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

Overview

Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)

Full Title of Study: “Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2020

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

Interventions

  • Drug: Ivermectin (IVM)
    • Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly

Arms, Groups and Cohorts

  • Experimental: Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
    • Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Baghdad
  • Provider of Information About this Clinical Study
    • Principal Investigator: Faiq Gorial, Professor and consultant rheumatologist – University of Baghdad
  • Overall Official(s)
    • Faiq I Gorial, Professor, Principal Investigator, University of Baghdad
    • Jawad I. Rasheed, Study Chair, Arab Board for Health Specialiazation in Iraq

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