USA: The RECOVER Initiative - Long Covid research

News coverage from The Washington Post:

"NIH announces long covid treatment studies with hundreds of patients"
Washington Post said:
The National Institutes of Health announced Monday that it is launching four clinical trials to test the safety and effectiveness of potential long covid treatments, with seven more to begin in coming months — efforts to alleviate the suffering of millions of patients that critics say are long overdue.

The launch of these clinical trials comes after more than two years of criticism by long covid patient activists and some researchers, who have contended that the nation’s largest sponsor of biomedical research has moved sluggishly in trying to find treatments for those facing lingering symptoms after coronavirus infection. The critics also expressed frustration that early parts of NIH’s special funding to study long covid have not yielded the expected fruits or recruited enough patients.
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Regular link: https://www.washingtonpost.com/health/2023/07/31/long-covid-treatment-studies-nih/

Gift link: https://wapo.st/3QgT6XR
 
NIH launches trials for long-COVID treatments: what scientists think

"The US National Institutes of Health (NIH) announced yesterday that it will launch its first trials to test the safety and efficacy of treatments against long COVID. These trials will focus on therapies aimed at some of the most debilitating symptoms of the disease, including brain fog and disturbed sleep.

The announcement comes after two years of criticism from researchers and people with long COVID about the direction and productivity of the NIH’s nearly-US$1.2-billion RECOVER initiative. They say that the agency has moved too slowly to enrol people in studies and start testing potential treatments for the condition, which affects an estimated 65 million people around the world.

Responding to this criticism, Kanecia Zimmerman, a clinician at Duke University School of Medicine in Durham, North Carolina, who is helping to coordinate the RECOVER studies, said at a press briefing yesterday that there are many steps to launching a clinical trial, including drafting study protocols, consulting with specialists and people with the disease and getting approval from authorities.

Researchers who spoke to Nature say that launching treatment trials is a crucial step, but that it will take tangible progress in these trials to assure those affected that US health officials are taking their concerns seriously. “The fact there were no trials until this point has been highly discouraging,” says Eric Topol, executive vice-president at Scripps Research in La Jolla, California. “The community of people suffering are desperate and want to see the investment by NIH bear fruit.”"

https://www.nature.com/articles/d41586-023-02472-1
 
Once again showing the disconnect. Someone at the NIH is quoted saying something like "this is what the patients have been demanding all along", which I guess simply means that there are trials, while the community has had a very unimpressed response that is basically, "yeah, we definitely have been waiting, but this is all you got?!"

That disconnect makes no sense. How is it that so many in this profession can have such an attitude that they're basically OK wasting over a billion with nothing to show for it, as if it doesn't matter. Seriously out of their depth here, and unable to stop and ask for directions. It's just not how it's done.
 
On Monday, July 31, 2023, the NIH announced:
https://www.nih.gov/news-events/new...through-recover-initiative-opening-enrollment
"Today, the National Institutes of Health launched and is opening enrollment for phase 2 clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven more treatments expected in the coming months."
"RECOVER-VITAL will initially focus on a treatment targeting SARS-CoV-2 persistence, ... The first intervention will test a longer dose regimen of the antiviral PAXLOVID (nirmatrelvir and ritonavir) than is used for treating acute COVID to see if it improves the symptoms of patients with long COVID."
"RECOVER-NEURO will examine accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol will include a web-based brain training program called BrainHQ, developed by Posit Science Corporation in San Francisco, that has been used to improve cognitive function; PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, New York City, that has been used to improve executive function; and a device used for home-based transcranial direct current stimulation developed by Soterix Medical, Inc., Woodbridge, New Jersey, which has been demonstrated to help brain activity and blood flow."
"RECOVER-SLEEP will test interventions for changes in sleep patterns or ability to sleep after having COVID-19. A trial for hypersomnia, or excessive daytime sleepiness, will test two wakefulness-promoting drugs compared to a placebo control. A second trial for sleep disturbances, such as problems falling or staying asleep, will test other interventions designed to improve sleep quality to learn if these interventions may help regulate sleep patterns in adults with long COVID."
"RECOVER-AUTONOMIC will examine interventions to help treat symptoms associated with problems in the autonomic nervous system, which controls a range of bodily functions including heart rate, breathing and digestive system activity. The initial trial will focus on postural orthostatic tachycardia syndrome (POTS), a disorder with a number of symptoms including irregular heartbeat, dizziness and fatigue, and will have multiple study arms. The first arm will evaluate a treatment used for immune diseases versus placebo. The second arm will evaluate a drug currently used to treat chronic heart failure in people with an elevated heart rate versus placebo. Participants within each arm will then be randomized to receive either more intensive coordinated care that does not involve additional medication, or usual care.

A fifth platform protocol, focusing on exercise intolerance and fatigue, is under development with input from the patient community and scientific experts."
See also:
https://www.nature.com/articles/d41...ail&utm_term=0_c9dfd39373-cfb3fc1e7e-47698184
 
Interventions under this protocol will include a web-based brain training program called BrainHQ, developed by Posit Science Corporation in San Francisco, that has been used to improve cognitive function; PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, New York City, that has been used to improve executive function.
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Imagine we find some sort or other chemo-therapy effective for ME achieving remission and also clearing brainfog. Would the inverse then be to start using that on kids that struggle in school? Who comes up with this shit?
 
Email to Emily Taylor of Solve:

Hi Emily,

Any way to protest these RECOVER projects? Basically none of these projects will be of any benefit to LC/MECFS patients.

Here is my list of meds off of the top of my head that are in need of clinical trials.

Cyclophosphamide (blinded)
Abilify/vraylar/rexulti (low dose)
Rapamune plus lithium
Fycompa

Cheers,

——————————————-
I am working with many advocates through the internal committee mechanisms. We’ll continue to work with our partners if a public approach is decided to be the right approach.


Thanks for the list of suggested research! I will share with our research department


Emily Taylor

Vice President of Advocacy and Engagement

Solve M.E. | www.solveme.org
 
Johanna de Haas said:
On Monday, July 31, 2023, the NIH announced:
https://www.nih.gov/news-events/new...through-recover-initiative-opening-enrollment
"Today, the National Institutes of Health launched and is opening enrollment for phase 2 clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven more treatments expected in the coming months."
"RECOVER-VITAL will initially focus on a treatment targeting SARS-CoV-2 persistence, ... The first intervention will test a longer dose regimen of the antiviral PAXLOVID (nirmatrelvir and ritonavir) than is used for treating acute COVID to see if it improves the symptoms of patients with long COVID."
"RECOVER-NEURO will examine accessible interventions for cognitive dysfunction related to long COVID, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol will include a web-based brain training program called BrainHQ, developed by Posit Science Corporation in San Francisco, that has been used to improve cognitive function; PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, New York City, that has been used to improve executive function; and a device used for home-based transcranial direct current stimulation developed by Soterix Medical, Inc., Woodbridge, New Jersey, which has been demonstrated to help brain activity and blood flow."
"RECOVER-SLEEP will test interventions for changes in sleep patterns or ability to sleep after having COVID-19. A trial for hypersomnia, or excessive daytime sleepiness, will test two wakefulness-promoting drugs compared to a placebo control. A second trial for sleep disturbances, such as problems falling or staying asleep, will test other interventions designed to improve sleep quality to learn if these interventions may help regulate sleep patterns in adults with long COVID."
"RECOVER-AUTONOMIC will examine interventions to help treat symptoms associated with problems in the autonomic nervous system, which controls a range of bodily functions including heart rate, breathing and digestive system activity. The initial trial will focus on postural orthostatic tachycardia syndrome (POTS), a disorder with a number of symptoms including irregular heartbeat, dizziness and fatigue, and will have multiple study arms. The first arm will evaluate a treatment used for immune diseases versus placebo. The second arm will evaluate a drug currently used to treat chronic heart failure in people with an elevated heart rate versus placebo. Participants within each arm will then be randomized to receive either more intensive coordinated care that does not involve additional medication, or usual care.

A fifth platform protocol, focusing on exercise intolerance and fatigue, is under development with input from the patient community and scientific experts."
See also:
https://www.nature.com/articles/d41...ail&utm_term=0_c9dfd39373-cfb3fc1e7e-47698184
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Is this seriously all they have :(

The RECOVER-NEURO is v poor. No chance of any of the cognitive training stuff helping. Guff. Just a complete waste of effort, time and money. Clueless :(
 
“The one on sleep will evaluate the effects of wakefulness-promoting drugs solriamfetol and modafinil, as well as those of light therapy, supplementation with the sleep-inducing hormone melatonin and coaching on how to get good sleep. “

I really need coaching on how to get good sleep?

Most MECFS doctors in the US will prescribe modafinil already, so if it works for you then you can get it. Solriamfetol, might help with fatigue, but is fairly expensive in the US—like $1000/month
 
The health coaching model is a giant grift. It allows people with no credentials, training, or ability to market themselves as experts in basic elements of daily life. To be fair to them, they know about as much as our benevolent BPS overseers.
 
Jaybee00 said:
“The one on sleep will evaluate the effects of wakefulness-promoting drugs solriamfetol and modafinil, as well as those of light therapy, supplementation with the sleep-inducing hormone melatonin and coaching on how to get good sleep. “

I really need coaching on how to get good sleep?

Most MECFS doctors in the US will prescribe modafinil already, so if it works for you then you can get it. Solriamfetol, might help with fatigue, but is fairly expensive in the US—like $1000/month
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I find the wakefulness-promoting drugs to be troublesome too. I sleep about 12 hours a day at the moment and I need those 12 hours. It's not that I have trouble staying awake, I have to force myself to go lie down to prevent further deterioration. Unless these drugs fix problems dealing with energy-production I fail to see how these are not dangerous instead of helpful.
 
Moved post

statnews
‘Underwhelming’: NIH trials fail to test meaningful long Covid treatments — after 2.5 years and $1 billion
More than 2.5 years after the National Institutes of Health received a $1 billion mandate from Congress to study and treat long Covid, the agency has finally launched clinical trials for the often-debilitating condition. But both scientists who study long Covid and patients who have struggled with it say the trials are unlikely to deliver meaningful treatments, suggesting the federal government’s landmark Covid research effort may have been wasted.
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https://www.statnews.com/2023/08/09/long-covid-nih-trials/
 
Last edited by a moderator:
The article linked in the above tweet is
https://www.statnews.com/2023/08/09/long-covid-nih-trials/
Stat news
‘Underwhelming’: NIH trials fail to test meaningful long Covid treatments — after 2.5 years and $1 billion
RECOVER funding has primarily gone to observational research

The article includes this data shown on a pie chart:

In December 2020, the National Institutes of Health received $1.15 billion from Congress to study and treat long Covid. As of June 2023, nearly all of this money has been allocated.

Observational study of patient cohort, NYU Langone (47%)
Other (3.6%)
Administrative Coodinating Center, RTI International (1.8%)
Research management services, Deloitte (3.1%)
Pathobiology studies (grants to outside researchers) (6%)
Follow-up tracking of patient cohort (11%)
Biobank and data analysis, Massachusetts General Hospital and Mayo Clinic (13%)
Clinical trials, Duke Clinical Research Institute (15%)
 

Eric Topol
More than 3 years in, with tens of millions of people still suffering, this is the comprehensive list of validated treatments for #LongCovid as established through rigorous, randomised clinical trials.
(Image is a big empty rectangle)
 
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