Olfactory Disfunction and Co-ultraPEALut

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.

Conditions

• Anosmia
• Covid19
• Hyposmia
• Parosmia
• Treatment Compliance

Interventions

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

Sponsors & Collaborators

• Azienda Ospedaliera Ospedali Riuniti Marche Nord, Italy

  collaborator UNKNOWN

• Federico II University

  collaborator OTHER

• Humanitas Hospital, Italy

  collaborator OTHER

• San Giovanni Addolorata Hospital

  collaborator OTHER

• Policlinico Universitario, Catania

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Azienda Ospedaliero Universitaria di Sassari

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

  collaborator OTHER

• Ospedale Universitario di Genova, Italy

  collaborator UNKNOWN

• Istituto per la Sicurezza Sociale (ISS) della Repubblica di San Marino

  collaborator UNKNOWN

• Ospedale Bufalini di Cesena, Italy

  collaborator UNKNOWN

• University Of Perugia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-15

Primary Completion

2021-10-28

Completion

2022-08-31

Countries

• Italy

Study Locations