Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management

NCT ID: NCT04343092

Last Updated: 2020-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-18

Study Completion Date

2020-06-01

Brief Summary

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Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

Detailed Description

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Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.

The comparison group was a historical control population and data collected from the current study were compared to that historical control population

Conditions

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COVID 19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)

Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily

Group Type EXPERIMENTAL

Ivermectin (IVM)

Intervention Type DRUG

Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly

Interventions

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Ivermectin (IVM)

Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly

Intervention Type DRUG

Other Intervention Names

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Ivermectin

Eligibility Criteria

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Inclusion Criteria

-1. Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.

2\. Understands and agrees to comply with planned study procedures.

Exclusion Criteria

1. Patients with hypersensitivity or severe adverse effects to Ivermectin
2. Renal impairment
3. Hepatic impairment.
4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
5. Breast feeding.
6. Patient with covid 19 positive and mild no pneumonia
7. Children under the age of five or those who weigh less than 15 kilograms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Faiq Gorial

Professor and consultant rheumatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faiq I Gorial, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Jawad I. Rasheed

Role: STUDY_CHAIR

Arab Board for Health Specialiazation in Iraq

Locations

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General Directorate of Medical City

Baghdad, Baghdad Governorate, Iraq

Site Status

Countries

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Iraq

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO20040001

Identifier Type: -

Identifier Source: org_study_id