Polyneuropathy and COVID-19 (PolyneuroCOVID)

Clinical Presentation of COVID-19 Patients With an Associated Diagnosis of Polyneuropathy: a Multicenter Observational Study

Since the onset of the Coronavirus pandemic disease 2019 (COVID-19), the Lombardy region and in particular the territory of the province of Brescia has been heavily affected. Current data show that the total number of confirmed cases in Italy of COVID-19 due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) exceeds 3.9 million cases, with more than 120 thousand deaths. As the COVID-19 epidemic continues to spread globally, more and more evidence is being gathered about the presence of neurological manifestations and symptoms associated with it. With the growing understanding of the disease, many non-pulmonary symptoms have been recognized, including neurological complications such as acute cerebrovascular disease, meningitis, encephalitis, and peripheral nervous system disease. The main objective of this study is to analyze the clinical and functional conditions of COVID-19 patients with an associated diagnosis of polyneuropathy who were admitted for rehabilitation in the rehabilitation centers of Brescia.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Polyneuropathies
• Intervention / Treatment: Other: Data collection from medical records

Detailed Description

The study will be conducted in all the centers considered following the same protocol based on data collection of COVID-19 patients with an associated diagnosis of polyneuropathy. Demographic information, clinical manifestations, laboratory results, electromyography (EMG), neuroimaging, and outcomes will be extracted from the medical records using a standardized data collection form. The data collection will be divided into demographic and clinical data, instrumental examinations, and functional assessment. In the section of demographic data will be collected information regarding age, sex, comorbidities (diabetes mellitus, dyslipidemia, hypertension, coronary artery disease, neoplasia, renal failure, anxiety-depressive syndrome or similar Etc. ), administration during hospitalization of antibiotics, antivirals, mechanical ventilation (invasive / non-invasive; Number of days of mechanical ventilation), pronation cycles (Yes / No), oxygen therapy (Yes / No; Number of days of oxygen therapy; L/min), time of hospitalization in an acute care facility (Number of days) and overall hospitalization time (Number of days). Concerning instrumental examinations will be collected data on neuroimaging tests (CT brain, MRI brain) and EMG more precisely: the type of polyneuropathy will be defined (axonal, demyelinating, mixed); the presence of conduction blocks (Yes/No); latency of F responses from posterior tibial; the amplitude of compound motor action potential (cMAP), distal latencies and motor conduction velocity of one nerve in the lower limbs and one in the upper limbs (possibly peroneal and ulnar); the presence of non-registrable responses (Yes/No); the amplitude of sural sensory-motor potential (SAP).

Data at admission and discharge will be collected on the: Cumulative Illness Rating Scale (CIRS), Barthel index, Modified Rankin scale (MRS), muscle strength of the four limbs (MRC muscle scale), walking (Autonomous, with aids, not autonomous). In terms of clinical outcomes will be considered the length of rehabilitation hospitalization (Number of days).

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Paolo Pedersini, MSc; Phone Number: 02 40308244; Email: ppedersini@dongnocchi.it

Study Locations

• Italy
  • Rovato, Italy, 25038
    • Recruiting
    • Centro "E. Spalenza - Don Gnocchi"
    • Contact: Chiara Arienti, PhD; Email: ctu@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of Sars-Cov2 infection, regardless of the degree of severity and negative results to 2 consecutive nasopharyngeal swabs. Diagnosis of Polyneuropathy is defined clinically and/or by electromyographic examination.

Description

Inclusion Criteria:

• Patients with a confirmed diagnosis of Sars-Cov2 infection, regardless of the degree of severity and negative results to 2 consecutive nasopharyngeal swabs.
• Diagnosis of Polyneuropathy is defined clinically and/or by electromyographic examination.
• Older age
• Both sexes

Exclusion Criteria:

• Presence of disabling conditions affecting the musculoskeletal system.
• Ischemic/hemorrhagic stroke
• Neurodegenerative diseases
• Presence of rheumatic and inflammatory diseases.
• Chronic diseases of the respiratory system.
• Hemodynamic instability
• Cognitive impairment (Mini-Mental State Examination <18)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel index	The Barthel Index (BI) is a measurement tool, based on an ordinal scale, commonly used to assess the Activities of Daily Living (ADLs) or all the basic activities that an adult individual performs independently and without the need for assistance to survive and take care of themselves.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Illness Rating scale (CIRS)	The Cumulative Illness Rating Scale is a reliable instrument for assessing physical impairment. Ratings are made on a 5-point "degree of severity" scale, ranging from "none" to "extremely severe."	through study completion, an average of 6 months
muscle strength of the 4 limbs (MRC muscle scale).	The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.	through study completion, an average of 6 months
Modified Rankin scale (MRs)	The Modified Rankin Scale (MR) is a scale for measuring the degree of disability in the daily activities.	through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the length of rehabilitation hospitalization (Number of days)	Number of days in the rehabilitation center	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Fondazione Salvatore Maugeri; Fondazione Poliambulanza Istituto Ospedaliero

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Polyneuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; COVID-19; Polyneuropathies
• Other Study ID Numbers: FDG_multicenter_COVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No