R&D Alliance begin I-Spy COVID trial

By The Science Advisory Board staff writers

August 3, 2020 -- A collaborative research effort that includes the U.S. government and leading pharmaceutical companies has launched a clinical trial to investigate a series of therapeutics to treat patients who are severely ill with the novel coronavirus disease.

The so-called I-Spy COVID trial will investigate several therapies that have the potential to affect the immune response of patients with COVID-19 who require high-flow oxygen. It is supported by the U.S. Food and Drug Administration, the Quantum Leap Healthcare Collaborative, and the COVID R&D Alliance, a group of 20 biopharmaceutical and life science companies that include AbbVie, Amgen, and Takeda.

The trial, which has enrolled its first patients, will investigate the following therapies:

  • Cenicriviroc, a chemokine dual-receptor antagonist
  • Otezla (apremilast), a PDE4 inhibitor
  • Firazyr (icatibant injection), a bradykinin B2 receptor antagonist

Cenicriviroc, Otezla, and Firazyr were chosen based on their potential to affect the immune response of patients with acute respiratory distress syndrome (ARDS). Notably, cenicriviroc blocks monocytes trafficking to tissues, Otezla may suppress immune response-related inflammation, and Firazyr may ameliorate bradykinin-driven pulmonary edema, the companies noted.

The trial will use Quantum Leap Healthcare Collaborative's adaptive platform design, which can attain the scientific rigor needed to test therapeutics while minimizing the number of participants needed and time required, according to the company.

The companies behind the COVID R&D Alliance decided to join together to test promising therapeutic candidates faster than any individual organization could do on its own, they noted. They are also employing several adaptive platform trial methodologies to test multiple therapies at once and modify protocols based on real-time outcomes.

The I-Spy COVID trial is one of several I-Spy trials being conducted by the Quantum Leap Healthcare Collaborative and the COVID R&D Alliance. Laura Esserman, PhD, lead investigator of the I-Spy trials and co-founder of the Quantum Leap Healthcare Collaborative, said the partnership is unprecedented.

"The level of cooperation among pharma companies in response to the pandemic is unprecedented," she stated in a press release.

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