The Food and Drug Administration has approved Octapharma USA‘s investigational new drug application submitted for a phase three clinical trial on the efficacy and safety of Octagam 10 percent in COVID-19 patients with severe disease progression.
The study will determine if high-dose Octagam 10 percent therapy will slow or stop respiratory deterioration in patients with severe COVID-19. Secondarily, the study aims to measure the effects of a high-dose of Octagam 10 percent on slowing or stopping the clinical progression of COVID-19 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,” said Octapharma USA President Flemming Nielsen in a prepared statement. “Intravenous immunoglobulin, 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.”
The study begins immediately at approximately 10 research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19 with a resting blood oxygen saturation, or SpO2, of less than or equal to 93 percent, requiring oxygen supplementation.
SpO2 is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.
Trial participants will be randomized to receive either Octagam 10 percent or a placebo, and will be monitored for around 33 days.
Octapharma hopes to report study results by third quarter of 2020.
“Several case reports on utilizing IVIG treatment for COVID-19 patients have shown positive results,” said Dr. Wolfgang Frenzel, head of research and development at Octapharma 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, hopeful that we will observe improved clinical status in the patients receiving Octagam 10 percent.”