CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
co-ultraPEALut +3 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04853836
NCT04853836Phase 4Completed
CompareCT.gov

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

University Of Perugia·interventional·Posted Apr 21, 2021·Updated Nov 16, 2022

In Brief

A Phase 4 clinical trial evaluating co-ultraPEALut, Olfactory Rehab, and 2 other interventions for Anosmia and 4 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnosmia, Covid19, Hyposmia, Parosmia, Treatment Compliance
CountriesItaly
CollaboratorsAzienda Ospedaliera Ospedali Riuniti Marche Nord, Italy, Federico II University, Humanitas Hospital, Italy, San Giovanni Addolorata Hospital, Policlinico Universitario, Catania, Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero Universitaria di Sassari, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Ospedale Universitario di Genova, Italy, Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino, Ospedale Bufalini di Cesena, Italy

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedApr 21, 2021
Enrollment StartNov 15, 2020
Primary CompletionOct 28, 2021
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.2 years ago

Interventions

co-ultraPEALutcombination

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

Olfactory Rehabprocedure

Olfactory Rehabilitation10 minutes twice a day for all the observation period

PEA-LUT 1 sachetdrug

Only 1 sachet day of PEA-LUT no olfactory training

PEA-LUT 2 sachet daydrug

2 sachets day of PEA-LUT no olfactory training