Octapharma USA has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a phase three clinical trial to assess the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in Covid-19 patients with severe disease progression.
Octagam 10% is an immune globulin intravenous (human) liquid preparation designated to treat chronic immune thrombocytopenic purpura (ITP) in adults.
According to the company, the primary objective of the randomised, double-blind, placebo-controlled, and multicentre study is to determine whether high-dose Octagam 10% therapy can slow or stop respiratory deterioration in patients with severe coronavirus disease.
The trial’s secondary objectives include the measurement of the effects of a high-dose of Octagam 10% on demonstrating or stopping the clinical progression of Covid-19 by enhancing pulmonary function, quality of life, and correlated impact on metabolic factors.
Octapharma will immediately commence the trial at 10 US research sites, and aims to recruit around 54 adult patients diagnosed with Covid-19 with a resting SpO2 of ≤93%.
The SpO2, or otherwise called oxygen saturation, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.
The company will randomise the patients in the trial to secure either Octagam 10% or a placebo, and will monitor for around 33 days.
The patients securing Octagam 10% will be administered with 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 is expecting to reveal the study results by the third quarter of 2020.
Octapharma USA president Flemming Nielsen said: “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.”
Octagam 10%, an immune globulin intravenous (human) liquid preparation, secured FDA approval to treat chronic immune thrombocytopenic purpura (ITP) in adults in July 2014.