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The GIST

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RECOVER

Is the NIH’s RECOVER program recovering?

Money, Money, Money

Why has Health Rising spent so much time on the RECOVER Initiative for long COVID? It’s simple – money.  Let’s not even think about the $1.15 billion Congress gave RECOVER over 4 years ago. That’s largely gone. In February 2024, however, RECOVER received a $515 million infusion from the Biden administration to support clinical trials.

Nobody else has anywhere close to that kind of money. If we want to more or less quickly get good treatments to the primary care doctors that most of us rely on, we need convincing clinical trials and, in that concern, RECOVER is unique. It alone has the funding to comprehensively explore multiple treatments and quickly get them into doctors’ offices. As ME/CFS researcher Al Aly asserted during the conference, “We need RECOVER to succeed”.

Something recently appears to have changed with the Initiative. It received its new money seven months ago, yet Dr. Marrazzo, the new Director of NIAID (which put on the conference), stated that the conference was quickly put together in the last month. Someone (Director Bertagnolli, Director Marrazzo?) decided it was time for RECOVER to open its doors and bring in some new viewpoints.

It was good they did. In her interview with Betsy Ladyzhets, Bertagnolli said the 2 1/2 day RECOVER TLC meeting – designed to open RECOVER up to new viewpoints – was “crucial” for the success of the Initiative. She’s likely right.

