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Wake Forest Baptist first in U.S. to enroll patients in innovative COVID-19 trial

WINSTON-SALEM — Wake Forest Baptist Health is the first health system in the country to enroll patients in a Phase 2 clinical trial designed to quickly determine whether drugs already approved for other uses can be repurposed to effectively treat COVID-19 in critically ill patients.

The study’s “adaptive platform trial design” means several possible drug treatments can be tested at the same time, with the most promising potentially moving forward for further exploration and the least promising being removed from the study. Several drugs have been identified that either neutralize the virus or help heal lung or other organ injuries that make people severely ill from coronavirus. All study volunteers also receive medications approved as standard of care for the virus.

Known as the Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning (I-SPY COVID Trial), the study is a collaboration among pharmaceutical industry members of the recently formed COVID Research & Development Alliance and others; the Quantum Leap Healthcare Collaborative, a partnership of medical researchers and investors; and the Food and Drug Administration.

Two Wake Forest Baptist faculty members are serving as co-principal investigators for the Wake Forest Baptist site: D. Clark Files, M.D., and Karl Thomas, M.D., both from the health system’s section of pulmonary, critical care, allergy and immunologic medicine.

“The adaptive design of this trial allows us constantly analyze the data and learn which drugs are working and which ones are not,” Files said.

“By identifying effective treatments in real-time, our goal is to reduce mortality and the length of time patients spend on ventilators,” Thomas added.

The adaptive platform design for the I-SPY COVID Trial was adapted from the I-SPY 2 TRIAL, a research study for patients with early-stage, high-risk breast cancer. In October 2019, Wake Forest Baptist became the first health system in the state to join that trial.

In addition to Wake Forest Baptist, the other initial I-SPY COVID Trial sites are Columbia University Medical Center, Montefiore Medical Center, Sanford USD Medical Center, University of Alabama, University of California San Francisco, University of Colorado Denver, University of Pennsylvania, University of Southern California and Yale University. Other sites are planned to open in the future.

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