Paramus-based Octapharma USA is supporting a new investigator-initiated clinical trial led by Dr. George Sakoulas of Sharp Memorial Hospital in San Diego, Calif., focused on treating the most critical patients at the heart of the COVID-19 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.
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 COVID-19 progression to respiratory failure requiring transfer into the intensive care unit 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 percent of COVID-19 subjects will require no medical treatment, 15 percent will require non-ICU medical care, and 5 percent may require ICU admission,” said 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.”
Secondary objectives of the study are to identify whether adding IVIG to the standard of care will reduce days requiring oxygen therapy or 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.”
“There have been few human cases analyzing the effects of utilizing IVIG for COVID-19 infection,” said Sakoulas. “One small case series of three patients from China demonstrated clinical improvement allowing hospital discharge in clinically deteriorating COVID-19 patients. 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.”
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.