I-SPY COVID trial enrolls first patients to test various therapeutics

A clinical trial dubbed I-SPY COVID enrolled its first patients last week, setting into motion plans to evaluate the efficacy of several COVID-19 therapeutics under the collaborative efforts of the COVID R&D Alliance, AbbVie, Inc., Amgen Inc., and Takeda Pharmaceutical Co. Ltd.

“I’m proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID,” Andy Plump, president of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance, said. “The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that, upon investigation, may show efficacy in this devastating disease.”

I-SPY will analyze the effects of cenicriviroc, Otezla, and Firazyr on inflammatory response among severely ill, hospitalized COVID-19 patients who require high-flow oxygen. It is based on Quantum Leap Healthcare Collaborative’s adaptive platform trial design and also includes the input of the U.S. Food and Drug Administration. The therapies chosen were picked based on their potential to affect immune system response in those needing respiratory support, given the acute respiratory distress syndrome (ARDS) prevalence in COVID-19 cases.

Otezla has the potential to suppress inflammation caused by immune responses, while Firazyr can ease conditions caused by excess fluid in the lungs — pulmonary edema. Cenicriviroc could help reduce the severity of ARDS cases by blocking monocytes from moving to tissues.

By working together in this platform trial, the respective organizations believe they will be able to test candidates faster than any single company could manage.

“Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly,” said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University. “The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation.”

Goals for the study include helping patients reach level four or less on the World Health Organization’s COVID scale for at least 48 hours and reducing both mortality and time spent on ventilators.