My Favorite Case Study: COVID-19 Applications for Monkeypox

Chapter 1: Setting the Stage: Monkeypox Outbreak

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Hi. Everyone. Welcome back to the Advarra In Conversations with… podcast! Today we’re going to be touching on what I think is a very timely topic, that is monkey pox and the current state of clinical research for this sort of unfolding epidemic. I’m Luke Gelinas, senior executive IRB Chair, Advarra and I’m very happy to introduce today’s Guest, Dr. Tim Wilkin.

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Thanks, Luke. Yes, I’m Dr. Tim Wilkin. I’m the Assistant Dean for Clinical Research Compliance at Weill Cornell medicine. I’m also an infectious disease Doctor and more relevant for today, I’m a study chair for an upcoming clinical trial on Tecovirimat for the treatment of human monkeypox disease.

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Excellent! Great, nice to have you! Let’s jump in. So, it seems just as though just when we were getting past sort of the worst of the Covid 19 pandemic, we started hearing rumblings about monkey pox. So, I’m wondering if we could just sort of start with sort of a clinical basics. I wonder if you could maybe explain in layman’s terms for someone who doesn’t have any or much clinical background, what monkey pox is, Is it new? What is it? Look like? Sort of what should we be worried about? And so on?

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Sure, so, monkey pox is not a new virus. It’s actually been described since 1958, and it actually has very little to do with monkeys. We don’t know where monkey pox lives, what we call the reservoir. So somewhere in nature there’s an animal that carries this virus that can then transmit to humans. So, the virus is endemic in parts of Africa, meaning that it’s something that they see routinely, and it can present with an initial stage of feeling poorly, fever, lymph node swelling, and then people generally develop a typical rash of small bumps that turn into pustules that can turn into sores and really be quite severe. It’s an interesting virus. It’s related to smallpox. So, as people know, small poxes are the one virus that we’ve eradicated from the earth.

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But it’s still a concerning infection for bioterrorism. So, this led people to (particularly the US. Government) to develop drugs, to treat smallpox, and that’s what the drug that we’re studying, Tecovirimat, was designed for.

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And because they’re closely related viruses, we think that Tecovirimat will treat human monkey pox disease. So, what’s interesting, what’s happened recently is that a type of monkey pox, a clade of this virus has begun being transmitted among men who have sex with men primarily, and what’s interesting is that it’s presenting in a different way than monkey pox.

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It has been known to present with what we call proctitis, so severe rectal pain and bleeding it’s presenting with a lot of genital lesions as well as mouth lesions and fortunately it doesn’t seem to be life-threatening for the vast majority of people. So out of approximately fifty thousand people that have been infected in this pandemic, there have been about four deaths that have been documented. So, it seems to be an emerging pandemic, and you know we’re keeping our eyes open for what’s going to happen next.

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So, as you mentioned, you have a NIH funded study. I believe it’s called Stomp! I want to ask you about that for sure, Maybe before we do that to kind of set the stage a little bit. I’m wondering if. And you’ve already started doing this a little bit if you could say more about sort of the current therapeutic landscape with respect to monkey pox. Are there any currently FDA-approved vaccines for monkeypox are there any therapies, the FDA approved or otherwise? Perhaps you know interventions or drugs that are being used off label. And what are the things look like in terms of a patient who comes to you for help?

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Sure, great questions, so as far as prevention, there are two vaccines that were developed for the prevention of smallpox. There’s one that we’re using the JYNNEOS vaccine primarily in the US, that’s given us two injections about four weeks apart. So, we know that the vaccine is safe, and we know that it can lead to antibodies that have been shown to protect against monkey pox infection. However, we don’t really have any data in humans to say that it works.

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So, one thing that is, I think, a little bit missed in the messaging is what’s unknown about the vaccination, and while we expect it to prevent monkeypox infection, we don’t have the same level of evidence that we do for, say, the covid vaccines for example. That being said, I fully recommend a vaccination if you’re identified as a person in need of it. but that that’s just something to keep in mind that we don’t really have high level data on that, on the efficacy.

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So, tell us a little bit about the vaccine. What about sort of for therapies for someone who shows up in your office and is symptomatic? Do we have approved therapies for treating it?

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There are, I guess, four therapies. One that I don’t know so much about is Vaccinia Immune Globulin, so um There’s a vaccine that can be used as a vaccine against smallpox, and in some cases the vaccine strain can disseminate and cause problems. So, there’s a preparation of antibodies that can help clear that disease and infection. So that’s an option.

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But much easier to implement would be oral medications. So, there’s two other ones besides Tecovirimat. There’s a drug called Cidofovir that’s used to treat CMV Disease. And then there’s a kind of a derivative of that called Brincidofovir, that is also used to treat CMV disease. So Cidofovir is very toxic I’ve only used it a couple of times in my career, and it causes significant kidney problems. So given that, you know the vast majority of people you know, recover without consequence the risk benefit doesn’t favor Cidofovir here. So, I don’t think that’s really being considered. but Brincidofovir is much better tolerated.  it’s been used in a few people with human monkey pox. However, there was a development of liver problems. It’s not clear if it was exactly related to the drug, or perhaps the human monkey pox infection. So that is still on the table to be considered. But I think people are most excited about Tecovirimat because it targets a very specific You know part of the life cycle of this family of viruses, and

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there’s much more of a rationale, for why? This would be effective. So there’s great data in animal models of orthopox and virus infections. But we really don’t have any data in efficacy than people.

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So, it sounds like the Tecovirimat is sort of the most promising candidate, and that’s the intervention your study, correct?

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correct. And what’s really interesting is that because we’ve had access through the expanded access sciences through the CDC, Many of our investigators in the study have a really good feel for the drug, and have used it in fifty people or so each. So, we do have a sense that the drug is very well tolerated, and seems to be efficacious. But you know there’s no control data.

Chapter 2: Weill Cornell Monkeypox Trial

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Yeah, very interesting. I wonder if you want to take a moment and just tell us about this study kind of maybe go into a little bit of detail on how it’s designed, and then maybe discuss some of the challenges you faced in designing it, and then in running it.

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Sure, Thanks. So, it’s been a whirlwind to get this study up and running. I’ll just start with that. So, I work with the AIDS Clinical Trials group, which is part of the NYAD NIH. And our clinical Trials group was asked to run this trial or develop and execute this trial.

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Our main concerns going into this is that we know that people can develop severe complications from the virus. So, I mentioned the eye problems. There can be deep scarring on the face lots of problems that can develop. We knew that Tecovirimat was available. It had a good rationale for being effective, and we knew that people were already starting to access this through the expanded access IND.

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we also had no idea. Well, we also were concerned about where the epidemic would evolve. Would it stay primarily with men who have sex with men, Or would it generalize to other populations? So, we really wanted to have a very inclusive study and to balance the need for efficacy data with the thought that Tecovirimat was very promising and safe. So, what we did was we first defined the population for the study. So basically, people with human monkeypox disease, and something that could be followed.

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It’s basically a three-armed study. So, there’s a blinded Tecovirimat placebo for Tecovirimat or open label Tecovirimat. So, our main question that we wrestled with was, Who do we feel is appropriate for randomization? And who do we think we should just give open label Tecovirimat to? So, we need to find a definition of severe disease. So, this included people with disease in the eye, lesions on the face that could be potentially scarring, people who were already hospitalized for infection because of pain or other reasons, people who had very deep ulcers that were requiring intervention. So those people, we just said, You know what we don’t need to have them in the randomized group. Let’s just provide them open labeled Drug.

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Then there were also a group of people that were at risk for severe disease just by their own personal health status. So, people with severe immunosuppression, people who have inflammatory skin conditions that we know that other viruses in this family can, basically they can just get in an incredibly rapid disease. So we thought it better just to provide them open label drug. And then there were groups of people where the main question was not necessarily is it efficacious? But how do we dose it? You know, children get infected with monkey pox in Africa all the time, and there have been probably about twenty

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children in the US already that have had been diagnosed with monkeypox. And really we don’t have any data on the pharmacokinetics of the drug in in children, especially younger children, lower body weight. So for children we thought it better just to give them all Tecovirimat, and really focus on understanding the pharmacokinetics and safety in that group.

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In addition, people who are pregnant or breastfeeding, we opted to provide access, because we think that monkeypox disease is more aggressive in pregnancy, and the pregnancy outcomes neonatal outcomes are poor in Africa, so we thought, it’s just better to give those people the choice of whether they want to receive Tecovirimat rather than putting them in a blinded study.

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So that was the broad outline. People who we did not feel were appropriate for randomization just received open label, tecovirimat, and then the advocacy question focuses on those that were eligible for randomization.

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So let me ask a clarifying question. The open label sort of arm is not necessarily an arm that people who are randomized to it’s an arm that you sort of allocated people to base on you know their status or their vulnerability, perhaps.

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Yes. Exactly.

Chapter 3: Ethical Considerations in Monkeypox Research

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that’s really interesting. I’m not sure. It seems also to me pretty novel and cutting edge. So you know um one of the challenges we always have when there’s a placebo, especially when there might be, you know, available alternatives, and certainly something we really wrestled with Covid-19, especially once the vaccines were shown to work was randomizing someone to a placebo when you might have other good options available. So I think that kind of the study design that you’ve just described. It seems to some extent mitigate that problem. So you’re basically saying, like the people for whom you know, the people who really need the alternative therapy. In some sense, we’re going to make that available in an open label cohort. But those for whom you know there’s not the same perhaps pressing concern, or who are a little bit healthier, those are the ones we’re sort of going to randomly randomize to Active versus the placebo. I think that’s a really nice way of dealing with ethical tension.

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Yes, you absolutely have it right. And I think the first thing that we did was to recognize there is an ethical tension here and there is our desire as providers to treat our individual patients with a drug that we think risk-benefit ratio probably favors treatment versus the need to get efficiency data. I think it’s problematic If we were to consider.

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Oh, it’s just saying, Oh, well, let’s just use the drug. We don’t have controlled data, and then suddenly that becomes the standard of care. And if there’s problems with the drug resistance or other need to develop a new therapy, you don’t have that basis to understand, Is this efficacious in the first place? Or you Don’t, have convincing data to say that it’s efficacious, or how efficacious it is. So you know, we, the FDA has felt very strongly that we have to have controlled data,

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and that having control data is really the only way that we can get to a place where it’s simply writing a prescription that’s filled at the pharmacy to treat this infection. Now it’s, you know it’s a complicated process to get it, and we did. We also did other things to kind of mitigate that um, that ethical tension. So, we have said that if you are in the blinded part of the study, you’re going along, and to be in that part of the study, you can’t have severe disease at baseline. But say, then, two days later, you’re hospitalized or you develop an eye lesion, we then we stop the blinded treatment, and then you just start in a course of open label Tecovirimat.

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Yeah, that’s a really nice. I mean, this was sort of like kind of finely specified individual withdrawal criteria, almost right. Yes, if people kind of deteriorate, we’re going to get you into that open where you are. Um, yes. So I think there’s a really nice statement of the tension, because this is kind of a topic in the bioethics literature. I’m sure you feel it even more acutely as a clinical, between, on the one hand having a product that’s available to be at least for right to try expanded access, and sort of knowing that perhaps it’s safe we don’t really know it seems to be efficacious, but we don’t really have great data that is, that efficacious and sort of the desire to treat the patient in front of you, on the one hand, versus you know, the need to really get that good efficacy data that you can only get through a randomized trial. I thought that was a really a nice statement of it, and that must be a difficult tension to navigate in clinical life.

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Yeah. And we are seeing that with our sites, the vast majority of sites we’ve approached have chosen to be a part of the study, but we’ve had a few sites that have you know whoever is running the site doesn’t feel comfortable with the ethics of randomization. I mean, I personally think it’s clearly reasonable to approach someone about this study, whether individuals would choose to do this versus accessing through the expanded access program, we really wanted to leave that to be an individual choice.

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So we’ve tried to address the concerns as best we can. But fundamentally we believe there needs to be a Placebo controlled assessment of the efficacy, and it’s also because what I didn’t really discuss yet is, what is the outcome? What are we measuring? What are we assessing? And so there are no completed studies of human monkey box virus disease. So, there’s no precedent about what’s the clear endpoint that one should use? there was a trial that should start soon in the Democratic Republic of Congo. That that’s using this drug to treat the clay of the virus that circulates in that area,

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and so they. Fortunately they had spent a long-time kind of discussing and figuring out what would be the most reasonable endpoint, so that a lot of that work had been done, and so we just adopted their endpoint. And so we’re looking at the time from randomization to what we’re calling clinical resolution. So that is following all of the skin lesions, the lesions in the mouth to the point that they’re all reach a certain level of healing. Yeah, And So that’s what we’re comparing between the two arms. And so we think that by having the healing shortened by three days, that that would be a clinically meaningful benefit. And yeah, and that’s how we powered the study.

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Sure, I guess that’s a surefire indication that you’re a trailblazer in the field. When there are no established endpoints, and you’re coming up with them on your own. So congrats on that.

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Yeah. And I don’t want to give the impression that we developed this. That was clearly the investigators from the NIH Sponsored study in the Congo called the palm trial.

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And then there’s a study that just started that’s interesting in the UK: That has a similar endpoint, but it’s one hundred percent remote. So it’s all self-assessment. So our study is using self-assessment by the participants as well as video visits And in-person visits to really document the healing.

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So, as an IRB chair, I have to ask you, did you have any trouble getting this through the IRB, or what was IRBs reaction to the ethical issues you’ve been describing.

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So I mean the approval. There’s the approval within dates. There’s the kind of FDA interactions and not exactly approval. But there are viewpoints on the study as well as the Irv. So it’s part of our NIH Review. Fortunately they included a medical ethicist who gave us really terrific feedback about the study, and really about how we justify the overall design. The FDA was highly involved. what we did was first of all, let them know this is this is coming along, and there’s a lot going on here. We need your opinions rapidly, and you know several times along the way. So we got a pre-review. They were initially concerned about including pregnant women because it is so different Right? Typically it just I think pregnant women and children tend to get left behind in clinical research. And so there, There’s needed data that really Isn’t collected for a long time because of concerns about conducting research in that in those vulnerable populations we made the argument. So I think they wanted a very firm rationale, which I totally understand. And so we provided that the known pregnancy outcomes.

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You know why we were including them. The fact that you know people had the choice to be in the study or not. And so those issues were worked out as we were getting the final protocol submitted. But other than that, you know just a lot suggestions about clarity of language and other things. But that was the main point that they came back to us with.

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You mentioned FDA I imagine you’re working pretty closely with them. What’s been sort of your experience? Is there a sense that they’re treating monkey pox with sort urgency, any lessons, or eye-opening situations or experiences?

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I’ve been in clinical research for twenty years, or so, and I’ve always had good experiences with the FDA. But I have to say. I’m incredibly impressed with all my interactions with the FDA. So at our first meeting we gave them sort of a list of questions. They had experts in every relevant area on the call prepared with specific recommendations. It was very impressive. They were the ones that really encouraged us to include children in this study, and once we included children to include the full range of children all the way down to Neonates, should that be necessary, and just really said, Why are you excluding people on medications that could induce the metabolism of the Tecovirimat. You know It’s a subtle group, but you know why don’t you provide them Tecovirimat and just give them open label to you. So you can look at the Pk interactions. So they really pushed us, and were very supportive and provided us expert opinions about a whole range of topics multiple times during the development. And this was all over the course of the whole protocol was developed over the course of four to six weeks.

