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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06060795
Other study ID # D20-P014
Secondary ID IDRCB : 2020-A01
Status Completed
Phase
First received
Last updated
Start date April 6, 2020
Est. completion date January 13, 2021

Study information

Verified date September 2023
Source Centre Hospitalier St Anne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Electro-conductance measurement
Interventions are done to diagnose Autonomic Nervous system Troubles

Locations

Country Name City State
France Centre Hospitalier Sainte-Anne Paris

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated Criterion 1: A significant change in the LF / HF ratio and AUCHR compared to baseline and control group
Criterion 2: A significant change in the measurement of average skin conductances on the hands and feet in COVID-19 patients compared to baseline and control group
Criterion 3: A significant change in basic tone and pupillary reactivity to light stimuli and pain in COVID-19 patients compared to baseline measures and control group
Criterion 4: A significant change in the tympanic reflex observed in COVID-19 patients compared to baseline and control group,
Criterion 5: Presence of significant changes in EEG pattern and evolution between COVID-19 patients and control group
Day1, Day3, Day7, Day14, Day21
Secondary Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS), proposed distinguished according to the PaO2 / FiO2 ratio measured in the presence of a positive external expiratory pressure (PEPe) of at least 5 cmH2O, three levels of ARDS severity in minimal (200 Day1, Day3, Day7, Day14, Day21
Secondary Mortality at 1 month - Vital status at 30 days Month 1
Secondary Mortality at 6 months - Vital status at 6 months Month 6
Secondary Sequential Organ Failure Assessment (SOFA score) SOFA score: grade the organ function or failure rate, from 0 to 24, severity increases as the score increases. Day1, Day3, Day7, Day14, Day21
Secondary Total duration of mechanical ventilation, ventilatory weaning, curarization, Total time of mechanical ventilation, weaning and use of neuromuscular blockade Day 21
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