Ivermectin In Treatment of COVID 19 Patients | NCT04425707

Studies
Ivermectin In Treatment of COVID 19 Patients

NCT04425707

Sponsor

Ministry of Health and Population, Egypt

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Covid19

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

Jun 9, 2020Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 11, 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 8, 2020

Last Update Posted Date

Jun 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Ehab kamal, general director of fever hospitals, Ministry of Health and Population, EgyptPrincipal Investigator

Lead Sponsor

Ministry of Health and Population, EgyptOTHER_GOV

Collaborators

Not provided

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

as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment

Detailed Description

the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A ivermectin alone	Experimental	ivermectin will be administarted alone to COVID 19 patients	Drug: Ivermectin
B standard care alone	Experimental	standard care will be administarted alone	Drug: Ivermectin
C ivermectin added to standard of care	Active Comparator	ivermectin will be administarted in adition to standard care	Drug: Ivermectin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivermectin	Drug	use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt	A ivermectin alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to evaluate the role of Ivermectin as a line of treatment for COVID 19	the role of ivermectin in the cure of COVID 19 patients	2 months

Secondary Outcomes

Measure	Description	Time Frame
To asses the rate of viral clearance in comparison to other treatment protocols.	to compare the results of ivermectin with the standard care	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap

Exclusion Criteria:

Contraindications for the drug: hypersensitivity.
Any medications with possible drug interactions.
Severe cases.
Any malignant condition.
Pregnant females.
Breast feeding females.
Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.

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
ehab ah kamal, MD	Contact	01006162663		ehabkamal2011@hotmail.com
noha mo asem, MD	Contact

Overall Officials

Name	Affiliation	Role
houssam ho masoud, MD	COVID sceintific comittee ministry of health and population	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
isolation and referal hospitals for COVID 19 patients	Recruiting	Cairo			Egypt

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

Intervention Browse Module

MeSH Terms

ID	Term
D007559	Ivermectin
D006886	Hydroxychloroquine

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided