Back to resultsEffectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Primary Purpose
COVID 19
Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Ivermectin (IVM)
Sponsored by
About this trial
This is an interventional treatment trial for COVID 19
Eligibility Criteria
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:
- 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
Sites / Locations
- General Directorate of Medical City
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Arm Description
Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04343092
Brief Title
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Official Title
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Arm Type
Experimental
Arm Description
Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily
Intervention Type
Drug
Intervention Name(s)
Ivermectin (IVM)
Other Intervention Name(s)
Ivermectin
Intervention Description
Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Primary Outcome Measure Information:
Title
Number of Cured Patients
Description
Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
Description
Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed
Time Frame
4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiq I Gorial, Professor
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jawad I. Rasheed
Organizational Affiliation
Arab Board for Health Specialiazation in Iraq
Official's Role
Study Chair
Facility Information:
Facility Name
General Directorate of Medical City
City
Bagdad
State/Province
Baghdad
ZIP/Postal Code
964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
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