The trial’s main goal is to compare the health status of participants in the combination treatment group with participants in the remdesivir-only group on day 7.
A phase 3 clinical trial investigating the safety, tolerability, and efficacy of remdesivir plus hyperimmune intravenous immunoglobulin (IVIG) has begun in the United States, Mexico, and 16 other countries on 5 continents.
The combination treatment is being tested in hospitalized adults with coronavirus disease 2019 (COVID-19) and is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID). The antibody solution, called anti-coronavirus hyperimmune IVIG (hIVIG), is derived from plasma donated by patients who have recovered from COVID-19. The antibodies are highly purified and concentrated so that it contains several times more neutralizing antibodies than typically found in plasma.
Remdesivir is currently recommended for the treatment of certain hospitalized patients with COVID-19, based on a trial that found hospitalized patients with COVID-19 and lower respiratory tract involvement who received the drug had a statistically significant shorter time to recovery. It is an investigational broad-spectrum antiviral developed by Gilead Sciences.
According to a press release, investigators hypothesize that giving patients anti-coronavirus hIVIG at the onset of their symptoms could augment the body’s natural response to the severe acute respiratory coronavirus 2 (SARS-CoV-2), thereby reducing the risk of more severe illness and death.
“Finding safe and effective treatments for COVID-19 is absolutely critical,” said NIAID Director Anthony Fauci, MD, in a statement. “The [Inpatient Treatment with Anti-Coronavirus Immunoglobulin] 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 investigators will enroll 500 hospitalized adults who have had COVID-19 symptoms for 12 days or fewer and who do not have life-threatening organ dysfunction or organ failure. hIVIG will be given as a single infusion of 400 mg/kg of body weight, and remdesivir infusions will be administered as a 200 mg loading dose followed by a once-daily 100 mg IV maintenance dose during hospitalization for up to 10 days. Study participants will be followed for 28 days.
The trial’s main goal is to compare the health status of participants in the combination treatment group with participants in the remdesivir-only group on day 7. Health status will be based on an ordinal outcome with 7 mutually exclusive categories, including no limiting symptoms due to COVID-19 and death. According to the press release, these categories capture the full range of severity experienced by hospitalized patients with COVID-19.
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 begins [news release]. National Institutes of Health; October 8, 2020. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-testing-hyperimmune-intravenous-immunoglobulin-plus-remdesivir-treat-covid-19-begins. Accessed October 16, 2020.