Covid 19Dyhor-19NCT04587375
Diagnosis of Endocrine Dysfunctions in Covid-19
An observational study of Covid 19, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid 19
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Covid-19 diagnosis hospitalized in Montpellier University hospital
Who may be able to join
- Patients with Covid-19 diagnosis and hospitalized in our clinic
Who cannot join
- Minor patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Covid 19
- Keywords
- Covid-19, Renin Angiotensin Aldosterone System, Hormon disorders
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma aldosterone levels
Plasma aldosterone levels
Measured: 1 day (at inclusion)
Plasma renin levels
Plasma renin levels
Measured: 1 day (at inclusion)
Secondary outcomes (20)
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).
Measured: 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).
Measured: 1 day (at inclusion)
Plasma aldosterone level
Plasma aldosterone level
Measured: 1 day (at the end of hospitalization)
Plasma ACTH level
Plasma ACTH level
Measured: 1 day (at the end of hospitalization)
Plasma cortisol level
Plasma cortisol level
Measured: 1 day (at inclusion)
Plasma cortisol level
Plasma cortisol level
Measured: 1 day (at the end of hospitalization)
Plasma T3l level
Plasma T3l level
Measured: 1 day (at the end of hospitalization)
Plasma T3l level
Plasma T3l level
Measured: 1 day (at inclusion)
Plasma ACTH level
Plasma ACTH level
Measured: 1 day (at inclusion)
Plasma LH level
Plasma LH level
Measured: 1 day (at inclusion)
Plasma LH level
Plasma LH level
Measured: 1 day (at the end of hospitalization)
Plasma DHEA level
Plasma DHEA level
Measured: 1 day (at the end of hospitalization)
Plasma DHEA level
Plasma DHEA level
Measured: 1 day (at inclusion)
Plasma estradiol (female) or testosterone (male) level
Plasma estradiol (female) or testosterone (male) level
Measured: 1 day (at the end of hospitalization)
Plasma estradiol (female) or testosterone (male) level
Plasma estradiol (female) or testosterone (male) level
Measured: 1 day (at inclusion)
Plasma FSH level
Plasma FSH level
Measured: 1 day (at the end of hospitalization)
Plasma FSH level
Plasma FSH level
Measured: 1 day (at inclusion)
type of treatments
type of treatments
Measured: 1 day
Clinical characteristics
Clinical characteristics extracted from electronic medical
Measured: 1 day
radiological characteristics
radiological characteristics : quantification of the percentage of lesional damage to the pulmonary parenchyma
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Mar 2020
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GUILPAIN, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587375
- Sponsor's protocol ID
- RECHMPL20_0205
- Acronym
- Dyhor-19
- Status last verified
- Sep 2020
- First submitted
- 18 Jun 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Endocrine Dysfunctions in Covid-19 : Explorations of the Plasma Renin and Aldosterone Levels in Patients With Covid-19 Infection.
- ClinicalTrials.gov ID
- NCT04587375
- Acronym / sponsor ID
- Dyhor-19 / RECHMPL20_0205
- Conditions
- Covid 19
- Keywords
- Covid-19, Renin Angiotensin Aldosterone System, Hormon disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Covid-19 diagnosis hospitalized in Montpellier University hospital
Key inclusion criteria (1 listed)
- Patients with Covid-19 diagnosis and hospitalized in our clinic
Key exclusion criteria (1 listed)
- Minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma aldosterone levels
Time frame: 1 day (at inclusion)
Plasma aldosterone levels
Plasma renin levels
Time frame: 1 day (at inclusion)
Plasma renin levels
20 secondary outcomes
covid-19 infection severity
Time frame: 1 day (at inclusion)
Maximum severity of Covid-19 infection
Time frame: 1 day (at inclusion)
Plasma aldosterone level
Time frame: 1 day (at the end of hospitalization)
Plasma ACTH level
Time frame: 1 day (at the end of hospitalization)
Plasma cortisol level
Time frame: 1 day (at inclusion)
Plasma cortisol level
Time frame: 1 day (at the end of hospitalization)
Plasma T3l level
Time frame: 1 day (at the end of hospitalization)
Plasma T3l level
Time frame: 1 day (at inclusion)
Plasma ACTH level
Time frame: 1 day (at inclusion)
Plasma LH level
Time frame: 1 day (at inclusion)
Plasma LH level
Time frame: 1 day (at the end of hospitalization)
Plasma DHEA level
Time frame: 1 day (at the end of hospitalization)
Plasma DHEA level
Time frame: 1 day (at inclusion)
Plasma estradiol (female) or testosterone (male) level
Time frame: 1 day (at the end of hospitalization)
Plasma estradiol (female) or testosterone (male) level
Time frame: 1 day (at inclusion)
Plasma FSH level
Time frame: 1 day (at the end of hospitalization)
Plasma FSH level
Time frame: 1 day (at inclusion)
type of treatments
Time frame: 1 day
Clinical characteristics
Time frame: 1 day
radiological characteristics
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe GUILPAIN, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid 19, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma aldosterone levels (time frame: 1 day (at inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.