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临床试验/NCT05395845
NCT05395845Unknown早期 1 期

Value of Platelet-Rich Plasma in Post Severe Acute Respiratory Syndrome Coronavirus 2 Smell Disorders

Aya abdelnasser hassani0 个研究点目标入组 88 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
早期 1 期
发起方
入组人数
88
主要终点
Change From Baseline in Loss of Smell on the Olfactory Determination etermination Rating scale for COVID-19 (ODoR-19) at 6 Weeks

研究概览

简要总结

The study will be conducted to evaluate :

The efficacy of Platelet Rich plasma in treatment of smell disorders post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via the growth factors involved in accelerating and enhancing healing.

详细描述

Smell is essential sensory function for good quality of life as its preservation helps in identifying several harmful odors .

Viral URTIs can lead to olfactory disorders of varying degree and duration 70% of URTI caused by rhinovirus, adenovirus ,influenza and parainfluanza virus Smell disorders are divided into two types Quantitative (anosmia and hyposmia) Qualitative (parosmia and phantosmia) Anosmia is a total loss of smell . hyposmia is a decrease in the sense of smell. parosmia is a distortion of the smell in presence of an existing stimulus . Phantosmia (Cacosmia) is distortion of the smell in absence of an existing stimulus severe acute respiratory syndrome coronavirus2 (SARS-coV-2)which is a global pandemic started in china 2019 one of respiratory tract infection that affect olfaction and cause varying types of smell impairment.

Smell disorders seem to be more common in SARS-coV2 than other respiratory infections as in some patient persist for long time after resolution of respiratory symptoms Current evidence suggest that olfactory impairment results from propensity of SARS-coV2 for neuroinvasion and neurotrophic activities .

Majority of patients experience some level of smell impairment most often temporary as olfactory neuroepithelium has regenerative power .

European study published on 16 July 2020 reported that some patient affected by SARS -coV2 come solely with olfactory symptoms and most of patient recovered within 2 weeks ,smell not recovered in one quarter of patient 15 Once olfactory dysfunction persists more than 2 weeks a therapy should be considered to avoid persistent impairment of smell One of therapies can be used in ttt of smell disorders ( Platelet _rich plasma) PRP is a process in which a small amount of blood from test subject is separated by special centrifugation process.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient age above 18 who suffer from anosmia post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 more than two weeks
  • Normal airway passage
  • CT Nose and Para nasal sinuses does not show any nasal lesion

排除标准

  • Lesions obstruct airway as nasal polyps, tumors, chronic sinusitis and severe nasal septum deviation
  • Previous Sino nasal surgery
  • Atrophic rhinitis
  • Diabetic patients and those with medical history of bleeding disorders
  • Recieving any medication affect platelets or bone marrow function for 2 weeks prior to testing

结局指标

主要结局

Change From Baseline in Loss of Smell on the Olfactory Determination etermination Rating scale for COVID-19 (ODoR-19) at 6 Weeks

时间窗: baseline

40 of Participants With Treatment will be improved

次要结局

未报告次要终点

研究者

发起方
Aya abdelnasser hassani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aya abdelnasser hassani

Principal Investigator

Assiut University

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