Respiratory SymptomsCOVENANT-ICUNCT06060795
CoVID-19 Evaluation of Neurological and Autonomic Nervous System Troubles in Intensive Care Unit Patients
An observational study of Respiratory Symptoms and Autonomic Nervous System Dysfunction, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Symptoms, Autonomic Nervous System Dysfunction
- What is being tested?
- Electro-conductance measurement
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2020to 13 Jan 2021
- 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: The 'experimental group' population in question consisted of patients over 18 years of age at the time of inclusion, admitted to an intensive care unit or intensive care unit for the management of an established SARS-CoV-2 infection. The 'control group' population consisted of adult patients, male or female, admitted to an intensive care unit or intensive care unit for the management of respiratory symptoms requiring continuous monitoring but whose final diagnosis was based on several clinical-biological and radiological a posteriori, is not related to SARS-CoV-2 infection and has two negative RT-PCRs for SARS-CoV-2 performed three days apart (1st PCR performed on admission to the ward and re-sampling in case of first negative PCR).
Who may be able to join
- Patients over 18 years old, hospitalized in an intensive care unit for the management of a suspected SARS-CoV-2 infection diagnosed by reference examination (PCR on nasopharyngeal Sample)
- Patient affiliated or benefiting from a social security system,
- Consent obtained from the trusted person, or close person or parent, under the conditions provided by the article L.1122-1-1 of the "CSP"
- Patient who has given consent to participate.
Who cannot join
- Bad command of French language or state incompatible with the patient's understanding and / or enlightened adherence to the study protocol
- Adults who are the subject of legal protection or unable to express their consent
- Minors
- Lack of possible collection of signed informed consent
- History of progressive and / or degenerative neurological pathology
- Pregnant women, parturients and nursing mothers
- Therapeutic limitation decision made before inclusion of patient
- Persons deprived of their liberty by a court or administrative decision, persons undergoing psychiatric care (article L1121-6)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence and Evolution of Autonomic Nervous System Dysfunction for the Management of SARS-COV 2 Infection in Intensive Care Unit Patients
Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.
Read the detailed description
Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.
Currently, there are few studies interesting by the neurological complications of patients with SARS-CoV-2, the mechanisms involved in its migration to target sites and the processes leading to damage by direct injury or related to neuro-inflammatory processes of the CNS and in particular of the brainstem, responsible for the regulation of the ANS.
The main objective of the study conducted is therefore to evaluate the prevalence and the evolution of autonomic nervous system dysfunction and its impact in patients with SARS-CoV-2 infection hospitalized in intensive care Unit (ICU) confirmed by the obtaining a positive RT-PCR (2nd PCR carried out 3 days after the first in the event of a negative first result). This dysfunction of Autonomic Nervous System will be diagnosed on the basis of a multimodal assessment including spectral analysis of heart rate variability, the tone, pupillary reactivity and tympanometry, the measurement of skin electro-conductance, evaluation of diaphragmatic function and analysis of electro-encephalographic characteristics.
This population of patients will be compared with a control group of subjects admitted in ICU for the management of a suspected SARS-CoV-2 infection with a diagnosis excluded on the basis of a set of clinical and biological and ultrasound arguments associated with two RT-PCRs on negative respiratory samples taken 3 days apart.
- Being tested
- Electro-conductance measurement
- Keywords
- COVID-19, SARS-COV 2, respiratory symptoms, Autonomic Nervous system dysfunction
- Medical subject headings
- Signs and Symptoms, Respiratory, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-conductance measurementDiagnostic test
Also called Tympanometry+Pupillometry
Interventions are done to diagnose Autonomic Nervous system Troubles
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Patient infected by COVID19 Receives: Diagnostic Test: Electro-conductance measurement | |
| Control group | Patient non infected by COVID19 Receives: Diagnostic Test: Electro-conductance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated
- Criterion 1: A significant change in the LF / HF ratio and AUCHR compared to baseline and control group
- Criterion 2: A significant change in the measurement of average skin conductances on the hands and feet in COVID-19 patients compared to baseline and control group
- Criterion 3: A significant change in basic tone and pupillary reactivity to light stimuli and pain in COVID-19 patients compared to baseline measures and control group
- Criterion 4: A significant change in the tympanic reflex observed in COVID-19 patients compared to baseline and control group,
- Criterion 5: Presence of significant changes in EEG pattern and evolution between COVID-19 patients and control group
Measured: Day1, Day3, Day7, Day14, Day21
Secondary outcomes (5)
Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS),
proposed distinguished according to the PaO2 / FiO2 ratio measured in the presence of a positive external expiratory pressure (PEPe) of at least 5 cmH2O, three levels of ARDS severity in minimal (200 <PaO2 / FiO2 ≤ 300 mmHg), moderate (100 <PaO2 / FiO2 ≤ 200 mmHg) and severe (PaO2 / FiO2 ≤ 100 mmHg),
Measured: Day1, Day3, Day7, Day14, Day21
Mortality at 1 month
- Vital status at 30 days
Measured: Month 1
Mortality at 6 months
- Vital status at 6 months
Measured: Month 6
Sequential Organ Failure Assessment (SOFA score)
SOFA score: grade the organ function or failure rate, from 0 to 24, severity increases as the score increases.
