NCT05395845

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2022

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

March 6, 2022

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

value of platlet rich plasma

EXPERIMENTAL
Biological: platelets rich plasma

Interventions

local ingection of platelets rich plasma

value of platlet rich plasma

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 32167747BACKGROUND
  • 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.

    PMID: 14755529BACKGROUND
  • 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.

    PMID: 24587881BACKGROUND

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

aya na hassani, bacalreos

CONTACT

ezzat mo saleh, profesor

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2022

First Posted

May 27, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

May 27, 2022

Record last verified: 2022-05