Clinical trial NCT04853836: Olfactory Disfunction and Co-ultraPEALut
Official title: Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anosmia
Covid19
Hyposmia
Parosmia
Treatment Compliance
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy
name: Federico II University
name: Humanitas Hospital, Italy
name: San Giovanni Addolorata Hospital
name: Policlinico Universitario, Catania
name: Azienda Ospedaliero-Universitaria Careggi
name: Azienda Ospedaliero Universitaria di Sassari
name: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
name: Ospedale Universitario di Genova, Italy
name: Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino
name: Ospedale Bufalini di Cesena, Italy
First posted: 2021-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded randomized clinical trial
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Recovery of smell
timeFrame: T1 (30 days), T2 (60 days), T3 (90 days)
Secondary outcomes:
measure: Parosmia after treatment
timeFrame: 60 days (T2) and 90 days (T3)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Multicentric
Study officials:
References:
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