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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343092
Recruitment Status : Completed
First Posted : April 13, 2020
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Faiq Gorial, University of Baghdad

Study Description
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Brief Summary:
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Ivermectin (IVM) Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Iraq
General Directorate of Medical City
Bagdad, Baghdad, Iraq, 964
Sponsors and Collaborators
University of Baghdad
Investigators
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Principal Investigator: Faiq I Gorial, Professor University of Baghdad
Study Chair: Jawad I. Rasheed Arab Board for Health Specialiazation in Iraq
  Study Documents (Full-Text)

Documents provided by Faiq Gorial, University of Baghdad:
Study Protocol and Statistical Analysis Plan  [PDF] July 15, 2020

More Information
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Responsible Party: Faiq Gorial, Professor and consultant rheumatologist, University of Baghdad
ClinicalTrials.gov Identifier: NCT04343092    
Other Study ID Numbers: PRO20040001
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents