Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
intranasal ivermectin spray
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Ivermectin intranasal spray in covid19
Eligibility Criteria
Inclusion Criteria:
- early covid19 pateints
Exclusion Criteria:
- children and pregnant women
Sites / Locations
- Zaky ArefRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
intranasal Ivermectin group
Control group
Arm Description
Ivermectin group Patients who will receive intranasal ivermectin
patients who will receive regular protocol drugs
Outcomes
Primary Outcome Measures
progression of covid 19 clinical picture
progress of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)with radiological assesment and blood tests
Secondary Outcome Measures
Full Information
NCT ID
NCT04716569
First Posted
January 19, 2021
Last Updated
March 15, 2021
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04716569
Brief Title
Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19
Official Title
Faculty of Medicine ,South Valley University
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (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 showed a strong viricidal effect upon covid19 virus in vitro as proved by many authors according to many studies , covid virus stay in postnasal space for 4 days before starting general manifestation, so ivermectin mucoadhesive nanosuspension sprayed inside the nose and post nasal space may help in early management of covid19 and may play a great rule in prophylaxis as well
Detailed Description
150 patient with early covid is devided into two groups first group will receive regular protocol of drugs second group will receive ivermectin nasal spray in addition to regular protocl of drugs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Ivermectin intranasal spray in covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intranasal Ivermectin group
Arm Type
Experimental
Arm Description
Ivermectin group Patients who will receive intranasal ivermectin
Arm Title
Control group
Arm Type
Other
Arm Description
patients who will receive regular protocol drugs
Intervention Type
Drug
Intervention Name(s)
intranasal ivermectin spray
Intervention Description
usage of ivermectin as intranasal spray for treating early covid patiens
Primary Outcome Measure Information:
Title
progression of covid 19 clinical picture
Description
progress of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)with radiological assesment and blood tests
Time Frame
[ Time Frame: within 14 days after enrollement ]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
early covid19 pateints
Exclusion Criteria:
children and pregnant women
Facility Information:
Facility Name
Zaky Aref
City
Qinā
State/Province
Qina
ZIP/Postal Code
83511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaky Aref, MD
Phone
01001771210
Email
doctor.aref@hotmail.com
First Name & Middle Initial & Last Name & Degree
mohammed hosny hassaan, MD
Phone
00201115390073
Email
mohammedhosnyhassaan@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34163159
Citation
Aref ZF, Bazeed SEES, Hassan MH, Hassan AS, Rashad A, Hassan RG, Abdelmaksoud AA. Clinical, Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID-19. Int J Nanomedicine. 2021 Jun 15;16:4063-4072. doi: 10.2147/IJN.S313093. eCollection 2021.
Results Reference
derived
Learn more about this trial
Evaluation of Ivermectin Mucoadhesive Nanosuspension as Nasal Spray in Management of Early Covid-19
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