Olfactory Disfunction After COVID-19: Conventional Therapy Versus Intervention Treatment With Co-ultraPEALut
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recovery of smell
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investor will assign patients to one of the groups before Sniff test evaluation at T0
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Rehabilitation therapy only (control group)
Olfactory training / stimulation through Sniffin' Sticks, administered twice every day (10 minutes session)
干预措施: Olfactory Rehab (Procedure)
Rehabilitation and treatment with PEA-LUT
Olfactory training / stimulation through Sniffin' Sticks, plus daily treatment with PEA/Luteolin oral supplement
干预措施: co-ultraPEALut (Combination Product)
Treatment with PEA-LUT one sachet daily
Patients in this group only used a single dose of PEA-LUT
干预措施: PEA-LUT 1 sachet (Drug)
Treatment with PEA-LUT two sachet daily
Patients in this group only used two doses of PEA-LUT
干预措施: PEA-LUT 2 sachet day (Drug)
结局指标
主要结局
Recovery of smell
时间窗: 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
次要结局
- Parosmia after treatment(60 days (T2) and 90 days (T3))
研究者
Arianna Di Stadio
Adjunct Professor
University Of Perugia