CompletedPhase 4

Olfactory Disfunction and Co-ultraPEALut

Italy200 participantsStarted 2020-11-15

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Recovery of smell

Timeframe: T1 (30 days), T2 (60 days), T3 (90 days)

Trial details

NCT IDNCT04853836

SponsorUniversity Of Perugia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-28

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