Covid19
Conditions
Keywords
COVID-19 Therapies
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.
Interventions
DRUG3-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
Sponsors
Ministry of Health, Uganda
Mbarara University of Science and Technology
Joint Clinical Research Center
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS COV 2 Viral clearance | Day 14 | SARS COV 2 Viral load |
| World Health Organization COVID-19 ordinal improvement score | Day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma concentration | Days one to six | average maximum ivermectin drug concentrations |
| Clinical recovery | Day 14 | disappearance or cessation of COVID-19 associated symptoms |
| Area Under the Curve | Days one to six | Population drug concentrations from time of the first drug administration to the time when the last dose is eliminated |
| Minimum Plasma concentration | Days one to six | average minimum drug concentrations |
| Spectrum and severity of adverse events | Days one to day 14 | Adverse drug reactions |
Contacts
Primary ContactJackson Mukonzo, PhD
Backup ContactRita Nakato, MSc
Outcome results
None listed