ahimsa
Senior Member (Voting Rights)
A new agenda has been posted for the RECOVER-TLC workshop:
Announcement here:
USA: The RECOVER Initiative - Long Covid research
- Thread starter rvallee
- Start date
Announcement here:
Dakota15
Senior Member (Voting Rights)
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.”
'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.”
V.R.T.
Senior Member (Voting Rights)
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.
rvallee
Senior Member (Voting Rights)
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.
Dakota15
Senior Member (Voting Rights)
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.
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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ahimsa
Senior Member (Voting Rights)
Recordings of the 2025 RECOVER-TLC workshop sessions from Sept. 9-10 are now available:
Dolphin
Senior Member (Voting Rights)
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
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
******* Detail on the RECOVER-CT trials (quote is all there is)
******** 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.
****** Detail on the RECOVER-TLC trials
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)
******** 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.
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?
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.
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.
V.R.T.
Senior Member (Voting Rights)
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.
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.
Sid
Senior Member (Voting Rights)
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.
Jonathan Edwards
Senior Member (Voting Rights)
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.
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.
rvallee
Senior Member (Voting Rights)
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.
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.
Nightsong
Senior Member (Voting Rights)
Just noting that there is a meeting report in Nature Immunology about a recent NIAID/NIH workshop on "Pathways to Treatments" for LC:
Link
Not able to review it in depth at the moment, but, according to the report:
- the outcome of a safety & tolerability study for LDN was reported, "with no differences in serious adverse events between the agent and placebo";
- Peluso described the REVERSE-LC baricitinib trial;
- David Kaufman described his experiences using the GLP-1 agonist terzepatide in clinical practice - "A survey of 800 health care providers who are treating more than 350 individuals with long COVID with tirzepatide indicated that between 60% and 90% of the patients with long COVID and myalgic encephalomyelitis/chronic fatigue syndrome responded to this treatment in days to weeks, with a decrease in systemic symptoms including fatigue, brain fog, pain and mast cell activation syndrome"
- there were updates and presentations on RECOVER-Adult and on the 8 ongoing RECOVER clinical trials
- there was a discussion about avenues for future treatment, assays & biomarkers, which seems focussed on viral persistence etc.
Also, several trials are ongoing or planned:
Link
Not able to review it in depth at the moment, but, according to the report:
- the outcome of a safety & tolerability study for LDN was reported, "with no differences in serious adverse events between the agent and placebo";
- Peluso described the REVERSE-LC baricitinib trial;
- David Kaufman described his experiences using the GLP-1 agonist terzepatide in clinical practice - "A survey of 800 health care providers who are treating more than 350 individuals with long COVID with tirzepatide indicated that between 60% and 90% of the patients with long COVID and myalgic encephalomyelitis/chronic fatigue syndrome responded to this treatment in days to weeks, with a decrease in systemic symptoms including fatigue, brain fog, pain and mast cell activation syndrome"
- there were updates and presentations on RECOVER-Adult and on the 8 ongoing RECOVER clinical trials
- there was a discussion about avenues for future treatment, assays & biomarkers, which seems focussed on viral persistence etc.
Also, several trials are ongoing or planned:
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