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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

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.

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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

Resource links provided by the National Library of Medicine


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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591600


Locations
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Iraq
Akarkh Healt hdirectorate
Baghdad, Iraq, 14222
Sponsors and Collaborators
Alkarkh Health Directorate-Baghdad
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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    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents