How to Beat COVID-19 with Real-Time, Real-World Data

Curious Dr. George

Mark Shapiro, PhD, Principal Investigator of BEAT19

As the COVID-19 pandemic continues, researchers around the world are working quickly to develop strategies to treat and prevent this disease. In partnership with the company xCures, Cancer Commons is studying how COVID-19 impacts cancer patients. Meanwhile, xCures has launched larger initiative, BEAT19, to gather information from everyone and anyone who wishes to participate—whether they’ve had cancer, COVID-19, or neither.

Here, our Curious Dr. George asks xCures’ Vice President of Clinical Development Mark Shapiro, PhD, about BEAT19. Shapiro is Principal Investigator of the BEAT19 registry (Behavior, Environment and Treatments for COVID19) and can be reached at mshapiro@xcures.com.

Q: In 2000, we said that “the internet changes everything,” and it did. In 2020, we can say that “COVID-19 changes everything,” and it will. The good news is that the internet allows a whole new approach to studying the coronavirus that causes COVID-19 using clinical trials to produce real world evidence (RWE). How might RWE be applied now to study COVID-19, using innovative methods?

Mark Shapiro, PhD: I certainly agree that everything has changed. This pandemic has moved much faster than biomedical science is generally designed to move. It is also a stark reminder of the connectedness of people, not just online but in real life. There is an information vacuum, and if we as scientists don’t fill it with accurate information, it will get filled with half-truths and speculation. The internet spreads information quickly, but it doesn’t discriminate.

I’ve been amazed by the efforts to publish so many small studies about COVID-19 in days or weeks, but they often raise as many questions as they answer. Having communicated frequently with friends in Italy, Singapore, and Hong Kong since January, I had the feeling that it would be increasingly difficult to run traditional clinical trials if a great many of the people experiencing this illness would be in isolation at home.

So, a small group at xCures worked tirelessly to launch an electronic registry, BEAT19, for daily symptom tracking with the ability to go back to later link up to medical records. We had some sense of the symptoms and have deployed patient-reported outcomes in our other work. Of course, there isn’t a validated SARS-CoV-2 symptom questionnaire, so we tried to adapt various questions that could characterize the natural time course of symptoms. The goal was to generate data that would help collective understanding the disease in an empirical way.

With BEAT19, we are trying to observe the symptom trajectory of COVID-19 and measure endpoints, such as seeking testing or hospitalization. The natural experiment investigates how the trajectory or endpoints differ between similar patients on different anti-hypertensives. I’m sure you saw yesterday’s report in the New England Journal of Medicine; the hypothesis around angiotensin signaling has been around for weeks. Similar questions have been posed about classes of diuretics and more generally about corticosteroids. While a vaccine is urgent, in the short term, answering these questions about how medical management could reduce the risk or severity of infection can have a major impact.

For a few weeks, we have also been aware of people taking hydroxychloroquine or lopinavir/ritonavir, so any evidence people on those medications have different risk or disease severity than similar people is valuable, for example in forming a strategy to protect front-line healthcare workers.

We are committed to running BEAT19 as a public service and have already received offers of collaboration from dozens of people in industry, academia, and government. A number of them have suggested important hypotheses to test, so we’re organizing working groups to formulate and design the analyses.

Thank you for your question, George. Please let your readers know that they can learn more or sign up at BEAT19.org.

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