Measured: Day1, Day3, Day7, Day14, Day21
Total duration of mechanical ventilation, ventilatory weaning, curarization,
Total time of mechanical ventilation, weaning and use of neuromuscular blockade
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start6 Apr 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SymptomsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DANIEL Matthieu, MD, PhD, Principal investigator, Centre hospitalier Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060795
- Sponsor's protocol ID
- D20-P014
- Other IDs
- IDRCB : 2020-A01003-36
- Acronym
- COVENANT-ICU
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2020
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence and Evolution of Autonomic Nervous System Dysfunction for the Management of SARS-COV 2 Infection in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06060795
- Acronym / sponsor ID
- COVENANT-ICU / D20-P014
- Keywords
- COVID-19, SARS-COV 2, respiratory symptoms, Autonomic Nervous system dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 29 Sep 2023 (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.
Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.
Detailed description
Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.
Currently, there are few studies interesting by the neurological complications of patients with SARS-CoV-2, the mechanisms involved in its migration to target sites and the processes leading to damage by direct injury or related to neuro-inflammatory processes of the CNS and in particular of the brainstem, responsible for the regulation of the ANS.
The main objective of the study conducted is therefore to evaluate the prevalence and the evolution of autonomic nervous system dysfunction and its impact in patients with SARS-CoV-2 infection hospitalized in intensive care Unit (ICU) confirmed by the obtaining a positive RT-PCR (2nd PCR carried out 3 days after the first in the event of a negative first result). This dysfunction of Autonomic Nervous System will be diagnosed on the basis of a multimodal assessment including spectral analysis of heart rate variability, the tone, pupillary reactivity and tympanometry, the measurement of skin electro-conductance, evaluation of diaphragmatic function and analysis of electro-encephalographic characteristics.
This population of patients will be compared with a control group of subjects admitted in ICU for the management of a suspected SARS-CoV-2 infection with a diagnosis excluded on the basis of a set of clinical and biological and ultrasound arguments associated with two RT-PCRs on negative respiratory samples taken 3 days apart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Diagnostic Test: Electro-conductance measurementPatient infected by COVID19 |
| Control group | – | Diagnostic Test: Electro-conductance measurementPatient non infected by COVID19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The 'experimental group' population in question consisted of patients over 18 years of age at the time of inclusion, admitted to an intensive care unit or intensive care unit for the management of an established SARS-CoV-2 infection. The 'control group' population consisted of adult patients, male or female, admitted to an intensive care unit or intensive care unit for the management of respiratory symptoms requiring continuous monitoring but whose final diagnosis was based on several clinical-biological and radiological a posteriori, is not related to SARS-CoV-2 infection and has two negative RT-PCRs for SARS-CoV-2 performed three days apart (1st PCR performed on admission to the ward and re-sampling in case of first negative PCR).
Key inclusion criteria (4 listed)
- Patients over 18 years old, hospitalized in an intensive care unit for the management of a suspected SARS-CoV-2 infection diagnosed by reference examination (PCR on nasopharyngeal Sample)
- Patient affiliated or benefiting from a social security system,
- Consent obtained from the trusted person, or close person or parent, under the conditions provided by the article L.1122-1-1 of the "CSP"
- Patient who has given consent to participate.
Key exclusion criteria (8 listed)
- Bad command of French language or state incompatible with the patient's understanding and / or enlightened adherence to the study protocol
- Adults who are the subject of legal protection or unable to express their consent
- Minors
- Lack of possible collection of signed informed consent
- History of progressive and / or degenerative neurological pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-conductance measurementAlso: Tympanometry+PupillometryInterventions are done to diagnose Autonomic Nervous system Troubles | Diagnostic test | Control group, Experimental Group |
Primary outcome
Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated
Time frame: Day1, Day3, Day7, Day14, Day21
* Criterion 1: A significant change in the LF / HF ratio and AUCHR compared to baseline and control group * Criterion 2: A significant change in the measurement of average skin conductances on the hands and feet in COVID-19 patients compared to baseline and control group * Criterion 3: A significant change in basic tone and pupillary reactivity to light stimuli and pain in COVID-19 patients compared to baseline measures and control group * Criterion 4: A significant change in the tympanic reflex observed in COVID-19 patients compared to baseline and control group, * Criterion 5: Presence of significant changes in EEG pattern and evolution between COVID-19 patients and control group
5 secondary outcomes
Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS),
Time frame: Day1, Day3, Day7, Day14, Day21
Mortality at 1 month
Time frame: Month 1
Mortality at 6 months
Time frame: Month 6
Sequential Organ Failure Assessment (SOFA score)
Time frame: Day1, Day3, Day7, Day14, Day21
Total duration of mechanical ventilation, ventilatory weaning, curarization,
Time frame: Day 21
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 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Respiratory Symptoms
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
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.
DANIEL Matthieu, MD, PhD principal investigator
Centre hospitalier Sainte Anne
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 Respiratory Symptoms and Autonomic Nervous System Dysfunction, run by Centre Hospitalier St Anne 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 4 inclusion and 8 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 29 Sep 2023. 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?
Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated (time frame: Day1, Day3, Day7, Day14, Day21). 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 29 Sep 2023.