A Long COVID / ME/CFS Moment Featuring NIH Director Monica Bertagnolli

The (Missing) Hunt for Biomarkers

The GIST

  • Why has Health Rising spent so much time on the RECOVER Initiative for long COVID? It’s simple – money.  In February 2024, RECOVER received a $515 million infusion from the Biden administration to support clinical trials.
  • Nobody else has anywhere close to that kind of money. If we want to more or less quickly get good treatments to the primary care doctors that most of us rely on, we need convincing clinical trials and, in that concern, RECOVER is unique.  As long COVID researcher Al Aly asserted during the conference, “We need RECOVER to succeed”.
  • In her interview with Lady Bezyhats, Bertagnolli said the 2 1/2 day RECOVER TLC meeting – designed to open RECOVER up to new viewpoints regarding its clinical trial efforts – was “crucial” for the success of the Initiative. She’s likely right.
  • RECOVER has put itself in a hole. Presenter after presenter acknowledged that the long-COVID field desperately needs biomarkers (“Biomarkers should be a holy grail”) RECOVER put most of its money into investigative studies that are characterizing long-COVID patients – not digging into their pathophysiology.
  • The only avenue RECOVER appears to have left to generate strong biological data is by tweaking patients’ systems with treatments and then analyzing how their systems respond. Indeed, in a new field like long COVID, one might have expected RECOVER to use clinical trials to ferret how what was happening with it. In a recent interview, Bertagnolli emphasized how much she expected RECOVER to learn from these kinds of “exploratory” clinical trials.
  • We learned, though, that RECOVER is only gathering biological data in its Paxlovid study.  Given that it was very good to hear NIAID Director Marrazzo declare that RECOVER would, for the first time, embrace small exploratory treatment trials that are designed not just to see if a drug works but what impact it has on the body as well. Using this approach even a negative clinical trial can provide important insights into what’s going on in long COVID.
  • Urgency was the theme of the day but RECOVER has seemed anything but urgent. Most of its clinical trials only opened up over the last year. From day one, RECOVER knew it needed a good long COVID definition but only funded one about 18 months ago and that definition was vague. One consequence is that RECOVER is using very general criteria in its clinical trial studies. Whether you have ME/CFS-like long COVID or pulmonary or kidney-long COVID, RECOVER is treating them as one in its trials.
  • While neither RECOVER nor the NIH has provided much of the biological data RECOVER needs to effectively design its clinical trials, Amy Proal of Polybio asserted that “clear leads” are already present and that “we can design really good trials” right now. Monoclonal antibodies that have proved effective in small trials are wasting away on drug company’s shelves unused.
  • Avindra Nath stated that he thought it was time to stratify patients on the kind of immune dysfunction present and target it in treatment trials. These are the kinds of exciting approaches being done outside of RECOVER which has focused its large trials on mostly conservative treatments (brain retraining, sleep hygiene, melatonin, exercise, Ivabradine).
  • The use of “Platform trials” was widely agreed on (Stephen Deeks (UCSF), Lisa McCorkell, Avindra Nath, NINDS representative). Because these trials use one control group to test multiple treatments, they are considerably cheaper and faster than using different control groups for each study – as RECOVER is doing now. Other suggestions such as using a “playoffs” model where treatments vie against each other in small studies before the winners move on to bigger studies, combination, and remote trials.
  • The Paxlovid trials underway are an example of what NOT to do. Four very similar trials were underway. Because Paxlovid hasn’t been assessed for safety beyond 2 weeks, the trials appear to have lasted all of 15 days (!) – probably far too short a time period to make a dent in as complex a disease as long COVID.
  • Several presenters asserted that LC patients need to be given a risk/benefit choice and that noted many LC would rather take some risk (say in a longer Paxlovid trial) than remain in their present state. Others asked why anyone thinks one drug is going to do the trick when multiple drugs are commonly needed for infections and chronic illnesses.
  • It was clear that a major stumbling block for the long-COVID field (and for ME/CFS, POTS, etc.) has been a lack of industry engagement. Avindra Nath, for instance, tried but failed to interest pharma in exploring checkpoint inhibitors in LC. One industry rep said pharma is perplexed by long COVID and is unclear which drugs to try.
  • Stephen Deeks (UCSF, LIINC), though, provided a blast of fresh air when he bluntly said that he didn’t believe that repurposed drugs would do the trick. In a recent article, Deeks called long COVID’s effects on the body as “chaos and mayhem” 🙂 and said what the field needs, above all, are objective markers.
  • There’s no mystery to beating LC, Deeks said. We simply have to do what we did with HIV/AIDS; that is, embark on a massive effort to understand the mechanisms that are driving it and develop the biomarkers that drug companies need to enter the LC space.
  • We also need good “endpoints” – the symptom markers by which drug companies can tell if the drug is working. Seth Lederman of Tonix, the company that developed the Tomnya drug that is under approval at the FDA for fibromyalgia, asserted that if FDA would PUBLICLY declare that the Patient Global Assessment of Change (PGIC) is a valid assessment for long COVID, drug companies would move in.
  • Not many people are excited about RECOVER’s clinical trials, but that may be changing. Meighan Stone, the founder and executive director of “The Long COVID Campaign” and co-author of “Awakening: #MeToo and the Global Fight for Women’s Rights” said she was hopeful for the first time in a long time.
  • Time will tell how this all sorts out, but the panels of speakers RECOVER brought in suggested it’s making a sincere effort to move forward. We need to give RECOVER a chance
  • RECOVER is staffed by people new to the field, who had to build a big project on the fly, and mistakes were probably bound to happen. If RECOVER self-corrects, this wouldn’t be the first time that a large endeavor at the NIH got off to a slow start but successfully rebooted itself.
  • NIAID Director Dr. Marrazzo pointed to a new, more open and creative RECOVER. She promised: small mechanistic/exploratory clinical trials and platform clinical trials will be done; that RECOVER will employ the same processes the ACCT/ACTIV network used to identify long COVID drugs; that RECOVER will work with the FDA to define endpoints to use in drug approvals; that the larger trials will be done in such a way to lead to FDA approval; that communication and collaboration, especially with patients groups, will increase and that monthly progress reports will be provided.
  • For RECOVER’s arguably most important challenge – its clinical trials effort – to succeed, it needs biological data to guide it, and that’s an even bigger challenge. Stephen Deeks asserted that a massive effort akin to what was done in HIV/AIDS is needed to uncover the biomarkers and mechanisms driving long COVID. Once those are discovered, the pharmaceutical companies – as they did with HIV/AIDS – will jump in.
  • The NIH, thus far, though, has not embraced long COVID (or ME/CFS or post-infectious diseases, in general) and no massive effort to uncover biomarkers is underway. One could be underway, though, and very quickly, if the Long COVID Moonshot Bill is passed. Get that bill passed and the circle is complete: we have a robust research effort that informs the search for good treatments. That’s where we want to be and that’s where we must put our efforts. Find out more here.
Director Marrazzo

Both NIH Director Bertagnolli and NIAID Director Marrazzo (pictured) are new to their jobs – and both appear to be interested in long COVID and ME/CFS.

The start of the first day kind of encapsulated the concerns regarding RECOVER: nothing worked! The Zoom link originally sent out was incorrect, leaving dozens of us staring at a mostly blank screen for 40 minutes. Eventually, someone remembered to tell us a new Zoom link had been sent out. NIH Director Bertagnolli’s opening talk was missed. (She reportedly hung around the conference for the rest of the day.)

Once the link was restored, the news was good. NIAID Director Marrazzo – who reportedly is very interested in both long COVID and ME/CFS – quickly uttered some words many of us wanted to hear: “exploratory clinical trials”.

RECOVER has put itself in a hole. Presenter after presenter acknowledged that the long-COVID field desperately needs biomarkers (“Biomarkers should be a holy grail”).

RECOVER, though, put most of its money into investigative studies that are simply characterizing long-COVID patients. (When Clint Wright, the NINDS representative, exclaimed about the urgent need for biomarkers, he might have looked into the mirror and asked himself how much long-COVID research NINDS is funding? (Answer: not much).

Right now neither RECOVER nor the NIH has produced the biological data it needs to guide it. RECOVER has created a huge biorepository of samples – a real strength – but appears to lack the money to assess them.

RECOVER did not do itself any favors when one representative said, with a straight face, “Thanks to RECOVER, we know much about the biology of long COVID”.  A review of RECOVER’s publications uncovered just 9 pathobiology studies, 3 of which did not apply to the ME/CFS-like subset, and most of which were quite small, (and which RECOVER only partially funded). That’s a pretty paltry result.

The fact that RECOVER used Michael VanElzakker’s fascinating study as a showcase of what it’s done for long-COVID (LC) pathophysiology was emblematic of the problem. VanElzakker’s study linked neuroinflammation to vascular problems – a potentially key finding – but employed just 12 LC patients!

Time will tell what’s coming down the pike, but the only avenue RECOVER appears to have left to generate strong biological data is by tweaking patients’ systems with treatments and then measuring how their systems respond. Indeed, in her Ladyzhets interview, Bertagnolli emphasized how much she expected RECOVER to learn from these kinds of “exploratory” clinical trials.

Thanks to an alert questioner, though, we learned RECOVER only gathered biological data in the”Vital Paxlovid” trial. It’s true that many of the trials (brain retraining, exercise, goal setting, sleep hygiene) probably wouldn’t have provided much information but the IVIG, modafinil, and rTMS trial might have. With the exception of IVIG, though, these aren’t the kind of treatments that could be used to provide relief and deeply probe long-COVID pathophysiology.

In the end, RECOVER chose a conservative clinical trial approach to assess a conservative set of treatments. (RECOVER has never, to my knowledge, publicly acknowledged their rationale for choosing the treatments they did.)

The lack of initiative RECOVER showed on the clinical trial front was puzzling because if any disease seemed to call for a creative approach, it seemed like long COVID did. Given that LC is a new and complex disease, one would have thought RECOVER would have found ways to take a poke at it, so to speak, with exploratory clinical trials.

Exploratory Clinical Trials

These trials have been happening at a small scale outside of RECOVER with the LIINC Initiative at UCSF, at PolyBio Research Foundation (whose motto is “Science in Action”, and at the REVERSE long COVID baritcinib trial. Amy Proal reported that PolyBio will not put on any clinical trials until it also has the funding to also explore LC patients’ biology. Steven Deeks said he knows of 4 or 5 drugs that could effectively probe LC’ patients biology.

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With Marrazzo immediately supporting these exciting projects, it appears RECOVER is about to change. With its $515 million infusion, RECOVER has the funding to dramatically expand these efforts. Let’s hope it fully embraces this opportunity.

Urgency!?

Urgency, ironically, given that RECOVER has not begun its exercise trial, has only recently begun its sleep trial, and only opened its autonomic nervous trial in March of this year, and its Neuro trial in October of last year, was a key theme. One RECOVER presenter said, “We have no time to waste”, and indeed, we don’t. On the one hand, it’s good to see RECOVER acknowledge that “we have no time to waste”; on the other, it’s a little jarring given how long RECOVER has taken to get its initial trials going. It took six months after RECOVER received its funding for it to decide to put this conference on!

