Physiopathology and Sequelae of COVID-19 Infection

Covid19 Clinical Trial

— SEQ-COV-PHYSIO  

Official title:

Physiopathology and Sequelae of COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04563676
• Other study ID #: PI2020_843_0096
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Claire ANDREJAK, Pr
• Phone: (33)3.22.08.79.98
• Email: andrejak.claire[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• patient under guardianship or curators

• patient refusing to participate

Related Conditions & MeSH terms

• Cortisol
• COVID-19
• Covid19
• TSH

Intervention

Biological:
• blood test
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).

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 0
Primary	TSH level in patients with Covid19 pneumonia	TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.	day 0