COVID R&D Alliance Starts Clinical Trial for Coronavirus Treatments

August 05, 2020 - Members of the COVID R&D Alliance, Abbvie, Amgen, and Takeda Pharmaceutical, recently announced that the first patients were enrolled in the I-SPY COVID clinical trial, which will evaluate the efficacy of potential coronavirus treatments for severely ill patients.

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The I-SPY COVID trial will evaluate cenicriviroc, a chemokine dual-receptor antagonist, Otezia, a PDE4 inhibitor, and Firazyr, a bradykinin B2 receptor antagonist, Abbvie said in the announcement. 

The study, launched in collaboration with Quantum Leap and the FDA, will leverage Quantum’s platform trial design to increase trial efficiency by decreasing the number of participants and time required to evaluate potential treatments.

“The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed,” Laura Esserman, MD, co-founder of Quantum and lead investigator of the I-SPY trials, said in the release.

“We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most.”

About 10 to 15 percent of patients infected with COVID-19 develop acute respiratory distress syndrome,and up to 60 percent of those patients admitted to an ICU require ventilation for an average of two weeks, Abbvie said.

The study aims to speed the development of potential therapies, antibodies, and anti-viral therapies for coronavirus and its related symptoms.

Experts believe that Otezla may reduce inflammation from an immune response, while Firazyr may improve bradykinin-driven pulmonary edema and cenicriviroc may block white blood cells going to tissues.

Improvement of any of these side effects could reduce or mitigate acute respiratory distress syndrome in COVID-19 patients.

“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,” said Andy Plump, president of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. 

The therapies selected for the study were based on their individual potential to accelerate the immune response of COVID-19 patients who need respiratory support. 

I-SPY COVID is just one of many platforms being utilized by members of the COVID R&D to test therapeutic candidates.

Currently, the alliance is evaluating over 1,900 preclinical candidates to find the most promising COVID-19 candidates, as well as reviewing promising candidates and linking them with potential funders to enable rapid development. 

They are also working with TransCElerate’s DataCelerate platform to allow for real-time data sharing and real-world evidence to inform ongoing and future COVID-19 trials. The group is also conversing with governments, regulators, and organizations to share insights, Abbvie said. 

"Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19,” said Mark McClellan, MD, director of the Robert J. Margolis, center for health policy at Duke University and former commissioner of FDA and administrator of CMS.

"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.”