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Efficacy of Ivermectin as Add on Therapy in COVID19 Patients

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
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Faiq Gorial, University of Baghdad

Brief Summary:
Comparing the efficacy of add on therapy of Ivermectin in covid19 patients to non ivermermectin group

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

Detailed Description:
Comparing the efficacy of add on therapy of single dose 12mg Ivermectin to hydroxychloroquine (HCQ) and azithromycin (AZT) in covid19 patients to non ivermermectin group ( HCQ+AZT)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Ivermectin as Add on Therapy in COVID19 Patients: A Pilot Randomized Study
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

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

No Intervention: Hydroxychloroquin+ azithromycin
Hydroxychloroquine 400mg/daily+ azithromycin 500mg daily



Primary Outcome Measures :
  1. Number of cured patients [ Time Frame: 4 weeks ]
    Number of patients cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for covid19 (PCR) in addtion to Chest xary


Secondary Outcome Measures :
  1. Mean time to cure of the covid 19 patients [ Time Frame: 4 week ]
    comparing mean time of cure of patients in IVM group with the the non IVM group



Information from the National Library of Medicine

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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

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
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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
Last Update Posted: June 5, 2020
Last Verified: June 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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Ivermectin
Antiparasitic Agents
Anti-Infective Agents