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Four companies, Emergent BioSolutions, Grifols SA, CSL Behring and Takeda Pharmaceuticals, jointly launched a Phase III clinical trial, ITATC (NCT04546581), to assess the safety, toadability and effectiveness of the anti-neoviral drug Redcive and high concentrations of SARS-CoV-2 and antibodies in adult patients hospitalized with COVID-19.
: The clinical trial will recruit 500 hospitalized patients (18 years and older) with COVID-19 symptoms≤12 days without life-threatening organ dysfunction or failure.
is being conducted in 58 locations in the United States, Mexico, Africa, Asia and Europe.
The antibodies tested in the ITOC trial were anti-coronavirus ultraimmune intravenous immunoglobulin (hIVIG), and the antibodies in hIVIG originated from plasma in patients with COVID-19 during the recovery period, and these antibodies were highly purified and concentrated, so the SARS-CoV-2 and antibodies contained in HIVIG were several times higher than in the plasma of patients recovered from COVID-19.
Photo Source: ITAC researchers hypothesized that HIVIG was given hivIG treatment before the body produced a protective immune response, and when a patient developed COVID-19 symptoms, thereby enhancing the patient's antibody response to SARS-CoV-2 and reducing the severity of the disease.
Dr Fucci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said: "The ITAC trial will detect the addition of anti-coronavirus HIVIG to the Remxivir programme to inhibit SARS-CoV-2 at an early stage of the disease, thereby suppressing infection in its infancy.
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