Remdesivir alone not effective for treating COVID 19: study
Washington - January 28 ANI A new study has found that a combination of remdesivir and a highly concentrated solution of antibodies that neutralize SARS-CoV-2 is not more effective than remdesivir alone for treating adults hospitalised with COVID 19 is not more effective than remdesivir alone.
The trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC, was sponsored and funded by the National Institutes of Health. The trial was conducted by the International Network for Strategic Initiatives in Global HIV Trials INSIGHT Mark Polizzotto, M.D., a NIAID-funded International Network for Strategic Initiatives in Global HIV Trials. The trial was led by a PhD, the head of the Clinical Hub for Interventional Research at the College of Health Medicine at The Australian National University in Canberra.
The antibody solution tested in the ITAC trial was anti-coronavirus hyperimmune intravenous immunoglobulin or hIVIG. 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-coronaviruses hIVIG consistently contained more SARS-CoV-2 neutralizing antibodies than typically found in the plasma of people recovering 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 fight the disease early in the course of hospitalization, said Anthony S. Fauci, M.D., NIAID Director Anthony S. Fauci, M.D.
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. He said that studies testing this strategy are underway in non-hospitalized adults earlier in the course of infection.
Four companies collaborated to provide anti-coronaviruses hIVIG for the trial: Emergent BioSolutions of Gaithersburg, Maryland, Grifols S.A. of Barcelona, CSL Behring of King of Prussia, Pennsylvania and Takeda of Tokyo.
Remdesivir is a broad-spectrum antiviral that is currently approved by the U.S. Food and Drug Administration and recommended for treating certain patients with COVID 19 based on data from several randomized clinical trials, including the NIAID-sponsored Adaptive COVID 19 Treatment Trial ACTT 1 FDA, which was approved by Gilead Sciences, Inc. of Foster City, California.
The ITAC study team enrolled nearly 600 hospitalized adults aged 18 years or older who had COVID 19 symptoms for up to 12 days and did not have life-threatening organ dysfunction or organ failure. The enrollment took place at 63 sites in 11 countries in Africa, Asia, Europe, North America and South America between October 2020 and February 2021.
The study participants were randomly assigned to receive infusions of either the anti-coronaviruses hIVIG and remdesivir or a placebo and remdesivir. Neither the participants nor the study team, except for pharmacists who prepared the infusions, knew who received the treatment regimen until the end of the trial. All participants received supportive care reflecting local practice and national guidelines.
The main goal of the trial was to compare participants' health status 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.
Participants who received hIVIG plus remdesivir did not have a better health status seven days after beginning treatment compared to participants who received remdesivir alone. 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.
The investigators found no overall difference in safety for people who received hIVIG plus remdesivir alone, compared to those who received remdesivir. The researchers also undertook a pre-specified subgroup analysis of safety among participants who had developed SARS-CoV -- 2 neutralizing antibodies before receiving hIVIG.