3 June 2020 - - Following positive preliminary data, Octapharma USA is extending funding for an investigator-initiated study 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 company said.

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, Calif., and Associate Professor in the Department of Pediatrics of the University of California San Diego School of Medicine.

The randomised open label study is evaluating the standard of care plus intravenous immunoglobulin compared to SOC alone in the treatment of COVID-19 infection, specifically in preventing mechanical ventilation in COVID-19 patients requiring high-flow oxygen.

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.

In addition to this investigator-initiated study, Dr. Sakoulas will lead a larger multicenter, randomized, double-blind, placebo-controlled study recently approved by US Food and Drug Administration 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 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 US 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.

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 named the SARS-CoV-2 pandemic COVID-19.

Octagam 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura in adults.

Thrombosis may occur with immune globulin intravenous products, including Octagam 10%.

Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) products in predisposed patients.

Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam 10% does not contain sucrose.

For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration.

Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

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 production sites licensed by the US Food and Drug Administration, providing a high level of production flexibility.