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Safety & Efficacy of Low Dose Aspirin / Ivermectin Combination Therapy for Treatment of Covid-19 Patients (IVCOM)

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19 Therapies

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Willingness to comply with all study procedures and availability over the study duration *Patients aged above 18years to 64 years
  • PCR positive for SARS-Cov-2 (COVID-19) from any of the MOH COVID-19 accredited testing laboratories
  • Moderately ill COVID-19 patients score 3(Hospitalized with no oxygen therapy) to 4 (Hospitalized with oxygen by mask or nasal prongs) according to the WHO ordinal scale for clinical improvement which translates to moderate to severe COVID-19 patients according to the Ministry of Health Uganda COVID-19 disease category.

Exclusion criteria:

  • Participants with known hypersensitivity to Ivermectin
  • Clinical diagnosis of severe renal and hepatic impairment.
  • Pregnancy or breast feeding.
  • Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affected ivermectin disposition and clinical outcomes
  • Co-morbidities including asthma
  • Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years
  • Persons clinically diagnosed with and receiving treatment for any diathesis and PUD
  • Active participation in another clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Arm1 (Control group)

    Arm 2

    Arm 3

    Arm Description

    standard of care

    Drug: 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)

    3-day Ivermectin 600 mcg/kg/day/14-day 75mgASA/day + standard of care (Intervention 2)

    Outcomes

    Primary Outcome Measures

    SARS COV 2 Viral clearance
    SARS COV 2 Viral load
    World Health Organization COVID-19 ordinal improvement score
    Minimum score is 0 (un infected, no clinical or virological evidence of infection) Maximum sore is 8 (death) Higher scores mean a worse outcome, low scores mean a better outcome

    Secondary Outcome Measures

    Clinical recovery
    disappearance or cessation of COVID-19 associated symptoms
    Spectrum and severity of adverse events
    Adverse drug reactions
    Maximum Plasma concentration
    average maximum ivermectin drug concentrations
    Minimum Plasma concentration
    average minimum drug concentrations
    Area Under the Curve
    Population drug concentrations from time of the first drug administration to the time when the last dose is eliminated

    Full Information

    First Posted
    February 14, 2021
    Last Updated
    February 23, 2021
    Sponsor
    Makerere University
    Collaborators
    Ministry of Health, Uganda, Mbarara University of Science and Technology, Joint Clinical Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04768179
    Brief Title
    Safety & Efficacy of Low Dose Aspirin / Ivermectin Combination Therapy for Treatment of Covid-19 Patients
    Acronym
    IVCOM
    Official Title
    A Randomized Clinical Trial to Investigate Safety & Efficacy of Low-dose Aspirin / Ivermectin Combination Therapy in Management of COVID-19 Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 19, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Makerere University
    Collaborators
    Ministry of Health, Uganda, Mbarara University of Science and Technology, Joint Clinical Research Center

