Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

Covid19 Clinical Trial

Official title:

Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591600
• Other study ID #: IVM-DOX
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: October 2020
• Source: Alkarkh Health Directorate-Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .

Description:

Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 14, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 86 Years

Eligibility

Inclusion Criteria:

• COVID-19 patients at any stage of this disease

Exclusion Criteria:

• Patients of allergic history to Ivermectin or to doxycyline

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Ivermectin and Doxycyline
Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
• Standard of care
Standard care Acetaminophen 500mg on need Vitamin C 1000mg twice/ day Zinc 75-125 mg/day Vitamin D3 5000IU/day Azithromycin 250mg/day for 5 days Oxygen therapy/ C-Pap if needed dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed Mechanical ventilation, if needed

Locations

Country	Name	City	State
Iraq	Akarkh Healt hdirectorate	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Alkarkh Health Directorate-Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients	Up to 8 weeks
Primary	Rate of progression disease	rate of patients under treatment who undergo progression of disease to a more advanced stage	up to 8 weeks
Secondary	Time to recovery	time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)	Up to 8 weeks