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

NCT ID: NCT04768179

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2021-09-30

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm1 (Control group)

standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Low dose aspirin for 14 days plus ivermectin at 200 mcg/kg/day or 600 mcg/kg/day for 3 days

Arm 3

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Low dose aspirin for 14 days plus ivermectin at 200 mcg/kg/day or 600 mcg/kg/day for 3 days

Interventions

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

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role: collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role: collaborator

Joint Clinical Research Center

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

College of Health Sciences

Chair and Associate professor Department of Pharmacology and Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jackson Mukonzo, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University, college of Health Sciences

Central Contacts

Jackson Mukonzo, PhD

Role: CONTACT

mukojack@yahoo.co.uk

256758113468

Rita Nakato, MSc

Role: CONTACT

nakato.ritah@gmail.com

References

Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

Reference Type: DERIVED

PMID: 37489818 (View on PubMed)

Other Identifiers

IVCOM PROTOCOL VERSION 03

Identifier Type: -

Identifier Source: org_study_id