Polyneuropathy and COVID-19

NCT05188690 | Unknown

• 1 other identifier: FDG_multicenter_COVID19
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Polyneuropathies

Keywords

COVID-19; Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cumulative Illness Rating scale (CIRS)

  through study completion, an average of 6 months

• muscle strength of the 4 limbs (MRC muscle scale).

  through study completion, an average of 6 months

• Modified Rankin scale (MRs)

  through study completion, an average of 6 months

Other Outcomes (1)

• the length of rehabilitation hospitalization (Number of days)

  through study completion, an average of 6 months

Interventions

Data collection from medical records OTHER

Data collection from medical records

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Poliambulanza Istituto Ospedaliero: collaborator
• Fondazione Salvatore Maugeri: collaborator

Study Sites (1)

Centro "E. Spalenza - Don Gnocchi"

Rovato, 25038, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Polyneuropathies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Paolo Pedersini, MSc

CONTACT

02 40308244; ppedersini@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 12, 2022
• Study Start: June 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: July 31, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

IT (1)