Virtual IDWeek 2020 started Wednesday morning with a 24-hour event entirely devoted to the COVID-19 global pandemic. “Chasing the Sun” brought together organizations from around the world to present clinical data on treatments, diagnostics, vaccine development, infection control, mitigation strategies, and other late-breaking issues.
In this exclusive MedPage Today video, David Aronoff, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, explains how he would measure the efficacy of current treatments, and how we should apply the lessons learned from past trials.
Following is a transcript of his remarks:
Right now we’re obviously seeing, in parallel, lots of clinical trials for lots of ways to hopefully prevent or treat COVID-19. Some of those involve use of monoclonal antibodies or cocktails of monoclonal antibodies. Some are using convalescent plasma and some are developing and trialing new drugs or combinations of drugs and even existing drugs off the shelf to see if disease can be reduced in severity or disease can be prevented.
I think what I want to see in clinical trials first and foremost for anything that’s being used in patients is safety. Number one, we need to make sure that we’re not doing anything that causes harm. Number two, we need to have pretty easy to measure and hard endpoints to look at effectiveness. So for example, maybe we’re trying to use monoclonal antibodies in patients who are early in their infection or have been exposed to infection. And we’re trying to keep them out of the hospital. That’s something obviously that we could measure easily, the number of people requiring hospitalization, or maybe we’re looking at hospitalized patients, but trying to protect them from getting worse and needing an increase in the level of care. For example, moving from a regular floor bed in the hospital to the intensive care unit setting or requiring things like life support, such as mechanical ventilation.
Right now about 1% or so of people who are diagnosed with COVID-19, unfortunately are dying of the infection. And so looking at treatments that could prevent death, obviously that’s a really important endpoint to be looking at. So what I’d like to see are measurable endpoints that are impactful, preventing hospitalization, preventing acceleration of care into the intensive care unit, preventing death in trials that are comparing with either placebos or standard of care. And that demonstrate a safety signal and that there is nothing that is causing harm and that the risk benefit ratio favors use of these new therapies, as opposed to not.
One of the things that we’ve really learned on the fly here with COVID-19 is the importance of well-designed clinical trials that compare any new therapy or prevention strategy with either standard of care or placebo, hopefully in a randomized blinded fashion to reduce the likelihood that bias is influencing the results or that confounding is influencing the results. Certainly we’ve learned that sometimes collections of anecdotes about a particular therapy don’t really add up to the same level of evidence of a randomized controlled trial. We saw a lot of promise and hope with interventions like hydroxychloroquine, the malaria drug for example, very early on in the pandemic, but rigorous well-controlled trials in a number of settings, preventing disease in exposed persons, preventing worsening of disease, or treating people who were in the hospital. None of those really well-designed randomized controlled trials demonstrated that it would be a good idea to use hydroxychloroquine. So that’s a setting where we really learned the value of evidence-based medicine, and we’re learning the same with drugs like remdesivir, or corticosteroids, or now with convalescent plasma, which is currently being studied in randomized placebo-controlled trials.
Source: MedicalNewsToday.com
