A Phase 4 interventional study of co-ultraPEALut and Olfactory Rehab in Anosmia, Covid19 and Hyposmia, sponsored by University Of Perugia. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by University Of Perugia · Phase 4, Interventional, and Treatment
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.
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
180 studies on the registry are indexed under Anosmia; 45 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 114 interventional studies indexed under Anosmia.
Browse Anosmia studies →University Of Perugia is the lead sponsor of 55 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)
Procedure: Olfactory Rehab
Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement
Combination Product: co-ultraPEALut
Patients in this group only used a single dose of PEA-LUT
Drug: PEA-LUT 1 sachet
Patients in this group only used two doses of PEA-LUT
Drug: PEA-LUT 2 sachet day
Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.
Olfactory Rehabilitation10 minutes twice a day for all the observation period
Only 1 sachet day of PEA-LUT no olfactory training
2 sachets day of PEA-LUT no olfactory training
Recovery of smell
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
Time frame: T1 (30 days), T2 (60 days), T3 (90 days)
Parosmia after treatment
Prevalence of anosmia among the groups in the recovery
Time frame: 60 days (T2) and 90 days (T3)
Plan to share: Yes — Shared, only anonymized data directly requested to PI
Supporting information: Study protocol, Statistical analysis plan
Access criteria: request to PI
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Of Perugia