The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored and funded a trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The clinical trial found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2 is not more effective than remdesivir alone for treating adults hospitalized with the disease.
The trial also found that the safety of this experimental treatment may vary depending on whether a person naturally generates SARS-CoV-2-neutralizing antibodies before receiving it. The results of the multinational Phase 3 trial were published in the journal The Lancet.
The antibody solution tested in the ITAC trial was anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. The antibodies in anti-coronavirus hIVIG came from the liquid portion of blood, or plasma, donated by healthy people who had recovered from COVID-19. These antibodies 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.
“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 NIAID Director Anthony S. Fauci, M.D. “Unfortunately, the ITAC 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.”
The main goal of the trial was to compare the health status of participants seven days after beginning treatment with hIVIG plus remdesivir with that of participants seven days after beginning treatment with remdesivir alone. The primary endpoint was an ordinal outcome with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death. Safety was assessed at day seven with a composite outcome that included death, serious adverse events including organ failure and serious infections, and severe events that made performing basic functions impossible.
The ITAC investigators found that participants who received hIVIG plus remdesivir did not have better health status seven days after beginning treatment compared with participants who received remdesivir alone. Similarly, participants who received hIVIG plus remdesivir had no improvement in other clinical outcomes during the 28-day follow-up period compared to those who received remdesivir alone.
