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

May 25, 2022 updated by: Aya abdelnasser hassani

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: value of platlet rich plasma
Biological: platelets rich plasma
local ingection of platelets rich plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya abdelnasser hassani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP in anosmia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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