NCT04591600

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 15, 2020

Last Update Submit

October 16, 2020

Conditions

Covid19

Keywords

IvermectinDoxycyclineCOVID-19CoronavirusSARS-CoV-2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Time to recovery

    Up to 8 weeks

Study Arms (2)

Ivermectin-Doxycycline

EXPERIMENTAL

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 DoxycylineDrug: Standard of care

Control

ACTIVE COMPARATOR

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

Interventions

Ivermectin and DoxycylineDRUG

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.

Also known as: Stromectol and Doxycin
Ivermectin-Doxycycline
Standard of careDRUG

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

Also known as: Control arm
ControlIvermectin-Doxycycline

Eligibility Criteria

Age16 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • COVID-19 patients at any stage of this disease

You may not qualify if:

  • Patients of allergic history to Ivermectin or to doxycyline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akarkh Healt hdirectorate

Baghdad, 14222, Iraq

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

IvermectinStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.Ch.,B., Phd Virology, Professor

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 19, 2020

Study Start

July 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 14, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)