Policy & Regulation
FDA Approves Octapharma USA Investigational New Drug Application for Severe COVID-19 Patients
21 May 2020 - - The US Food and Drug Administration has approved the investigational new drug application submitted by Switzerland-based protein products Octapharma's Octapharma USA business 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 company said.

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.

The study will begin immediately at approximately 10 US 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 3Q20.

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.
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