The Grapevine

COVID-19 Update: FDA Approves Phase 3 Clinical Trial For Octagam For Severe Cases

Switzerland-headquartered pharmaceutical company Octapharma’s American subsidiary, Octapharma USA, was given approval by the Foods and Drugs Administration (FDA) to conduct a phase III clinical trial on the drug Octagam 10% for severe COVID-19 cases. 

Octagam 10% is an immune globulin intravenous (IGIV) drug, which is a sterilized solution created from blood plasma that holds antibodies to help the body fend off infection. 

Octapharma, being one of the prime human-protein product manufacturers from human plasma and cell lines, currently makes Octagam 10% to treat immune thrombocytopenia (ITP), an immune disorder caused by abnormally low platelet count. The treatment was approved by the FDA in 2014, suggesting that the agency could potentially green light this drug again for another purpose.  

"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," Octapharma USA President Flemming Nielsen explained.

What The Study Said

This research about to take off almost immediately at 10 different research sites is a randomized, placebo-controlled and double-blind study. The aim of the study is to establish whether a high dose of Octagam 10% can slow down or completely stop respiratory trouble in people with acute COVID-19 infection. 

The underlying objective is to check the progress of the COVID-19 disease and observe the effect of Octagam 10% on improving pulmonary function, and its role in restoring normal life again. 

Fifty-four COVID-19 patients with oxygen saturation levels higher than resting SpO2 of 93 percent and requiring oxygen supplementation were enrolled by Octapharma researchers. SpO2 is the measurement that indicates how much oxygen is being transported by the hemoglobin in the blood in comparison to the lack of hemoglobin performing this function.

The trial was randomized into half the patients receiving Octagam 10%, who were given a total dose of 2 g/kg as an intravenous infusion of 0.5 g/kg over two hours, for four days continuously. The other half were given placebo treatment. Researchers plan to report these findings by the third quarter of the year after monitoring the study's participants for 33 days. 

"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%," Wolfgang Frenzel, M.D., Head of Research & Development at Octapharma, said. 

intravenous therapy Image Wikimedia Commons

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