Olfactory Disfunction and Co-ultraPEALut

November 12, 2022 updated by: Arianna Di Stadio, University Of Perugia

Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Multicentric

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Rehabilitation therapy only (control group)
Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)
Procedure: Olfactory Rehab
Olfactory Rehabilitation10 minutes twice a day for all the observation period
Active Comparator: Rehabilitation and treatment with PEA-LUT
Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement
Combination product: co-ultraPEALut
Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.
Active Comparator: Treatment with PEA-LUT one sachet daily
Patients in this group only used a single dose of PEA-LUT
Drug: PEA-LUT 1 sachet
Only 1 sachet day of PEA-LUT no olfactory training
Active Comparator: Treatment with PEA-LUT two sachet daily
Patients in this group only used two doses of PEA-LUT
Drug: PEA-LUT 2 sachet day
2 sachets day of PEA-LUT no olfactory training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of smell
Time Frame: 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
T1 (30 days), T2 (60 days), T3 (90 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parosmia after treatment
Time Frame: 60 days (T2) and 90 days (T3)
Prevalence of anosmia among the groups in the recovery
60 days (T2) and 90 days (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Collaborators

Federico II University
Azienda Ospedaliero-Universitaria Careggi
Humanitas Hospital, Italy
San Giovanni Addolorata Hospital
Policlinico Universitario, Catania
Azienda Ospedaliero Universitaria di Sassari
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy
Ospedale Universitario di Genova, Italy
Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino
Ospedale Bufalini di Cesena, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

October 28, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 12, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20112020PGFN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Shared, only anonymized data directly requested to PI

IPD Sharing Access Criteria

request to PI

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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