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Completed

NCT Number: NCT04587375

Diagnosis of Endocrine Dysfunctions in Covid-19

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.

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor patient

Treatment and study plan

Primary outcomes

  1. Plasma aldosterone levels

    Time frame: 1 day (at inclusion)

    Plasma aldosterone levels

  2. Plasma renin levels

    Time frame: 1 day (at inclusion)

    Plasma renin levels

Secondary outcomes

  1. covid-19 infection severity

    Time frame: 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).

  2. Maximum severity of Covid-19 infection

    Time frame: 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).

  3. Plasma aldosterone level

    Time frame: 1 day (at the end of hospitalization)

    Plasma aldosterone level

  4. Plasma ACTH level

    Time frame: 1 day (at the end of hospitalization)

    Plasma ACTH level

  5. Plasma cortisol level

    Time frame: 1 day (at inclusion)

    Plasma cortisol level

  6. Plasma cortisol level

    Time frame: 1 day (at the end of hospitalization)

    Plasma cortisol level

  7. Plasma T3l level

    Time frame: 1 day (at the end of hospitalization)

    Plasma T3l level

  8. Plasma T3l level

    Time frame: 1 day (at inclusion)

    Plasma T3l level

  9. Plasma ACTH level

    Time frame: 1 day (at inclusion)

    Plasma ACTH level

  10. Plasma LH level

    Time frame: 1 day (at inclusion)

    Plasma LH level

  11. Plasma LH level

    Time frame: 1 day (at the end of hospitalization)

    Plasma LH level

  12. Plasma DHEA level

    Time frame: 1 day (at the end of hospitalization)

    Plasma DHEA level

  13. Plasma DHEA level

    Time frame: 1 day (at inclusion)

    Plasma DHEA level

  14. Plasma estradiol (female) or testosterone (male) level

    Time frame: 1 day (at the end of hospitalization)

    Plasma estradiol (female) or testosterone (male) level

  15. Plasma estradiol (female) or testosterone (male) level

    Time frame: 1 day (at inclusion)

    Plasma estradiol (female) or testosterone (male) level

  16. Plasma FSH level

    Time frame: 1 day (at the end of hospitalization)

    Plasma FSH level

  17. Plasma FSH level

    Time frame: 1 day (at inclusion)

    Plasma FSH level

  18. type of treatments

    Time frame: 1 day

    type of treatments

  19. Clinical characteristics

    Time frame: 1 day

    Clinical characteristics extracted from electronic medical

  20. radiological characteristics

    Time frame: 1 day

    radiological characteristics : quantification of the percentage of lesional damage to the pulmonary parenchyma

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Dyhor-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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