131 - Dr Wes Ely - What is Immuno-modulation & how could it help with Long Covid?

Episode 131 of the Long Covid Podcast is a chat with the wonderful Dr Wes Ely, internist & pulmonologist, clinical triallist & also author & Long Covid advocate. We chat through some of his experiences with Long Covid patients as well as the clinical trial of baricitinib for Long Covid which is enrolling very soon.

ICUdelirium.org
Stat News - "Don't give longhaulers the silent treatment"
RVLC - Reverse Long Covid trial on Clinicaltrials.gov
RVLC Trial website
Every Deep Drawn Breath book
COV-BARRIER study

For more information about Long Covid Breathing courses & workshops, please check out LongCovidBreathing.com

(music credit - Brock Hewitt, Rule of Life)

Transcript

Jackie Baxter  
Hello, and welcome to this episode of the long COVID Podcast. I am absolutely delighted to be joined today by Dr. Wes Ely, who is an internist pulmonologist and critical care physician. So he's going to tell us a load more about what that actually means in a moment. So a very, very warm welcome to the podcast today. I'm really excited to dive into this.

Wes Ely  
Thank you, Jackie, I appreciate being with you today. And thank you, for your listeners taking time out of their busy lives. I hope that we can continue to learn from one another, and that anything I can share will be of service to those who are suffering.

Jackie Baxter  
Thank you so much. Yeah, I think there's so so much suffering out there. So let's see what we can do. So perhaps before we kind of dive down too many rabbit holes, would you just be able to say a little bit about yourself and what it is that you do? 

Wes Ely  
Sure, and important for me to say for all of you listening, that you can't say all my gray hair, but I'm an old 60 year old guy who cherishes the privilege of being a physician and being able to stand next to and stand with my patients. I've been a doctor for over 30 years and I went to school in Louisiana. I grew up there and went to a school called Tulane University, and then trained also at Barnes Jewish in St. Louis with lung transplantation and immunosuppression. So I learned a lot about the immune system, and also trained in lung disease and critical care. 

I am primarily an intensivist now, so I cared for patients during the COVID pandemic, in our COVID ICU, it was a very difficult time, as we all know. And I got involved in COVID research, because I am a clinical triallist. So I do research funded by federal agencies like the National Institute of Health NIH, and the Veterans Administration. And we design large clinical trials to try and help save lives, get people through the healthcare system faster and more successfully, and into survivorship. 

And we can talk a bit more in a moment about the type of work that led us into COVID. But we did design the cov-barrier study with some other investigators which we came the first ever double blind placebo controlled trial of baricitinib, a now FDA approved immunomodulator for acute COVID. And we proved that that immunomodulator was a lifesaver for patients with severe COVID on oxygen. And it to date has provided the largest survival advantage of any drug in COVID. And so now we're setting out to try and understand if that same immunomodulator will improve the lives of people with long COVID. 

And before I forget, I have no conflicts of interest financially with the makers of that drug. The drug is made by Eli Lilly, I take no money, not a penny, in consultancy fees, stocks, they give us no money for this research. They are going to provide the study drug itself, but they are not in charge whatsoever or have any editing characteristics or qualities of how we do the study, how we analyze the data or how we report the data.

Jackie Baxter  
Wow. So there's so much to dive into here. And I'm super excited to dive into the sort of the research and stuff. But maybe before we go down that rabbit hole, can we talk a little bit about the sort of the patterns and trends and what's helping people, what isn't helping people with the sort of long COVID that you've seen?

Wes Ely  
Sure. You may it dawns on me that the listener might actually benefit from knowing what came before COVID. 

Jackie Baxter  
Sure, yeah, 

Wes Ely  
in terms of acquired brain dysfunction. So in the early 2000s, we began studying acute brain dysfunction, call it brain fog, during critical illness, and we call this delirium. And that delirium story, we created a way to measure delirium in the ICU. And it's now translated into over 40 languages called the CAM ICU. And our website has a lot of information on it. The website is ICUdelirium.org. 

And that work in acute critical care showed us that a period of time with confusion during acute illness would lead to a dementia, a back end, long term neuropsychological impairment. And so we have been studying neuropsychological impairment after acute illness for 25-30 years. And that's what brought us up to COVID. Okay, and we've done numerous large RCTs, randomized controlled trials, published them in journals like the New England Journal of Medicine, Lancet, Jama. We've been federally funded for all that period of time for almost three decades. 

