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

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

Status: Completed

Conditions: COVID-19; Neurophysiologic Abnormality; Cognitive Deficit; Fatigue

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

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05311852

PEA-LUT-in-Post-Covid-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 2 patient groups, including a placebo group

PEA-LUT

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo