Focusing on the Problem with an Important New Solution

About the I-SPY COVID Trial

The COVID-19 pandemic is a crisis primarily because of the lung toxicity and high chance of death for a relatively small fraction who get this virus. The corona virus is highly contagious, and we cannot predict who will suffer the most. Our only good weapon right now is to follow public health precautions. And even though most people don’t get really sick, the virus can be extremely severe for some, and it is now the highest cause of death everyday in the US, killing over 100,000 people in the US alone.

But there is another critically important approach to preventing death from COVID-19 and that is to rapidly develop treatments for those who are critically ill. Solving this problem is essential for SARS-COV2 and other future viruses.

Our solution
We are opening the I-SPY COVID TRIAL designed to rapidly screen and confirm high impact treatments to reduce mortality and time on ventilators. This work is independent and equally as important as vaccine efforts. The I-SPY COVID TRIAL is a platform trial which means that you can put an infrastructure in place and test many drugs and combinations quickly. This is the most efficient way to learn and find solutions.

Our trial is unique
We are focusing on those patients whose reactions to the virus make them critically ill and, in many cases, cause them to die. We have identified several very promising drugs that either neutralize the virus, help heal the lung damage from the virus (caused by Adult Respiratory Distress Syndrome or ARDS) or change the immune system reaction that makes people so sick (for younger people, this is especially important). We are opening this trial in June and will keep it open until we find a drug or combinations of drugs that prevent people from dying and staying on ventilators.

All of the drugs we are testing are available and ready to be distributed world-wide if we find they help. We are testing many agents at once, learning in real time, confirming when a drug is working, and then using it in combinations with other new promising drugs. We can learn very quickly what has a big impact, what does not, and build on what makes a big difference.This is a fast and efficient approach to solving the problem. The study schema is shown below:

Our approach
For I-SPY COVID, we are tapping the best and brightest in intensive care medicine and drug development, building ideas through our culture of innovation and collaboration, and moving quickly because of process efficiencies and our longstanding partnership with FDA. Our precompetitive collaboration with industry (pharma/biotech/diagnostics/information technology)allows to work with everyone who can contribute to finding a solution.

In just 6 weeks, we repurposed our tools and approach to care in the I-SPY 2 TRIAL and built the I-SPY COVID trial.  We have many exciting therapies to test and will be opening our sites by the end of June 2020.  We are very hopeful that this approach will make a difference in the coming months. Time and resources are dedicated to push this initiative forward, as better lifesaving treatments would make all the difference to our communities and our country.

The initial I-SPY COVID 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, Wake Forest Baptist Medical Center, and Yale with others opening as the initiative is funded.

More information:

To learn more about making a difference please contact Tracey Heather:
t.heather@quantumleaphealth.org or 415.425.1731.

If you know of sites that want to join the initiative, contact Karyn DiGiorgio:
karyn.digiorgio@quantumleaphealth.org or 415.307.1539.




Map of I-SPY COVID sites

For researchers interested in conducting COVID research, The I-SPY COVID Trial has a central repository for biospecimens, clinical and biomarker research data.  Requests for access to samples and data can be made in the concept proposal document here.

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