Ivermectin in Treatment of COVID-19 | NCT04445311

Studies
Ivermectin in Treatment of COVID-19

NCT04445311

Sponsor

Zagazig University

Status

Unknown status

Last Update Posted

Jun 24, 2020Actual

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

COVID

Interventions

Ivermectin

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

Jun 2020

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

May 31, 2020Actual

Primary Completion Date

Jul 30, 2020Estimated

Completion Date

Aug 15, 2020Estimated

First Submitted Date

Jun 19, 2020

First Submission Date that Met QC Criteria

Jun 19, 2020

First Posted Date

Jun 24, 2020Actual

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

Jun 19, 2020

Last Update Posted Date

Jun 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt

Detailed Description

Not provided

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ivermectin group	Experimental	group that will receive ivermectin plus standard of care ttt	Drug: Ivermectin
Control group	No Intervention	group that will receive standard of care ttt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivermectin	Drug	3 successive days ttt of ivermectin started within 48 hours of symptoms	Ivermectin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to be symptoms free	duration from day 1 symptoms till 3 days without symptoms	within 21 days after enrollment

Secondary Outcomes

Measure	Description	Time Frame
hospitalization	need hospital admission	within 21 days after enrollement
Mechanical ventilation	need mechanical ventilation	within 21 days after enrollement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 patients during period of the study more than 18 years old

Exclusion Criteria:

refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with ivermectin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Waheed Shouman, MD	Contact	+201114812048		shouman66@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Waheed Shouman	Recruiting	Zagazig	Sharqia Province	44519	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D007559	Ivermectin

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided