Diagnosis of Endocrine Dysfunctions in Covid-19

Covid 19 Clinical Trial

— Dyhor-19  

Official title:

Diagnosis of Endocrine Dysfunctions in Covid-19 : Explorations of the Plasma Renin and Aldosterone Levels in Patients With Covid-19 Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587375
• Other study ID #: RECHMPL20_0205
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with Covid-19 diagnosis and hospitalized in our clinic

Exclusion criteria:

• Minor patient

Related Conditions & MeSH terms

• Covid 19

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma aldosterone levels	Plasma aldosterone levels	1 day (at inclusion)
Primary	Plasma renin levels	Plasma renin levels	1 day (at inclusion)
Secondary	covid-19 infection severity	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).	1 day (at inclusion)
Secondary	Maximum severity of Covid-19 infection	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).	1 day (at inclusion)
Secondary	Plasma aldosterone level	Plasma aldosterone level	1 day (at the end of hospitalization)
Secondary	Plasma ACTH level	Plasma ACTH level	1 day (at the end of hospitalization)
Secondary	Plasma cortisol level	Plasma cortisol level	1 day (at inclusion)
Secondary	Plasma cortisol level	Plasma cortisol level	1 day (at the end of hospitalization)
Secondary	Plasma T3l level	Plasma T3l level	1 day (at the end of hospitalization)
Secondary	Plasma T3l level	Plasma T3l level	1 day (at inclusion)
Secondary	Plasma ACTH level	Plasma ACTH level	1 day (at inclusion)
Secondary	Plasma LH level	Plasma LH level	1 day (at inclusion)
Secondary	Plasma LH level	Plasma LH level	1 day (at the end of hospitalization)
Secondary	Plasma DHEA level	Plasma DHEA level	1 day (at the end of hospitalization)
Secondary	Plasma DHEA level	Plasma DHEA level	1 day (at inclusion)
Secondary	Plasma estradiol (female) or testosterone (male) level	Plasma estradiol (female) or testosterone (male) level	1 day (at the end of hospitalization)
Secondary	Plasma estradiol (female) or testosterone (male) level	Plasma estradiol (female) or testosterone (male) level	1 day (at inclusion)
Secondary	Plasma FSH level	Plasma FSH level	1 day (at the end of hospitalization)
Secondary	Plasma FSH level	Plasma FSH level	1 day (at inclusion)
Secondary	type of treatments	type of treatments	1 day
Secondary	Clinical characteristics	Clinical characteristics extracted from electronic medical	1 day
Secondary	radiological characteristics	radiological characteristics : quantification of the percentage of lesional damage to the pulmonary parenchyma	1 day