SARS-CoV 2COVIDANSNCT04374045
Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study
An observational study of SARS-CoV 2, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
A number of clinical features suggest the possibility of dysautonomia in patients infected with SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). At the same time, there is now strong experimental evidence that SARS-CoV-2 can cross the blood-brain barrier, probably via the olfactory nerves, and reach the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- ECG-Holter
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 18 Jun 2020
- How long will I take part?
- 1 Month
- 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 clinical signs of SARS-CoV-2 (covid-19).
Who may be able to join
- major
- with clinical signs of SARS-CoV-2
- understanding and speaking French fluently to understand the explanations and participate in the study
- who have given their oral consent to participate in the study
- affiliated or entitled to a social security scheme.
Who cannot join
- with a history of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomic stage
- with atrial fibrillation on the ECG trace taken at the time of their entry.
- refusing to participate in the study
- intubated prior to inclusion in the study
- that are within the exclusion period of another research protocol
- with a history of head injury, neurological pathology with a brain impact, or serious unstable somatic disease
- patient under guardianship.
- pregnancy woman
Trial locations and contacts
1 site in 1 country.
About this study
A number of clinical features suggest the possibility of dysautonomia in patients infected with SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2).
At the same time, there is now strong experimental evidence that SARS-CoV-2 can cross the blood-brain barrier, probably via the olfactory nerves, and reach the brain stem, which is located in close proximity.
Read more
Damage to the brainstem nuclei could explain the suspected dysautonomic episodes, but also the severity of respiratory distress in infected patients, and the difficulty of ventilatory withdrawal encountered in resuscitation, potentially through damage to the ventilation control and regulation centers located in the brainstem.
The objective of this study is to record the long term variability in heart rate, reflecting autonomic balance, of patients screened positive for SARS-CoV-2 throughout their stay in conventional care units at the Saint-Etienne University Hospital, in order to see whether there is an autonomic imbalance at screening, whether the worsening of the autonomic imbalance precedes the worsening of the clinical condition, and how quickly the expected correction of the autonomic imbalance follows or precedes that of the disease.
Read the detailed description
In this study, patients will have a continuous recording of their heart rhythm via a holter-ECG throughout their hospitalization.
- Conditions
- SARS-CoV 2
- Being tested
- ECG-Holter
- Keywords
- COVID-19, SARS-CoV-2, Coronavirus, Dysautonomia
- Medical subject headings
- COVID-19, Coronavirus Infections, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-HolterOther
Patient will have a ECG-Holter recording during all their hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SARS-CoV-2 | patients having a continuous recording of the heart rhythm during their hospitalization Receives: Other: ECG-Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of dysautonomia patients found within the first 24 hours of hospitalization (%)
Dysautonomia will be measured by the LF/HF ratio (sympatho-vagal balance), obtained from a Holter-ECG recording over the first 24 hours of hospitalisation, and compared to normal values given by charts for each age group and sex, making it possible to obtain the percentage of dysautonomic patients.
Measured: Hours: 24
Secondary outcomes (3)
Analyse the other mathematical indices measuring autonomic balance, obtained by Holter-ECG recording over the first 24 hours and throughout their hospitalisation, in search of possible dysautonomia
Measured by the LF/HF ratio (sympathy-vagal balance)
Measured: up to 5 months
To investigate whether the autonomic balance of patients with CoV-2 SARS correlates with the severity of their clinical condition during their hospital stay.
Measured by the LF/HF ratio (sympathy-vagal balance)
Measured: up to 5 months
To investigate whether the various autonomic parameters recorded are predictive of clinical worsening or improvement, by calculating a prediction threshold for each of the parameters.
Measured by the LF/HF ratio (sympathy-vagal balance)
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start30 Apr 2020
- Primary completion17 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374045
- Sponsor's protocol ID
- 20CH095
- Other IDs
- 2020-A01082-37
- Acronym
- COVIDANS
- Status last verified
- Jan 2021
- First submitted
- 30 Apr 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniel M, Charier D, Pereira B, Pachcinski M, Sharshar T, Molliex S. Prognosis value of pupillometry in COVID-19 patients admitted in intensive care unit. Auton Neurosci. 2023 Mar;245:103057. doi: 10.1016/j.autneu.2022.103057. Epub 2022 Dec 17.
