SEQ-COV-PHYSIO: Physiopathology and Sequelae of COVID-19 Infection

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04563676

Collaborator

(none)

400

Enrollment

Location

14.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 TSH Cortisol	Biological: blood test	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 22, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

8-hour cortisol level in patients with Covid19 pneumonia [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 [day 0]
TSH level in patients with Covid19 pneumonia will be determined the day of consultation for respiratory sequelae.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04563676

Other Study ID Numbers:

PI2020_843_0096

First Posted:

Sep 24, 2020

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Covid19

TSH

cortisol

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 21, 2021