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Physiopathology and Sequelae of COVID-19 Infection (SEQ-COV-PHYSIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563676
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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


Condition or disease Intervention/treatment Phase
Covid19 TSH Cortisol Biological: blood test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Physiopathology and Sequelae of COVID-19 Infection
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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).

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563676


Contacts
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Contact: Claire ANDREJAK, Pr (33)3.22.08.79.98 andrejak.claire@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Claire ANDREJAK, Pr    (33)3.22.08.79.98    andrejak.claire@chu-amiens.fr   
Sub-Investigator: Valery Salle, MD         
Sub-Investigator: Rachel DESAILLOUD, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04563676    
Other Study ID Numbers: PI2020_843_0096
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Covid19
TSH
cortisol
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases