USA: The RECOVER Initiative - Long Covid research

Dakota15 said:
Some updated names I quickly see listed on the updated agenda for he upcoming RECOVER-TLC workshop on Sept. 9–10:

- Dr. Peter Rowe, Johns Hopkins
- Dr. David Kaufman, Center for Complex Diseases
- Jessica Martinez, Gates Foundation
- Dr. Amy Proal, PolyBio
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A new agenda has been posted for the RECOVER-TLC workshop:


Announcement here:

 
Dakota15 said:
C&EN by Rowan Walrath :'NIH plans to test GLP-1s, other drugs for long COVID'

'The RECOVER initiative is plotting new clinical trials'

"We need commitment. We need candor. Patience is growing thin." - Mike Zissis, long COVID patient advocate

“I’ll add a few words,” Zissis continued. “Urgency, focus, and relentlessness.”
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The fact that they decided on these drugs after a year of deliberation is a scathing indictment of the NIH. How is it possible that they chose one drug that we know barely helps if it helps at all, a fad drug being touted as a cure all for everything, and a poorly evidenced and risky treatment with barely any rationale behind it?

I do welcome the expansion and consquent speeding up of the Baricitinib trial, that is a good thing.

But the rest is bitterly disappointing.
 
V.R.T. said:
The fact that they decided on these drugs after a year of deliberation is a scathing indictment of the NIH. How is it possible that they chose one drug that we know barely helps if it helps at all, a fad drug being touted as a cure all for everything, and a poorly evidenced and risky treatment with barely any rationale behind it?

I do welcome the expansion and consquent speeding up of the Baricitinib trial, that is a good thing.

But the rest is bitterly disappointing.
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Going for large trials was always a mistake. Medicine rarely achieves anything without a strong biological foundation. This is about the most inefficient way to go about it. Especially since even if a drug trial showed better outcomes than some of the awful rehab ones, they would report it honestly, while the rehab ones would be pure hype propagandized large. It's a total disaster so far, it's hard to even imagine more inept performance from professionals with the time and resources to do something about such a large problem.

I guess they don't want us to get better, is about the most appropriate reattribution of a terrible excuse. What else can explain such a pathetic lack of results from people who can genuinely do better, if not for a lack of trying? That is the lie that has been popularized to discriminate against us, and it actually applies to them. So much projection.
 
Of the RECOVER Pathobiology Studies, I'm most curious on the 'Vascular metabolic dysfunction in skeletal muscle for explaining post-exertional malaise in PASC’ led by Robert Motl out of University of Illinois.

I believe their target date for publication is late 2026. I know the study is using a CPET and are studying vascular function using flow mediation dilation and strain gauge plethysmography. Then they are studying metabolic features using blood samples and advanced assays of cell free DNA and other markers.

Also curious to see the 'Maintenance and Incidence of ME/CFS following Mono' RECOVER Pathobiology Study led by Lenny Jason out of DePaul Univ., that I believe is still collecting data and hope to be releasing some reports on it over the next year.
 
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From #MEaction Facebook:

Want to know what is happening with RECOVER-TLC, aka NIH’s Long COVID research program?

Check out our summary of the 2nd annual RECOVER-TLC research workshop that took place in September. Read the full summary here: https://bit.ly/RECOVER-TLC

RECOVER-TLC is currently funded at $300 million for FY2025 - 2029, and is an offshoot of the NIH’s original Long COVID research program, RECOVER.

At the workshop, NIH staff announced that RECOVER-TLC will fund four pharmaceutical drug treatment trials. NIH will begin clinical trials on the interventions low-dose naltrexone (LDN); glucagon-like peptide-1 receptor agonist (GLP-1) and stellate ganglion blocks (SGBs). It also expanded funding for an existing trial, called REVERSE-LC, on the drug baricitinib.

There was also an update on the RECOVER-CT clinical trials. Launched in 2023, eight different Phase II trials for adults are testing 13 interventions (pharmaceutical and non-pharmaceutical) across 100 sites. These trials are organized into five different categories of study they call “platforms.”

The workshop also gave an update on its observational cohorts - pediatric, pregnancy and adult. These cohorts are following large groups of people with Long COVID over time and collecting a lot of data and biospecimens.

Scientists discussed assays, biomarkers, pathogenesis and trial design, and specific projects outside the NIH that are investigating these areas. Our summary also discusses community perspective on what needs to happen next.

Read the full summary here: https://bit.ly/RECOVER-TLC
 
From the #MEAction summary

****** Detail on the RECOVER-TLC trials

THE RECOVER-TLC CLINICAL TRIALS: RECOVER-TLC will begin clinical trials on the interventions low-dose naltrexone (LDN); glucagon-like peptide-1 receptor agonist (GLP-1) and stellate ganglion blocks (SGBs). It also expanded funding for an existing trial, called REVERSE-LC, on the drug baricitinib. NIH staff said their decision to trial these drugs was based on feedback from last year’s workshop, and treatment suggestions solicited from the public. Patients showed up: of 572 total submissions, 79% were from patients or caregivers. People with lived experience also make up 26% of TLC’s working groups.

Low Dose Naltrexone (LDN) will be trialed in ~1,300 people aged 6-25 across ~100 sites and primarily measure fatigue severity. LDN is already being explored off-label for Long COVID and ME/CFS in multiple trials outside the NIH. The trial aims to develop a “regulatory-grade LDN study product” that may be officially authorized as a Long COVID treatment. This may make it more rapidly accessible to people with Long COVID.

Glucagon-like Peptide-1 Receptor Agonist (GLP-1)’s trial is in the design stage. GLP-1 may have anti-inflammatory effects in the brain and modulate the immune system. Hundreds of clinicians who treat patients with complex chronic illness are finding that over half their patients have positive effects from GLP-1.

Stellate Ganglion Block (SGBs) trial is in the design stage. To administer an SGB, a provider injects an anesthetic medicine into the stellate ganglion nerves to “block” overactive sympathetic nervous system activity. It is a minimally invasive procedure. Case studies show that some patients improve with stellate ganglion block therapies, while others have not.

Baricitinib: REVERSE-LC is the existing clinical trial being expanded from 4 to 15 study sites. Baricitinib may modulate inflammation and immune responses. The trial primarily explores whether it can reverse Long COVID-related cognitive impairment.
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The #MEAction summary is very strong on patient engagement, citing the RECOVER-TLC trials as what has been achieved by engagement. Advocating for people with PEM to be included in trials and for trial designs to take into account PEM is welcome. But, patient engagement that results in trials of the latest fad probably isn't the best use of scarce funds.

******* Detail on the RECOVER-CT trials (quote is all there is)
Launched in 2023, eight different Phase II trials for adults are testing 13 interventions (pharmaceutical and non-pharmaceutical) across ~100 sites. These trials are organized into five different categories of study they call “platforms.” Patient advocates protested against the “ENERGIZE” platform last year, because it included a CPET exercise study. Since then, RECOVER has added a pacing study arm to ENERGIZE, but they are still carrying out the CPET study, and it is unclear how they are screening for or managing PEM. All these studies should complete enrollment by the end of this year, with results disseminated by summer 2027.
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******** Day 2 discussions
There was a call for Long Covid trials to include people who face structural inequities. Fair enough to some extent, and certainly having research that includes good-sized cohorts of people with different ethnic backgrounds could be useful. But, when it comes to treatment trials, I think there's a lot to be said for going for homogeneous cohorts to start with.
People who are pregnant and immunocompromised, with multiple diagnoses, and children also need to be studied in trials.
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Why would you trial a ME/CFS/Long Covid treatment on children, for example, when you have no evidence that the treatment works for adults?


Patients also emphasized that studies are not advancing with enough urgency, or being translated to results usable to patients rapidly enough. Millions have been suffering for years, and still there is no FDA-approved treatment. There are challenges specific to the field that make speed difficult. For instance, Long COVID does not have biomarkers or validated instruments to measure outcomes. To understand Long COVID, mechanistic and exploratory trials must take place in addition to treatment trials, with limited resources at hand. The patient community knows that these realities are due to the way science and medicine have dismissed infection-associated chronic diseases like ME for decades.
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Good to see this - the explaining to the (impatient) patient community that it's difficult to pluck a treatment from nowhere, and so a focus on treatment trials isn't the only way to go. Also good to see a message being sent to the NIH that much more effort is needed.

Finally, ME organizations have asked that RECOVER use subgroup tracking and analysis for ME/CFS, POTS/Dysautonomia, and MCAS in all trials.
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There's a focus on POTS/Dysautonomia and MCAS from the ME/CFS organisations; there's a suggestion that POTS affects 70% of people with Long Covid. I guess these ideas are so entrenched that at this point it's hard to pull back from them and keep all the advocates working together.
 
Hutan said:
There's a focus on POTS/Dysautonomia and MCAS from the ME/CFS organisations; there's a suggestion that POTS affects 70% of people with Long Covid. I guess these ideas are so entrenched that at this point it's hard to pull back from them and keep all the advocates working together.
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Whatever we want to call POTS and MCAS, we need to separate them as subgroups from ME/CFS and measure when they appear together or separately if we want reliable study/trial results.

Unless we want to claim that whilst our condition is legitimate, pwPOTS or MCAS are imagining theirs? I don't think that helps anybody, even if we might disagree on how to categorise POTS/OI, or the allergic type symptoms many pwME and (pwLC without PEM) experience.

Hutan said:
patient engagement that results in trials of the latest fad probably isn't the best use of scarce funds.
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Agreed. I also don't understand the prioritisation of these three drugs. Baricitinib I understand but these others are an insane waste of funds. LDN, for example, has two ongoing trials in ME/CFS due to report next year. SGB has at least as many reports of worsening as improvement, not even counting the reports of no response. And GLP1 drugs are in fashion, i suppose.