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And it was amazing.. We had our first meeting, July the twenty first. We have our first sites that are, have it approved by Advarra, their own local approvals, and are ready to hopefully enroll on Friday. Friday, the ninth. Yeah. Hopefully. And so it’s just in addition to the FDA, the full resources of NIAD, NIH, And it’s just been really gratifying to see so many people put their whole effort into getting this protocol up and running in a timely manner, so we could really get this needed data out as soon as possible.

Chapter 4: Learnings from COVID-19 Research

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I mean that’s how it should be ideally right, but off too often probably isn’t. I wanted to ask you to maybe try to draw out some comparisons, or to see if you think there are any comparisons between kind of research on Monkeypox and research on Covid 19, and you know a ton that’s been written about kind of the research community’s response to Covid19

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Clinical research seems to be in the public eye, like never before. people actually kind of understand what an IRB is now, to some extent, or at least they seem a lot more willing to kind of engage in these conversations and interested about it. I would love to hear your thoughts if someone has been doing this for a while about how, if that all Covid has changed the research landscape

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Yeah, I mean great question. It’s super interesting to have gone through this as a clinical researcher. So I would say that our current response, and how quickly we’ve gotten this study up and running would not have been possible if we hadn’t had the experience of Covid. So yeah, there’s a ton of parallels, so they’re both transmissible viruses. And so the whole idea of

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How do you physically conduct the research? You know we didn’t really spend any time thinking about it, because people had already figured it out with Covid.  you know when we set offhandedly up. At the Investigator meeting. Oh, and it’s probably a great idea to do remote, consenting ahead of time, so you can take your time, and you know not. Use up the space and sites already know how to do that, and know how to do it in an FDI compliant manner. Because of so, you know.

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The FDA has lived through that experience, and so knows the importance of getting the research up and running in a timely manner. I think we are much better prepared. Now that we were prior to Covid,

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and just to know those are hopefully changes that will persist right. It’s sort of the Research Committee’s got a hang of the whole econsent thing you can sort of. That’s just a stick of a standard tool in your toolbox.

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Absolutely. I mean, there’s just. There’s a whole number of reasons why that makes a lot of sense for a lot of people. So it’s been very, very interesting. And one thing that’s different about this is that we don’t have at the beginning of Covid. There were, fifty, one hundred different things that were being studied here. It’s much more limited. As far as I know, this is the only us trial of Tecovirimat, so it is much more contained and controlled,

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Interesting, that was gonna be my next question cause we saw such a proliferation at the first year of Covid in clinical research for everything and it seems like people were not to be crass but throwing stuff at the wall, repurposing things and seeing what sticks so it seems like there hasn’t been quite the same proliferation of clinical research generally on monkey box.

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No, I mean, I think it was this unique situation where this drug had already been developed, I believe, by the CDC. And the U.S. Government for treatment of smallpox, should it be used as a bioterrorism, agent, and to treat Vaccinia like disseminated vaccinia you know the type of immunization against smallpox. So, it was already sitting there, and it already had, you know, safety data and looked great, so it was almost shelf ready. It actually was shop ready because they had a stockpile of it. So you know, it was just it was much, like ninety percent of the work had been done already to get a new therapy in. So, it was a unique situation.

00;24;51;26 –> 00;25;11;29

One of the perennial concerns in clinical research generally is enrolling enough people to power your study and sort of. If you look at the data here. Rates of rates of under enrollment are kind of sadly, generally high. A lot of studies start, and then Don’t finish any concerns about enrolling enough people into some.

00;25;11;29 –> 00;25;56;28

Yes, I’ve had studies that have enrolled amazingly fast, and others that have languished and are still languishing. So, I personally experience the full gamut. So there’s a lot that’s unknown about the enrollment. First of all, we have our estimates that were used to power the study. But those estimates are not. It’s not a whole lot of data to inform. Yeah, the choice of them. So there’s that issue. The fact that this pandemic has kind of exploded in the Us. And it seems to be on the way down which is terrific. So there could be a dwindling population, which is, you know, a great problem for us to have as a country.

