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Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

Primary Purpose

Covid19

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Ivermectin and Doxycyline
Standard of care
Sponsored by
Alkarkh Health Directorate-Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Ivermectin, Doxycycline, COVID-19, Coronavirus, SARS-CoV-2

Eligibility Criteria

16 Years - 86 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COVID-19 patients at any stage of this disease

Exclusion Criteria:

  • Patients of allergic history to Ivermectin or to doxycyline

Sites / Locations

  • Akarkh Healt hdirectorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ivermectin-Doxycycline

Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Mortality rate
The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
Rate of progression disease
rate of patients under treatment who undergo progression of disease to a more advanced stage

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2020
Last Updated
October 16, 2020
Sponsor
Alkarkh Health Directorate-Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04591600
Brief Title
Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients
Official Title
Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alkarkh Health Directorate-Baghdad

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Ivermectin, Doxycycline, COVID-19, Coronavirus, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin-Doxycycline
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ivermectin and Doxycyline
Other Intervention Name(s)
Stromectol and Doxycin
Intervention Description
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
Intervention Name(s)
Standard of care
Other Intervention Name(s)
Control arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Mortality rate
Description
The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
Time Frame
Up to 8 weeks
Title
Rate of progression disease
Description
rate of patients under treatment who undergo progression of disease to a more advanced stage
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Time to recovery
Description
time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COVID-19 patients at any stage of this disease Exclusion Criteria: Patients of allergic history to Ivermectin or to doxycyline
Facility Information:
Facility Name
Akarkh Healt hdirectorate
City
Baghdad
ZIP/Postal Code
14222
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

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