A combination of remdesivir and a concentrated solution of antibodies did not work well in people hospitalized with COVID-19, according to a newly published study.
The clinical trial tested remdesivir, an antiviral from Gilead Sciences, combined with anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG), the concentrated solution, but the combination did not significantly improve favorable outcomes among the patients, researchers reported in The Lancet.
The antibody solution was made using antibodies from blood plasma donated by people who recovered from COVID-19, the CCP (Chinese Communist Party) virus.
About 600 patients spread across Africa, Asia, Europe, North America, and South America were divided into two cohorts for the study. About half received the experimental drug combination while the other half received a placebo and remdesivir.
When measuring the outcomes among the patients after seven days following the treatment, there was little difference between the groups.
Researchers reported that “there was no evidence that patients who received a single infusion of hIVIG in addition to remdesivir and other standard of care had better clinical outcomes at day 7 after randomization than patients who received placebo plus remdesivir and standard of care.”
The hope was when starting the trial that giving people hIVIG at the onset of COVID-19 symptoms could bolster the body’s natural immune response, leading to a reduction of serious illness and death.
The phase 3 trial that researchers reported the results of was funded by the National Institute of Allergy and Infectious Diseases, a U.S. institute directed by Dr. Anthony Fauci.
“Unfortunately, the trial demonstrated that this strategy did not improve the health of adults hospitalized with COVID-19 and may be harmful for a certain subset of patients. Studies testing this strategy in non-hospitalized adults earlier in the course of infection are underway,” Fauci said in a statement.
Studies testing the same combination in adults who have COVID-19 but are not hospitalized are underway.
Remdesivir is one of the most-recommended COVID-19 treatments by the COVID-19 Treatment Guidelines Panel, a panel convened by National Institutes of Health (NIH). Fauci’s institute is part of the NIH. Remdesivir was recently cleared by U.S. drug regulators for use outside hospitals.
The panel said in a recent statement that remdesivir “is expected to be active against” Omicron, a variant of the CCP virus. Gilead said recently that its drug retained activity against Omicron in laboratory testing. U.S. regulators have effectively banned use of two monoclonal antibodies after several preprint studies found lower or little effectiveness against Omicron, which is dominant in the United States.
Remdesivir has drawn criticism from some experts because of its cost and studies indicating it has little to no effect on COVID-19, though other research has suggested it does help COVID-19 patients, at least in some settings. The drug also has serious side effects including kidney failure. The World Health Organization currently recommends against its use in hospitalized patients.