Quantum Leap Healthcare's I-SPY 2 Investigators, ARDS Experts and COVID R&D Consortium Unite to Bring Success from the I-SPY Adaptive Platform Clinical Trial to COVID-19 ARDS ICU Patients

SAN FRANCISCO, April 28, 2020 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC), a non-profit organization focused on uniting patient care and research, and sponsor of the adaptive platform I-SPY 2 Trial™, announced today a unique pre-competitive consortium created for an I-SPY COVID Trial to rapidly identify therapies to treat acute respiratory distress syndrome (ARDS) in critically ill COVID-19 patients.  Approximately 10-15% of patients infected with SARS-CoV2 develop a severe acute respiratory illness, and nearly 70% of patients admitted to an ICU require ventilation for an average of two weeks; it is estimated over half of those patients will not survive.

"The COVID-19 pandemic has brought Acute Respiratory Distress Syndrome (ARDS) to the forefront of public attention. It is one of the deadliest diseases that we face every day in critical care medicine. Patients with COVID-19 who wind up on ventilators have far too high a death rate, and I believe that the I-SPY 2 adaptive platform model will position us to work together to rapidly test agents and approaches that may decrease deaths and time on ventilators," said Carolyn Calfee, MD, Professor of Medicine and Critical Care, University of California at San Francisco (UCSF).  "The members of this partnership are all committed and have the experience and desire to help us make a difference for ICU ventilated COVID patients."

This unique partnership will include ARDS experts from the University of California at San Francisco and from more than 20 I-SPY 2 U.S. sites along with the COVID R&D Consortium, which is a consortium organized by the R&D heads of major US and European pharmaceutical and biotechnology companies. Through this unprecedented alliance, the I-SPY 2 principal investigators are supporting and partnering with ARDS colleagues at their institutions across the U.S. to adapt the efficiency and rigor of the I-SPY 2 adaptive platform breast cancer model to rapidly test a large number promising agents for their potential use against COVID-19 related ARDS.

"Collaboration between pharmaceutical companies in a pre-competitive setting like the COVID R&D consortium is the best way forward to address the profound reality of ARDS in COVID-19 patients – no sector can move quickly enough on their own. But with the right investigators, agents and collaborators across disciplines, we will rapidly learn what does and does not work," says Laura Esserman, MD, founder and Co-Principal Investigator of I-SPY 2, Member, QLHC Board of Directors, Director, Carol Franc Buck Breast Care Center, UCSF. "Through our I-SPY 2 investigators teaming up with equally committed ARDS physicians, we can apply all that we have learned in I-SPY 2 for the benefit of current and future COVID-19 patients."

The I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID

Therapeutic Response with biomarker Integration and Adaptive Learning) is the first COVID-19 ARDS trial to employ an adaptive platform design. This will enable comparing any new potential treatment for COVID-related ARDS to existing therapies. Over time, the COVID-19 ARDS trial will become a learning system for what does and does not work in this disease.

Data from the agents tested in adaptive platform trials can quickly demonstrate whether a new therapy is better, worse or equivalent than standard of care treatments for this challenging disease.  Like the I-SPY 2 trial, the adaptive platform trial approach offers the opportunity to utilize multiple arms so that several potential ARDS therapies can be evaluated simultaneously. As shown in over 10 years of the I-SPY 2 trial for breast cancer, when these advantages come together through this novel design, it will be possible to rapidly evaluate many more agents, including combinations of therapies, for ARDS in COVID-19 patients than would be possible in classic clinical trials.   The goal is to evaluate 10-20 agents in a year, depending on how long the virus persists and the associated rate of respiratory distress.

"The I-SPY framework is well suited to find effective treatments for COVID-19 caused ARDS that is proving to be so deadly for patients.  QHLC is honored to lead this unique consortium and we are all committed to success for the benefit COVID ARDS patients who are in such desperate need," said James Palazzolo, CEO, QHLC.

QLHC will employ its existing I-SPY clinical trials network of over 20 sites to operationalize the I-SPY COVID Trial.  A subset of these sites will begin enrollment of the I-SPY COVID Trial to enable a rapid launch followed by expansion to all sites in the following weeks.

The combined power of this QLHC partnership is further strengthened through regular communications with the Food and Drug Administration (FDA), which has long sought to increase the efficiency and speed of identifying safe and efficacious agents through innovative clinical trials designs.  Like this COVID-19 ARDS collaboration, the I-SPY 2 trial was originally developed through a partnership between the Foundation for the NIH and the FDA over a decade ago.  In the aggregate the overall goal of this combination of QLHC, ARDS investigators, I-SPY 2 Site Partners, COVID R&D Consortium, with counsel from FDA,  is to substantially decrease the number critically ill patients that have to be ventilated and die of this disease, and the number of days they spend on ventilators and in the ICU.

"I-SPY has proven to be effective in identifying promising treatments, while maintaining safety standards and statistical rigor," said Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration.  "Precompetitive collaborative efforts like this one are critical to rapidly identify effective agents against the ARDS we are seeing in COVID-19 patients to decrease suffering and lower mortality."

The I-SPY COVID Trial will have up to 4 experimental treatment arms being studied at any one time. Agents can be dropped in or out of the trial without stopping the trial. Each arm will receive a standard-of-care treatment as a common "backbone" which will serve as a control. If therapies are found to be effective, they will "graduate" at which point they will stay in the trial, or if the signal for patient improvement is strong, a successful therapy could become the new standard-of-care when appropriate. New therapies could then be added to the new standard-of-care which becomes the backbone, enabling testing combinations of therapies that may be essential to improve outcomes in this complex disease.

"A key component of the adaptive trial is its speed: the more effective a treatment is, the more quickly it can graduate and move into patient care.  Preventing this terrible outcome from COVID-19 is essential if we are to be able to return to our lives and livelihood. We are impressed by the collaborative nature of this effort and the pace of progress and we have committed to work with them as partners," said Keith Gottesdiener MD, Chair of the COVID R&D Consortium, Therapeutics Sub-team.   

A standing committee, the Agents Working Group, of the I-SPY COVID Trial will evaluate the safety and potential for effectiveness of numerous agents – both repurposed and novel drugs.  Successful candidates will also be evaluated on the basis of the capacity of the pharmaceutical sponsor to rapidly produce sufficient drug for use on a global scale.

"While an effective vaccine is our best strategy to address the challenges of COVID-19 in the future, it will take time, and in parallel we need to identify agents to reduce both the time on ventilators and the mortality of  COVID-19 ICU patients.  This unique partnership is exactly what we should be doing – using knowledge from innovative trials like I-SPY 2 to quickly address a problem like ARDS in COVID-19.  This type of collaborative teamwork is the way science should be done," stated Dr. Anna Barker, PhD, Chief Strategy Officer, USC Lawrence J. Ellison Institute for Transformative Medicine, Member, QLHC Board of Directors and Former Deputy Director, National Cancer Institute (NCI).

About Quantum Leap Healthcare Collaborative
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. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to the I-SPY Trials. For more information, visit www.QuantumLeapHealth.org.

About the I-SPY Trials
The I-SPY Trials were designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 20 major U.S. medical research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org. 

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