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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05311852
Other study ID # PEA-LUT-in-Post-Covid-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2021
Est. completion date March 15, 2022

Study information

Verified date September 2022
Source Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date March 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
Placebo
assumption of a placebo product 2 time/day for 8 weeks

Locations

Country Name City State
Italy Hospital of Vipiteno-Sterzing Vipiteno BZ

Sponsors (2)

Lead Sponsor Collaborator
Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other changes in Montreal Cognitive Assessment score changes in Montreal Cognitive Assessment score, for evaluating the global cognition, are expected Montreal Cognitive Assessment was assessed at enrollment and after 8 weeks of treatment duration
Other changes in Frontal Assessment Battery score changes in Frontal Assessment Battery score, for evaluating the executive functions, are expected Frontal Assessment Battery was assessed at enrollment and after 8 weeks of treatment duration
Primary 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 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 SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration
Secondary change in LTP-like cortical plasticity change of MEP modulation after intermittent theta burst stimulation (iTBS) LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration
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