The University of Missouri School of Medicine is one of the first institutions in the world to enroll a patient in a new National Institutes of Health (NIH) clinical trial designed to test the safety, tolerability and efficacy of a combination treatment for COVID-19.
The study involves hospitalized adults with COVID-19 in the U.S. and 17 other countries on five continents. The patients will receive the anti-viral drug remdesivir plus hyper-immune immunoglobulin, a highly concentrated solution of antibodies from the plasma of patients who have recovered from COVID-19.
“Instead of transfusing the plasma from recovered patients directly into patients with the virus, the antibodies are purified and concentrated,” said site principal investigator Christian Rojas Moreno, MD, associate professor of clinical medicine and infectious disease specialist at MU Health Care. “Patients will receive several times more virus-neutralizing antibodies than typically contained in the plasma alone. The trial will test the hypothesis that giving patients these concentrated antibodies at the onset of COVID-19 symptoms could assist the body’s natural response to the virus. By attacking the virus in the early stages, this treatment may reduce the risk of complications or death.”
The study will enroll 500 hospitalized adults who’ve had COVID-19 symptoms for 12 days or fewer and do not have life-threatening respiratory failure or other organ dysfunction or organ failure. Study participants will be assigned at random to receive either hyper-immune immunoglobulin and remdesivir or a placebo plus remdesivir. Investigators will follow the progress of the patients for 28 days.
“Our team did an amazing job of getting our clinical site registered and open for this study,” said Mark McIntosh, PhD, vice chancellor for research and economic development. “We are excited to be one of the first institutions involved in such an important contribution to the international efforts to combat this pandemic.”
The hyper-immune immunoglobulin trial is just one of the major COVID-19 trials ongoing at the MU School of Medicine. Past projects involved testing hydroxychloroquine as a COVID-19 prophylaxis for health care workers and the convalescent plasma trial involving donated plasma from those who’ve recovered from the virus given to hospitalized patients seriously ill with the virus.