Olfactory Disfunction and Co-ultraPEALut

Phase 4

Completed

• Conditions: Anosmia; Hyposmia; Covid19; Parosmia; Treatment Compliance
• Interventions: Procedure: Olfactory Rehab; Combination Product: co-ultraPEALut; Drug: PEA-LUT 1 sachet; Drug: PEA-LUT 2 sachet day

• Registration Number: NCT04853836
• Lead Sponsor: University Of Perugia

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2020-11-15
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Primary Completion: 2021-10-28
• Study Completion: 2022-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-12
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation therapy only (control group)	Olfactory Rehab	Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)
Rehabilitation and treatment with PEA-LUT	co-ultraPEALut	Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement
Treatment with PEA-LUT one sachet daily	PEA-LUT 1 sachet	Patients in this group only used a single dose of PEA-LUT
Treatment with PEA-LUT two sachet daily	PEA-LUT 2 sachet day	Patients in this group only used two doses of PEA-LUT

Primary Outcome Measures

Name	Time	Method
Recovery of smell	T1 (30 days), T2 (60 days), T3 (90 days)	Change of Sniff scores from T0.The Sniffin' Sticks battery was administered following a previously established protocol, using pen-like devices filled with odorants.Three score subtests were conducted to measure olfactory function: 1. detection threshold ("T", the lowest concentration at which an odor can be perceived),; 2. odor discrimination ("D", ability to distinguish between odors) and; 3. odor identification ("I" ability to assign names to odors). Possible scores ranged from 1-16 for the detection threshold subtest and 0-16 for both the discrimination and identification subtests. Adding these for yielded a TDI "Sniff score." Anosmia was defined as a score of \<17, hyposmia by a score 17 to 30.75, and normosmia by a score of ≥31

Secondary Outcome Measures

Name	Time	Method
Parosmia after treatment	60 days (T2) and 90 days (T3)	Prevalence of anosmia among the groups in the recovery

Trial Locations

Locations (1)

Multicentric; 🇮🇹 Roma, Italy