Back to resultsEfficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
Primary Purpose
Covid-19
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ivermectin impregnated mask
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 focused on measuring Covid-19, antiviral mask, nano ivermectin
Eligibility Criteria
Inclusion Criteria:
- health care personells and family contact of confirmed COVID-19 cases.
Exclusion Criteria:
- refusal of participate to use the masks.
- pregnancy or lactation known hypersensitivity to ivermectin.
Sites / Locations
- Zaky ArefRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ivermectin mask group
ordinary mask group
Arm Description
Contacts who will use ivermectin masks
Contacts who will use regular masks
Outcomes
Primary Outcome Measures
Number of persons in each group who Complain of any suspected Symptoms
( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)
Secondary Outcome Measures
Number of persons in each group who are diagnosed as COVID-19 patients
swab test
Full Information
NCT ID
NCT04723459
First Posted
January 20, 2021
Last Updated
March 15, 2021
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04723459
Brief Title
Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
Official Title
Nano-Ivermectin Impregnated Masks Versus Ordinary Surgical Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2021 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
March 28, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks
Detailed Description
Antiviral effecacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Covid-19, antiviral mask, nano ivermectin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin mask group
Arm Type
Active Comparator
Arm Description
Contacts who will use ivermectin masks
Arm Title
ordinary mask group
Arm Type
No Intervention
Arm Description
Contacts who will use regular masks
Intervention Type
Other
Intervention Name(s)
ivermectin impregnated mask
Intervention Description
mask with ivermectin nano solution
Primary Outcome Measure Information:
Title
Number of persons in each group who Complain of any suspected Symptoms
Description
( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)
Time Frame
within 14 days after enrollement
Secondary Outcome Measure Information:
Title
Number of persons in each group who are diagnosed as COVID-19 patients
Description
swab test
Time Frame
within 21 days after enrollement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
health care personells and family contact of confirmed COVID-19 cases.
Exclusion Criteria:
refusal of participate to use the masks.
pregnancy or lactation known hypersensitivity to ivermectin.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaky Aref
Phone
+201001771210
Email
doctor.aref@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed hosny hassaan
Phone
01115390073
Ext
002
Email
mohammedhosnyhassaan@yahoo.com
Facility Information:
Facility Name
Zaky Aref
City
Qina
ZIP/Postal Code
83511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaky Aref
Phone
01001771210
Ext
002
Email
doctor.aref@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Links:
URL
https://druginfo.nlm.nih.gov/drugportal/name/Ivermectin
Description
Related Info
Learn more about this trial
Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
We'll reach out to this number within 24 hrs