Ivermectin as a Novel Therapy in COVID-19 Treatment | NCT04403555

Studies
Ivermectin as a Novel Therapy in COVID-19 Treatment

NCT04403555

Sponsor

Tanta University

Status

Completed

Last Update Posted

Aug 2, 2021Actual

Enrollment

164Actual

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 31, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

May 23, 2020

First Submission Date that Met QC Criteria

May 23, 2020

First Posted Date

May 27, 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

Jul 29, 2021

Last Update Posted Date

Aug 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ivermectin	Experimental	Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days	Drug: Ivermectin
Standard of care	No Intervention	Standard of care treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivermectin	Drug	Ivermectin treatment	Ivermectin	iverzine, ivermectin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients with mortality	Improvement of survival	1 month

Secondary Outcomes

Measure	Description	Time Frame
Length of hospital stay	Effect on the length of hospital stay	1 month
The need for mechanical ventilation	Need for mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.

Exclusion Criteria:

Allergy or contraindication to the drugs used in the study.
Pregnant and lactating mothers.
Patients with cardiac problems.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sherief Abd-Elsalam, Ass. Prof.	ass. Prof. Tropical Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam		Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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