in COVID patients
Time frame: through study completion, average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 37738336Roux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Predisposition to severe forms of COVID-19 (time frame: through study completion, average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.