Physiopathology and Sequelae of COVID-19 Infection (SEQ-COV-PHYSIO)
Primary Purpose
Covid19, TSH, Cortisol
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood test
Sponsored by
About this trial
This is an interventional screening trial for Covid19 focused on measuring Covid19, TSH, cortisol
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
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.
TSH level in patients with Covid19 pneumonia
TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Secondary Outcome Measures
Full Information
NCT ID
NCT04563676
First Posted
September 23, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04563676
Brief Title
Physiopathology and Sequelae of COVID-19 Infection
Acronym
SEQ-COV-PHYSIO
Official Title
Physiopathology and Sequelae of COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, TSH, Cortisol
Keywords
Covid19, TSH, cortisol
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
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).
Primary Outcome Measure Information:
Title
8-hour cortisol level in patients with Covid19 pneumonia
Description
8-hour cortisol level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Time Frame
day 0
Title
TSH level in patients with Covid19 pneumonia
Description
TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire ANDREJAK, Pr
Phone
(33)3.22.08.79.98
Email
andrejak.claire@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire ANDREJAK, Pr
Phone
(33)3.22.08.79.98
Email
andrejak.claire@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Valery Salle, MD
First Name & Middle Initial & Last Name & Degree
Rachel DESAILLOUD, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiopathology and Sequelae of COVID-19 Infection
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