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
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19 Therapies
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
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
NCT ID
NCT04768179
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
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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