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Trial to Test Many Covid-19 Lung Disease Treatments

Human lungs illustration

(NIH.gov)

28 Apr. 2020. A clinical trial designed to make quick changes to accommodate new conditions plans to assess 10 to 20 drugs for a serious lung complication from Covid-19 infections. The I-SPY Covid trial is applying an ongoing clinical study framework testing cancer drugs, to treatments for acute respiratory distress syndrome, a serious and life-threatening complication from Covid-19 infections.

The continuing Covid-19 pandemic is creating an urgent need for drugs to treat patients with advanced forms of the disease. One of the more serious and deadly complications of Covid-19 infections is acute respiratory distress syndrome, or ARDS, a life-threatening complication where fluid leaks into the lungs. ARDS is often triggered by injury to the lungs, and in the case of Covid-19 infections, from inflammation reacting to the SARS-CoV-2 virus responsible for the infections. The fluid build-up makes breathing difficult and adequate oxygen does not get to the body, requiring supplemental oxygen or mechanical ventilation for weeks at a time in some cases.

A group of organizations, academic labs, and drug companies are testing a series of proposed treatments for breast cancer in the I-SPY2 trial — short for Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2 — a project also experimenting with alternatives to conventional randomized clinical trials. As reported by Science & Enterprise in September 2018, the I-SPY2 trial helped advance seven new breast cancer drugs by that time to FDA for review.

The I-SPY2 study uses an adaptive design with algorithms that make it possible to alter factors such as treatment regimens or sample sizes based on interim results. Adaptive trials often are governed by a master protocol, where a single basic study structure can test a series of treatments, making it possible to accommodate new treatments, samples, or changes in direction without starting over from scratch.

The I-SPY2 trial and now I-SPY Covid trial are sponsored by QuantumLeap Healthcare Collaborative. The group began in 2005 as a collection of medical researchers at University of California in San Francisco and Silicon Valley entrepreneurs aiming to reform or disrupt time-honored clinical trial processes with advances in technology and innovative business practices often missing in life sciences research.

The I-SPY2 trial organizers plan to apply these techniques to treatments for ARDS. The study aims to test ARDS therapy candidates with current treatments, quickly revealing effective single drugs or combinations and those not working. The study team expects to evaluate 10 to 20 ARDS treatments per year, depending on persistence of the virus and continued ARDS complications, in a pre-competitive setting where results are openly shared among participating drug makers.

Quantum Leap will use 20 existing I-SPY trial sites for the I-SPY Covid trial, starting with a subset of sites, then expanding to the full roster in the following weeks. The study will look primarily for changes in the number of critically ill ARDS patients needing ventilation, days spent on ventilators, time spent in intensive care units, and number of deaths.

Laura Esserman, professor of surgery at UC San Francisco and Quantum Leap co-founder, says in an organization statement released through PRNewswire that this kind of study and consortium are “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.”

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