Octapharma USA is extending funding for an investigator-initiated study (IIS) focused on treating the most critical patients with coronavirus, those experiencing hypoxia and who are at the highest risk of requiring mechanical ventilation. The research is led by infectious disease clinician George Sakoulas, M.D. of Sharp Memorial Hospital and the Sharp Rees-Stealy Medical Group in San Diego, CA, and 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 Dr. Sakoulas. “If you can prevent the need for ventilation, the disease becomes much easier to manage at many levels.”

Currently 27 adult patients are enrolled. 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 Dr. Sakoulas. “We are expanding patient enrollment in the study to 40 patients and are deeply thankful to Octapharma for continuing to fund the research.”