Octapharma USA and BioMatrix Specialty Pharmacy are supporting a new investigator-initiated research study led by Kelly McCants, M.D., Medical Director of the Norton Heart & Vascular Institute in Louisville, Ky., focused on treating patients with the coronavirus (COVID-19) and presenting with COVID-19-associated myocardial dysfunction.
Octapharma USA is donating Octagam® 10% and cutaquig® 16.5%, the company’s intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), for the study. BioMatrix will be donating patient education, including instruction in subcutaneous injection.
“While acute lung injury (ALI) and pulmonary edema are feared COVID-19 complications, many patients present with elevated cardiac biomarkers and evidence of left ventricular (LV) dysfunction,” said Dr. McCants. “Although evidence supports immunomodulatory treatment for myocardial injury associated with severe influenza, there is not yet an evidence-based approach to treat the cytokine milieu associated with COVID-19 and the immunologic storm associated with systemic inflammatory response syndrome (SIRS). We propose investigating Octagam® 10% and cutaquig® 16.5% and steroids as a possible treatment regimen for select patients with ALI, LV dysfunction, and elevated cardiac biomarkers.”
Though current analyses of COVID-19 risk factors for severe illness and mortality are still largely unadjusted, evidence is rapidly accumulating that older age, cardiovascular disease, diabetes, obesity, and hypertension are associated with increased risk of death. The same association was noted for its predecessors, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). While the primary presentation is SIRS complicated by ALI, there is increasing evidence of myocardial injury, noticeable through myocarditis, LV dysfunction, and arrhythmias, demonstrated by a rise in troponins, which correlates with other inflammatory biomarkers like ferritin, IL6, and LDH, which is suggestive of cytokine release.
“There is an urgent need to monitor and manage myocardial injury during hospitalization for severely or critically ill COVID-19 patients,” said Octapharma USA President Flemming Nielsen. “We are privileged to have the opportunity to donate Octagam® 10% and cutaquig® 16.5% for this important study. Our team has been committed to advancing important research and new therapy options since the company’s inception.”
“We are extremely excited to partner with BioMatrix and Octapharma in this ground-breaking endeavor,” said Dr. McCants. “This project will investigate whether immune modulation with intravenous immunoglobulin alongside medical therapy can recover left ventricular function in patients hospitalized with COVID-19 associated myocardial dysfunction as evidenced by a rise in cardiac biomarkers predicated by cytokine release.”
Jefferson County, where Norton Healthcare is located, is the epicenter of the COVID-19 outbreak in Kentucky. Centers for Disease Control and Prevention (CDC) data compiled by America’s Health Rankings (AHR) place Kentucky 46th and 49th for obesity and smoking – two behaviors associated with COVID-19 mortality risk. Moreover, Kentucky ranks 42nd, 44th, and 50th respectively for death from cardiovascular disease, diabetes, and death from cancer – also clinical outcomes associated with increased morbidity and mortality from COVID-19. Over the next nine months, the study aims to identify and enroll at least 15 patients ages 40-75 who are admitted to a Norton Intensive Care Unit or dedicated COVID Care Area with ALI and elevated cardiac biomarkers suspected or confirmed positive for COVID-19.
The coronavirus has been a known pathogen in animals since the early 1970s that resulted in gastrointestinal symptoms. Bats have been identified as the main carrier and cats have been identified as the primary means of transmission to other animals. In late 2019, the coronavirus evolved to infect the human respiratory system (SARS-CoV-2) as seen in the outbreak in Wuhan, China. The World Health Organization (WHO) named the SARS-CoV-2 pandemic COVID-19.
Cutaquig® (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults.