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Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

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

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE July 1, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
140
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 14, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • COVID-19 patients at any stage of this disease

Exclusion Criteria:

  • Patients of allergic history to Ivermectin or to doxycyline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 86 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iraq
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04591600
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Sahib Abdulamir, Alkarkh Health Directorate-Baghdad
Study Sponsor  ICMJE Alkarkh Health Directorate-Baghdad
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alkarkh Health Directorate-Baghdad
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP