Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

Phase 1

Completed

• Conditions: Covid19
• Interventions: Drug: Ivermectin and Doxycyline; Drug: Standard of care

• Registration Number: NCT04591600
• Lead Sponsor: Alkarkh Health Directorate-Baghdad

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-09-30
• Status Verified: 2020-10
• Study Completion: 2020-10-14
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• COVID-19 patients at any stage of this disease

Exclusion Criteria

• Patients of allergic history to Ivermectin or to doxycyline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin-Doxycycline	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 of care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
Ivermectin-Doxycycline	Standard of care	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.
Control	Standard of care	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Akarkh Healt hdirectorate; 🇮🇶 Baghdad, Iraq