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
About this trial
This is an interventional treatment trial for Anosmia
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 )
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
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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