NIH launches phase 3 trials of potential three immunomodulators for COVID-19

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Last week, the National Institutes of Health launched a large phase 3 clinical trial to graph the safety and efficacy of three modulators being considered for use in patients admitted with COVID-19. ..

The three drugs used are Janssen Research & Development, LLC’s Infliximab (REMICADE), Bristol Myers Squibb’s Abatacept (ORENCIA), and AbbVie’s Cenicriviroc (CVC). These were selected from over 130 pools based on their association with COVID-19 and strong evidence of their use against both inflammatory responses and cytokine storms.

Cytokine storms are inflammations that occur as a result of an excessive immune response in some COVID-19 patients. It can cause acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications. However, NIH wants to determine if balancing this immune response can reduce the need for ventilators and shorten hospital stays, and is investigating using the ACTI V-1 immunomodulator test. doing.

“This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented time frame, focusing on the treatments with the highest expectations for the treatment of COVID-19,” said the NIH director. One Francisco Lins said. “Immunomodulators provide another treatment for the ACTIV treatment toolkit, helping to manage complex multisystem conditions that can be caused by this very serious disease.”

The trial is randomized, placebo-controlled, and uses an adaptive master protocol that enhances coordination and efficiency in assessing these agents. Those that do not work are eliminated, and others may replace them. Approximately 2,100 inpatient adults with moderate to severe COVID-19 cases will be enrolled in US and Latin American healthcare facilities to be tested. It should last about 6 months and the results will be available soon.

This trial will study different combinations of treatment regimens, paying attention to disease severity, recovery rate, mortality, and hospital resource utilization. NIH coordinates trials through the National Center for Advancing Translational Sciences and is funded and supported by the Biomedical Advanced Research and Development Agency.

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