PARAMUS, N.J. (April 16, 2020) - Octapharma USA is supporting a new investigator initiated clinical trial led by George Sakoulas, M.D. of Sharp Memorial Hospital in San Diego, California focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing respiratory failure who become ventilator dependent. The trial is entitled Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection.
Dr. Sakoulas, an infectious disease clinician and Associate Editor for the New England Journal of Medicine's NEJM Journal Watch Infectious Diseases, hopes to identify:
- Whether or not IVIG can halt coronavirus progression to respiratory failure requiring transfer into the intensive care unit (ICU) and mechanical ventilation in admitted COVID-19 patients; and
- Whether adding IVIG to the standard of care will reduce days requiring oxygen therapy and total hospital days.
"It is currently believed that 80% of COVID-19 subjects will require no medical treatment, 15% will require non-ICU medical care, and 5% may require ICU admission," said Dr. Sakoulas. "The goals of this study are to evaluate three parameters: the rate of subjects requiring mechanical ventilation; number of days patients require oxygen therapy; and length of hospital stay."1
Secondary objectives of the study are to identify whether adding IVIG to the standard of care will reduce days requiring oxygen therapy; and to identify whether adding IVIG to the standard of care will reduce total hospital days.
"Although we are currently collecting convalescent plasma for future preparations, we need a treatment option for COVID-19 now for critical and soon-to-be critical patients," said Octapharma USA President Flemming Nielsen. "There is no known effective treatment for patients who are infected with COVID-19. IVIG is well-understood to treat immune mediated diseases and for prophylaxis and treatment of severe infections, especially in immunocompromised patients."2
COVID-19 causes an immune response in some patients that ranges from insufficient to overly-active. In an earlier clinical trial in Wuhan, China, where the coronavirus outbreak began, it was noted that death from the disease is frequently the result of an abnormal pulmonary immune system response with multiple respiratory viral infections in which there is an elevation of cytokine and chemokine production referred to as a "cytokine storm" and associated with poor clinical outcomes.3, 4
"There have been few human cases analyzing the effects of utilizing IVIG for COVID-19 infection," said Dr. Sakoulas. "One small case series of three patients from China demonstrated clinical improvement allowing hospital discharge in clinically deteriorating COVID-19 patients.5 Motivated by this small study, our team employed a similar algorithm in a 62-year-old female with diabetes, hypertension, and a history of prior chemotherapy due to breast cancer who was clinically deteriorating from COVID-19 infection, with oxygen requirement increasing from 2L to 6L in the first 48 hours of hospitalization. After receiving IVIG, the patient demonstrated a remarkable clinical improvement, becoming afebrile and breathing normally without external oxygen treatment in less than 72 hours, accompanied by improvement in inflammatory markers. She was discharged home uneventfully. We believe that at least some COVID-19 patients may benefit from IVIG treatment, especially when given at the right time before full-blown acute respiratory distress syndrome (ARDS) sets in ."1
Dr. Sakoulas hopes to enroll 20 adults hospitalized with COVID-19 requiring significant oxygen, but not on mechanical ventilation. Patients will be randomized to receive standard of care alone, or standard of care with IVIG treatment. For complete study information, please contact Huub Kreuwel, Vice President Scientific and Medical Affairs, Octapharma, at firstname.lastname@example.org.
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.
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 http://www.octapharmausa.com.
- 1. Sakoulas G. Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection. Sharp Memorial Hospital, San Diego, Calif. Data on file, April 2020.
2. Galeotti C, Kaveri SV, Bayry J. IVIG-mediated effector functions in autoimmune and inflammatory diseases. Int Immunol 2017; 29:491-8.
3. De Ranieri D, Fenny NS. Intravenous immunoglobulin in the treatment of primary immunodeficiency diseases. Pediatr Ann 2017; 46:e8-e12.
4. Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on analysis of data of 150 patients from Wuhan China. Intensive Care Med. 2020.
5. Cao W, Liu X, Bai T, Fan H, Hong K, Song H, Han Y, Lin L Ruan L, Li Taisheng. High-dose intravenous immunoglobulin as a therapeutic option for deteriorating patients with Coronavirus Disease 2019. Open Forum Infectious Diseases, 7(3), ofaa102, March 2020. https://doi.org/10.1093/ofid/ofaa102