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AbbVie, Amgen and Takeda Pharmaceutical, which are members of the COVID R&D Alliance, have started patient enrolment in the I-SPY COVID Trial.
The study will assess the efficacy of cenicriviroc, Otezla (apremilast), Firazyr (icatibant injection) in severely ill, hospitalised Covid-19 patients requiring high-flow oxygen.
Cenicriviroc is a chemokine dual-receptor antagonist of CCR2 and CCR5, while Otezla inhibits PDE4 and Firazyr is a bradykinin B2 receptor antagonist.
The drug candidates were selected based on their potential effect on the immune system response in Covid-19 patients who need respiratory support.
Otezla is expected to suppress inflammation caused by an immune response, Firazyr may mitigate bradykinin-driven pulmonary edema and cenicriviroc may reduce the ARDS response severity in severely ill patients.
The I-SPY COVID study leverages Quantum Leap Healthcare Collaborative’s adaptive platform trial design. This design is meant to improve trial efficiency by decreasing the number of participants and assessment duration of potential therapies.
Primary endpoint of the trial is time to reach level four or less for at least 48 hours on the World Health Organization (WHO) COVID scale while key secondary endpoints include duration of time on ventilator and mortality.
Quantum Leap Healthcare Collaborative co-founder and I-SPY Trials lead investigator Dr Laura Esserman said: “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.
“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.”
In addition to AbbVie, Amgen and Takeda, the COVID R&D Alliance includes approximately 20 drugmakers focused on the development of potential Covid-19 treatments.
Members are evaluating marketed and late-stage therapies, which are indicated for various other disease states and may have a therapeutic impact in Covid-19 patients.