Anosmia, Covid19, Hyposmia, Parosmia, Treatment Compliance
Conditions
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 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
Interventions
COMBINATION_PRODUCTco-ultraPEALut
Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.
PROCEDUREOlfactory Rehab
Olfactory Rehabilitation10 minutes twice a day for all the observation period
DRUGPEA-LUT 1 sachet
Only 1 sachet day of PEA-LUT no olfactory training
2 sachets day of PEA-LUT no olfactory training
Sponsors
Azienda 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
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
Intervention model description
Single-blinded randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of smell | 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
| Measure | Time frame | Description |
|---|---|---|
| Parosmia after treatment | 60 days (T2) and 90 days (T3) | Prevalence of anosmia among the groups in the recovery |
Countries
Italy
Outcome results
None listed