PubMed 36549090
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study
- ClinicalTrials.gov ID
- NCT04374045
- Acronym / sponsor ID
- COVIDANS / 20CH095
- Conditions
- SARS-CoV 2
- Keywords
- COVID-19, SARS-CoV-2, Coronavirus, Dysautonomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 5 May 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.
A number of clinical features suggest the possibility of dysautonomia in patients infected with SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2).
At the same time, there is now strong experimental evidence that SARS-CoV-2 can cross the blood-brain barrier, probably via the olfactory nerves, and reach the brain stem, which is located in close proximity.
Damage to the brainstem nuclei could explain the suspected dysautonomic episodes, but also the severity of respiratory distress in infected patients, and the difficulty of ventilatory withdrawal encountered in resuscitation, potentially through damage to the ventilation control and regulation centers located in the brainstem.
The objective of this study is to record the long term variability in heart rate, reflecting autonomic balance, of patients screened positive for SARS-CoV-2 throughout their stay in conventional care units at the Saint-Etienne University Hospital, in order to see whether there is an autonomic imbalance at screening, whether the worsening of the autonomic imbalance precedes the worsening of the clinical condition, and how quickly the expected correction of the autonomic imbalance follows or precedes that of the disease.
Detailed description
In this study, patients will have a continuous recording of their heart rhythm via a holter-ECG throughout their hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2 | – | Other: ECG-Holterpatients having a continuous recording of the heart rhythm during their hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical signs of SARS-CoV-2 (covid-19).
Key inclusion criteria (5 listed)
- major
- with clinical signs of SARS-CoV-2
- understanding and speaking French fluently to understand the explanations and participate in the study
- who have given their oral consent to participate in the study
- affiliated or entitled to a social security scheme.
Key exclusion criteria (8 listed)
- with a history of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomic stage
- with atrial fibrillation on the ECG trace taken at the time of their entry.
- refusing to participate in the study
- intubated prior to inclusion in the study
- that are within the exclusion period of another research protocol
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 |
|---|---|---|
| ECG-HolterPatient will have a ECG-Holter recording during all their hospitalization. | Other | Patients with SARS-CoV-2 |
Primary outcome
Percentage of dysautonomia patients found within the first 24 hours of hospitalization (%)
Time frame: Hours: 24
Dysautonomia will be measured by the LF/HF ratio (sympatho-vagal balance), obtained from a Holter-ECG recording over the first 24 hours of hospitalisation, and compared to normal values given by charts for each age group and sex, making it possible to obtain the percentage of dysautonomic patients.
3 secondary outcomes
Analyse the other mathematical indices measuring autonomic balance, obtained by Holter-ECG recording over the first 24 hours and throughout their hospitalisation, in search of possible dysautonomia
Time frame: up to 5 months
To investigate whether the autonomic balance of patients with CoV-2 SARS correlates with the severity of their clinical condition during their hospital stay.
Time frame: up to 5 months
To investigate whether the various autonomic parameters recorded are predictive of clinical worsening or improvement, by calculating a prediction threshold for each of the parameters.
Time frame: up to 5 months
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 Jan 2021.
- Derived from this study: PubMed 36549090Daniel M, Charier D, Pereira B, Pachcinski M, Sharshar T, Molliex S. Prognosis value of pupillometry in COVID-19 patients admitted in intensive care unit. Auton Neurosci. 2023 Mar;245:103057. doi: 10.1016/j.autneu.2022.103057. Epub 2022 Dec 17.
- Individual participant dataSharing planned: No
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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.
David CHARIER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 SARS-CoV 2, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 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 14 Jan 2021. 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?
Percentage of dysautonomia patients found within the first 24 hours of hospitalization (%) (time frame: Hours: 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04374045, which also lists 1 linked publication.
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 Jan 2021.