Polyneuropathy and COVID-19

COVID-19 Clinical Trial

— PolyneuroCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188690
• Other study ID #: FDG_multicenter_COVID19
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2021
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Paolo Pedersini, MSc
• Phone: 02 40308244
• Email: ppedersini[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 31, 2022
• Est. primary completion date: January 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Polyneuropathies

Intervention

Other:
• Data collection from medical records
Data collection from medical records

Locations

Country	Name	City	State
Italy	Centro "E. Spalenza - Don Gnocchi"	Rovato

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Fondazione Poliambulanza Istituto Ospedaliero, Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the length of rehabilitation hospitalization (Number of days)	Number of days in the rehabilitation center	through study completion, an average of 6 months
Primary	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	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
Secondary	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
Secondary	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