Skip to main content
OpenTrials
Completed

NCT Number: NCT04374045

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV 2 Autonomic Nervous System Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Hopital nord

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG-Holter

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Measured by the LF/HF ratio (sympathy-vagal balance)

  2. 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

    Measured by the LF/HF ratio (sympathy-vagal balance)

  3. 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

    Measured by the LF/HF ratio (sympathy-vagal balance)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: COVIDANS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.