We learned that it was only about 18 months ago, or 2 and 1/2 years after long COVID came on the scene, that RECOVER tasked the National Academy of Sciences (NASEM) to create criteria for long COVID. Given the critical need to define the illness for its studies and trials, one wonders what took RECOVER so long.

NASEM then took about 18 months to produce the criteria. While the criteria have been lauded, they are intentionally inclusive and not precise enough to define subtypes. (Note that the NASEM reported that the biggest problem with defining #longCOVID is a lack of a biomarker.)

We’ll see that the lack of a biomarker doesn’t necessarily stop the clinical trials – there are ways around that – but finding one would propel the field forward tremendously. Finding a biomarker, though, will surely require that RECOVER uncover the distinct subsets in the long-COVID population and explore them deeply.

RECOVER’s Broad Brush 

I would have thought uncovering these subsets would have been one of RECOVER’s first tasks, but that hasn’t happened. As a consequence, RECOVER is taking a broad brush in its current clinical trials.

Participants must have had an “acute onset of fever AND cough (influenza-like illness)” OR “acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia”, as well as cognitive dysfunction (for the Neuro trial), sleep issues (for the sleep trial), etc.

RECOVER, then, is investigating very general symptoms (sleep/cognitive problems/fatigue”) – any of which could be caused in any number of ways – across a wide variety of unidentified subsets. Surely the pulmonary subset, for instance, could be experiencing cognitive problems for different reasons than the ME/CFS-like subset. (Notice that post-exertional malaise is not mentioned.)

That’s one reason we need biological data to guide the clinical trials.

Infrastructure Needed

Thankfully, there are no illusions about the scope of the task ahead. Despite the fact that long COVID is produced by a single pathogen, I don’t think anyone hasn’t been surprised by how complex the disease is. (HIV/AIDS is looking like a cakewalk compared to long COVID right now.) Given that, it was good to see a speaker acknowledging the need to “plan for infrastructure because this is going to go on for a long time”.

Infrastructure, or more specifically, the lack of it in the NIH (outside of the RECOVER program), is a crucial point. I could find no evidence of an organized effort at the NIH to combat long COVID. The fact is that few grant opportunities can account for the low levels of funding and a scattershot approach to the disease as a whole. The NIH has clearly not gotten behind long COVID.

Treatment Approaches

While what’s ultimately causing LC is unclear, there are no lack of potential treatments to explore. Amy Proal of PolyBio declared, “we can design really good trials” right now, and she referenced the “clear leads” that were already present.

She noted the success that monoclonal antibody drugs have had with some LC patients, plugged Michael Peluso’s and Stephen Deeks’s small exploratory mAb trial (no NIH funding), and decried the fact that monoclonal antibodies are sitting unused on drug company shelves – and are about to expire. (One article stated that “gallons of monoclonal antibodies” are losing efficacy over time). Some think that monoclonal antibodies will be more effective than antivirals at bottling up the coronavirus (or other pathogens).

Nancy Klimas found dramatic success with some older mAbs, and received funding from the state of Florida for another which should be underway now.

Three Severely Ill Long COVID Patients – Three Rapid Recoveries: Monoclonal Antibodies, LC and ME/CFS

(At Mt. Sinai, David Putrino, who was not at the conference, is assessing the effects of two broad-spectrum antivirals, monoclonal antibodies, immune modulators, and anti-clotting drugs this year. He hopes to launch a major multi-treatment platform in 2026).

Avindra Nath – who believes that problems with B-cell maturation is driving ME/CFS and LC, said it was time to stratify patients on the kind of immune dysfunction present and target that in treatment trials. That’s the kind of biological approach that’s needed.

In that vein, one commenter noted that the remarkable hepatitis C treatment success came about largely because of government support but that the NIH is currently providing no funding for direct long-COVID drug trials.

Platform Trials

Some time ago, Nath introduced the idea of “platform trials“; indeed, he suggested that the ME/CFS and LC fields would be lost without them. Stephen Deeks (UCSF), Lisa McCorkell, and the NINDS representative also endorsed the platform trial concept.

