Olfactory Disfunction and Co-ultraPEALut

Last updated: November 12, 2022
Sponsor: University Of Perugia
Overall Status: Completed

Phase

4

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04853836
20112020PGFN
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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, olfactoryhallucination)
  • previous sinonasal
  • nasopharyngeal tumors.

Study Design

Total Participants: 200
Study Start date:
November 15, 2020
Estimated Completion Date:
August 31, 2022

Study 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

Connect with a study center

  • Multicentric

    Roma,
    Italy

    Site Not Available

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