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COVID R&D consortium launches I-SPY adaptive trial with Quantum Leap

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.

The COVID R&D consortium is making good on its intention to push forward experimental therapies as fast as possible, partnering with Quantum Health to launch an I-SPY adaptive trial to evaluate 10-20 agents within a year to treat ARDS, the late-stage respiratory failure that can lead to death in COVID-19. The trial is the first output of the COVID R&D group unveiled by BioCentury this month.

COVID R&D, a precompetitive industry consortium comprising more than a dozen of the top pharma companies, has prioritized the use of master protocols as an efficient way to study multiple candidates in parallel. It is evaluating compounds from the member pharmas’ own pipelines as well as from other investigators or companies, agnostic to market potential (see “Pharmas Align Behind Crowdsourcing Solution”).

In partnering with Quantum Leap Healthcare Collaborative, the consortium gains the expertise behind the I-SPY 2 breast cancer master protocol, plus the I-SPY clinical trials network of over 20 sites that will help it operationalize the I-SPY COVID (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning) trial. At least two therapies in the breast cancer trial received accelerated approval (see “Quantum Leap Provides Update on I-SPY 2”).

The partnership includes Carolyn Calfee, professor of medicine and critical care at the University of California San Francisco; Laura Esserman, the lead PI on the I-SPY 2 trial and director of the UCSF Carol Franc Buck Breast Care Center; and Keith Gottesdiener, chair of the COVID R&D consortium therapeutics sub-team.

The new adaptive trial will evaluate up to four treatments simultaneously to identify therapies to treat acute respiratory distress syndrome in patients with severe COVID-19.

The COVID-19 trial will evaluate repurposed and novel therapies; the total number of molecules tested will depend in part on how long the virus persists, and the associated rate of respiratory distress.

Under the trial’s adaptive design, agents can be added or removed from the trial without stopping. Each arm will receive a standard-of-care treatment and an effective therapy could become the new SOC if found to be effective.

The breast cancer I-SPY 2 trial, on which the I-SPY COVID trial is based, relied on Bayesian predictive probability to determine whether a regimen would be statistically superior to standard therapy.

The partners did not disclose a date but said a few sites would begin enrollment to enable a rapid launch, and enrollment will expand to the remainder in the following weeks. They did not respond to a question about clinical endpoints in time for publication.

The I-SPY COVID trial is the first master protocol designed with a selective focus on ARDS patients. At least seven other multicenter master protocols have been announced globally for COVID-19 (see “Master Protocols Emerge as a Critical Clinical Tool Against COVID-19”).

The goal is for the trial to become a learning system for what works in the disease. Gottesdiener previously told BioCentury that creating a lasting network and protocols was an important objective of the COVID R&D consortium.

As part of its service to the biomedical community, BioCentury has coordinated with the consortium to collate publicly available information on molecules under investigation for COVID-19. More than 300 therapies and vaccines are listed in BioCentury’s COVID-19 Resource Center, with more being added daily.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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