Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
1 other identifier
interventional
16
1 country
1
Brief Summary
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedStudy Start
First participant enrolled
April 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 4, 2020
November 1, 2020
1 month
April 5, 2020
June 11, 2020
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Cured Patients
Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
4 weeks
Secondary Outcomes (1)
Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
4 week
Study Arms (1)
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
EXPERIMENTALIvermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily
Interventions
Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Eligibility Criteria
You may qualify if:
- 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.
- \. Understands and agrees to comply with planned study procedures.
You may not qualify if:
- Patients with hypersensitivity or severe adverse effects to Ivermectin
- Renal impairment
- Hepatic impairment.
- Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
- Breast feeding.
- Patient with covid 19 positive and mild no pneumonia
- Children under the age of five or those who weigh less than 15 kilograms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Directorate of Medical City
Baghdad, Baghdad Governorate, 964, Iraq
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
small sample size; single center design, and short time for the study
Results Point of Contact
- Title
- Faiq I. Gorial
- Organization
- College of Medicine-University of Baghdad
Study Officials
- PRINCIPAL INVESTIGATOR
Faiq I Gorial, Professor
University of Baghdad
- STUDY CHAIR
Jawad I. Rasheed
Arab Board for Health Specialiazation in Iraq
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and consultant rheumatologist
Study Record Dates
First Submitted
April 5, 2020
First Posted
April 13, 2020
Study Start
April 18, 2020
Primary Completion
May 31, 2020
Study Completion
June 1, 2020
Last Updated
November 4, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share