Grifols phase 3 Covid-19 trial of hyperimmune globulins fails to meet objective

Spanish pharma company Grifols said that the phase 3 ITAC clinical trial assessing hyperimmune globulins as a treatment for patients hospitalized with Covid-19 has failed to meet its primary endpoints.

ITAC expands to Inpatient Treatment with Anti-Coronavirus Immunoglobulin.

Also called INSIGHT-013, the late-stage trial was sponsored and supported by the US National Institute of Allergy and Infectious Diseases (NIAID), did not yield statistically significant results.

It was designed for evaluating the safety, tolerability, and efficacy of a combination treatment regimen of remdesivir and an anti-SARS-CoV-2 hyperimmune intravenous immunoglobulin.

The antibodies in the anti-SARS-CoV-2 hyperimmune globulin are from the plasma donated by healthy people who had recovered from Covid-19.

Grifols phase 3 Covid-19 trial of hyperimmune globulins fails to meet objective. Image courtesy of fernando zhiminaicela from Pixabay.

The ITAC clinical trial featured close to 600 adult patients across 67 sites in the US and 10 other countries across five continents.

Grifols said that it will continue to move ahead with its work on over 20 research initiatives to find promising treatment options for various stages of Covid-19.

The Spanish pharma company stated: “Regarding treatment of early-stage COVID-19 to halt disease progression, Grifols has a multifaceted approach. It will participate in an international study in collaboration with the NIAID and NIH to test an intravenous anti-SARS-CoV-2 hyperimmune globulin in outpatients.

“The company will also evaluate, in a study in Spain, a subcutaneously administered anti-SARS-CoV-2 hyperimmune globulin for asymptomatic outpatients, and is participating, also in Spain, in a clinical study to test convalescent plasma as early treatment in non-hospitalized mild or moderate COVID-19 patients.”

Grifols said that it is also assessing the effect of alpha-1 antitrypsin, immunoglobulins, antithrombin III, and other plasma-derived treatments on Covid-19 patients in different disease stages to alleviate the effects of the infection.