Hospitalized COVID-19 patients who received a combination of remdesivir and hyperimmune intravenous immunoglobulin — a highly concentrated solution of antibodies that neutralize SARS-CoV-2 — did not fare better than those who received remdesivir alone, according to phase 3 trial results published Jan. 27 in The Lancet.
The study, funded by the National Institutes of Health, involved nearly 600 adults hospitalized with COVID-19 across 11 countries from October 2020 to February 2021. Participants were randomly assigned to receive either remdesivir alone, or in combination with anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG — an antibody solution made from the plasma of healthy donors who had recovered from COVID-19. The antibodies in the solution "were highly purified and concentrated so that the anti-coronavirus hIVIG consistently contained several times more SARS-CoV-2 neutralizing antibodies than typically found in the plasma of people who have recovered from COVID-19," making it different from convalescent plasma, according to a news release.
Seven days after beginning treatment, participants who received both hIVIG and remdesivir did not have better health status relative to the cohort who only received remdesivir. Among the group that received hIVIG, the odds of a worse safety outcome was higher among participants who had naturally developed antibodies before receiving it.
"In our quest to find safe and effective treatments for COVID-19, we had hoped that adding anti-coronavirus hIVIG to a remdesivir regimen would give the immune system a boost to help suppress the virus early in the course of hospitalization," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
"Unfortunately, the [Inpatient Treatment with Anti-Coronavirus Immunoglobulin] 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."