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Olfactory Disfunction and Co-ultraPEALut

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ClinicalTrials.gov Identifier: NCT04853836
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Arianna Di Stadio, 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.

Condition or disease Intervention/treatment Phase
Anosmia Covid19 Hyposmia Parosmia Treatment Compliance Combination Product: co-ultraPEALut Dietary Supplement: PEALut Procedure: Olfactory Rehab Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blinded randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investor will assign patients to one of the groups before Sniff test evaluation at T0
Primary Purpose: Treatment
Official Title: Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut
Estimated Study Start Date : April 25, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Placebo Comparator: Rehabilitation therapy only (control group)
Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)
Procedure: Olfactory Rehab
Olfactory Rehabilitation10 minutes twice a day for all the observation period

Active Comparator: Rehabilitation and treatment with PEA
Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement
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.

Active Comparator: PEA only
Daily treatment with PEA/Luteolin oral supplement
Dietary Supplement: PEALut
Oral PEALut (700 PEA + 70 Luteolin) 1 dose daily.




Primary Outcome Measures :
  1. Recovery of smell [ Time Frame: T1 (30 days), T2 (60 days), T3 (90 days) ]

    Change of Sniff scores from T0.The Sniffin' Sticks battery was administered following a previously established protocol, using pen-like devices filled with odorants.Three score subtests were conducted to measure olfactory function:

    1. detection threshold ("T", the lowest concentration at which an odor can be perceived),
    2. odor discrimination ("D", ability to distinguish between odors) and
    3. odor identification ("I" ability to assign names to odors). Possible scores ranged from 1-16 for the detection threshold subtest and 0-16 for both the discrimination and identification subtests. Adding these for yielded a TDI "Sniff score." Anosmia was defined as a score of <17, hyposmia by a score 17 to 30.75, and normosmia by a score of ≥31


Secondary Outcome Measures :
  1. Parosmia after treatment [ Time Frame: 60 days (T2) and 90 days (T3) ]
    Prevalence of anosmia among the groups in the recovery



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853836


Locations
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Italy
Multicentric
Roma, Italy
Contact: Arianna Di Stadio    00393356236711    ariannadistadio@hotmail.com   
Sponsors and Collaborators
University Of Perugia
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
Publications:

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Responsible Party: Arianna Di Stadio, Adjunct Professor, University Of Perugia
ClinicalTrials.gov Identifier: NCT04853836    
Other Study ID Numbers: 20112020PGFN
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shared, only anonymized data directly requested to PI
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Access Criteria: request to PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases