72 - Prof Amitava Banerjee - STIMULATE-ICP Study

Episode 72 of the Long Covid Podcast is a chat with Professor Amitava Banerjee about the STIMULATE-ICP study which he is co-lead of. We chat a load about the different "arms" of the study itself, how it has been developed and the role of patient involvement.

We also chat about how you might be able to get involved in different parts of the study.

Link to website: https://stimulate-icp.org/

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

(music credit - Brock Hewitt, Rule of Life)

Transcript

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Jackie Baxter  0:00  
Welcome to the long COVID podcast with me, Jackie Baxter. I'm really excited to bring you today's episode. Please check out the podcast website, longCOVIDpodcast.com, where there's a collection of resources, as well as a link to the Facebook support group. If you're able to, please consider supporting the show using the link in the show notes. If social media is your thing, you can follow me on Facebook @LongCOVIDpodcast, or on Twitter and Instagram, both @longCOVIDpod. I'm really keen to hear from you. If there's anyone you'd like to hear on the podcast, or if you've got any other feedback, please do get in touch through any of the social media channels or email longCOVIDpodcast@gmail.com - I really hope you enjoy this episode. So here we go.

Hello, and welcome to this episode of The Long COVID Podcast. I am delighted to welcome my guest today Professor Amitava Banerjee, who is the chief investigator on the stimulate ICP study taking place in the UK. So I'm really looking forward to finding out a load about this. So welcome to the podcast Ami.

Amitava Banerjee  1:29  
Thank you very much for having me, Jackie.

Jackie Baxter  1:31  
I'm really excited to have you here. So to start with, would you mind just giving a brief introduction of yourself and what it is you do?

Amitava Banerjee  1:39  
Certainly. So I am Amitava Banerjee - i am a cardiologist, so a heart specialist, in London at 2 hospital trusts, Barts and University College London. But I'm also a Professor of Clinical Data Science at University College London. And where am I research at - I'm trained in epidemiology in data science. So looking at large data sets, to spot trends and what's happening with disease at Big Picture level if you like. And during the pandemic, since the beginning, I've been interested in the different ways that the pandemic has led to both acute effects. But in the case of long COVID more chronic effects. And which led to this current research and the stimulate ICP study.

Jackie Baxter  2:32  
Wow. So it sounds to me like a very busy existence that you have there. But yeah, I suppose it's this kind of big data set that is particularly what you're kind of looking at here? 

Amitava Banerjee  2:47  
Stimulate ICP, let's dive into that. Because you're right, there is definitely a big element of, or elements, of data analysis going on, but also intervention studies and looking at inequalities and so on. So the acronym STIMULATE ICP is a mouthful, because we were trying to do a study that in the words of Melissa Heitmann, my colleague and CO Chief Investigator of this study, she's the national lead for long COVID and started the UCL long COVID clinic. She talked about building the plane while we're flying it - in that we're trying to define and understand long COVID at the same time as needing to treat people because of so many people being infected and affected by  Long COVID. So, it stands for symptoms, trajectory inequalities in management, understanding long COVID to address and transform existing integrated care pathways. 

And I have to look that up because it's a mouthful, but in essence, it's looking at the description and definition of long COVID. It's looking at the trajectory of long COVID and the management of long COVID. But also the ICP bit is looking at integrated care pathways. Now integrate care pathways are not new to COVID or long COVID. If you take chronic obstructive pulmonary disease, COPD or heart failure, I'm a cardiologist - that's a disease that I'm specialized in. It's where you have an integration of care across primary care in hospital from community to the hospital, it's where you're kind of trying to take a big picture view and holistically look at the whole pathway of patient care. And that's what we were trying to do in the stimulate ICP study. And both myself and Melissa Heitmann are kind of that way inclined in terms of integrated care and zoom-out kind of clinicians if you like, that's our approach to chronic disease. 

The stimulate ICP study has three parts. The first part is describing the symptoms and characteristics of people with long COVID. And their trajectory over the first two, now three years of the pandemic, and we're doing that in a number of ways. In terms of quantitative data, we've got really detailed electronic health records from University College London Hospital, where Melissa and team have been, actually they started this clinic in April-May of 2020. So it's remarkable, really, that they had the foresight to do that. And we also have access to national electronic health records. And we're also working with NHS England to look across the 90 clinics in England that have been set up to see what data we can look at. There's a bit of detective work to be done there to get because the coding is not perfect. But that's, that's something we're doing. 

We're also interviewing people in the different clinics that we're focused on. So we're in our study with, we're particularly looking at six clinics around the geography of England, so Hull, Leicester and Derby, Liverpool, Exeter and London, and we're interviewing patients and healthcare professionals to see what care has been delivered over the last couple of years. 

And then in the second part of this study, we are doing this large complex trial. And it's looking at cross the pathway at three things. One is an investigation, which is a multi organ MRI scan called Coverscan. Two is a platform drug trial. So like what has been done in acute COVID in various trials, like the Recovery trial, Panoramic trial. We've started a platform study, with three drugs initially, which are Colchicine, which is an anti inflammatory drug, Rivaroxaban, which is an anti clotting drug, and a combination of antihistamines - loratadine and Famotidine, which are also being used. 

And this trial is looking at the whole pathway, but each of those components as well. And the what we call the primary outcome is looking at fatigue at three months, on something called the fatigue Assessment Scale. But we're looking at a whole host of different physical, functional, psychological and so on outcomes. Also from that trial, well, from the Coverscan, we're getting information about organ function, but we're also taking bloods from these people, we're aiming to recruit 4500 people. So this will be the largest biobank of information for the global research community to find out about and quickly research the different aspects of this new disease. And that trial, we're hoping we'll be able to recruit fully by beginning of next year, in 2024. 

The third part, where I know you've spoken with my colleague Professor Nisreen Alwan as well. So Nisreen and colleagues are leading work looking at inequalities in provision of care for long COVID across different clinics and geographies, and communities in England and  the UK. And also, we're looking - this work is led by my colleague Professor Christina Vander felts Cornelius, she's at York university, and is a psychiatrist. But she's interested in comparing long COVID with other long term conditions from cardiac and respiratory to mental health and other diseases, such as ME & CFS. And the reason to do that is to compare the healthcare utilization at scale for this disease long COVID, but also to see what we can learn beyond the pandemic for treating long term conditions and planning for them in future. 

So, that's an example of how we've bitten off more than we can chew. And we're working hard at it - it's a massive piece of work funded by the National Institute for Health Research. It's one of the core funded national states for long COVID. And we're very grateful to our funders, but also it involves universities, hospitals, charities, such as long COVID SOS, industry partners, such as Perspectum who developed the scan, Coverscan. But also, I should have said in the trials, we're testing a digital rehabilitation platform called Living with COVID recovery, as well. So our industry partner "living with" providing that as well. 

So, yeah, it's hopefully answering a few different things, we could have taken one or less of those parts, but we felt that actually, that would mean that you're kind of just looking at the arm and not looking at the whole person, or you know, just looking at one bit and not looking at the whole system. So that's, that's the ethos. 

Jackie Baxter  10:59  
Yeah, I mean, like you say, it's quite a lot. But, you know, long COVID is quite a lot in itself, isn't it? You know, it's got lots of different variations of it, but also, it affects people in many, many different ways as well, you know, so it doesn't just affect your physical health, you know, that's maybe the most outwardly obvious part of it, but you know, it affects all parts of your life, you know, your physical, your mental health, your family life, your social well being your, you know, the list goes on, doesn't it? So, like you say it is, it is a big thing. 

You just mentioned long COVID SOS, and I was wondering if - was that part of your patient participation kind of arm, maybe isarm, maybe the right word of that? Because, you know, it's definitely something I have never come across until I got long COVID. And then started looking into kind of research and, you know, this idea of patient participation and that it just never crossed my mind that patients could and should be involved in research. But, you know, actually, it's really important, isn't it?

Amitava Banerjee  12:05  
So, Jackie, thanks for raising that. I have been doing medicine and doing research for a while. I know this is an audio podcast, but you can see I've lost some hair. So but PPI or patient and public involvement, which is now more often referred to as PPIE, patient and public involvement and engagement. It's been part of the process for some time. And I've been involved whether it's cardiology patients, people with diabetes, my homeless patients who have cardiovascular disease, but I think during the pandemic, I myself have had a bit of an epiphany in the need - when you have a kind of public health emergency that we have had both acutely with COVID, and with long COVID, where you are defining the disease and trying to design services, it's absolutely essential to have patients with lived experience and their carers or others who are involved in the process at the table. And not just involved but you know, leading the agenda. 

You know, I often say long COVID SOS, and other patient-led organizations, raised awareness of this disease and called for research, rehabilitation and recognition. And that's why, you know, the grant calls were put out by the government. So I think we've been involved with not just Long COVID SOS, but different patient groups since we applied for the grant, since we started writing and they were involved. But during the project we have developed a stronger and stronger PPIE panel for stimulate ICP. We now have 11 regular members, we have monthly meetings, an active Whatsapp group. 

And we don't do anything without involving them, whether it's writing scientific papers, whether it's, you know, just recently we've put an amendment in to our study, because we're having difficulty recruiting in some of our sites. And so, in some sites, we're going to be recruiting drug only patients, not to the rehabilitation and the scanning, in order to increase numbers and answer the questions about drugs quicker. That's been with the blessing of our PPI panel. And through a charity that long COVID SOS, and I should say, over the last nine months or so I've been a trustee of long COVID SOS, as well. So I've got conflict of interest, but in a good way, I think, it allows us to survey and access a wider community of patients. 

And there are several charities which are linked and they're all on the same team, really, we need to, I think we need to keep listening as researchers and clinicians, I think also, we need to do better. This is for the patient organizations and charities as well, to make sure that we're representative, I think there's a tendency that the Twittersphere is all the voices of people with long COVID or patients and of course, that's not the case. And we need to strive to find the people who haven't been heard or aren't represented there. And that's more challenging work, it's easy to kind of respond to the Twitter noise. 

So I think, PPIE to summarize is, really, in our DNA, and we've had loads of really big successes through that, for example, watch this space, the stimulate ICP patient panel, have led an ebook about their lived experience of long COVID, which, at best I facilitated, but they've set the agenda for that, they've written that, they've edited it, and it's going to be coming out from them, which we're very, very proud of. That's what happens if you involve patients, on their terms, I think,

Jackie Baxter  16:53  
Yeah, and that's really, really wonderful. I mean, you've kind of just highlighted two things to me. One is that, you know, as important as PPIE is, it's not easy. You know, it's not just having a quick chat with a couple of people, you know, it's much more of a Thing, isn't it, but also this idea of bringing people together, and, you know, everyone gets something out of it. 

And I've definitely found that through doing this, I've made connections with people that I would never have done otherwise, I find myself sitting here speaking to someone like yourself, and you know, and it's all these kinds of connections and people that I've met, and, you know, some of whom who I would now call good friends, and all of these things that have been made out of this awful situation that we find ourselves in, but the sense of community, you know, really does make a difference, doesn't it? I think to everybody.

Amitava Banerjee  17:49  
Yeah, I think I think if you ask members of public panel, they would say that that friendship and support that they get from each other, as well as, you know, joining - they join all of our kind of team meetings, they're part of the team. And I think they, they find it reassuring that we are all on the same team trying to work together. Whereas sometimes, if we don't do it that way, it can feel like, you know, they're not being involved, or it can feel like things are being done at them or to them. And that's not the case. And I should say, we're not the only research study by a long way that's doing this. You know, I think that was the NIHR long COVID studies, the patient and public involvement is - has had to be strong to push us along.

Jackie Baxter  18:45  
Yeah, yeah, definitely. I'd love to talk a little bit more, you described your three kind of arms, if that's the kind of correct word you know, you've got your describing symptoms, and you so the data for that goes all the way back to April 2020, which is amazing, because, you know, in April 2020, I couldn't get out of my bed and didn't know what was happening. So it's amazing that there was actual kind of like gathering of data and research already happening at that point.

Amitava Banerjee  19:14  
Yeah, well outside of the UCLH clinic, where Dr Melissa Heitmann and colleagues were setting up the first long COVID clinic, definitely in the UK and maybe wider than that. At the same time, my colleagues at Perspectum, which is a company that prior to the pandemic specializing in imaging of the liver, and by imaging, I mean doing scans, they use MRI, and they were tasked to develop a quicker solution to assess multiple organs. And the purpose was originally to prove that COVID doesn't affect organs, not the opposite, which is what we found. 

So in that study, we recruited people from April to September 2020, and then followed them up through a year end in a quite unique dataset - the data has been published late, but it's coming shortly in the Journal of the Royal Society of medicine, it will be published to show that there's lasting signs of organ impairment at one year, in the first wave, there was anyway. We'll be able to compare that with the data from stimulate ICP, where we have people in the era where you had vaccination, where you had better treatment of COVID in the community, and in intensive care and in the hospital, to see whether the same degrees of impairment are being seen. 

So yes, we have that, we have a huge research effort around the world, some of it led by patients and public themselves, which is, you know, looks at symptoms and clusters of symptoms, looked at different investigations, looked at trying to understand who recovers who doesn't. On the clusters, we're not there yet, we would love to be able to say to somebody on the basis of the symptoms, or the tests that we do, Oh, you're suffering from this variety of long COVID, which is going to get better in X number of months. And this other variety is one that seems to be harder to recover from, or this one responds to this particular treatment. This is the type of granularity or precision that we don't have, despite all of the studies. And despite what you might hear in media or social media, that's what we don't have, that's that's in a scientifically reviewed form. 

And also, in terms of treatments, there are lots that people have tried themselves out of frustration and desperation. But what we need is to understand what's placebo effect, what's real, particularly because people until now, across the world are paying out of pocket for whether it's supplements, drugs, different treatments. And so I think the trials effort needs to be upscaled, but there's challenges there as well, because the disease definition of who you recruit into the study is important so that you're comparing representative spectrum of the disease, but also one that you can you can understand and analyze. And then also, which outcomes should you look at? Is it just fatigue, is it some kind of combined or composite outcome of different things. So all of these things, we know what to do when it's a disease like heart disease or heart attacks, because we've done that for 50 60 70 years, we've had to design all of that in Long Covid. So it's not easy.

Jackie Baxter  23:06  
Yeah. And that's where this kind of very broad illness becomes very, very difficult, doesn't it? Because, you know, like you say, how do you actually measure it? Do you measure it on, you know, which particular symptom and you know, everybody has different symptoms, a lot of them crossover, but no two people's symptoms are exactly the same. And, you know, of course, then, you know, different people's symptoms are different on different days as well. So it must be a really, really difficult thing to kind of be able to show your results, I guess, you know, even if you do find something,

Amitava Banerjee  23:42  
Yeah. So, as a researcher, you're watching and learning and analyzing, and there's all of the above to be done in this. And I think, trying to get the best possible data that we can is it's the first step. And as I said, there's lots of people doing that. But getting the funding, getting the research through ethical approval, getting it started all takes time. 

And I think it's important to note, although the progress might seem slow to many, not least the people suffering with long COVID like yourself, that there's more progress been made in this disease that we didn't know about until middle of 2020. In those two and a half plus years, we've learned more than pretty much any other disease that's, you know, just been recognized. The kind of mobilization we couldn't have had in different eras and there are many advances both in the rehabilitation side. 

Also, there's some that you know, for example, we know that keeping your infection re-infection rate down helps. We know that vaccination, although not curative, helps. So you know, getting your vaccinations is a good thing and these things weren't there in March, April, May, October 2020. So there's lots of progress, but lots to be done.

Jackie Baxter  25:18  
Yeah, I think that's a really good point, actually, you know, as patients, we are sitting around going, why isn't this fixed? What is happening to me, you know, why am I not better? And, you know, we are all frustrated, and we're all ill, and we want to be not ill. But actually, yeah, you know, there are a lot of people working, you know, probably more hours than they should be, in order to try and do something about this. 

And I certainly find it quite sobering when I remember, or am reminded of, you know, people with MECFS, for example, who have been sick for decades, you know, and I think been largely ignored, certainly by, you know, a lot of people. So, you know, that's a very good point, actually, you know, we're not going so slowly as maybe we feel like it.

Amitava Banerjee  26:07  
Also, it's important to remember that many of even our own research team, but the broader scientific and clinical community, are affected by long COVID as well. You know, we've had some of our work delayed in inverted commas, because people have been off sick. People have been unable to work, but they're still working hell for leather on this. Then obviously, we've got, as I mentioned, our PPI panel, who, by definition, have Long COVID, or are caring for people with long COVID, who also giving up time to do this. So yeah, it does take up a lot of woman or man hours.

Jackie Baxter  26:51  
Yeah, definitely. Yeah. So what kind of stage are you at at the moment? Are you still - you said, you're still recruiting for the trial part?

Amitava Banerjee  27:00  
Yeah, we definitely are, we're up to about 400 people recruited. And we want to get up to 4500. That's what we were funded to do. That's what we aim to do, with the help of you the public. And we need to understand that we haven't maybe been able yet to recruit as quickly as we'd like. And some of that is because people feel that we need to be looking at other drugs, or they want to be in other studies. But in order to get to that, we need to answer the questions. For example, if we don't test, this one anticoagulant, people have asked why aren't you testing three anti clotting drugs together? Well, the answer is because we haven't got evidence that even one works in a trial setting yet. 

Also in the heart field, in the cardiovascular space, we deal with the clotting and anti-clotting drugs a lot, and giving them in combination like that carries a bleeding risk. And you wouldn't get ethical approval to do that, without evidence of it in, you know, one combination or two. And yet, if you go on Twitter, people are asking for, why aren't we giving triple combination already and doing trials of that. That's why we need to do this trial first. So I would encourage people to bear with us. 

And you know, the worst thing that can happen is that we don't follow good evidence based science, we've got decades of experience that if we end up doing things without that basis, then we can end up going down rabbit holes and or into cul-de-sacs, where we're doing things that might actually do harm. Or we might be giving people no more than a placebo effect, which costs them, you know, their savings. So I think this is an important study that will give us important answers so that we can scale up the right long COVID services.

Jackie Baxter  29:09  
Yeah, of course, because there's a lot of sort of hoops to jump through to get anything up and running, isn't there? And you've got to get all those boxes ticked before you can even actually start doing something.

Amitava Banerjee  29:23  
So there are hoops and there's a lot of red tape and bureaucracy, but a lot of it is there for a good reason. But I wasn't even talking about that - I was talking about the fact that science is an incremental steps. You very rarely have the the moonshot that gets you there. You kind of find evidence that there are clots. You try one clotting drug, it works or doesn't work, why didn't it work? And you try another, try in combination if you've got some evidence that it's helping and build up, rather than going straight in for the big project. That's how it works, both for ethical reasons and funder reasons and just the way we gather knowledge,

Jackie Baxter  30:05  
of course, it's building up that kind of evidence from the bottom? 

Amitava Banerjee  30:08  
Absolutely. 

Jackie Baxter  30:10  
Yeah, that makes sense. How do people get involved? And have you got any kind of criteria for people getting involved? Or is it literally anybody?

Amitava Banerjee  30:20  
Yes. So the stimulate ICP study for the trial, we do definitely have criteria. Because we're looking at this pathway, you have to be in one of our sites. And so initially, it's Hull, Leicester, Liverpool, Derby, Exeter, and north central London served by University College London. We're going to be adding two or three more sites and possibly more. At the moment, we're looking at people who are referred to the long COVID clinic, and people who are being seen for the first time  -we had to do that as well, rather than people who've had treatment already and had long covid for some time, so that we can tease out what works in that, if you like, early in their disease process in an untouched population first, before we roll out to people with later disease. 

And people ask why you only go for people who've been referred to clinic? It's because the problem that we're trying to pick the population who've been assessed by clinicians, and got the firm diagnosis of long COVID, so that we can again, find the answer or not, before we go elsewhere. There are other studies which are recruiting more in the community and more widely, but this is how we'd set up our study. So anybody who's referred by their GP, in those sites can be referred to our study. And hopefully, other sites will be coming out in very soon.

Jackie Baxter  32:04  
Fantastic. Yeah. So hopefully, you'll get loads more people. But, so, you know, Bob who lives in Cornwall, for example, wouldn't actually be able to sort of say, I'd love to get involved in this. But at the moment, that wouldn't work.

Amitava Banerjee  32:21  
Bob from Cornwall might actually be served by Exeter. So he's, he's lucky.

Jackie Baxter  32:28  
That was a terrible example of a place thing, wasn't it?!

Amitava Banerjee  32:31  
Yeah, but it raises the point, Jackie, that the different clinics are serving really different geographies. Hull where I'm from originally, which is one of our sites, serves the whole Humber area from North Yorkshire to South Humberside, Grimsby, Scunthorpe and so on. So geographically, getting tired patients to a clinic that might be an hour or more away is no mean feat, getting them to do scans and repeat visits and fill in lots of questionnaires. But, yes, some of our clinics cover wide areas - Derby is another site where there's a wide geography that's covered in the East Midlands.

Jackie Baxter  33:11  
Cool. So it's definitely worth checking if you're sort of within... 

Amitava Banerjee  33:15  
Yeah, we have a website, look at stimulate-icp.org is our website, you'll find up to date patient information, new sites, the protocols, the study, publications, videos about the study. But there's also the non trial parts of the study, whether it's about inequalities or discovering about the disease where people don't necessarily have to be at the sites. So do get in touch with us.

Jackie Baxter  33:41  
Perfect, I will make sure that the link to that website goes into the show notes. So if there's anyone who is interested in any way in the study, but also might be interested in taking part in whatever way, so whether they're able to get to one of the sites or not, make sure you check that link out. Perfect. Well, thank you so much for joining me today. It's been really, really interesting hearing about all of this. And thank you for all the efforts that you're putting into it as well. And maybe you'll come back and talk to me when you have some of your results?

Amitava Banerjee  34:14  
I'd love to Jackie, I'd love to come back and tell you about results.

Jackie Baxter  34:17  
Wonderful. Thank you so much. 

Amitava Banerjee  34:19  
Thank you. 

Jackie Baxter  34:20  
Thank you so much to all of my guests, and to you for listening. I hope you've enjoyed it, or at least found it useful. The long COVID podcast is entirely self produced and self funded, I'm doing all of this myself. If you're able to please go to buymeacoffee.com/longCOVIDpod to help me cover the costs of hosting the podcast. Please look out for the next episode of long COVID podcast. It's available on all the usual podcast posting things and do get in touch - I'd love to hear from you

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