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

NCT04768179 | Unknown Phase 2 DMC

• 1 other identifier: IVCOM PROTOCOL VERSION 03
• Study Type: interventional
• Target: 490
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

COVID-19 Therapies

Outcome Measures

Primary Outcomes (2)

• SARS COV 2 Viral clearance

  SARS COV 2 Viral load

  Day 14

• 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 Outcomes (5)

• Clinical recovery

  Day 14

• Spectrum and severity of adverse events

  Days one to day 14

• Maximum Plasma concentration

  Days one to six

• Minimum Plasma concentration

  Days one to six

• Area Under the Curve

  Days one to six

Study Arms (3)

Arm1 (Control group)

NO INTERVENTION

standard of care

Arm 2

EXPERIMENTAL

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

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

Arm 3

EXPERIMENTAL

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

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

Interventions

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

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

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

Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• Ministry of Health, Uganda: collaborator
• Mbarara University of Science and Technology: collaborator
• Joint Clinical Research Center: collaborator

Related Publications (1)

• 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.

  PMID: 37489818 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jackson Mukonzo, PhD

  Makerere University, college of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackson Mukonzo, PhD

CONTACT

256758113468; mukojack@yahoo.co.uk

Rita Nakato, MSc

CONTACT

nakato.ritah@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate professor Department of Pharmacology and Therapeutics

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 24, 2021
• Study Start: February 19, 2021
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02