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

NCT05311852 | Completed

• 1 other identifier: PEA-LUT-in-Post-Covid-19
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue; Cognitive Deficit; COVID-19; Neurophysiologic Abnormality

Keywords

fatigue; cognitive deficits; post-covid19 syndrome

Outcome Measures

Primary Outcomes (1)

• changes in % of test amplitude in LICI 100

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

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

Secondary Outcomes (2)

• changes in % of test amplitude in SAI 20

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

• change in LTP-like cortical plasticity

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

Other Outcomes (2)

• changes in Montreal Cognitive Assessment score

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

• changes in Frontal Assessment Battery score

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

Study Arms (2)

PEA-LUT

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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

PEA-LUT

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy: lead
• I.R.C.C.S. Fondazione Santa Lucia: collaborator

Study Sites (1)

Hospital of Vipiteno-Sterzing

Sterzing, BZ, 39049, Italy

Location

MeSH Terms

Conditions

Fatigue; Cognition Disorders; COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Leopold Saltuari, Md

  Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind randomized placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PsyD, Principal Investigator

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

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 5, 2022
• Study Start: August 16, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

IT (1)