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

Anosmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05395845
• Other study ID #: PRP in anosmia
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: aya na hassani, bacalreos
• Phone: 01015582316
• Email: yotaaya10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• platelets rich plasma
local ingection of platelets rich plasma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aya abdelnasser hassani

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline