Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff

March 15, 2021 updated by: Zaky Aref, South Valley University

Nano-Ivermectin Impregnated Masks Versus Ordinary Surgical Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivermectin mask group
Contacts who will use ivermectin masks
Other: ivermectin impregnated mask
mask with ivermectin nano solution
No Intervention: ordinary mask group
Contacts who will use regular masks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of persons in each group who Complain of any suspected Symptoms
Time Frame: within 14 days after enrollement
( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)
within 14 days after enrollement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of persons in each group who are diagnosed as COVID-19 patients
Time Frame: within 21 days after enrollement
swab test
within 21 days after enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2021

Primary Completion (Actual)

February 19, 2021

Study Completion (Anticipated)

March 28, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU MED CIT0 23 4 21 1 121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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