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

NCT ID: NCT04374045

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-06-18

Brief Summary

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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

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

Conditions

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SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with SARS-CoV-2

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

ECG-Holter

Intervention Type OTHER

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

Interventions

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ECG-Holter

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David CHARIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Hopital nord

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 36549090 (View on PubMed)

Other Identifiers

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2020-A01082-37

Identifier Type: OTHER

Identifier Source: secondary_id

20CH095

Identifier Type: -

Identifier Source: org_study_id

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