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Completed

NCT Number: NCT05311852

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

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

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Key information

Conditions

Fatigue COVID-19 Chronic Disease Cognition Disorders Cognitive Deficit Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Mental Disorders Neurocognitive Disorders Neurophysiologic Abnormality Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Vipiteno-Sterzing

Sterzing, BZ, 39049, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. changes in % of test amplitude in LICI 100

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

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

Secondary outcomes

  1. changes in % of test amplitude in SAI 20

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

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

  2. change in LTP-like cortical plasticity

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

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

Other outcomes

  1. changes in Montreal Cognitive Assessment score

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

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

  2. changes in Frontal Assessment Battery score

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

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

Sponsors and collaborators

Lead sponsor

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

Network

Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

Registry information

Official study 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.

Acronym: PL-PC19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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