Grifols has reported that the Phase III ‘Inpatient Treatment with Anti-Coronavirus Immunoglobulin’ (ITAC) clinical trial of a combination treatment regimen failed to meet its primary endpoints with statistically significant results for treating Covid-19.
The treatment comprises the antiviral remdesivir in combination with an anti-SARS-CoV-2 hyperimmune intravenous immunoglobulin, which has a highly concentrated solution of SARS-CoV-2 neutralising antibodies.
These antibodies are derived from the liquid portion of blood, or plasma from Covid-19 recovered individuals.
The trial, which is also known as INSIGHT-013, was sponsored and supported by the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID).
The global, multi-centre, double-blind, placebo-controlled, randomised trial analysed the safety, tolerability and efficacy of the combination treatment in adult subjects who were hospitalised with Covid-19. They also had disease symptoms for 12 days or less without any life-threatening organ dysfunction or end-organ failure.
The study team enrolled approximately 600 subjects at 67 sites in the US and ten other countries on five continents through the NIAID-funded INSIGHT network.
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On behalf of the CoVIg-19 Plasma Alliance, the investigational anti-SARS-CoV-2 hyperimmune globulin materials needed for the study were provided by CSL Behring and Takeda as well as Emergent BioSolutions and Grifols.
Grifols will conduct its work on over 20 research initiatives to identify potential treatment options for various Covid-19 stages.
The company has a multifaceted method for the treatment of early-stage of the disease to prevent its progression.
Along with the NIAID and NIH, Grifols will be part of an international study to assess an intravenous anti-SARS-CoV-2 hyperimmune globulin in an outpatient setting.
In a trial in Spain, the company will also analyse a subcutaneously administered anti-SARS-CoV-2 hyperimmune globulin in asymptomatic outpatients.
It is also part of a clinical study in the country to evaluate convalescent plasma as an early treatment for non-hospitalised mild or moderate Covid-19 patients.