Diagnosis of Endocrine Dysfunctions in Covid-19

Completed

• Conditions: Covid 19

• Registration Number: NCT04587375
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

As observed with SARS-CoV responsible for SARS 2003, the new coronarovirus SARS-CoV-2 uses the angiotensin converting enzyme type 2 (ACE2) as cellular receptor to infect cells. The renin aldosterone angiostensin system (RAAS) has known effects in the lungs: some receptors are pro-inflammatory, others are anti-inflammatory. Thus the deregulation of the RAAS induced by the SARS-CoV-2 could explain the inflammatory response of Covid-19 infection and be a modulator of the severity of its course.

Furthermore, the SARS 2003 experience suggests that there may be others endocrine involvment, particularly an failure on the hypothalamus-pituitary and adrenal axis. Indeeed, cases of hypocorticism and hypothyroidism of central origin were described.

Altogether, the endocrine system might play a role both in the pathophysiology of Covid-19 infection and in the activity and severity of the disease.

In this study, the investigators proposed to explore endocrine functions on biological samples in a series of patients admitted for Covid-19 in our clinic.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-30
• Study First Submitted: 2020-06-18
• Status Verified: 2020-09
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma aldosterone levels	1 day (at inclusion)	Plasma aldosterone levels
Plasma renin levels	1 day (at inclusion)	Plasma renin levels

Secondary Outcome Measures

Name	Time	Method
type of treatments	1 day	type of treatments
Plasma aldosterone level	1 day (at the end of hospitalization)	Plasma aldosterone level
Maximum severity of Covid-19 infection	1 day (at inclusion)	Maximum severity of Covid-19 infection using a seven-category ordinal scale at at the end of hospitalization : Ordinal scale of 7 values from 1 to 7 (1- not hospitalized, no limitation on activities; 2- not hospitalized, limitations on activities; 3- hospitalized, not requiring supplemental oxygen; 4- hospitalized, requiring supplemental oxygen; 5- hospitalized, on non-invasive ventilation or high flow oxygen devices; 6- hospitalized, on invasive mechanical ventilation or ECMO and 7- death).
Plasma DHEA level	1 day (at inclusion)	Plasma DHEA level
Plasma FSH level	1 day (at inclusion)	Plasma FSH level
Clinical characteristics	1 day	Clinical characteristics extracted from electronic medical
covid-19 infection severity	1 day (at inclusion)	covid-19 infection severity : Ordinal scale of 7 values from 1 to 7 (1- not hospitalized, no limitation on activities; 2- not hospitalized, limitations on activities; 3- hospitalized, not requiring supplemental oxygen; 4- hospitalized, requiring supplemental oxygen; 5- hospitalized, on non-invasive ventilation or high flow oxygen devices; 6- hospitalized, on invasive mechanical ventilation or ECMO and 7- death).
Plasma ACTH level	1 day (at inclusion)	Plasma ACTH level
Plasma T3l level	1 day (at inclusion)	Plasma T3l level
Plasma LH level	1 day (at the end of hospitalization)	Plasma LH level
Plasma cortisol level	1 day (at the end of hospitalization)	Plasma cortisol level
Plasma estradiol (female) or testosterone (male) level	1 day (at inclusion)	Plasma estradiol (female) or testosterone (male) level
radiological characteristics	1 day	radiological characteristics : quantification of the percentage of lesional damage to the pulmonary parenchyma

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France