Dyhor-19: Diagnosis of Endocrine Dysfunctions in Covid-19

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04587375
Collaborator
(none)
50
1
3
16.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnosis of Endocrine Dysfunctions in Covid-19 : Explorations of the Plasma Renin and Aldosterone Levels in Patients With Covid-19 Infection.
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    May 1, 2020
    Actual Study Completion Date :
    May 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Plasma aldosterone levels [1 day (at inclusion)]

      Plasma aldosterone levels

    2. Plasma renin levels [1 day (at inclusion)]

      Plasma renin levels

    Secondary Outcome Measures

    1. 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).

    2. 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).

    3. Plasma aldosterone level [1 day (at the end of hospitalization)]

      Plasma aldosterone level

    4. Plasma ACTH level [1 day (at the end of hospitalization)]

      Plasma ACTH level

    5. Plasma cortisol level [1 day (at inclusion)]

      Plasma cortisol level

    6. Plasma cortisol level [1 day (at the end of hospitalization)]

      Plasma cortisol level

    7. Plasma T3l level [1 day (at the end of hospitalization)]

      Plasma T3l level

    8. Plasma T3l level [1 day (at inclusion)]

      Plasma T3l level

    9. Plasma ACTH level [1 day (at inclusion)]

      Plasma ACTH level

    10. Plasma LH level [1 day (at inclusion)]

      Plasma LH level

    11. Plasma LH level [1 day (at the end of hospitalization)]

      Plasma LH level

    12. Plasma DHEA level [1 day (at the end of hospitalization)]

      Plasma DHEA level

    13. Plasma DHEA level [1 day (at inclusion)]

      Plasma DHEA level

    14. Plasma estradiol (female) or testosterone (male) level [1 day (at the end of hospitalization)]

      Plasma estradiol (female) or testosterone (male) level

    15. Plasma estradiol (female) or testosterone (male) level [1 day (at inclusion)]

      Plasma estradiol (female) or testosterone (male) level

    16. Plasma FSH level [1 day (at the end of hospitalization)]

      Plasma FSH level

    17. Plasma FSH level [1 day (at inclusion)]

      Plasma FSH level

    18. type of treatments [1 day]

      type of treatments

    19. Clinical characteristics [1 day]

      Clinical characteristics extracted from electronic medical

    20. radiological characteristics [1 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Patients with Covid-19 diagnosis and hospitalized in our clinic
    Exclusion criteria:
    • Minor patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Philippe GUILPAIN, MD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04587375
    Other Study ID Numbers:
    • RECHMPL20_0205
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2020