Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

• ClinicalTrials.gov Identifier: NCT04591600
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Alkarkh Health Directorate-Baghdad
• Information provided by (Responsible Party): Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad

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. .

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: Ivermectin and Doxycyline; Drug: Standard of care	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: October 14, 2020

Arms and Interventions

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 Name: 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 Name: 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 Name: Control arm

Outcome Measures

Primary Outcome Measures :

1. Mortality rate [ Time Frame: Up to 8 weeks ]
   The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
2. Rate of progression disease [ Time Frame: up to 8 weeks ]
   rate of patients under treatment who undergo progression of disease to a more advanced stage

Secondary Outcome Measures :

1. Time to recovery [ Time Frame: Up to 8 weeks ]
   time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 86 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• COVID-19 patients at any stage of this disease

Exclusion Criteria:

• Patients of allergic history to Ivermectin or to doxycyline

Contacts and Locations

Locations

Iraq

Akarkh Healt hdirectorate

Baghdad, Iraq, 14222

Sponsors and Collaborators

Alkarkh Health Directorate-Baghdad

More Information

• Responsible Party: Ahmed Sahib Abdulamir, M.B.Ch.,B., Phd Virology, Professor, Alkarkh Health Directorate-Baghdad
• ClinicalTrials.gov Identifier: NCT04591600
• Other Study ID Numbers: IVM-DOX
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad:

Ivermectin; Doxycycline; COVID-19; Coronavirus; SARS-CoV-2

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ivermectin; Antiparasitic Agents; Anti-Infective Agents