Olfactory Disfunction and Co-ultraPEALut

University Of Perugia

Status and phase: Completed; Phase 4

Conditions: Anosmia; Hyposmia; Parosmia; Covid19; Treatment Compliance

Treatments: Drug: PEA-LUT 1 sachet; Procedure: Olfactory Rehab; Combination Product: co-ultraPEALut; Drug: PEA-LUT 2 sachet day

Study type: Interventional

Funder types: Other

Identifiers

NCT04853836

20112020PGFN

Details and patient eligibility

About

Olfactory dysfunction is common among patients with Corona-Virus-Infection-Disease (COVID)-19, and up to 30% of patients may report persistent disorders of smell or taste as a long-term sequelae. This randomized-controlled study has addressed to compare the efficacy of neuro-protective and anti-inflammatory agents palmitoylethanolamide (PEA) and Luteolin(Treatment) with control (olfactory training) in a cohort of patients who present persistent smell disorders after resolution from Covid-19 and negative swab for 4 months at least.

Full description

Patients ages 18 to 70 years with confirmed history of COVID-19 (positive nasopharyngeal swab for SARS-CoV-2) and subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative COVID-19 nasopharyngeal swab are eligible.

All patients will undergo nasal endoscopic examination to look for presence of polyps, masses, anatomic blockage, or other pathology which presence will require exclusion from the study. Patients then will be evaluated at the baseline with Sniffin' Sticks (Burghardt®, Wedel, Germany) prior to initiating olfactory training and/or supplement treatment (T0). One group received daily olfactory training, patients in the supplement group additionally received a daily oral tablet that contained PEA 700 mg and Luteolin 70 mg (Glialia ®, Epitech pharmaceutical, Milano, Italy), or 1 dose of PEA-LUT only or aTwo Dose of PEA-LUT.

Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 90 years with confirmed history of COVID-19 (positive nasopharyngeal swab for SARS-CoV-2)
• subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative COVID-19 nasopharyngeal swab

Exclusion criteria

• previous history of olfactory-gustatory disorders
• impaired cognitive function
• history of neurodegenerative disease
• medical therapy with possible effects on olfactory function
• presence of rhinological disorders (sinusitis, rhinosinusitis, sinonasal polyposis, atrophic rhinitis, allergy)
• history of chemo-radiotherapy of the head and neck region
• history of stroke or neurotrauma
• severe nasal blockage from stenosis of deformity
• severe psychiatric illness (e.g. schizophrenia, bipolar disorder, olfactory hallucination)
• previous sinonasal
• nasopharyngeal tumors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Rehabilitation therapy only (control group)

Placebo Comparator group

Description:

Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)

Treatment:

Procedure: Olfactory Rehab

Rehabilitation and treatment with PEA-LUT

Active Comparator group

Description:

Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement

Treatment:

Combination Product: co-ultraPEALut

Treatment with PEA-LUT one sachet daily

Active Comparator group

Description:

Patients in this group only used a single dose of PEA-LUT

Treatment:

Drug: PEA-LUT 1 sachet

Treatment with PEA-LUT two sachet daily

Active Comparator group

Description:

Patients in this group only used two doses of PEA-LUT

Treatment:

Drug: PEA-LUT 2 sachet day