Clinical trial NCT05188690: Polyneuropathy and COVID-19
Official title: Clinical Presentation of COVID-19 Patients With an Associated Diagnosis of Polyneuropathy: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Polyneuropathies
Keywords: COVID-19
Polyneuropathy
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Fondazione Poliambulanza Istituto Ospedaliero
name: Fondazione Salvatore Maugeri
First posted: 2022-01-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Barthel index
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Cumulative Illness Rating scale (CIRS)
timeFrame: through study completion, an average of 6 months
measure: muscle strength of the 4 limbs (MRC muscle scale).
timeFrame: through study completion, an average of 6 months
measure: Modified Rankin scale (MRs)
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: the length of rehabilitation hospitalization (Number of days)
timeFrame: through study completion, an average of 6 months
Locations:
city: Rovato
country: Italy
facility: Centro "E. Spalenza - Don Gnocchi"
Study officials:
References: