Olfactory Disfunction and Co-ultraPEALut

• Status: Completed
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Of Perugia
• 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

Criteria

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.