Platform trials compare “multiple, simultaneous…interventions against a single … control group. They attempt to answer the question: “which therapy will best treat this disease”. Because these trials use one control group to test multiple treatments, they are considerably cheaper and faster than using different control groups for each study – as RECOVER is doing now. Again and again, speakers urged RECOVER to incorporate platform trials into their program.

Other suggestions such as using a “playoffs” model where treatments vie against each other in small studies before the winners move on to bigger studies, combination, and remote trials.

The Paxlovid Predicament

The Paxlovid trials underway are an example of what NOT to do. With limited funding available, there’s no reason that we needed 4 Paxlovid trials. Even Dr. Marrazzo appeared to think that was too much.

Plus, because Paxlovid hasn’t been assessed for safety beyond 2 weeks, the trials appear to have lasted all of 15 days (!) – probably far too short a time period to make a dent in as complex a disease as long COVID. The NIH’s Paxlovid trial was 900 persons strong and probably cost tens of millions of dollars to bring off.

Several presenters asserted that LC patients need to be given a risk/benefit choice and that noted many LC would rather take some risk (say in a longer Paxlovid trial) than remain in their present state. Others asked why anyone thinks one drug is going to do the trick when multiple drugs are commonly needed for infections and chronic illnesses.

That brought to mind Skip Pridgen’s early success with adding Paxlovid to his 2-antiviral regimen to treat herpesviruses.

Triple Antiviral Coronavirus/Herpesvirus Approach Scores in Very Early Long COVID Testing

The Big Stumbling Block – Getting Industry Engaged

It was clear that a major stumbling block for the long-COVID field (and for ME/CFS, POTS, etc.) has been a lack of industry engagement. Avindra Nath, for instance, tried but failed to interest pharma in exploring checkpoint inhibitors in LC. I missed the industry talk on the last day but an industry rep said that pharma is perplexed by long COVID and unclear which drugs to try.

That provided a nice entry for Stephen Deeks (UCSF, LIINC), though, who provided a blast of fresh air when he bluntly said that he didn’t believe that repurposed drugs will do the trick. In a recent article, Deeks called long COVID’s effects on the body as “chaos and mayhem” 🙂 and said what the field needs, above all, are objective markers.

There’s no mystery to beating LC, Deeks said. We simply have to do what we did with HIV/AIDS; that is, embark on a massive effort to understand the mechanisms that are driving it and develop the biomarkers that drug companies need to enter the LC space.

(That kind of effort is not even close to happening at the NIH. The massive research effort that Deeks believes will win the day for long COVID – and could do so rather quickly – could happen in a flash, though, if we pass the Long COVID Moonshot bill currently making its way through Congress. The bill provides $10 billion over ten years for long COVID, ME/CFS, POTS, and post-infectious disease research.)

Our future is in our hands! Please support the Moonshot bill!

Changing the World: the Fight for the Long COVID Moonshot Bill Begins

It’s not just the lack of biomarkers that’s scaring drug companies off. Absent them, they need good clinical endpoints (symptom assessments) they can trust to tell them if their drug is working or not, and they don’t feel they have them. Seth Lederman of Tonix, the company that developed the Tomnya drug that is under approval at the FDA for fibromyalgia, had some ideas around that.

Lederman asserted that if the FDA PUBLICLY declared that the Patient Global Assessment of Change (PGIC) is a valid assessment for long COVID, drug companies would feel secure enough to enter the field. Lederman noted that early on, using the PGIC in cancer dramatically accelerated the number of cancer drugs under investigation.

The Next Drug for Fibromyalgia? Tonix’s Tonmya Sleep AND Pain Drug Heads to the FDA

Todd Davenport (Workwell Foundation) asserted that we do actually have objective measures, such as reduced blood flows to the brain, that could readily be established to assess treatment effectiveness. Plus, the ME/CFS field, in collaboration with the CDC, produced a set of Common Data Elements that could be helpful in standardizing research efforts and assessing clinical trial effectiveness.

In other words, there are ways to move forward with clinical trials while the work to uncover biomarkers goes forward.

Others

Jaime Seltzer (#MEAction) aptly noted that every long-COVID patient who testified had gotten better after learning what helped with ME/CFS. She argued for the inclusion of ME/CFS patients in clinical trials. She (and Todd Davenport after her) also noted the strange disappearance of PEM from the discussion thus far. Davenport reported that PEM is uniquely disabling, highly individual, dramatically effects functioning, and assessing it must be part of any long-COVID clinical trial regimen.

