Efficacy of Nano-Ivermectin Impregnated Masks in Preventi... | NCT04723459

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

NCT04723459

Sponsor

South Valley University

Status

Unknown status

Last Update Posted

Mar 17, 2021Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Covid-19

Interventions

ivermectin impregnated mask

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2021Actual

Primary Completion Date

Feb 19, 2021Actual

Completion Date

Mar 28, 2021Estimated

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 22, 2021

First Posted Date

Jan 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ivermectin mask group	Active Comparator	Contacts who will use ivermectin masks	Other: ivermectin impregnated mask
ordinary mask group	No Intervention	Contacts who will use regular masks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ivermectin impregnated mask	Other	mask with ivermectin nano solution	Ivermectin mask group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zaky Aref	Contact	+201001771210		doctor.aref@hotmail.com
mohammed hosny hassaan	Contact	01115390073	002	mohammedhosnyhassaan@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zaky Aref	Recruiting	Qina		83511	Egypt

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

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

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided