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

Covid19 Clinical Trial

— IVCOM  

Official title:

A Randomized Clinical Trial to Investigate Safety & Efficacy of Low-dose Aspirin / Ivermectin Combination Therapy in Management of COVID-19 Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04768179
• Other study ID #: IVCOM PROTOCOL VERSION 03
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 19, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2021
• Source: Makerere University
• Contact: Jackson Mukonzo, PhD
• Phone: 256758113468
• Email: mukojack[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 490
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• 3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)
Low dose aspirin for 14 days plus ivermectin at 200 mcg/kg/day or 600 mcg/kg/day for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Makerere University	Joint Clinical Research Center, Mbarara University of Science and Technology, Ministry of Health, Uganda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS COV 2 Viral clearance	SARS COV 2 Viral load	Day 14
Primary	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	Day 14
Secondary	Clinical recovery	disappearance or cessation of COVID-19 associated symptoms	Day 14
Secondary	Spectrum and severity of adverse events	Adverse drug reactions	Days one to day 14
Secondary	Maximum Plasma concentration	average maximum ivermectin drug concentrations	Days one to six
Secondary	Minimum Plasma concentration	average minimum drug concentrations	Days one to six
Secondary	Area Under the Curve	Population drug concentrations from time of the first drug administration to the time when the last dose is eliminated	Days one to six