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Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia

Primary Purpose

Anosmia

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
intranasal spray ivermectin
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anosmia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • post covid19 anosmia
  • negative swab test for covid19

Exclusion Criteria:

  • other types of anosmia ,
  • no local or central other causes of anosmia
  • still active covid 19 pateints ( positive swab test )

Sites / Locations

  • Zaky ArefRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intranasal Ivermectin group

saline nasal spray

Arm Description

49 pateints with anosmia received ivermectin nanosuspension nasal spray

47 pateints with anosmia received saline nasal spray

Outcomes

Primary Outcome Measures

regaining of smell
regaining of smell

Secondary Outcome Measures

Full Information

First Posted
June 30, 2021
Last Updated
April 14, 2022
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04951362
Brief Title
Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia
Official Title
Studying the Expected Effect of Ivermectin Nanosuspension as Nasal Spray Upon Post covid19 Persistant Anosmia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
May 12, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia
Detailed Description
ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia as one of the most characteresic symptoms of covid19 infection

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
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intranasal Ivermectin group
Arm Type
Active Comparator
Arm Description
49 pateints with anosmia received ivermectin nanosuspension nasal spray
Arm Title
saline nasal spray
Arm Type
Placebo Comparator
Arm Description
47 pateints with anosmia received saline nasal spray
Intervention Type
Drug
Intervention Name(s)
intranasal spray ivermectin
Other Intervention Name(s)
saline spray
Intervention Description
intranasal spray of saline
Primary Outcome Measure Information:
Title
regaining of smell
Description
regaining of smell
Time Frame
within 14 days after enrollemen ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post covid19 anosmia negative swab test for covid19 Exclusion Criteria: other types of anosmia , no local or central other causes of anosmia still active covid 19 pateints ( positive swab test )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaky Aref, MD
Phone
+201001771210
Email
doctor.aref@hotmail.com
Facility Information:
Facility Name
Zaky Aref
City
Qina
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaky Aref
Phone
01001771210
Email
doctor.aref@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36164334
Citation
Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Ghweil AA, Sayed MAA, Rashad A, Mansour H, Abdelmaksoud AA. Possible Role of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Recovery of Post-COVID-19 Anosmia. Infect Drug Resist. 2022 Sep 19;15:5483-5494. doi: 10.2147/IDR.S381715. eCollection 2022.
Results Reference
derived

Learn more about this trial

Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia

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