Hyperimmune intravenous immunoglobulin does not improve outcomes for adults hospitalised with COVID-19: NIH

The National Institute of Allergy and Infectious Diseases (NIAID) sponsored and funded the trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC

A clinical trial has found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralise SARS-CoV-2 is not more effective than remdesivir alone for treating adults hospitalised 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-neutralising antibodies before receiving it. The results of the multinational Phase 3 trial were published in the journal The Lancet.

The National Institute of Allergy and Infectious Diseases (NIAID) sponsored and funded the trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The trial was conducted by the NIAID-funded International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Mark Polizzotto, M.D., Ph.D., head of the Clinical Hub for Interventional Research at the College of Health & Medicine of The Australian National University in Canberra, led the trial.

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 neutralising antibodies than typically found in the plasma of people who have recovered from COVID-19.

Anthony S. Fauci, NIAID Director said, “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 hospitalisation. Unfortunately, the ITAC trial demonstrated that this strategy did not improve the health of adults hospitalised with COVID-19 and may be harmful for a certain subset of patients. Studies testing this strategy in non-hospitalised adults earlier in the course of infection are underway.”

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.