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

Phase 1

Completed

• Conditions: COVID 19
• Interventions: Drug: Ivermectin (IVM)

• Registration Number: NCT04343092
• Lead Sponsor: University of Baghdad

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

Study Timeline

• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Study Start: 2020-04-18
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-01
• Results First Submitted: 2020-06-11
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Results First Posted: 2020-11-04
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)	Ivermectin (IVM)	Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily

Primary Outcome Measures

Name	Time	Method
Number of Cured Patients	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

Name	Time	Method
Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group	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

Trial Locations

Locations (1)

General Directorate of Medical City; 🇮🇶 Bagdad, Baghdad, Iraq