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Completed

NCT Number: NCT04853836

Olfactory Disfunction and 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

co-ultraPEALut

Combination Product

Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.

Olfactory Rehab

Procedure

Olfactory Rehabilitation10 minutes twice a day for all the observation period

PEA-LUT 1 sachet

Drug

Only 1 sachet day of PEA-LUT no olfactory training

PEA-LUT 2 sachet day

Drug

2 sachets day of PEA-LUT no olfactory training

Primary outcomes

  1. 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:

    • 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 outcomes

  1. Parosmia after treatment

    Time frame: 60 days (T2) and 90 days (T3)

    Prevalence of anosmia among the groups in the recovery

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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