USA: The RECOVER Initiative - Long Covid research

10/2/24: 'Happenings from the September Meeting of NIAID’s Advisory Council'

'Legislative Activities: In June, Dr. Marrazzo participated, along with Dr. Bertagnolli, Dr. David Goff (National Heart, Lung, and Blood Institute Director), Dr. Walter Koroshetz (National Institute of Neurological Disorders and Stroke Director), and Dr. Joe Breen (NIAID Division of Allergy, Immunology, and Transplantation) in a “Lunch and Learn” on Long COVID for congressional staff.'
 
Dakota15 said:
https://twitter.com/user/status/1842205164884672591
Click to expand...

Dr. Marrazzo: “There probably is persistence of virus. There definitely is immune dysregulation. There definitely is mitochondrial dysfunction, T-cell exhaustion. Probably complement dysregulation, prothrombotic inflammation, and maybe even some dysbiosis in the gut microbiome that may be contributing to breakdown of the gut barrier and the transportation of bacteria that then promotes systemic inflammation.”

Sounds very confident.
 
TSP: 10/6/24 - "How Metformin May Lower Long COVID Risk: Insights from NIH's Dr. David Goff"

'Dr. David Goff, Director of the Division of Cardiovascular Sciences at the NIH's NHLBI, and lead epidemiologist for RECOVER, discusses the study'

'Metformin inhibits protein translation which inhibits that process of viral replication inside the cells and that's one way in which metformin might work - both to help acute COVID but also to Long COVID - if the amount of virus in the body is important in driving the risk of Long COVID through mechanisms related to inflammation, immune activation, auto-antibodies and auto-reaction to those antibodies. Metformin has also been shown to have some direct anti-inflammatory effects to tamp down some of the inflammatory mediators that our cells create when we when we have an inflammatory stimulus like an infection.."
 
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10/19/24, IDTV Week: "The Continued Battle Against COVID-19 | Jeanne M. Marrazzo"

5-minute interview with NIAID Director (transcript below)

Marrazzo: "Long COVID, I think of as one of the most challenging conditions of our time, right? We’re just starting to unravel the mystery of what Long COVID is about - it's pretty clear that for some cases there is persistence of the virus - so, targeting what might be a reservoir either a virus or viral antigens is one strategy that people are looking at. The other is looking at the immune response to the virus - is there this legacy immune response that's continuing to drive inflammation, T-cell exhaustion - all these things that are really coming together to make this syndrome what it is? It also I think is a testament to the fact that if you can avoid getting COVID, you should avoid getting COVID and you should avoid getting it multiple times if you can and you know that means obviously vaccines for the most part.

Host: "So, when it comes to the future down the line not only just with COVID but also new variants as you mentioned are there new technologies I mean what's the major push moving forward to mitigate”

Marrazzo: "So, the major push moving forward is embodied in part by the RECOVER-TLC program which we are taking forward in NIAID, it's RECOVER - Treat Long COVID - the idea behind this to leverage everything we're learning about the pathogenesis to design clinical trials that can be done rapidly - sort of like we did during COVID - so scale them up quickly, make sure you can effectively discard hypothesis once you have a candidate you think might help people - study it, study it and as many people as you need - if it doesn't work, it doesn’t work and move on. So, the tools to look at the immune response are much more sophisticated than they’ve ever been - with tools to detect the virus - in some of these hidden reservoirs for example, like the gut, the brain other places are more sophisticated than we’ve ever been, so we can't overpromise but we can't stop. we really have to keep pushing. I am always hopeful because we have amazing people who are really committed we and especially for Long COVID - there's a very engaged advocacy community of patients, providers who have really, I think, struggled to be heard as an entity so very important to engage them - very important to continue to listen to those concerns and to act accordingly."
 
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Assuming many received this message yesterday, but sharing in case below on RECOVER-TLC submissions:

"The RECOVER-TLC Leadership Team would like to extend sincere thanks for submitting a potential intervention via the online submission portal.

We wanted to provide a brief update that we have received over 220 submissions thus far and are working to categorize them to help streamline review. NIAID has submitted a Request for Information (RFI) that is under review and will be posted soon. Within the RFI there will be a Form any individual can fill out who has interest in serving on an agent review working group.

As a reminder, agents will be reviewed on a rolling basis and every submitter will receive an email updating them on the status of their submission once the information is available. Additionally, the portal will remain open for the foreseeable future – there is not currently a deadline imposed for submissions."
 
9/11/23, Ground Truths: 'Ziyad Al-Aly: Illuminating Long Covid'

“Hopefully the RECOVER folks will take it to heart & will rethink the approach & allocation of funds..what really bothers me is a lot of the money has been allocated to the observational arms.."

“And my argument to them is that actually we can produce the same...We have produced all that evidence for peanuts two years ago. You know, we need a study in JAMA to tell us that, well, long Covid is characterized by fatigue and brain fog. I know that already. I think we did that like two years ago.”

“Well, we need interventional studies. Most of the money should really be allocated to interventions, not really observational arm. And it's not too late to correct course. It's absolutely not too late to correct course.”

“It's great that we had the NIH to allocate significant funds, but maybe a lot of that, unfortunately, has been wasted. But I think we can do much better in getting the point across that this is a really big deal, that so many people, their lives have been changed. We don't have a remedy in sight.”
 
6/6/23, Ground Truths: 'Hannah Davis: A 360° on Long Covid'

Davis: “I think the one I'm most excited about right now are JAK-STAT inhibitors. And this is because one of the leading researchers in viral onset illness, Ron Davis and Rob Phair…”

"Well, I mean, so I think RECOVER really messed up by not putting experts in the field in charge, right? Unfortunately, RECOVER’s our best hope still, or at least the best funded hope. So I really want to see it succeed. I think that they have a long way to go in terms of really understanding why patient representation matters and patient engagement matters.”

“It's been a couple of years, it's still very hard to do engagement with them. It's kind of a gamble when you get placed on a committee if they are going to respect you or not, and that's kind of hard as people who are experts now. I've been in the field of long Covid research more than anyone really I'm working with there.”

“I really hope that they improve the research process, improve the publication process. A lot of the engagement right now is just tokenization. They have patient reps that are kind of like, a couple of the patient reps are kind of yes men. They get put on higher positions and things like that, but I think there's 57 patient reps in total spread across committees. We don't have a good organizing structure. We don't know who each other are. We don't really talk to each other. There's room for a lot of improvement..”

Topol: “And yeah, so lack of treatments. And then the first intervention study that was launched incredibly was exercise. Can you comment about that?

Davis: "It's unreal. You know, it just speaks to the lack of understanding the existing research that's in the space. Exercise is not a treatment for people with PEM...I get that it's hard. I get that when you see patients on the screen, you think that they're fine, and that's just how they must look all the time. But RECOVER doesn't understand that."

Topol: “When I did sit down with Gary Gibbons recently and he was in a way, wanting to listen about how could RECOVER fulfill its goals - and I said, well, firstly, you got to communicate and you got to take the people very seriously, not just, as I say, put them at the kiddies' table - and then really importantly, why isn't there a clinical trial testing any treatment? Still today, not even a single trial has been mounted. There's been some that have been, you know, kind of in the design phase, but still not with a billion dollars."

All that's been done is basically following people with symptoms as already had been done for years previously. So it's just so vexing to see this waste and basically confusion that's been the main product of RECOVER to date and exemplified by this paper, which is apparently going to go through some correction phases and stuff. I mean, I don't know, but really, whether that's going to change the two institutes, it's NHLBI, the Heart, Lung, and Blood, and the Neurologic Institute, NINDS, that are the two now in charge of making sure that RECOVER, recovers from where it's right now.”

“I think we're really struggling because, yeah, there's gonna be five trials, as I understand it, and that's not enough. And none of them should be behavioral or lifestyle interventions at all. You know, I think it also communicates just the not understanding how severe this is."
 
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9/20/23, TLC Sessions - Living with Long Covid: Episode 63: Eric Topol

Topol: “Today I got called early this morning by the HHS, the government of the US, because they were gonna be making their big announcement today about starting clinical trials, which is about at least a year or two years overdue…they were trying to make sure that I didn't say anything negative about their efforts, which I have in the past. So the future, we could be much further along, but we have not one single validated treatment for all the different aspects of long Covid. And it's so vexing. So much of this could have been accelerated.”

“we're working at glacial speed. And actually, ironically, Julia wrote today in LA Times op-ed about her experience and how desperately we need, urgently pressing need for some treatments. And so, no, we haven't really made any progress. It's unexplainable that we didn't rise to the occasion. So in the US, they've dedicated a billion dollars, which is, for medical research, that's a pretty good chunk of funds, and so-called RECOVER. So it was the right idea, but it has basically poorly executed.”

