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Olfactory Disfunction and Co-ultraPEALut

Sponsor
University Of Perugia (Other)
Overall Status
Completed
CT.gov ID
NCT04853836
Collaborator
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy (Other), Federico II University (Other), Humanitas Hospital, Italy (Other), San Giovanni Addolorata Hospital (Other), Policlinico Universitario, Catania (Other), Azienda Ospedaliero-Universitaria Careggi (Other), Azienda Ospedaliero Universitaria di Sassari (Other), Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Other), Ospedale Universitario di Genova, Italy (Other), Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino (Other), Ospedale Bufalini di Cesena, Italy (Other)
200
Enrollment
1
Location
2
Arms
10.5
Actual Duration (Months)
19
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: co-ultraPEALut
  • Procedure: Olfactory Rehab
 Phase 4

Detailed Description

Patients ages 18 to 90 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/nasal spray (T0). Three groups received weekly olfactory training, and 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), while the one in spray group -nasal cortisone.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blinded randomized clinical trialSingle-blinded randomized clinical trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investor will assign patients to one of the groups before Sniff test evaluation at T0
Primary Purpose:
Treatment
Official Title:
Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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: detection threshold ("T", the lowest concentration at which an odor can be perceived), odor discrimination ("D", ability to distinguish between odors) and 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

  1. Parosmia after treatment [60 days (T2) and 90 days (T3)]

    Prevalence of anosmia among the groups in the recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Multicentric Roma Italy

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Arianna Di Stadio, Adjunct Professor, University Of Perugia
ClinicalTrials.gov Identifier:
NCT04853836
Other Study ID Numbers:
  • 20112020PGFN
First Posted:
Apr 21, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
COVID-19
Anosmia
Olfaction Disorders

Study Results

No Results Posted as of Oct 26, 2021