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Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients (PL-PC19)

Primary Purpose

Fatigue, Cognitive Deficit, COVID-19

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)

Placebo

About this trial

This is an interventional treatment trial for Fatigue focused on measuring fatigue, cognitive deficits, post-covid19 syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.

Exclusion Criteria:

prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions;
clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
anaemia;
current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study

Sites / Locations

Hospital of Vipiteno-Sterzing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PEA-LUT

Placebo

Arm Description

patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks

patients were required to assume granulated placebo, 2 time/day for 8 weeks

Outcomes

Primary Outcome Measures

changes in % of test amplitude in LICI 100

changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected

Secondary Outcome Measures

changes in % of test amplitude in SAI 20

changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected

change in LTP-like cortical plasticity

change of MEP modulation after intermittent theta burst stimulation (iTBS)

Full Information

NCT ID

NCT05311852

First Posted

March 30, 2022

Last Updated

September 22, 2022

Sponsor

Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy

Collaborators

I.R.C.C.S. Fondazione Santa Lucia

1. Study Identification

Unique Protocol Identification Number

NCT05311852

Brief Title

Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

Acronym

PL-PC19

Official Title

Effects of Palmitoylethanolamide Co-ultramicronized With Luteoline (Pea-lut) on Frontal Lobe Functions and GABAergic Transmission in Long Covid Patients. An 8-week Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 16, 2021 (Actual)

Primary Completion Date

February 15, 2022 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy

Collaborators

I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid

Detailed Description

Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue, Cognitive Deficit, COVID-19, Neurophysiologic Abnormality

Keywords

fatigue, cognitive deficits, post-covid19 syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study

Masking

ParticipantInvestigator

Masking Description

This is a double-blind randomized placebo-controlled study

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEA-LUT

Arm Type

Experimental

Arm Description

patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

patients were required to assume granulated placebo, 2 time/day for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)

Intervention Description

assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

assumption of a placebo product 2 time/day for 8 weeks

Primary Outcome Measure Information:

Title

changes in % of test amplitude in LICI 100

Description

changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected

Time Frame

LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration

Secondary Outcome Measure Information:

Title

changes in % of test amplitude in SAI 20

Description

changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected

Time Frame

SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration

Title

change in LTP-like cortical plasticity

Description

change of MEP modulation after intermittent theta burst stimulation (iTBS)

Time Frame

LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration

Other Pre-specified Outcome Measures:

Title

changes in Montreal Cognitive Assessment score

Description

changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected

Time Frame

Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration

Title

changes in Frontal Assessment Battery score

Description

changes in Frontal Assessment Battery score, for evaluating the executive functions, are expected

Time Frame

Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab; subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day; mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission; complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection. Exclusion Criteria: prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions; clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease; anaemia; current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leopold Saltuari, Md

Organizational Affiliation

Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing

Official's Role

Study Director

Facility Information:

Facility Name

Hospital of Vipiteno-Sterzing

City

Vipiteno

State/Province

ZIP/Postal Code

39049

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

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