Covid19SEQ-COV-PHYSIONCT04563676
Physiopathology and Sequelae of COVID-19 Infection
A study testing blood test in people with Covid19 and TSH, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- blood test
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- patient having a covid19 infection hospitalized at the Amiens Picardie University Hospital
- Patient who is seen in Pneumology consultation for a respiratory assessment at 3 months of his hospitalization (between M2 and M4) to evaluate presence of respiratory sequelae
- Patient who agreed to participate in the protocol
- Patient affiliated to a Social Security
Who cannot join
- patient under guardianship or curators
- patient refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration.
The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19
- Being tested
- blood test
- Keywords
- Covid19, TSH, cortisol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testBiological
covid19 infected patient will have a blood test in order to make an autoimmune assessment (antinuclear antibodies, soluble nuclear anti-antigen, ANCA, antiphospholipid antibodies, FT3, FT4 , TSH, antithyroid antibodies, ACTH cortisol, and creation of a serotheque).
What is being measured
The primary outcome is the main question the study is designed to answer.
8-hour cortisol level in patients with Covid19 pneumonia
8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Measured: day 0
TSH level in patients with Covid19 pneumonia
TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start22 Sep 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563676
- Sponsor's protocol ID
- PI2020_843_0096
- Acronym
- SEQ-COV-PHYSIO
- Status last verified
- May 2025
- First submitted
- 23 Sep 2020
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology and Sequelae of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04563676
- Acronym / sponsor ID
- SEQ-COV-PHYSIO / PI2020_843_0096
- Keywords
- Covid19, TSH, cortisol
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Sep 2020 (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 data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration.
The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient having a covid19 infection hospitalized at the Amiens Picardie University Hospital
- Patient who is seen in Pneumology consultation for a respiratory assessment at 3 months of his hospitalization (between M2 and M4) to evaluate presence of respiratory sequelae
- Patient who agreed to participate in the protocol
- Patient affiliated to a Social Security
Key exclusion criteria (2 listed)
- patient under guardianship or curators
- patient refusing to participate
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 |
|---|---|---|
| blood testcovid19 infected patient will have a blood test in order to make an autoimmune assessment (antinuclear antibodies, soluble nuclear anti-antigen, ANCA, antiphospholipid antibodies, FT3, FT4 , TSH, antithyroid antibodies, ACTH cortisol, and creation of a serotheque). | Biological | – |
Primary outcome
8-hour cortisol level in patients with Covid19 pneumonia
Time frame: day 0
8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
TSH level in patients with Covid19 pneumonia
Time frame: day 0
TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- 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?
A study testing blood test in people with Covid19 and TSH, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
8-hour cortisol level in patients with Covid19 pneumonia (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.