“They're great, and they have a seat at the table of RECOVER. And I said to Hannah, it's kind of like the kiddie table. You know, when you have a gathering and you have the adults at one table, and you have the real Long Covid people at the kiddie table. That's kind of what it's like, is their input isn't getting the highest level of respect, and it should. And it goes along with the trials that were announced today. There were just two, one for cognitive decline and one for Paxlovid or persistence of virus.”

“The only reason today I was at all interested is because there hasn't been any clinical trial for the billion-dollar investment. Not a single one.”

“But it's amazing that here we are, 2023, and we have nothing. And we have tens of millions of people who are affected. I know the medical community moves slowly, but I've not seeing anything quite mismatched between desperate unmet need and action, even when there's allocation of big funding.”

“So we've had more writing, but not in the way of action. One thing I would add, you know, that Long Covid review that we did, it's near 1 million downloads now, 980,000. I've never seen anything like this in my career. I've written, I think, 1,300 peer reviewed papers. So the interest in it is intense. It just goes along with the tens of millions of people who are looking for help, either for themselves or for loved ones or friends or whoever. I've never had a paper in my whole career that's drawn this much attention.”

“That's what I told the HHS this morning. I said, you're asking, they only work through clinics. You have to show up. I said, you're asking people that, some people, they barely can get out of bed. They can't even do their daily life activities. You're asking them to go through all these hassles when you could do so much of this remotely”

“They don't get it, but that's absolutely true. That's the future of medical research. The only reason you have to come in is if it was an investigational drug that wasn't approved or something like that."

“Well, in the US the barrier has been this RECOVER organization that's unwilling to go digital, not really listening to the patients, citizen scientists, if you will. I think they're not listening as much, but at least they do have them involved. And that's a step in the right direction. They've gotten the message from many of us that they better get moving here because the frustration level is mounting past the boiling point.”

"We screwed it up here. The billion dollars is great. And thank goodness to Francis Collins, the director of the NIH, who made that happen. But he's no longer the director of the NIH. And it was basically given to two institutes, within NIH to execute the heart, lung and blood, it's called NHLBI, and NINDS, which is the neurologic institute. Those are the two institutes that were charged to getting this done. And what they've done is they've gone through the old playbook, get a bunch of sites, give them a lot of money, and then wait X number of years to get something. And so this old playbook, not using any digital, spending all sorts of money, not doing trials, just doing observational, the first things they've done is the symptoms. We know the symptoms. We don't need to spend another year to look at the symptoms. My goodness, there's been enough publications, there's been as many publications as symptoms times 10. So we don't need that.”

“I guess your question is, does it get the respect, the acknowledgement of how big an issue this is? And the answer is no. We also have doctors dissing me. We have people who I used to think were credible researchers who are saying these are just malingerers. It's psychosomatic.."

“I'm optimistic we'll get there, but it isn't going to happen by natural. It needs help. You know, just like the whole ME/CFS world was ignored for decades, and other post-viral syndromes that converge with Long Covid, there weren't the numbers of people. There weren't the millions upon millions. But these people didn't get better naturally, and the work that's being done here should help, should spill over across the board for post-viral clinical impact by force.”
 
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12/22/22, TLC Sessions - Living with Long Covid: Dr. Benjamin Natelson

“In the spring of 2020, I started writing grants to NIH because I saw a tidal wave of illness coming with no one being prepared. NIH said, we don't care, that's not our problem right now”

“They've started a program called RECOVER. And what RECOVER is, is $1.1 billion to understand Long Covid. I guess the only problem I see with RECOVER is that it's a top-down program. The NIH usually is a bottom-up program. Researchers like me have a bright idea, lay out the logic, compete with other people, and if you're lucky, get the grant, do it. Here, it's really administered top-down. So there are sites that make decisions about who's going to do what.”

“In other words, to get a therapeutic trial approved through RECOVER, that's a big process where an individual puts forth an idea and then it's reviewed by a number of committees and then it goes up the flagpole.”

“I'm optimistic that this huge investment that they finally made here in the United States to fund this RECOVER program is going to bring a lot of knowledge. It's going to help us understand the disease. I'm a little disappointed because the powers that be don't see the value of including a group of patients who have ME/CFS and not Covid to understand how the two may be the same or different. That's why I'm so thrilled with our imaging grant that was funded.”
 
11/1/23, TLC Sessions - Living with Long Covid: Episode 65: Dr. Amy Proal

“Now we are highly encouraging NIH to just create NIH grants for Long COVID that anyone can apply to, any team can. RECOVER is just a select group. One of the big problems that we face right now is that the NIH is not funding Long COVID research very much. There's not even a very reliable Long COVID funding mechanism, which is crazy.”
 
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