COVID-19 > Phase 3 Trial

FDA Approves Octapharma IND Application

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application submitted by Octapharma USA for a phase 3 clinical trial on the efficacy and safety of IVIg treatment in COVID-19 patients with severe disease progression. A multi-center U.S. clinical trial will begin immediately to evaluate if high-dose intravenous immunoglobulin (IVIg) can stabilize or improve patient clinical status.

Intravenous immunoglobulin, which consists of pooled IgG preparations from thousands of donors, has been used to treat patients with immunodeficiency diseases for almost 40 years. The hypothesis is that the successful use of IVIg in the prophylaxis of severe infections, especially in immunocompromised patients, makes it an attractive therapeutic possibility for COVID-19. The clinical trial will test this working hypothesis.

The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose IVIg treatment will slow or stop respiratory deterioration in patients with severe COVID-19 disease. The secondary objectives of the study are to measure the effects of a high-dose of IVIg on slowing or stopping the processes impacted by COVID-19, by improving pulmonary function, quality of life, and correlated impact on metabolic factors.

Read the press release.


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