Study using Octagam® 10% and cutaquig® 16.5% as an investigational treatment for select patients with acute lung injury, left ventricular dysfunction, and elevated cardiac biomarkers
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,1,2,3 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.4,5,6,7
"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."
"BioMatrix welcomes the opportunity to participate in research on mitigating myocardial damage from COVID-19," said Marc Stranz, PharmD, Chief Clinical Officer at BioMatrix. "We are fortunate to have extensive experience with immunonoglobulin therapy and the tools to enhance effective drug administration."
The project will investigate whether treatment with Octagam® 10% and cutaquig® 16.5% alongside maintenance guideline-directed medical therapy8 can recover LV function in patients hospitalized for COVID-19 and presenting with COVID-19-associated myocardial dysfunction as evidenced by a rise in cardiac biomarkers associated with ALI.9
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.
- Thrombosis may occur with immune globulin products, including cutaquig®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
- For patients at risk of thrombosis, administer cutaquig® at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Please see full prescribing information for complete boxed warning and other important information at cutaquigus.com.
About Octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.
Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. For full prescribing information, including complete boxed warning and other important information, please visit octagamus.net.
About BioMatrix Specialty Pharmacy
BioMatrix Specialty Pharmacy offers comprehensive, nationwide specialty pharmacy services and digital health technology solutions for patients with chronic, difficult to treat conditions. Our commitment to every patient is to provide individualized pharmacy services, timely access to care, and focused education and support. We offer a tailored approach for a wide range of therapeutic categories, improving health and empowering patients to experience a higher quality of life.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit octapharmausa.com.
1 - Jordan, R. E., Adab, P., & Cheng, K. K. (2020). Covid-19: risk factors for severe disease and death. BMJ (Clinical Research Ed.), 368, m1198. https://doi.org/10.1136/bmj.m1198
2 - Huang R, Zhu L, Xue L, et al. Clinical findings of patients with coronavirus disease 2019 in Jiangsu Province, China: a retrospective, multi-center study. 2020. https://ssrn.com/abstract=3548785
3 - Chen, T., Wu, D., Chen, H., Yan, W., Yang, D., Chen, G., Ma, K., Xu, D., Yu, H., Wang, H., Wang, T., Guo, W., Chen, J., Ding, C., Zhang, X., Huang, J., Han, M., Li, S., Luo, X., ... Ning, Q. (2020). Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ (Clinical Research Ed.), 368, m1091. https://doi.org/10.1136/bmj.m1091
4 - Shi S, Qin M, Shen B, et al. Association of Cardiac Injury with Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. Online March 25, 2020. doi:10.1001/jamacardio.2020.0950
5 - Chen C, Chen C, Yan JT, et al. Analysis of myocardial injury in patients with COVID-19 and association between concomitant cardiovascular diseases and severity of COVID-19. Zhonghua xin xue Guan Bing za zhi. 2020 Mar;48(0):E008. DOI: 10.3760/cma.j.cn112148-20200225-00123.
6 - He XW, Lai JS, Cheng J, et al. Impact of complicated myocardial injury on the clinical outcome of severe or critically ill COVID-19 patients. Zhonghua xin xue Guan Bing za zhi. 2020 Mar;48(0):E011. DOI: 10.3760/cma.j.cn112148-20200228-00137.
7 - Li, B., Yang, J., Zhao, F. et al. Prevalence and impact of cardiovascular metabolic diseases on COVID- 19 in China. Clin Res Cardiol (2020). https://doi.org/10.1007/s00392-020-01626-9
8 - Tran, R. H., Aldemerdash, A., Chang, P., Sueta, C. A., Kaufman, B., Asafu-adjei, J., Vardeny, O., Daubert, E., Alburikan, ... & Rodgers, J. E. (2018). Guideline-Directed Medical Therapy and Survival Following Hospitalization in Patients with Heart Failure. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 4, 406. https://doi.org/10.1002/phar.2091
9 - Barnett, N., & Ware, L. B. (2011). Biomarkers in acute lung injury--marking forward progress. Critical Care Clinics, 27(3), 661–683. https://doi.org/10.1016/j.ccc.2011.04.001
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