In a nice analogy, Davenport reported that the long-COVID field “is now rushing to catch a flight without packing a suitcase”. I took that to mean that it and RECOVER still has much to learn from both the ME/CFS field and the historical underfunding and marginalization of ME/CFS research.

We need to understand why, even after decades of demonstrating the great needs of the ME/CFS community and the field itself, ME/CFS remains stuck with low and even declining funding at the NIH. Something in the way the NIH operates not only prevents it from embracing “outsider” diseases like ME/CFS, fibromyalgia, POTS, ME/CFS, long COVID etc. but seems to actively work against them.

Until the reasons for that are made clear and rectified, all these disease are at risk.

Conclusions

Not many people are excited about RECOVER’s clinical trials, but that may be changing. Meighan Stone, the founder and executive director of “The Long COVID Campaign” and co-author of “Awakening: #MeToo and the Global Fight for Women’s Rights” said she was hopeful for the first time in a long time.

Time will tell how this all sorts out, but the panels of speakers RECOVER brought in suggested that it’s making a sincere effort to move forward. From Ziyad Al Aly to Michael VanElzakker to Amy Proal to Jaime Seltzer to Hannah Davis to Peter Rowe to Ian Lipkin to Micheal Peluso to Avindra Nath to Steven Deeks and Paul Utz, RECOVER included panelists it must have known would push it to move forward in new ways.

Giving RECOVER a Chance

The post-infectious disease field is essentially a new one. RECOVER is staffed by people new to the field, who had to build a big project on the fly, and mistakes were probably bound to happen. If RECOVER self-corrects, this wouldn’t be the first time that a large endeavor at the NIH got off to a slow start but successfully rebooted itself.

RECOVER has going for it a large infrastructure (too large?) (157 clinical sites, 243 principal investors) that can track patients over time, and produce clinical trials that use the same endpoints, as well as a huge sample biorepository (about 1,000,000 samples that includes over 200 (unlucky) participants in its autopsy program).

Now, a new way forward has been provided that RECOVER appears to be embracing. Time will tell how much, ultimately, that RECOVER will take on board, but NIAID Director Dr. Marrazzo seems to be committed to dramatically changing its course. She promised:

  • While outlining it in red, Marrazzo made a special point that addressing “mechanistic questions” (i.e. what’s causing the disease) would inform RECOVER’s priorities in the next trials. (Instead of treating symptoms, RECOVER will focus more on getting at the heart of the disease in the next trials).
  • RECOVER will employ the same process that worked in ACCT/ACTIV network to assess COVID-19 drugs to help identify LC drugs to test.
  • Small mechanistic/exploratory clinical trials to get at long COVID’s underlying pathophysiology will be done.
  • Platform drug trials to more quickly and cheaply assess multiple treatment possibilities will be included.
  • RECOVER will work with the FDA to define endpoints that RECOVER and industry can use to get drug approvals.
  • The larger trials that are done will be done in such a way so that, if they are successful, they will help lead to FDA approval.
  • Communication and collaboration, especially with patients groups, will increase. New working groups with the appropriate expertise will be produced.
  • Monthly progress reports will be provided.

Ziyad Al Aly is right: failure is not an option for RECOVER. RECOVER’s clinical trials program appears to be moving in the right direction, but it is only one piece of the puzzle. For RECOVER’s arguably most important challenge – its clinical trials effort – to succeed, it needs biological data to guide it, and that’s an even bigger challenge.

Stephen Deeks asserted that a massive effort akin to what was done in HIV/AIDS is needed to uncover the biomarkers and mechanisms driving long COVID. Once those are discovered, the pharmaceutical companies – as they did with HIV/AIDS – will jump in.

The NIH, thus far, though, has not embraced long COVID (or ME/CFS or post-infectious diseases, in general) and no massive effort to uncover biomarkers is underway. One could be underway, though, and very quickly, if the Long COVID Moonshot Bill is passed. Get that bill passed and the circle is complete: we have a robust research effort that informs the search for good treatments. That’s where we want to be and that’s where we must put our efforts.

Changing the World: the Fight for the Long COVID Moonshot Bill Begins

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