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

Primary Purpose

Anosmia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
platelets rich plasma
Sponsored by
Aya abdelnasser hassani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anosmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    value of platlet rich plasma

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Loss of Smell on the Olfactory Determination etermination Rating scale for COVID-19 (ODoR-19) at 6 Weeks
    40 of Participants With Treatment will be improved

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Aya abdelnasser hassani
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05395845
    Brief Title
    Value of Platelet-Rich Plasma in Post Severe Acute Respiratory Syndrome Coronavirus 2
    Official Title
    Value of Platelet-Rich Plasma in Post Severe Acute Respiratory Syndrome Coronavirus 2 Smell Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Aya abdelnasser hassani

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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. PRP contains many growth factor which have a neuroregenerative feature as well as therapeutic effect

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anosmia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    value of platlet rich plasma
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    platelets rich plasma
    Intervention Description
    local ingection of platelets rich plasma
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Loss of Smell on the Olfactory Determination etermination Rating scale for COVID-19 (ODoR-19) at 6 Weeks
    Description
    40 of Participants With Treatment will be improved
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    aya na hassani, bacalreos
    Phone
    01015582316
    Email
    yotaaya10@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ezzat mo saleh, profesor
    Phone
    01006722404
    Email
    ezzatsaleh@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32167747
    Citation
    Baig AM, Khaleeq A, Ali U, Syeda H. Evidence of the COVID-19 Virus Targeting the CNS: Tissue Distribution, Host-Virus Interaction, and Proposed Neurotropic Mechanisms. ACS Chem Neurosci. 2020 Apr 1;11(7):995-998. doi: 10.1021/acschemneuro.0c00122. Epub 2020 Mar 13.
    Results Reference
    background
    PubMed Identifier
    14755529
    Citation
    Chen X, Fang H, Schwob JE. Multipotency of purified, transplanted globose basal cells in olfactory epithelium. J Comp Neurol. 2004 Feb 16;469(4):457-74. doi: 10.1002/cne.11031.
    Results Reference
    background
    PubMed Identifier
    24587881
    Citation
    Woo SH, Jeong HS, Kim JP, Koh EH, Lee SU, Jin SM, Kim DH, Sohn JH, Lee SH. Favorable vocal fold wound healing induced by platelet-rich plasma injection. Clin Exp Otorhinolaryngol. 2014 Mar;7(1):47-52. doi: 10.3342/ceo.2014.7.1.47. Epub 2014 Feb 5.
    Results Reference
    background

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

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