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.
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.