Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

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

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. .

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Ivermectin and Doxycyline; Drug: Standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 14222
    • Akarkh Healt hdirectorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 84 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COVID-19 patients at any stage of this disease

Exclusion Criteria:

• Patients of allergic history to Ivermectin or to doxycyline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Stromectol and Doxycin; 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; Other Names: Control arm
Active Comparator: 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.	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; Other Names: Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients	Up to 8 weeks
Rate of progression disease	rate of patients under treatment who undergo progression of disease to a more advanced stage	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recovery	time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Alkarkh Health Directorate-Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; Doxycycline; Ivermectin
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: IVM-DOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No