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

COVID 19 Clinical Trial

Official title:

Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (An Externally Controlled Pilot Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343092
• Other study ID #: PRO20040001
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19

Intervention

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

Locations

Country	Name	City	State
Iraq	General Directorate of Medical City	Bagdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cured Patients	Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.	4 weeks
Secondary	Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group	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	4 week