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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2
• Intervention / Treatment: Other: ECG-Holter

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Hopital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with clinical signs of SARS-CoV-2 (covid-19).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with SARS-CoV-2; patients having a continuous recording of the heart rhythm during their hospitalization	Other: ECG-Holter; Patient will have a ECG-Holter recording during all their hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): June 17, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; Dysautonomia
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 20CH095; 2020-A01082-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No