It is inexcusable to trial these drugs when cd38 drugs are right there and showing promise.
 
Dolphin said:
NIH will begin clinical trials on the interventions low-dose naltrexone (LDN); glucagon-like peptide-1 receptor agonist (GLP-1) and stellate ganglion blocks (SGBs). It also expanded funding for an existing trial, called REVERSE-LC, on the drug baricitinib.
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Oh dear. LDN has been around for many, many years. If it worked for ME/CFS (and, reasonable to assume, Long COVID by extension) we'd know by now. Literally millions of Americans are on GLP-1 agonists; again, if these drugs led to reliable improvements in ME/CFS symptoms, you can bet this information would have spread like wildfire on social media. Stellate ganglion blocks seem to be a few fringe clinicians making money off of these injections. I don't know enough about the JAK inhibitor to comment. To me, all this looks like the dark side of PPI involvement in clinical trials.
 
V.R.T. said:
Unless we want to claim that whilst our condition is legitimate, pwPOTS or MCAS are imagining theirs? I don't think that helps anybody, even if we might disagree on how to categorise POTS/OI, or the allergic type symptoms many pwME and (pwLC without PEM) experience.
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This is missing the point of the argument. It is not that people diagnosed with POTS or MCAS are imagining their disease. It is that these terms are not useful categories because they are so universally abused by physicians making the diagnosis. Stratifying by postural tachycardia might be useful but the evidence for a syndrome is not there. MCAS is so poorly defined nobody knows how to categorise patients. I do not know of any physician I would trust to do a sensible research study who uses the term MCAS. I don't even know what symptoms or signs it is supposed to include. The recent diagnostic discussion has said that it must include repeated anaphylaxis to qualify. I don't know of anyone with ME/CFS who has actually had anaphylaxis, even if there are a few on the forum for all I know but there are tens of thousands of people with ME/CFS who get given this diagnosis. ME/CFS, in contrast, is a useful category that is well enough defined to do research on.
 
Sid said:
To me, all this looks like the dark side of PPI involvement in clinical trials
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I think it's quite possible RECOVER would have found even worse ways to spend this money without PPI, given the first round of trials.

There were many suggestions on the big list of drugs that looked like much better bets than bloody LDN and GLP1.
 
V.R.T. said:
Unless we want to claim that whilst our condition is legitimate, pwPOTS or MCAS are imagining theirs? I don't think that helps anybody, even if we might disagree on how to categorise POTS/OI, or the allergic type symptoms many pwME and (pwLC without PEM) experience.
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No one here is suggesting that people are imagining their health condition, I'm certainly not, quite the opposite. We can criticise labels and hypotheses of causal mechanisms without suggesting that people aren't really ill.

There are legitimate problems with the MCAS label. It's not at all clear what it means. If someone thinks they know, please read our MCAS thread and then tell us on that thread. One issue with MCAS is that it provides a mechanism for the symptoms - in which case there needs to be evidence to support that mechanism. In contrast, ME/CFS is just a label for a recognisable pattern of symptoms. We aren't claiming to know the cause. When I looked into the MCAS literature, it didn't seem to hold together.

With POTS, my main questions are how relevant it is to ME/CFS and how reliable/repeatable the test results are. For sure, we have orthostatic intolerance. I think there is a pattern of increased heart rate, and possibly a pattern of the body trying to cope with an inadequate supply of blood to the heart and brain when upright, although fainting doesn't seem to be a typical part of ME/CFS. Repeated studies have not found anything like 70% of people with ME/CFS having POTS and we don't have good evidence that POTS treatments help us. There is confusion between POT and POTS, there is confusion about definitions. Things are not as clear as I once thought.
 
Dolphin said:
From #MEaction Facebook:

Want to know what is happening with RECOVER-TLC, aka NIH’s Long COVID research program?
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Well, this is not surprising but still very demoralizing. $1.15B and absolutely nothing to show for it, and nothing they describe here convinces otherwise. The NIH has completely dropped the ball here, and they can't use RFK Jr as an excuse, they started it all wrong and haven't put in the effort.
 
V.R.T. said:
Unless we want to claim that whilst our condition is legitimate, pwPOTS or MCAS are imagining theirs? I don't think that helps anybody, even if we might disagree on how to categorise POTS/OI, or the allergic type symptoms many pwME and (pwLC without PEM) experience.
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FFS, nobody is saying that.

That kind of response is just doing the psycho-behavioural club's dirty propaganda work for them. They love to claim that we are dismissing patients with the FND label, for a recent example, as not having a 'real' illness/disease, just because we critique the FND concept and label that is being used to (mis)characterise their problems. It is a smear job, a standard deflection and misdirection technique, used by politicians and con-artists all the time to avoid having to address the actual criticisms and questions, to avoid legitimate scrutiny and accountability.

I have been watching and involved with ME/CFS stuff for over three decades, and I have never seen ME/CFS patients dismiss any other group of patients in the way you say.
 
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