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Clinical Trials/NCT05395845
NCT05395845UnknownPhase 1

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

Aya abdelnasser hassani0 sites88 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Sponsor
Enrollment
88
Primary Endpoint
Change From Baseline in Loss of Smell on the Olfactory Determination etermination Rating scale for COVID-19 (ODoR-19) at 6 Weeks

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

value of platlet rich plasma

Experimental

Intervention: platelets rich plasma (Biological)

Outcomes

Primary Outcomes

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

Time Frame: baseline

40 of Participants With Treatment will be improved

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aya abdelnasser hassani
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Aya abdelnasser hassani

Principal Investigator

Assiut University

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