NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 begins
A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun, according to a press release. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC.
The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. The antibodies in anti-coronavirus hIVIG come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19. These antibodies are highly purified and concentrated so that the anti-coronavirus hIVIG consistently contains several times more SARS-CoV-2 neutralizing antibodies than typically found in the plasma of people who have recovered from COVID-19.
The ITAC investigators hypothesize that giving people anti-coronavirus hIVIG at the onset of COVID-19 symptoms, before the body makes a protective immune response on its own, could augment the natural antibody response to SARS-CoV-2, thereby reducing the risk of more serious illness and death.
The ITAC study team will enroll 500 hospitalized adults ages 18 or older who provide informed consent, have had COVID-19 symptoms for 12 days or fewer, and do not have life-threatening organ dysfunction or organ failure. Enrollment will occur at up to 58 sites in Africa, Asia, Europe, North America and South America. Study participants will be assigned at random to receive infusions of either anti-coronavirus hIVIG and remdesivir or a placebo and remdesivir. Neither the participants nor the study team will know who is receiving which treatment regimen.
The main goal of the ITAC trial is to compare the health status of participants in the combination treatment group with participants in the remdesivir-only group on day seven. Health status will be based on an ordinal outcome with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death. These categories capture the full range of severity experienced by hospitalized patients with COVID-19, according to the study investigators.
ITAC study participants will be followed for 28 days. If the trial goes to completion, the primary analysis will be completed after all participants finish 28 days of follow-up. An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity.
