Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
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|ClinicalTrials.gov Identifier: NCT04343092|
Recruitment Status : Completed
First Posted : April 13, 2020
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
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|Condition or disease||Intervention/treatment||Phase|
|COVID 19||Drug: Ivermectin (IVM)||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)|
|Actual Study Start Date :||April 18, 2020|
|Actual Primary Completion Date :||May 31, 2020|
|Actual Study Completion Date :||June 1, 2020|
Experimental: Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily
Drug: Ivermectin (IVM)
Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Other Name: Ivermectin
- Number of Cured Patients [ Time Frame: 4 weeks ]Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
- Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group [ Time Frame: 4 week ]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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
-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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343092
|General Directorate of Medical City|
|Bagdad, Baghdad, Iraq, 964|
|Principal Investigator:||Faiq I Gorial, Professor||University of Baghdad|
|Study Chair:||Jawad I. Rasheed||Arab Board for Health Specialiazation in Iraq|
Documents provided by Faiq Gorial, University of Baghdad:
|Responsible Party:||Faiq Gorial, Professor and consultant rheumatologist, University of Baghdad|
|Other Study ID Numbers:||
|First Posted:||April 13, 2020 Key Record Dates|
|Results First Posted:||November 4, 2020|
|Last Update Posted:||November 4, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases