Duke Joins COVID-19 Study of Remdesivir

so what we've been able to open here is part of a nih-sponsored multicenter study looking at at a drug called REM d so via so REM Desa vr is a drug manufactured by Gilead and it's probably the farthest along in terms of any other therapeutics that we know

that we're hopeful can treat coronavirus so what has been unique about this study is that there's a number of different sort of large hospitals across the United States who've all teamed up in a sense with the guidance of the NIH driving this to say how can we as

as quickly as possible get an answer that's safe and that helps us understand which of the different therapeutics are the most effective for us to treat patients there's a number of things that I think are really important the first is that this has happened at an astonishing rate

for us to be able to get this open and that is true of Duke and that is true of many of the other big hospitals who've been able to make this work you know usually protocols like this a complex and need many many weeks to get off sort

of operationalized I think because everyone recognizes this is so crucial for our patients who are coming in we've been able to get this going in sort of six to eight days which is just really humbling from a investigator point of view to see so many people here make

this happen I think from North Carolina's point of view it's also incredibly helpful because of the timing so this is a drug that's designed to be studied in patients who are sick enough to require hospitalization with coronavirus and who are either sort of moderately to the severe end

of the spectrum in terms of being ill it's designed in a study that's called a placebo study so at this stage people get randomized into one of two different arms one would get the active drug the other would actually get a placebo and really the purpose of that

is to make sure that we can fully understand how much benefit is being delivered by this medicine or for that matter how many side effects may be coming with that so we think it's the farthest along in terms of the development it's been studied a lot in actually

a whole range of other viruses some that are quite similar to Corona var such as SARS and and Middle Eastern respiratory syndrome it's not yet all the way through its testing but we think it's getting close so we're actually pretty happy to be able to bring that to

patients and and bring that to clinicians as an option that I think all I hope proved very helpful it does it's not a drug that's available at this stage for our patients it's really people who are on the sicker end of the spectrum the other part of the

study that's really I think quite novel and I hope to be really impactful is this this comes with an adaptive study design so the purpose there is that you know we are in the midst of an unprecedented pandemic and so we would like to be able to offer

answers to the question of does this work as soon as we can and it's also a time when there's lots of other information being fed in from different hospitals and studies and universities and trends and we want to be able to be nimble and sort of move with

that most studies lock in a protocol and they follow it all the way through until the end here the design is if you have multiple centers trying to answer this question after we've got a certain number of people in we can stop have a look really quick understand

if we're heading in the right direction if we need to adapt the design of the study to answer questions or to feed in new information we can do that and so that part I think offers us a real sort of almost flexibility to move this study and gain

results and become informative probably a much quicker pace frankly than what we could normally do in an inner study so the way this would sort of pan out for patients is that if you have to be admitted because of a proven coronavirus here at Duke we would look

to see whether you'd be suitable to be on this study and based on sort of clinician evaluation and individual patient characteristics we could we could ask for patients to be consented it's some it it's a phase three study so really what that means is that it's gone through

pre it's gone through lab studies first of all we we think the lab science is good it's gone through healthy human studies and individuals who are just volunteers and we know it's safety profile therefore it's going through basic illness and now we're looking at it right let's let's

look at it in a clinical situation with people coming in through the hospital and prove that it really works in the way that we hope it does and that's kind of a typical pathway for most drugs