Adverse Effects of Ivermectin Used in Egypt During COVID-19 | NCT04747678

Studies
Adverse Effects of Ivermectin Used in Egypt During COVID-19

NCT04747678

Sponsor

Menoufia University

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Covid19
Ivermectin Poisoning
Drug Toxicity
Drug Side Effect

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2021Estimated

Primary Completion Date

Feb 28, 2021Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Feb 1, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 10, 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

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ahmed mohamed esmat fahim mansour, Principal Investigator, Menoufia UniversityPrincipal Investigator

Lead Sponsor

Menoufia UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Detailed Description

ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivermectin	Drug	retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020	all data will be collected from retrospective manner as a retrospective study	the data will be collected from February 2021 to march 2021

Secondary Outcomes

Measure	Description	Time Frame
all data will be arranged according to time and dose manner	data for each dose will be identified together	February to match 2021

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

all healthy and diseased people who used ivermectin the last three months either as a treatment or as a prophylaxis with mention of the doses used and the adverse effects experienced during and after the usage

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Mansour		Shibīn al Kawm	Menoufia	24222	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D064420	Drug-Related Side Effects and Adverse Reactions

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

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided