Immunomodulators for COVID-19 Focus in Major NIH Clinical Trials – Washington University in St. Louis School of Medicine

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Phase 3 trials include inpatients with moderate to severe illness

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Dr. William G. Powdery is discussing patient care with Dr. Maana Sisamant in the intensive care unit of Burns Jewish Hospital. Powderly, director of the Clinical and Translational Sciences Institute at Washington University in St. Louis School of Medicine, is a protocol chair for international Phase 3 clinical trials funded by the National Institutes of Health (NIH) and has three drug possibilities. I am investigating. Treatment of COVID-19. The drug was selected because it may reduce the dangerous inflammatory response experienced by some patients with the virus.

One of the most annoying aspects of the COVID-19 pandemic is the ability of the new coronavirus to direct the body’s immune system to the body. After the virus is cleared from the body, the immune system can continue to damage the arsenal of immune proteins with the already defeated virus, causing a dangerous inflammatory reaction called a cytokine storm. Such cytokine storms can contribute to acute respiratory distress syndrome, multiple organ failure, and death.

In a new international Phase 3 clinical trial led by the University of Washington School of Medicine in St. Louis and funded by the National Institutes of Health (NIH), three drugs developed for other inflammatory diseases tame cytokines. Investigate the possibility. It causes storms, shortens hospital stays, and reduces the need for patients to be placed on a ventilator to aid in breathing.

The goal is to enroll 2,000 patients admitted with moderate to severe COVID-19 throughout the United States and Latin America. All patients receive standard treatment, including remdesivir, an antiviral drug that has been shown to be capable of accelerating recovery and reducing mortality. In addition to standard treatments, participants are randomly assigned to receive placebo or one of three anti-inflammatory drugs.

“In severe COVID-19 infections, we believe that the virus causes an abnormal immune response, which causes inflammation of the lungs, which is the main reason people need a ventilator and sometimes die. “The University of Washington said. William G. Powdery, MD, Chair of the Protocol of the International Tribunal, J.William Campbell, Professor of Medicine, and Institute of Clinical Translation Science.. “Viral infections can cause the need for hospitalization, but the illness seen in such patients is primarily an abnormal immune response. Approximately 10 days after the initial infection (many people with severe illness are hospitalized). Many people no longer have the active virus, so antiviral drugs are not very effective at this point. We believe that the addition of immunomodulators may help, and this study said The purpose is to determine if such drugs would benefit patients with serious illness. “

Trial, part COVID-19 Intervention and Acceleration of Vaccines (ACTIV) The initiative is coordinated and supervised by the National Center for Advancing Translational Sciences (NCATS), which is part of the NIH.It is expected to last about 6 months and COVID-19 patients Barnes-Jewish Hospital You may be eligible to participate in the trial.

Results will be available sooner after the study is completed, or if analyzes performed during the study show that either drug is beneficial. An independent data and safety oversight committee oversees the study and conducts regular reviews of the data to ensure that the study is conducted safely and effectively.

The drug being evaluated in the study is infliximab under the trade name Remicade, developed by Janssen Research and Development LLC, one of Johnson & Johnson’s Janssen pharmaceutical companies. Developed under the trade name Orencia by Abatacept, Bristol Myers Squibb. Cenicriviroc is an investigational drug developed by AbbVie in late-stage clinical trials for inflammatory diseases.

All three are designed to suppress the immune system and reduce inflammation. Infliximab is approved by the Food and Drug Administration (FDA) for the treatment of several chronic inflammatory conditions such as rheumatoid arthritis, Crohn’s disease and ulcerative colitis. Abatacept has been approved by the FDA for the treatment of various forms of arthritis, including rheumatoid arthritis, psoriatic arthritis, and juvenile polyarticular arthritis. Cenicriviroc has been evaluated in clinical trials for the treatment of liver inflammation caused by the accumulation of liver fat and is being clinically studied for the treatment of HIV infection.

Three immunomodulators were selected for research from a list of over 130 drugs known to regulate the immune system. They were selected based on their potential relevance in the treatment of COVID-19, evidence of use for inflammation and cytokine storms, safety profiles, and wide availability of large clinical studies.

The design of clinical trials is known as the adaptive master protocol. This allows investigators to evaluate up to five drugs at a time and stop or start drug evaluation based on current evidence. Drugs that are unlikely can be excluded from the study and replaced with others. The study also gives the flexibility to change standard treatment if another study identifies new treatments that are safe and effective for patients enrolled in the ACTIV trial.

“If the drug doesn’t work, we can quickly remove it from the protocol and add new treatments as they become available,” said Powderley, director of the University of Washington. I am. Public Health Institute Co-directed with Infectious disease department At the medical school. “All patients under study receive the highest levels of treatment, including remdesivir, and are three-quarters more likely to receive one of the investigational drugs.”

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative is a public-private partnership funded by Operation Warpspeed through the Biomedical Advanced Research and Development Agency of the US Department of Health and Human Services’ Deputy Secretary’s Office. For preparation and response.

NIH announced the ACTIV Initiative in April. The goal of this program is to prioritize the development of the most promising COVID-19 therapies and vaccines and to develop a national research response to accelerate their development. Led by the National Institutes of Health Foundation, ACTIV coordinates partnerships between government, industry, academia and nonprofits.

Sarah Moser