Clinical trial NCT04374045: Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study
Official title: Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Keywords: COVID-19
SARS-CoV-2
Coronavirus
Dysautonomia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical signs of SARS-CoV-2 (covid-19).

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of dysautonomia patients found within the first 24 hours of hospitalization (%)
timeFrame: Hours: 24
Secondary outcomes:
measure: 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
timeFrame: up to 5 months
measure: To investigate whether the autonomic balance of patients with CoV-2 SARS correlates with the severity of their clinical condition during their hospital stay.
timeFrame: up to 5 months
measure: 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.
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Hopital nord
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References: