Polyneuropathy and COVID-19 (PolyneuroCOVID)

January 11, 2022 updated by: Fondazione Don Carlo Gnocchi Onlus

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Rovato, Italy, 25038
        • Recruiting
        • Centro "E. Spalenza - Don Gnocchi"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Barthel index
Time Frame: through study completion, an average of 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative Illness Rating scale (CIRS)
Time Frame: through study completion, an average of 6 months
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).
Time Frame: through study completion, an average of 6 months
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)
Time Frame: through study completion, an average of 6 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the length of rehabilitation hospitalization (Number of days)
Time Frame: through study completion, an average of 6 months
Number of days in the rehabilitation center
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Don Carlo Gnocchi Onlus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondazione Salvatore Maugeri
Fondazione Poliambulanza Istituto Ospedaliero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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