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    COVID-19, caused by the novel Severe Acute Respiratory Syndrome Corona Virus 2 (SARSCoV-2), has become a global pandemic. Fortunately, most of the COVID-19 cases confirmed are categorized as mild for whom home- based symptomatic management with monitoring of clinical deterioration is recommended. Despite providing symptomatic management, a therapeutic drug that would limit the course of infection is greatly needed to stop COVID-19 disease progression. Considering the current SARS-CoV-2 epidemiology and the legitimate rash towards appropriate therapies, our study seeks to evaluate the safety and efficacy of low dose aspirin and ivermectin combination therapy in COVID-19 patients.
    Detailed Description
    Micro clotting is to date reported as a major cause of death among COVID-19 patients. SARS-CoV-2 associated micro clotting results into acute respiratory distress syndrome (ARDS) and death. This micro-clotting cascade supports the potential role of anticoagulants like aspirin, heparin in the clinical management of COVID-19 patients. Other areas that could be considered for potential treatment of COVID-19 include drugs and analogues of drugs that have demonstrated potential in-vitro and or in-vivo activity against SARS-CoV-2 like hydroxychloroquine, azithromycin, lopinavir/ritonavir and remdesivir and ivermectin. Ivermectin has demonstrated broad-spectrum anti-viral activity and inhibition of the causative virus (SARS-CoV-2) with ability to cause a 5000-fold reduction in viral RNA within 48hrs. Although aspirin and ivermectin do not exhibit any synergistic or potentiation at cellular level, a clinical additive effect resulting from combination therapy with low dose aspirin and ivermectin is plausible. There is no documented drug-drug interactions or other biological basis that contra-indicate co-administration of low dose aspirin and ivermectin. We therefore propose, to explore the clinical use of combination anticoagulant: lower dose aspirin and the FDA-approved anti-parasitic drug: ivermectin, in treatment of COVID-19 patients in an exploratory randomized trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19
    Keywords
    COVID-19 Therapies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    490 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm1 (Control group)
    Arm Type
    No Intervention
    Arm Description
    standard of care
    Arm Title
    Arm 2
    Arm Type
    Experimental
    Arm Description
    Drug: 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)
    Arm Title
    Arm 3
    Arm Type
    Experimental
    Arm Description
    3-day Ivermectin 600 mcg/kg/day/14-day 75mgASA/day + standard of care (Intervention 2)
    Intervention Type
    Drug
    Intervention Name(s)
    3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)
    Other Intervention Name(s)
    3-dayIVM 600 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 2)
    Intervention Description
    Low dose aspirin for 14 days plus ivermectin at 200 mcg/kg/day or 600 mcg/kg/day for 3 days
    Primary Outcome Measure Information:
    Title
    SARS COV 2 Viral clearance
    Description
    SARS COV 2 Viral load
    Time Frame
    Day 14
    Title
    World Health Organization COVID-19 ordinal improvement score
    Description
    Minimum score is 0 (un infected, no clinical or virological evidence of infection) Maximum sore is 8 (death) Higher scores mean a worse outcome, low scores mean a better outcome
    Time Frame
    Day 14
    Secondary Outcome Measure Information:
    Title
    Clinical recovery
    Description
    disappearance or cessation of COVID-19 associated symptoms
    Time Frame
    Day 14
    Title
    Spectrum and severity of adverse events
    Description
    Adverse drug reactions
    Time Frame
    Days one to day 14
    Title
    Maximum Plasma concentration
    Description
    average maximum ivermectin drug concentrations
    Time Frame
    Days one to six
    Title
    Minimum Plasma concentration
    Description
    average minimum drug concentrations
    Time Frame
    Days one to six
    Title
    Area Under the Curve
    Description
    Population drug concentrations from time of the first drug administration to the time when the last dose is eliminated
    Time Frame
    Days one to six

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Willingness to comply with all study procedures and availability over the study duration *Patients aged above 18years to 64 years PCR positive for SARS-Cov-2 (COVID-19) from any of the MOH COVID-19 accredited testing laboratories Moderately ill COVID-19 patients score 3(Hospitalized with no oxygen therapy) to 4 (Hospitalized with oxygen by mask or nasal prongs) according to the WHO ordinal scale for clinical improvement which translates to moderate to severe COVID-19 patients according to the Ministry of Health Uganda COVID-19 disease category. Exclusion criteria: Participants with known hypersensitivity to Ivermectin Clinical diagnosis of severe renal and hepatic impairment. Pregnancy or breast feeding. Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affected ivermectin disposition and clinical outcomes Co-morbidities including asthma Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years Persons clinically diagnosed with and receiving treatment for any diathesis and PUD Active participation in another clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jackson Mukonzo, PhD
    Phone
    256758113468
    Email
    mukojack@yahoo.co.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rita Nakato, MSc
    Email
    nakato.ritah@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jackson Mukonzo, PhD
    Organizational Affiliation
    Makerere University, college of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety & Efficacy of Low Dose Aspirin / Ivermectin Combination Therapy for Treatment of Covid-19 Patients

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