NCT04853836

Olfactory Disfunction and Co-ultraPEALut

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Anosmia
• Covid19
• Hyposmia
• Parosmia
• Treatment Compliance

Interventions

Type	Name	Description
COMBINATION_PRODUCT	co-ultraPEALut	Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.
PROCEDURE	Olfactory Rehab	Olfactory Rehabilitation10 minutes twice a day for all the observation period
DRUG	PEA-LUT 1 sachet	Only 1 sachet day of PEA-LUT no olfactory training
DRUG	PEA-LUT 2 sachet day	2 sachets day of PEA-LUT no olfactory training

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-10-28
• Completion: 2022-08-31
• First posted: 2021-04-21
• Last updated: 2022-11-16

Locations

1 site across 1 country: Italy