Octapharma USA is supporting a new investigator initiated clinical trial led by George Sakoulas, M.D. of Sharp Memorial Hospital in San Diego, CA focused on treating the most critical patients with coronavirus 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.

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.

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.