Olfactory Disfunction and Co-ultraPEALut

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

Sponsors

Lead Sponsor: University Of Perugia

Collaborator: Ospedali Riuniti Ancona
University of Roma La Sapienza
Federico II University
Humanitas Hospital, Italy
San Giovanni Addolorata Hospital
Policlinico Universitario, Catania
Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero Universitaria di Sassari
Azienda Ospedaliera di Padova
Manchester Royal Eye Hospital

Source University Of Perugia
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 90 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/nasal spray (T0). Three groups received weekly olfactory training, and 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), while the one in spray group -nasal cortisone. Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days

Overall Status Not yet recruiting
Start Date 2021-04-25
Completion Date 2021-12-31
Primary Completion Date 2021-06-30
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Recovery of smell T1 (30 days), T2 (60 days), T3 (90 days)
Secondary Outcome
Measure Time Frame
Parosmia after treatment 60 days (T2) and 90 days (T3)
Enrollment 400
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: co-ultraPEALut

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

Arm Group Label: Rehabilitation and treatment with PEA

Intervention Type: Dietary Supplement

Intervention Name: PEALut

Description: Oral PEALut (700 PEA + 70 Luteolin) 1 dose daily.

Arm Group Label: PEA only

Intervention Type: Procedure

Intervention Name: Olfactory Rehab

Description: Olfactory Rehabilitation10 minutes twice a day for all the observation period

Arm Group Label: Rehabilitation therapy only (control group)

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Location
Facility: Contact: Multicentric Arianna Di Stadio 00393356236711 [email protected]
Location Countries

Italy

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Of Perugia

Investigator Full Name: Arianna Di Stadio

Investigator Title: Adjunct Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Rehabilitation therapy only (control group)

Type: Placebo Comparator

Description: Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)

Label: Rehabilitation and treatment with PEA

Type: Active Comparator

Description: Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement

Label: PEA only

Type: Active Comparator

Description: Daily treatment with PEA/Luteolin oral supplement

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Single-blinded randomized clinical trial

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Masking Description: The investor will assign patients to one of the groups before Sniff test evaluation at T0

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