Diagnosis of Endocrine Dysfunctions in Covid-19 (Dyhor-19)

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

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.

Study Overview

• Status: Completed
• Conditions: Covid 19

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Covid-19 diagnosis hospitalized in Montpellier University hospital

Description

Inclusion criteria:

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

Exclusion criteria:

- Minor patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma aldosterone levels	Plasma aldosterone levels	1 day (at inclusion)
Plasma renin levels	Plasma renin levels	1 day (at inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Plasma aldosterone level	Plasma aldosterone level	1 day (at the end of hospitalization)
Plasma ACTH level	Plasma ACTH level	1 day (at the end of hospitalization)
Plasma cortisol level	Plasma cortisol level	1 day (at inclusion)
Plasma cortisol level	Plasma cortisol level	1 day (at the end of hospitalization)
Plasma T3l level	Plasma T3l level	1 day (at the end of hospitalization)
Plasma T3l level	Plasma T3l level	1 day (at inclusion)
Plasma ACTH level	Plasma ACTH level	1 day (at inclusion)
Plasma LH level	Plasma LH level	1 day (at inclusion)
Plasma LH level	Plasma LH level	1 day (at the end of hospitalization)
Plasma DHEA level	Plasma DHEA level	1 day (at the end of hospitalization)
Plasma DHEA level	Plasma DHEA level	1 day (at inclusion)
Plasma estradiol (female) or testosterone (male) level	Plasma estradiol (female) or testosterone (male) level	1 day (at the end of hospitalization)
Plasma estradiol (female) or testosterone (male) level	Plasma estradiol (female) or testosterone (male) level	1 day (at inclusion)
Plasma FSH level	Plasma FSH level	1 day (at the end of hospitalization)
Plasma FSH level	Plasma FSH level	1 day (at inclusion)
type of treatments	type of treatments	1 day
Clinical characteristics	Clinical characteristics extracted from electronic medical	1 day
radiological characteristics	radiological characteristics : quantification of the percentage of lesional damage to the pulmonary parenchyma	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Renin Angiotensin Aldosterone System; Hormon disorders
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RECHMPL20_0205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No