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And Then there’s also this added challenge of will people really choose to um access the drug through the expanded access program right? So there’s a lot that’s unknown. So to address that the NIH made the strategic decision early that they want to include a large number of sites. So we’re really trying to include eighty sites in the Us. And then there are a few international states that we think could be brought on as well. Yes, so that’s what we can do, we’ll follow it and make adjustments as we need to try to facilitate a accrual

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this is kind of where that that tension on the availability of something like the environment through an expanded access pathway starts to bite Right? Because you worry about it frankly, or you might worry about it siphoning away people from the clinical trial, and I know that some bioethicists you worry about. It’s interesting. If you look at the FDA regulations. There’s sort of this clause that says, you know, in order for expanded access to be appropriate.

00;26;59;02 –> 00;27;24;22

It can’t interfere with the clinical development of that drug. And I always wonder if that’s sort of something that’s ever enforced by institutions. In other words, you might say, look, we’re not going to make this drug available through the pathway, because we have this clinical trial, and we think it’s important to power. I don’t think that’s something that you know would be popular, and I think that the patient groups would probably react pretty strongly to it. But I wonder if you have thoughts on that.

00;27;24;22 –> 00;28;08;23

Well, I mean, that was why we designed the study the way that we did, and to try to address those very valid concerns. I haven’t taken care of many patients with human monkey box, mainly because I’ve been working on this protocol, but I mean people are suffering, and it’s scary, and there’s groups of people that have really severe disease and could have lasting complications. You know it’s just something that we discussed at length. It was really the central question of how we designed the study. So my whole goal is to get the study enrolled quickly, so we don’t have to really entertain that or the FDA Doesn’t have to entertain that that possibility. But yeah, for my understanding, that is a possibility.

00;28;08;23 –> 00;28;27;04

Yeah. Fingers crossed. One of my hopes is that kind of the role that Covid has played and kind of raising the public profile of clinical research will result in more people in the public. But to understand how important that you know clinical research is, and you know, will result in higher volunteer rates. But I think that’s what it remains to be seen.

00;28;27;04 –> 00;28;40;15

I think a lot of people said, “Look if we can get these vaccines approved so quickly on the basis of big phase, three trials, Why can’t we do this?” Why can’t we move this quickly for other devastating, debilitating diseases? And I think to some extent that’s a fair question.

00;28;40;15 –> 00;29;14;01

Yeah, I I think it’s a great question. If you look long, long term, the FDA did change pretty radically with the HIV epidemic. So the activists, really pressured and stormed the FDA and said, taking three years to approve a drug isn’t acceptable when we’re all dying from it. So, the FDA did make changes. They have their faster track status, for you know things that are breakthrough, or you know I’m no expert on it, but they have made modifications, and I think it is important just to say for the Covid vaccinations.

00;29;14;01 –> 00;29;46;26

It wasn’t as if steps were skipped. They were kind of layered on each other and done in a way that was much, much faster, but it was also much riskier and more expensive. But you know, completely warranted in the situation. So, who knows that’ll generalize to other things? But I think it is critically important for people, consumers, to be involved and to understand and to make their voices heard, because it does affect change. And so, if you know, the Government should be responding to the priorities of the people, and people need to just speak up about it.

00;29;46;26 –> 00;30;03;00

Well, that’s well said, and perhaps a nice note to end on. Dr. Wilkin I’ve really enjoyed speaking with you. It’s been fascinating, very grateful for you joining us on this episode of Advarra in conversations with. I would love to convince you to come back on once your research is complete, and to share its results with our listeners.

00;30;03;00 –> 00;30;08;09

I would love to, and hopefully, that will be very soon in the future. Thank you, Luke. I really enjoyed the conversation.

00;30;08;09 –> 00;30;27;02

Okay, that’s all for this week’s episode. Thanks. Everyone for listening. If you enjoyed today’s episode, please keep a lookout on Advarra’s social channels on advarra.com for our next episode.

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