NCT04587375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

June 18, 2020

Last Update Submit

October 13, 2020

Conditions

Keywords

Covid-19Renin Angiotensin Aldosterone SystemHormon disorders

Outcome Measures

Primary Outcomes (2)

  • Plasma aldosterone levels

    Plasma aldosterone levels

    1 day (at inclusion)

  • Plasma renin levels

    Plasma renin levels

    1 day (at inclusion)

Secondary Outcomes (20)

  • covid-19 infection severity

    1 day (at inclusion)

  • Maximum severity of Covid-19 infection

    1 day (at inclusion)

  • Plasma aldosterone level

    1 day (at the end of hospitalization)

  • Plasma ACTH level

    1 day (at the end of hospitalization)

  • Plasma cortisol level

    1 day (at inclusion)

  • +15 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Covid-19 diagnosis hospitalized in Montpellier University hospital

You may qualify if:

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

You may not qualify if:

  • \- Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philippe GUILPAIN, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

October 14, 2020

Study Start

March 1, 2020

Primary Completion

May 1, 2020

Study Completion

May 30, 2020

Last Updated

October 14, 2020

Record last verified: 2020-09

Locations