PARAMUS, N.J.—Following positive preliminary data, Octapharma USA is extending funding for an investigator-initiated study (IIS) focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing hypoxia and who are at the highest risk of requiring mechanical ventilation. The research is led by infectious disease clinician Dr George Sakoulas of Sharp Memorial Hospital and the Sharp Rees-Stealy Medical Group in San Diego, who is also an associate professor in the Department of Pediatrics of the University of California San Diego School of Medicine.
The randomized open-label study is evaluating the standard of care (SOC) plus intravenous immunoglobulin (IVIG) compared to SOC alone in the treatment of COVID-19 infection, specifically in preventing mechanical ventilation in COVID-19 patients requiring high-flow oxygen. “Most of the morbidity and mortality in COVID-19 patients, as well as the burden on healthcare resources, follows the need for mechanical ventilation,” said Sakoulas. “If you can prevent the need for ventilation, the disease becomes much easier to manage at many levels.”
Sakoulas originally planned to enroll 20 patients in the study and has currently enrolled 27 adult patients. Patients are randomized into the two groups. To date the study has observed:
- Six patients in the SOC arm and two patients in the IVIG arm required intubation.
- Fourteen cumulative ventilator-dependent patient days among the total of 14 IVIG arm patients, as compared to a cumulative 74 ventilator-dependent patient days from the 13 patients in the SOC arm.
- All of the first five patients enrolled in the IVIG arm during the first week of May have been discharged home and are breathing independently on room air.
- Of the first five patients enrolled in the SOC arm, one has died, one has been discharged home, one remains ventilator dependent, and two are hospitalized on a medical floor.
“Although these preliminary data are very promising, we would like to enroll a larger number of patients to better establish IVIG as an effective treatment modality for COVID-19 patients,” said Sakoulas. “We are expanding patient enrollment in the study to 40 patients and are deeply thankful to Octapharma for continuing to fund the research.”
In addition to this investigator-initiated study, Sakoulas will lead a larger multicenter, randomized, double-blind, placebo-controlled study recently approved by U.S. Food and Drug Administration (FDA) under an Investigational New Drug Application. The primary objective of this study is to determine if high-dose Octagam 10% [Immune Globulin Intravenous (Human)] therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease. The secondary objectives of the study are to measure the effects of a high-dose of Octagam 10% on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors.
“The Sharp Memorial study’s preliminary data are encouraging and could mean a world of difference to the most critically ill COVID-19 patients,” said Octapharma USA President Flemming Nielsen. “IVIG has been used to treat patients with immune-mediated diseases for almost 40 years.2 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 sets in. Octapharma is honored to be able to support this vital research initiative.”
The potential role of IVIG in COVID-19 has been further evaluated in two recent studies, one from an Italian group published in The Lancet, the other from U.S. researchers published in The Journal of the Pediatric Infectious Diseases Society. Both studies focused on treating severe Kawasaki-like disease or Multisystem Inflammatory Syndrome observed in pediatric patients with high-dose IVIG therapy with positive results.
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.