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

Tracking Information

• First Submitted Date: October 15, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 16, 2020)

• Mortality rate [ Time Frame: Up to 8 weeks ]
  The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 16, 2020)

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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Drug: Ivermectin and Doxycyline
  • Drug: Standard of care
• 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.
  Intervention: Drug: Standard of care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2020): 140
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 14, 2020
• Actual Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• COVID-19 patients at any stage of this disease

Exclusion Criteria:

• Patients of allergic history to Ivermectin or to doxycyline

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 86 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iraq

Administrative Information

• NCT Number: NCT04591600
• Other Study ID Numbers: IVM-DOX
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad
• Study Sponsor: Alkarkh Health Directorate-Baghdad
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Alkarkh Health Directorate-Baghdad
• Verification Date: October 2020