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
About this trial
This is an interventional treatment trial for Anosmia
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
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
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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