Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study

SARS-CoV 2 Clinical Trial

— COVIDANS  

Official title:

Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374045
• Other study ID #: 20CH095
• Secondary ID: 2020-A01082-37
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: June 18, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Description:

In this study, patients will have a continuous recording of their heart rhythm via a holter-ECG throughout their hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 18, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Primary Dysautonomias
• SARS-CoV 2

Intervention

Other:
• ECG-Holter
Patient will have a ECG-Holter recording during all their hospitalization.

Locations

Country	Name	City	State
France	CHU Hopital nord	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hours: 24
Secondary	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)	up to 5 months
Secondary	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)	up to 5 months
Secondary	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)	up to 5 months