Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients.
Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release.
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 disease progression. The study’s secondary objective is to measure the effects of Octagam 10% in relation to slowing or stopping the clinical progression of the virus by improving pulmonary function, quality of life and correlated impact on metabolic factors.
“Although many therapies based on provisional data have been proposed for patients who suffer from COVID-19, known treatments are limited,” Octapharma USA president Flemming Nielsen said in the release. “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 said it will begin the study immediately across 10 U.S. research sites with intentions to enroll about 54 adult patients diagnosed with COVID-19 with a resting SpO2 of ≤93%, requiring oxygen supplementation
Patients will be randomized to receive either Octagam 10% treatment or a placebo and will be monitored for approximately 33 days. The company hopes to report study results by the third quarter of 2020.
“Several case reports on utilizing IVIG treatment for COVID-19 patients have shown positive results,” Octapharma head of R&D Dr. Wolfgang Frenzel said. “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%.”