And then when COVID hit, we started hearing that the people in surviving COVID Were having all these brain fog problems. And I was wrong. I thought that they were suffering from the post intensive care syndrome. We call PICS. Because that's what I've been studying for 30 years. And I kept seeing patients in the ICU. And I knew they were all going to have PICS, most of them, post intensive care syndrome. 

PICS is described on our website. But it's basically an acquired dementia, a neck up problem, also acquired PTSD and depression, and then neck down problems with muscles and nerves. Sounds a lot like long COVID In a way, doesn't it? So I thought these people had PICS. 

But then people started coming to our center because we have support groups every day of the week for survivors of the ICU and hospitalization. But the long COVID patients started contacting us and saying, Can we be part of your support groups? And they said, We've never been hospitalized. And I said, Oh, my goodness, they've never been hospitalised, they can't have PICS. So I realized that I was wrong about this. 

And I wrote an article in stat news, maybe you could put a link to that on the podcast. And it was called "Don't silence long COVID patients" and I use, I was able to learn the story and tell the story of three patients, one of whom had PICS only, one of whom was never hospitalized and had long COVID only, and one of whom had both long COVID and PICS. 

And it was it was a great example of how we in medicine, have to educate ourselves and remain open to the notion that we are ignorant in many, many ways. And the way to learn is by listening to you, Jackie, to listen to you and our patients. And the famous aphorism Osler says, "if you listen to your patient, she will tell you what is wrong". And so that's how I learned about long COVID was by listening to long COVID patients. 

Jackie Baxter  
And that's amazing, because, like, I hear you describing this, and I'm thinking, Well, you know, you have a lot of experience in all sorts of things that are super useful when we're talking about long COVID. For years and years and years, like you said, 30 years or something of experience, and all of everything that you've learned is going to be useful. 

But actually what I loved so much was that you said, I had this idea, and realized I was wrong. And that is something that you don't hear very much in medicine, or like I certainly don't, and you know that the idea that we can have an idea, we can have hypotheses, and you know, actually, then we change them as we learn more. We think, Oh, actually, I wasn't quite right, I'm going to slightly tweak that. And you know, then change direction. 

And that's how we learn, isn't it? By kind of hearing more, changing what we're doing, hearing more, improving what we're doing, you know, and, and I think that's amazing. That's kind of what we need to be doing, because there's loads that we can do now. And then as we learn more, there's even more that we can then do, it's kind of improving the process as we go on, isn't it? 

Wes Ely  
Absolutely. And I'll just go ahead and share with everyone here that my favorite position with my patients is on my knees. I like to be on my knees at the bedside, because that makes me smaller, it makes my patient bigger. If I'm on my knees, and I say to myself, she or he must increase, I must decrease. And when I can get myself in that frame of mind, then I'm in a place of service. And the whole point of medicine is to be a servant to the person who's suffering. 

In medical school. I remember staying up all night long studying for a test. And my partner and I, my roommate. His name is Darren Portnoy, he went on to work for Doctors Without Borders, medicine sans frontiers, MSF. And we decided that night as we were as the sun was coming up, that we wanted to devote our lives to improving the lives of people we would never meet. And that became our motto. 

We didn't tell anybody because it's kind of embarrassing for a while. But I'll tell people now that my goal is to improve the lives of people I'll never meet. And what that means is that through research and through investigations, like these trials, that hopefully somebody in India or Australia or Latin America, or Inverness can find an answer to their suffering. 

The bottom line is that we can provide mercy to one another. And Mercy means my willingness to dive into your chaos, and somehow provide lifting and healing. And I think for too long as a physician, I was willing to dive into those chaos, but I wasn't providing lifting and healing. And if I were to continue thinking that I was right, then I would not be a healer for the person. So I have to admit I'm wrong, learn and recalibrate and redirect. 

And that's what's brought me into this world of long COVID research. Never in a million years, did I anticipate or even want to study this. But now I view it as such a privilege and an unearned opportunity to contribute. And so that to me, is a campaign of human service. And we don't do campaigns on our own, do we, we do them with other people. So this, this will be done in community with the long COVID patient community.

Jackie Baxter  
Yeah, exactly. And I think, I mean it's something that I'm learning myself, through my own journey with long COVID and beyond, is the importance of connections with other people, whether that's people who are also suffering, or people I've met through the podcast like yourself, and these networks. And then you know, the networks of people who are researchers and doctors, and who are speaking to each other. And they're saying, I discovered this thing, but I need to work with someone who's a cardiologist. So let's join together, let's work together. 

You know, it's like not one person can solve this on their own. But everyone can put a piece of the puzzle in on their own. I think it's really lovely, that there is this kind of sense of community, of connection, kind of all over. And to be a part of that even in some small way. 

So maybe that's a good place to segue into themes and patterns and stuff. You were absolutely right, that we should have started with the backstory. Because that makes so much more sense.

Wes Ely  
So I think that people are suffering in such a multitude of ways. If we start at the top of our head, and then work our way down, we have so many long COVID patients who come into our support groups in our clinics every week. And they're telling us, you know, starting at the top, I can't do my job, I can't remember people's names, or I can't remember lists, my executive function is hitting the tank here. I don't have good processing speed anymore. And I am really suffering. 

A man called me on the phone, on my cell phone, two days ago. And, you know, that's not giving away any particular information. So nobody would know is private information. But I did ask him if I could share this piece of things. And he said, Yes. He said, You know, I'm a middle aged person. And I've lost my sense of purpose. I can't find my "why" again, because of long COVID. 

And that's what we want to do is help each other find our why again. You know, Nietzsche wrote in Twilight of the idols, "if a man has a why to live, he can get by with almost anyhow." And long COVID is a heck of a how. That's a tough how, and I don't have it. So I don't know exactly what all of you are going through. But I'm told and taught that it's a very difficult road. And I think that it will become easier and better if we can all remember our why to live. 

One of my patients whose name was Paul, and I have permission to use his name as well. He had lost his why to live. And he had said he was an actor. He liked Shakespeare. And so I knew a nurse who loved Shakespeare as well. And they got connected, he ended up helping her. And he realized that he had a why to live, he was still of purpose. And he found his way again. 

And I want all of us to remember our why, every single person of inestimable value, priceless. So that entire person needs to be seen and heard, and how they're suffering. 

And when you move down to the chest, people are suffering for PoTS, and rapid heart rates, and low blood pressures and dizziness, and then GI disturbances, and then muscle and nerve problems and profound autoimmune diseases, sjogrens, rheumatoid arthritis, lupus, there's just this multitude of ways. 

And we're going to study all of that, and try and see if modifying the immune system with an immunomodulator will work. And the other major hypothesis is ongoing viral replication. And, you know, people are studying suppression of that with drugs like Paxlovid. 

We are going to take a different hypothesis with the immunomodulation. And we will meet in the middle and study those two things independently. And then perhaps in the future, we'll end up bringing them together and doing studies that involve patients taking both. But right now we have to do it scientifically. And you know, we were all taught in second grade, that scientific method is to change one thing and one thing only at a time. So that's what we're starting with.

Jackie Baxter  
Yeah, and this is one of the difficult things with long COVID, or certainly what I discovered, was that, you know, you go into a support group, and 1000 different people are suggesting 1000 different things. And you're desperate because you are sick, and you can't do the things that you want to do and your life is a living hell for many people. 

So you think, oh, gosh, right. Well, I'm going to try all of the things and you know, hopefully some of them help but then you're like, Well, which one was it that helped? Was it the you know, 20 different supplements? Was it the breathing exercises? Was it this, was it that? So it's a totally non scientific way, but I think it got to the point where I thought, well, if I've seen some improvement, I don't really care what it was. 

But as you say, in research that is not useful. You know, you have to start one thing at a time and build it up like that, don't you? Because it's not sort of experimentation on yourself as a guinea pig in the same way. 

Wes Ely  
Well, I want the audience to hear me say this too. You know, when we as a researcher write a big grant. And in this case, this grant was like 500 pages of writing and submitting it and getting it reviewed. It's a lot of work. But who cares? I mean, that's what the job requires. 

When we get the grant. When I receive that, I think to myself, I better be a good steward of his money. These are federal funds, I want to be a good steward of this money. So on the back end of this grant, I want to produce something that everybody who reads the study, or studies, depending how many papers we have come out of it, will trust the information. And if they don't trust it, it won't be used, and it won't end up shifting the field forward. So it's got to move the field forward. 

Also, I have two rules for any research. One rule is that study what I have a lot of, so if I have the best idea, but only five people have it. There are people who study rare diseases, but I don't do that. I study diseases where it's a prominent public health problem and long COVID clearly fits that rule. 

The second rule, though, is really important. It's either answer matters. I do not conduct a study or design a study where it only matters in one direction. So in this case, if the baricitinib, if this jak stat inhibitor, immunomodulator works, then great, we have a new treatment for long COVID. And that's huge. 

If it doesn't work, and we have altered these 15-20 things, the immune system, which we know this jak stat pathway does, and that doesn't help long COVID, that's incredibly important to the mechanism by which people get disease, by which the human body is suffering and long COVID. And that will hugely advance the field for our understanding of where to go next. 

And in every scientific paper, the second to last paragraph you write, the paragraph just before the conclusion paragraph, is called limitations and future directions. And in that limitations and future directions paragraph, we will suggest what the next best ideas are based on what we learned. And you see, so since either answer matters, we will have great future directions to take after the studies over. 

The study is called RVLC, which stands for reverse Long COVID. And the study website will be out in April. And hopefully you'll put a link to it. 

Our goal is to move the field forward whether the immunomodulator works or not, we're going to provide answers. And those answers will then be applicable into the entire umbrella of IACC's, infection associated chronic conditions, whether it be long Lyme, previous SARS infections, flu like IACCs, or fibromyalgia, MECFS. MS. Lots of other types of IACCs out there.

Jackie Baxter  
Yeah, that's a really good point. Yeah, you know, whatever the answer is, it's going to be useful. And, you know, this whole thing with research that as a musician, I didn't understand this at all. I've never looked at a research study in my life beyond, you know, year 10 Biology kind of thing, you know, and that was some years ago. 

So, you know, kind of starting to understand this, you know, that each research study, each trial, it's a piece of a wider puzzle, and whatever you find out from that is going to be part of something that is useful, and that moves forward. So yeah, I think that's, that's awesome. 

So maybe it would be cool to dive a bit into this study. And I want to know all about it. But could you talk a little bit about what an immunomodulator does, and what that means?

Wes Ely  
Absolutely. If you take acute COVID, and then transferring it to long COVID, you know, the, the virus comes into our body attacks us through the respiratory epithelium, and then it goes on to involve itself in the rest of our body. And it gets through the bloodstream, it goes through what's called the endothelium, which is the lining of our blood vessels. And so we then get a huge release of something we call cytokines which drive the inflammatory program for an acute infection, okay. 

And then we learned over time that the virus goes on to involve cells inside our brain. And we didn't think this was the case at first, because the first autopsy studies didn't see staining of the virus in the brain. But what we learned is that the virus is involving, not the neurons directly, but the support structure for the neurons. 

So they're all these cells up in the brain, things like astrocytes, oligodendrocytes, etc. And these cells provide a nurturing environment for the neuron, if you will. So when they get diseased, it's kind of like a kid growing up without any adults around to help them. They're kind of on their own. And maybe they sometimes they do okay, a lot of times they don't. I grew up without a dad, and I'm telling you, it was not great. 

So anyway, this whole body systemic problem, you think that it gets over with when the acute infection goes away, and your fever gets better and your cough gets better etcetera. But what we learned is that months later, there's this ongoing problem with the immune system, it's almost like a light switch got turned on. 

And we need that light switch to be turned back off again for the body to rest. Because while the lights on is too bright, we can't go to sleep. I'm speaking figuratively here, although there are big sleep problems in long COVID. And the body needs to rest but it can't because that immune system is still going until the light switch gets turned off. 

So what we're studying now is, would it be helpful to turn off the light switch of long COVID, ie normalize the immune system by doing things like affecting interferons, and immunoglobulins, and all kinds of TNF and interleukins, et cetera. These things are what drive in long COVID ongoing cytokine persistence and immune activation, and microglial activation in the brain. All kinds of turns cells on that ought not to be on, something we call reactive astrocyte ptosis. 

And we don't know if berry will successfully turn those off and stop long covid. But we do know that it does work on those systems. We already know the mechanism of this drug will be to dampen and turn down those programs. And we know that because the drug has been studied in HIV and lots of other chronic illnesses. 

And so we have very good evidence in animals and humans that the drug does this in chronic condtions, not just in acute conditions. So it's a very scientifically driven hypothesis to test, in this case, and that's why the NIH decided to give us this large grant to do it, the investigation.

Jackie Baxter  
I suppose I'm in not being a researcher, kind of spitballing here, but there must be an awful lot of drugs to choose from. And the fact that this one has been used in other sort of comparable conditions, that kind of led you to think this is the best one for us to try in this situation?

Wes Ely  
Yeah, well, if I'm totally open, this is one of these things where AI came into play. So early in COVID, is really a great story. Early in COVID a couple of authors, one of whom was named Justin Stebbing, in London, ran a program through benevolent AI. And the computer analyzed hundreds and hundreds of drugs for repurposing. And on the pages of Lancet, they published in April of 2020, that of all the drugs they analyzed, baricitinib was the most likely to be a success in COVID. 

And that paper is what gave us the idea to design the cov-barrier study, which ended up as I said earlier, proving to be the largest life saving survival advantage of any drug in COVID. Right before that came out corticosteroids from the British recovery study. And so steroids began getting used quickly. 

80% of people in our study, were already on steroids, get this, already on steroids, and then got either barri or placebo. And on top of the steroids, the Barri provided even a larger survival advantage than the steroids ever did originally. So who knows how much it could have been without the steroids, really interesting situation. But anyway, so we know immunomodulation works for acute COVID. We don't know about chronic long term COVID. But that's what we're going to figure out. 

Jackie Baxter  
So if you're using this drug, for the study, for the long COVID. And it's the drug that worked with acute. That suggests that you're kind of hypothesis is that long COVID is a continuation of something that started in COVID? And that resolved in some people because they recovered. But whatever that mechanism is, and it's to do with the immune system, presumably, that it's now just kind of going round and round in circles effectively in long COVID patients?

Wes Ely  
That's a great way of putting it. I think that whether it be genetic pre determinants, like who your parents were, or the variant you got, or how long you had viral replication, meaning did you get Paxlovid originally, or did you not. There's some evidence to say that Paxlovid reduces the likelihood of developing severe long COVID. Those are data published in JAMA, although there's conflicting evidence in that area. 

That somehow that milieu of things that are who you are, when you got it, how long you had it, how bad you had it, contribute to a merry go round of symptomatology driven by a disordered immune system. And that's the hypothesis we're working under. 

And so it makes absolute sense to test that hypothesis by taking we're gonna take 550 people, randomize them to a placebo versus Berry. We call it berry like a raspberry. And then they're gonna stay on it for six months. And we'll test them at the beginning. And then intermittently during the study and then again at six months and then off the drug for six months. We'll test them at a year. Let's see what happened. 

And the testing will be very comprehensive. This is not a low touch study, it's a high touch study. So we're going to, we're going to need our patients in person. And for this reason, we'll start with North American patients. I'm totally open to the idea of expanding this to, to people if they want to come from other countries. But obviously, the very beginning will be most convenient for people from North America. 

We're going to enroll in California, and in Nashville, Tennessee, and in Atlanta, Georgia. And in Minnesota, I suspect people from the Northeast will come over to Minnesota or Atlanta or something. And we'll enroll people who say to us, we had COVID, here's our proof of having had COVID. We now have had over six months of symptoms. 

Now I know that the World Health Organization definition is three months, we know that some people get better after three months. And so we made our criteria for this study to be six months worth of symptoms. And that way we infused a study with people who really have ongoing problems with this disease process. We call that enriching the study. So we're gonna enrich it with people who have had at least half a year of problems. 

And then they will go through the enrollment criteria, get their baseline testing, go on this drug, which is a four milligram tablet once a day PO in the morning, and then we'll see what happens to them. Nobody will know what anybody's on; the doctors, the coordinators, the patients, the families, it's double blind, so nobody's gonna have any idea of that. And then we'll test them again in six months and 12 months and try and learn what happened, and then get people answers.

Jackie Baxter  
So that's quite a long time, isn't it? I think, you know, a lot of the studies that have been going on are sort of, you know, a couple of weeks or a couple of months, and then you know, they, they might have testing through that, or they may have a bit of testing, you know, beyond the end of that. But, you know, six months, and then six months, that is a long time. 

I think because with the shorter things, you know, we get so many fluctuations within just like regular long COVID, you know, you can have a couple of really good weeks, and then you're back down the bottom again, and you're back in your bed for a couple of weeks. And, you know, actually over the longer time, it kind of wipes out those kind of shorter term fluctuations a bit more, doesn't it, and hopefully gives you more of a kind of a longer term picture of what is happening or not happening.

Wes Ely  
Yeah, and we really want everybody to realize that this is robustly scientifically driven. So for example, in other disease processes like rheumatoid arthritis, lupus, alopecia areata, these disease processes are chronic immune disorders. And the way that they have been shown to be controlled, is by months of therapy, not weeks of therapy. 

So this drug berry, is already FDA approved, that's the regulatory authority in the United States. It's already FDA approved for those diseases I just mentioned. So this is not an experimental drug. It's an FDA approved drug. And it's even FDA approved for acute COVID. So that I think gives people a lot of reassurance that we have a ton of safety data in this area. 

The drug is not without side effects, you know, it's an immune modulator. So you could have things come up like, we're going to test for EBV reactivation, and other types of viral reactivation. We're gonna watch that like a hawk. And in the acute COVID studies, we did not get dangerous side effects, we only gave it for 14 days. In that circumstance, we did not have increased clotting problems or increased infection problems or any of those things. But it could be that six months of therapy does do that. So we're going to test hat. 

And at the end what we're doing is assessing risk versus benefit. And hopefully, the benefit will outweigh the risk. But as I said earlier, at the end of this study, if Berry didn't help, didn't benefit long COVID. That's not a failure at all. It's not a negative study, that's a very important positive scientific finding that we take forward. 

So I will not refer to the study is failing, I will only refer to the study as if we found truth, then we accomplish our goal. And so we are trying to establish a study that will have a design, which will allow us to determine truth. And that's the main point.

Jackie Baxter  
Yeah, that's really interesting. My brain is just trying to take that in for a moment. So you're launching this quite soon, aren't you? In fact, when this episode airs, hopefully it will be literally as you launch. So what's the enrollment criteria for people, you know, location, that's gonna come into it a fair bit, I think, as you said, but what other sort of criteria are there?

Wes Ely  
So the main criteria will go like this. Did you have COVID? And can you show us proof that you had COVID? Some people might not have that, like, if you took a home test, and you threw the test away. And I hate that, but we have to be able to show these journals that we had proof, otherwise they're gonna be like, you just took them Pinky promise? No. 

And I sympathize with that problem. But just for as you said earlier, for the science to be believed, we have to have proof. So did you have COVID? Can you show me a picture of your home test or a PCR or anything like that. 

And we'll take people from the first wave, we're going to actually factor in 50 People will be studied in a randomized fashion who never had proof because they had COVID before the test was available. So we are very aware of that problem. And we want those people to be included, inclusivity, in our investigation for that reason. And most studies have not included that patient population, but we are. 

In addition, if you have had COVID, then did you develop long COVID after three months, and do you still have symptoms six months later? And we just have to be able to go through a checklist for that. And then the patient will consent and and then we'll get a short cognitive battery, and see if there actually are brain problems, like thinking problems, memory problems, etc. 

And if those things are met, then there's a list of exclusions, like, profound liver disease, or, you know, active ongoing tuberculosis, I'm making some things up. But these are real, actual exclusions. And we don't want to put somebody on immunomodulator, who has a very prominent active infection, because we're going to make them worse, potentially. 

So those are the things we're going to inclusion, exclusion wise, and then hopefully bring 550 people into this study, who are invested, who want to help humankind provide answers, and will be diligent in taking this one pill for six months, and then being tested at those time points. 

Jackie Baxter  
Yeah, I mean, you just touched on something there, that is a big thing, you know, that it's a commitment. You know, it's not just taking the pill every day, it's actually signing up to do all these tests, to engage with the study, to then do more tests when asked, you know, and all these regular intervals. And then, you know, six months down the line afterwards, you know, so it's, it's quite a lot, and potentially, some of these people are having to travel as well. 

So people get excited about research studies, because it's like, oh, gosh, I can get on this trial, and it might help me. And yeah, hopefully it will. But it's not cost free is it, in terms of, you know, energy and time and, and everything. So that's definitely a factor, I think, isn't it when people are sick,

Wes Ely  
And there will be, there will absolutely be money to reimburse patients for their time and inconvenience, so patients will be reimbursed for the time and inconvenience. 

I want to mention some of the other investigators like Carolyn Bramante from Minnesota. She has lead the Metformin study that you may be aware of, metformin. Priscilla Shu and Michael Peluso and Steve Deeks and Matt DorstenFeld from UCSF University of California San Francisco, very prominent long COVID researchers. Vince Marconi, Nate and Raphael, Christina gabbiano from Emory. Also pioneers in this baricitinib work for HIV and now involved in this. And then you might know Akiko Iwasaki famous immunologist from Yale, and Mayan Levy, from Penn and in their groups. 

So all of us are doing this together, forming this kind of band of brothers and sisters to see what we can do to help out in this field. And we're servants. Bear in mind, we are absolute servants in this and, and we want to hear from the long covid community. And we care that we do this right. 

We also have some very devoted patients and scientists lived experience, Hannah Davis, Jaime Seltzer, Lisa McCorkel, have all helped us in various different ways and are involved with us as scientists. So we're listening to the patient community quite a bit.

Jackie Baxter  
Yeah, absolutely. And that's so important, isn't it? Because there's no point you designing a trial that no one actually is capable of doing because they're too sick, for example? You know, I think the patient voice is so important. And, you know, it seems that studies and trials and researchers and doctors are listing more than they were before. And, you know, I'm sure some listen more and a lot better than others. But it always fills me with that warm, fuzzy feeling when someone says that they've, you know, really listened to that. I think that's awesome. 

So the question everybody wants to know is, so when do we get results? So obviously, you say that you're, you know, starting in April, people have got six months of the drug, and then six months off the drug. So we're looking a year, but it's more than a year, isn't it? Because there's all sorts of other things that need to happen to?

Wes Ely  
It is. And if people go on to clinicaltrials.gov and read about the study, you're gonna see the classic timeline for a five year NIH grant. Now, believe you me, we want to get these answers out earlier than that and faster. And we will, if we are able to. But the classic way that an RCT like this goes is six months startup, three years enrollment, one year follow up on the back end, six months start down. So that's five years. That's the classic five year program. 

Now, if we can get these patients enrolled, much faster than three years, that shortens the whole thing down doesn't it? So we want to get that compressed if we can. And we're going to try. And if people want to give us feedback for how we can do better, we're here to learn. 

Jackie Baxter  
yeah, definitely. Again, I think that's, that's awesome that people are listening to the patients, because this is something that I'm starting to realize more and more is that actually, the patients do have an important voice in that, you know, that they may not have the expert. In fact, they probably don't have the expertise that you have, which is why we need you as well. But, you know, the patients and their experience are, you know, extremely important in all that research. 

Wes Ely  
We need each other. 

Jackie Baxter  
Exactly. Yeah. You know, is it symbiotic? Is that the right words? 

Wes Ely  
Yes, yeah. 

Jackie Baxter  
Yeah, absolutely.

Wes Ely  
Yo, in the middle of long COVID, I wrote this book, it's called "every deep drawn breath." It's come from Steinbeck's East of Eden, EDDB. And I tell patients stories. And one of the things I did in there was I recorded people's stories. And their names are in there, I kind of played medical historian where they got their story back, they edited their own story. And they were involved in the ability to tell their own story and let other people learn from it. 

And that book EDDB, we used the money from that book to hire social workers in our own research program. And we have every day we have a social worker working with patients to help them find jobs, find housing if they lost housing, and I'm talking about long COVID patients here. And they work through cognitive rehabilitation programs, at their own speed, very much taking into account PEM, post exertional malaise and brain slowness and crashes, etc. 

And the reason I bring all this up is that I'm recording lots of people's stories and long COVID doing the same thing. And I hope that at some point that I will be able to tell this story for and with other people. I love being a medical historian. 

And what I've learned is that it's not about me, and it's not about the doctors view of things. But what did the patient's experience as they went through the process of perhaps hopelessness at the beginning, not having answers? And then what happens when we start getting answers? There's a ray of light. And then we actually do have treatments. And that's the sojourn that I think we're on together. 

Jackie Baxter  
Yeah, absolutely. That's amazing. And I will put a link to that book, to all of the websites and studies and things that you've mentioned, and obviously your trial into the shownotes. 

So yeah, well, thank you so much for joining me today. It's been an absolute pleasure. I'm so excited to hear what the trial comes up with. So maybe you can come back and share when you have results. That would be awesome.

Wes Ely  
It'd be my privilege, Jackie, and thank you for everything you're doing for other people.

Transcribed by https://otter.ai