Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

NCT ID: NCT04591600

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-10-14

Brief 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. .

Detailed 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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ivermectin-Doxycycline

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 of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.

Group Type: EXPERIMENTAL

Ivermectin and Doxycyline

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Control

Control group: The patients in this group received only standard care which included all or some of the following, according to the clinical condition of each patient.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Stromectol and Doxycin; Control arm

Eligibility Criteria

Inclusion Criteria

• COVID-19 patients at any stage of this disease

Exclusion Criteria

• Patients of allergic history to Ivermectin or to doxycyline

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkarkh Health Directorate-Baghdad

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Sahib Abdulamir

M.B.Ch.,B., Phd Virology, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Akarkh Healt hdirectorate

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

IVM-DOX

Identifier Type: -

Identifier Source: org_study_id