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

NCT04374045 | Completed

• 2 other identifiers: 20CH0952020-A01082-37
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV 2

Keywords

COVID-19; SARS-CoV-2; Coronavirus; Dysautonomia

Outcome Measures

Primary Outcomes (1)

• 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 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

  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.

  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.

  up to 5 months

Study Arms (1)

Patients with SARS-CoV-2

patients having a continuous recording of the heart rhythm during their hospitalization

Other: ECG-Holter

Interventions

ECG-Holter OTHER

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

Patients with SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• with a history of head injury, neurological pathology with a brain impact, or serious unstable somatic disease
• patient under guardianship.
• pregnancy woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Hopital nord

Saint-Etienne, France

Location

Related Publications (1)

• 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.

  PMID: 36549090 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases

Study Officials

• David CHARIER, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: April 30, 2020
• Primary Completion: June 17, 2020
• Study Completion: June 18, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)