Wake Forest Baptist the First Health System to Enroll Patients in the Adaptive I-SPY COVID-19 Trial

Wake Forest Baptist the First Health System to Enroll Patients in the Adaptive I-SPY COVID-19 Trial

Wake Forest Baptist Health was the first trial site location in a health system to enroll patients in the Phase 2 clinical trial known as the I-SPY COVID Trial. The Phase 2 clinical trial seeks to rapidly screen promising repurposed therapeutic agents in an adaptive platform trial setting to treat critically ill COVID-19 patients. The study team uses a suite of repurposed therapies including Remdesivir, Cenicriviroc, Icatibant, Razuprotafib and Apremilast. Based on this report, TrialSite recognizes Wake Forest Baptist under the Site Watch leading category.

What is the I-SPY COVID Trial?

On July 20, TrialSite introduced the I-SPY Trial formally known as the Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning (NCT04488081)

TrialSite reported that this Quantum Leap Healthcare Collaborative sponsored study sought out to rapidly screen promising experimental treatments while helping to identify those most effective in particular subgroups based on molecular characteristics (e.g. biomarker signatures).

The study represents a unique collaborative approach by an open, engaging consortium including the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors and clinicians from 16 major U.S. cancer research centers.

Study Comments

Recently, the local Boone, NC, press called Watauga Democrat reported on the news. Co-principal investigator D. Clark Files, MD reported, “The adaptive design of this trial allows us to constantly analyze the data and learn which drugs are working and which ones are not.” Karl Thomas, MD, added, “By identifying effective treatments in real time, our goal is to reduce mortality and the length of time patients spend on ventilators.”

The Study Drugs

While Remdesivir was recently approved by the U.S. FDA for COVID-19, it’s not proven to impact mortality rate associated with COVID-19. And the recent World Health Organization study concluded its had little to no impact on fighting the pathogen.

What about Cenicriviroc? This inhibitor of CCR2 and CCR5 receptors enables the experimental drug to function as an entry inhibitor, hence potentially preventing a virus from entering the human cell. Known as TAK-652 or TBR-652, it’s an experimental drug candidate for the treatment of HIV infections and in combination with Tropifexor for non-alcoholic steatohepatitis under development by both Takeda and Tobira Therapeutics. Thereafter, Cenicriviroc was acquired by Allergan from Tobira in 2016 for a deal worth up to $1.695 billion.

Icatibant is an anti-inflammatory drug with a trade name of Firazyr. It’s used to treat sudden attacks of hereditary angioedema (HAE). Razuprotafib is a novel small molecule Tie2 activator that enhances endothelial function and stabilizes blood vessels, including pulmonary and renal vasculature. Its produced by a company called aerpio

With a trade name of Otezla, Apremilast is a medication used for some types of psoriasis and psoriatic arthritis. But it also may be useful against other immune system related inflammatory diseases. In 2019, Amgen acquired Otezla from Celgene for $13.4 billion

The Sponsor

Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs with a mission to integrate care and research, this includes supporting and promoting high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to trial matching, and greater benefit to patients, providers and researchers. Quantum Leap seeks to improve and save lives by providing the operational, financial and regulatory oversight to the I-SPY initiative.

Lead Research/Investigators

D. Clark Files, MD 

Karl Thomas, MD 


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