FDA Approves Octapharma USA Investigational New Drug Application for Severe COVID-19 Patients
Phase 3, multicenter U.S. clinical trial utilizing Octagam® 10% will start immediately to evaluate if high-dose IVIG can stabilize or improve patient clinical status
PARAMUS, N.J. (May 20, 2020) – The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam® 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression.
The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam® 10% 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.
“Although many therapies based on provisional data have been proposed for patients who suffer from COVID-19, known treatments are limited,” said Octapharma USA President Flemming Nielsen. “Intravenous immunoglobulin (IVIG), which consists of pooled IgG preparations from thousands of donors, has been used to treat patients with immune-mediated diseases for almost 40 years. Our hypothesis is that the use of IVIG in the prophylaxis of severe infections, especially in immunocompromised patients, makes it an attractive therapeutic possibility for COVID-19.”
The study will begin immediately at approximately 10 U.S. research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19 with a resting SpO2 of ≤93%, requiring oxygen supplementation. SpO2, also known as oxygen saturation, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.
Patients in the trial will be randomized to receive either Octagam® 10% or a placebo, and will be monitored for approximately 33 days. Those receiving Octagam® 10% will be administered a total dose of 2 g/kg as an intravenous infusion of 0.5 g/kg over a two-hour period daily for four consecutive days. Octapharma hopes to report study results by the third quarter of 2020.
“Several case reports on utilizing IVIG treatment for COVID-19 patients have shown positive results,” said Wolfgang Frenzel, M.D., Head of Research & Development at Octapharma. “The effects of the immune-modulating properties of IVIG in severely-ill COVID-19 patients appeared to be demonstrated in the case reports and we are, therefore, hopeful that we will observe improved clinical status in the patients receiving Octagam® 10%.”
For complete study information, please contact Huub Kreuwel, Ph.D., Octapharma USA, Vice President Scientific and Medical Affairs, at firstname.lastname@example.org.
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 (WHO) named the SARS-CoV-2 pandemic COVID-19.
About Octagam® 10%
Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.
Thrombosis may occur with immune globulin intravenous (IGIV) 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) (IGIV) 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. For full prescribing information, including complete boxed warning and other important information, please visit octagamus.net.
About the Octapharma Group
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 state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit octapharmausa.com.
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