The Food and Drug Administration (FDA) has approved Octapharma’s Investigational New Drug Application (IND) allowing the Company to initiate a phase 3 trial of Octagam® (immune globulin intravenous [human]) in patients with coronavirus disease 2019 (COVID-19) with severe disease progression.
The multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy and safety of Octagam to slow or stop respiratory deterioration in patients with severe COVID-19. In addition, a high dose of Octagam will be evaluated to measure its effects on improving pulmonary function, quality of life, and metabolic factors.
The study will be conducted at approximately 10 US research sites enrolling 54 adult patients diagnosed with COVID-19 who require oxygen supplementation with a resting oxygen saturation of ≤93%. Patients will be randomized to receive either a total dose of 2g/kg of Octagam 10% administered as an intravenous infusion of 0.5g/kg over 2 hours daily for 4 consecutive days or placebo. Patients will be monitored for approximately 33 days.
“Several case reports on utilizing IVIG treatment for COVID-19 patients have shown positive results,,” said Wolfgang Frenzel, MD, 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%.”
The Company expects to report study results by the third quarter of 2020.
Octagam is currently approved for the treatment of primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
A recently published case series involving 3 patients with severe COVID-19 showed that the administration of high dose intravenous immunoglobulin at the time of initial respiratory distress led to improved outcomes in these patients.
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