Officials with the FDA have approved Octapharma’s investigational new drug (IND) application for intravenous immune globulin (IVIG) (Human, Octagam 10%) therapy.
Officials with the FDA have approved Octapharma’s investigational new drug (IND) application for intravenous immune globulin (IVIG) (Human, Octagam 10%) therapy for severe coronavirus disease 2019 (COVID-19), according to a press release.
The IND approval will allow the start of a phase 3, multicenter clinical trial evaluating the efficacy and safety of IVIG in patients with severe disease progression.
According to Octapharma, the study will begin immediately at approximately 10 US research sites and aims to enroll approximately 54 adult patients diagnosed with COVID-19 with a resting oxygen saturation, or SpO2, of ≤93%, requiring oxygen supplementation.
Patients in the study will be randomized to receive either IVIG or a placebo and will be monitored for approximately 33 days. Patients in the IVIG treatment group will be administered a total dose of 2g/kg as an IV infusion of 0.5 g/kg over a 2-hour period daily for 4 consecutive days.
The primary objective of the study is to determine if high-dose IVIG therapy will slow or stop respiratory deterioration in patients with severe disease, according to the release. The secondary objectives are to measure the effects of high-dose IVIG on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors.
IVIG consists of pooled IgG preparations from thousands of donors, according to Octapharma USA President Flemming Nielsen. IVIG is used in the prophylaxis of severe infections, especially in immunocompromised patients. Octagam 10% is currently indicated for the treatment of chronic immune thrombocytopenia purpura in adults.
“Severe case reports on utilizing IVIG treatment for COVID-19 patients have shown positive results,” Wolfgang Frenzel, MD, head of research & development at Octapharma, said in a statement. “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, hopefuly that we will observe improved clinical status in the patients receiving Octagam 10%.”
1. FDA approves Octapharma USA investigational new drug application for severe COVID-19 patients. News Release. May 20, 2020. Accessed May 22, 2020. https://www.octapharma.com/news/press-release/2020/fda-approves-octapharma-usa-investigational-new-drug-application/