A phase 3 trial evaluating a combination of anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) plus the investigational antiviral remdesivir for the treatment of coronavirus disease 2019 (COVID-19) has been initiated.
The antibody solution is derived from plasma donated by healthy individuals who have recovered from COVID-19. The highly purified and concentrated anti-coronavirus hIVIG contains several times more severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies than that found in the plasma of recovered patients.
The multicenter, randomized, double-blind, placebo-controlled ITAC trial will assess the safety, tolerability, and efficacy of anti-coronavirus hIVIG plus remdesivir in hospitalized adults 18 years of age and older who have had COVID-19 symptoms for 12 days or less, and do not have life-threatening organ dysfunction or failure (N=500). Patients will be randomized to receive infusions of either anti-coronavirus hIVIG or placebo, in addition to remdesivir.
The primary objective of the study is to compare the clinical status of patients in each group on day 7 of follow-up using the primary ordinal outcome with 7 mutually exclusive categories ranging from no limiting symptoms due to COVID-19 to death. The trial will follow patients for 28 days.
An independent Data and Safety Monitoring Board will review interim safety and efficacy data, along with study integrity. The trial is being sponsored and funded by the National Institutes of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).
“Finding safe and effective treatments for COVID-19 is absolutely critical,” said NIAID Director Anthony S. Fauci, MD. “The ITAC trial will examine whether adding anti-coronavirus hIVIG to a remdesivir regimen can give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.”
The 4 companies collaborating to provide anti-coronavirus hIVIG for the trial include Emergent BioSolutions, Grifols SA, CSL Behring, and Takeda Pharmaceuticals.
For more information visit nih.gov.
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 begins. [press release]. Bethesda, Maryland: National Institutes of Health; October 9, 2020.