“We understand the frustration and respect it completely,” said NIAID program officer and TLC leader Joseph Breen, when asked about the more than a year that’s gone between RECOVER-TLC trials’ announcement and enrolling participants.
Last week, Long COVID researchers, patient advocates, and government officials met in Bethesda, Maryland to hear and discuss updates on the National Institutes of Health’s clinical trials initiative, RECOVER-Treating Long COVID. This two-day event was the third iteration of the RECOVER-TLC workshop, jointly hosted by the NIH and Foundation for the National Institutes of Health (FNIH).
In between sessions on Wednesday, I (managing editor Betsy Ladyzhets) interviewed Joseph Breen, a program officer at the National Institutes of Allergy and Infectious Diseases (NIAID) who is involved with leading RECOVER-TLC and co-chaired the workshop. NIAID acting director John H. Powers III also joined the interview over the phone, though he was not able to answer all questions due to technical difficulties.
I asked about the long time that’s passed between the TLC trials’ announcement in September 2025 and their projected launch for enrolling participants, which NIH officials said at the workshop may come by the end of this year. Breen noted that one of those trials, testing low-dose naltrexone (LDN) in children and young adults, had received approval from the Food & Drug Administration (FDA) to proceed; a second trial, testing the stellate ganglion block procedure, received the FDA’s go-ahead the day after this interview was conducted.
Breen and Powers also discussed the initiative’s future plans: RECOVER-TLC has the funding to potentially support further clinical trials, but the initiative’s leadership has not yet determined how many studies, their scale, or which treatments they may examine. I additionally asked about community feedback for the initiative, decentralized trials, connections to other infection-associated chronic conditions, and more.
This interview has been edited and condensed for clarity. Read The Sick Times’ full live blog of the 2026 RECOVER-TLC workshop here.
Betsy Ladyzhets: My first question: It’s been over a year since the three new trials were announced at the prior meeting. A lot of people in the patient community are disappointed that it’s taken a lot of time for the trials to start enrolling people, I’m sure this is not news to you. So I wanted to ask, why it’s been this amount of time? What are some of the challenges?
Joseph Breen: They’re different for each intervention. I think LDN is probably the biggest effort overall, and there, we had to take special care because of the populations we were touching, and in fact, creating an additional way to deliver the medicine so that we have a dissolvable caplet. Because we couldn’t deliver the same drug that a 20-year-old would take to the smallest participants. And it turned out to be that that’s really important … Having a consistent drug quality and stability, and then in two forms. It took a little longer.
It’s also the case that these things always take longer than people would like, and it’s never soon enough [for people living with debilitating symptoms]. Very soon, we’re going to start enrolling. And then people are going to have to wait through the trial, which is also painful.
So we certainly recognize that. And I think we are, frankly, buoyed that we have progress, and we know we are really close. FDA has given us the go-ahead for the LDN study, for example. On behalf of the TLC leadership, we understand the frustration and respect it completely. One of the reasons why we’ve integrated patients, and parents of patients, is to help us drive but also recognize that this is worth working out because we have to do this well.
BL: That’s another thing I wanted to ask about too, with the patient input that’s been happening throughout the trial design process. How would you anticipate that continuing as the trials are starting to move into actually recruiting people and collecting data? What will the work groups continue to do?
JB: The protocols, as I learned through RECOVER 1.0, they actually don’t stay the same [throughout the trial]. Sometimes they change over time. So I anticipate that [the working groups] probably will be involved, certainly through the course of the trial, and then there’s a process by where, eventually, those groups are told about the results when all that is completed at the other end.
Then, the other piece which I mentioned this morning, is that we’ve had increasing involvement of the Community Advisory Board. They’re giving us suggestions on how to recruit better, how to make this easier for parents. Some of those folks have actually been involved with RECOVER 1.0 trials. It’s a balance, those people [on the Community Advisory Board] are going to help us more and more as we get towards launching these trials. But protocol folks, it’s not over, as the protocols are updated… and we figure out how to do things better.
On behalf of the TLC leadership, we understand the frustration and respect it completely. One of the reasons why we’ve integrated patients, and parents of patients, is to help us drive but also recognize that this is worth working out because we have to do this well.
Joseph Breen, NIAID
BL: I know the protocols were shared online when they had the review periods. Are the final versions of those going to be published soon?
JB: Yes. Certainly, it will be put on clinicaltrials.gov.
BL: I was also curious — you mentioned the Community Advisory Board. Is it public, who is on that [board]? I think somebody asked about this at one of the webinars [in March of this year], and you mentioned wanting to get consent from the board members.
JB: Yes, we have to ask them. The things that they tell us, there’s a confidentiality. … So we’re doing that, we’re making it so that it’s transparent as it can be. And if someone wants to stay anonymous, we have to respect that.
[Editor’s note: At this point in the interview, the NIAID communications staffer facilitating was able to get John Powers III on the phone.]
BL: The next thing I wanted to ask about is including people who have more severe symptoms. This has already come up in the questions [at the sessions] today as well. There’s a lot of interest in remote trials, people being able to participate when they’re not able to go to a site in person. I’m curious how you all are thinking about this for the three studies that are starting soon, and/or for other research that might come out of RECOVER-TLC or other NIH Long COVID research, and ME [myalgic encephalomyelitis] research, too.
John Powers: In principle, doing remote trials is actually a fine idea. We’ve been able to, especially during the COVID pandemic, to even get remote blood draws from people, where we can actually send tubes to their house and they can draw their own blood.
There are some things obviously you can’t do, like physical examinations. Those are hard to do remotely. … Or we can do a hybrid [format] where people can come in for less visits than they would have ordinarily, and we can get some other information electronically at home. In principle, I don’t see any reason not to do it. I think clinical trials in general have been moving that way now for the last several years.
JB: REVERSE-LC [the baricitinib trial] has started to use remote blood sampling, for things like surveys and blood samples. They can actually use remote nursing staff to really lessen the burden of folks. I heard this morning that we’re trying to provide the surveys up front [in the new TLC trials], so that people don’t have to spend as much time in the medical facility.
As someone mentioned here, [participating in a trial] is an energy-depleting activity. We don’t want to make them feel worse than we have to, to do part of the study. Like John said, I think it’s where this is going. I would anticipate that going forward, we would be looking for even more of those opportunities. But we have to balance patient safety.
And there was a lot of consideration of a remote trial, and we just decided, for the GLP-1, that we couldn’t do a completely remote trial. But we can compare to the one that’s underway at Scripps.
BL: That’s great. About the connection with the pathobiology research that’s also part of RECOVER, I think Dr. Rao mentioned when she was presenting on the semaglutide trial that there’s been lessons learned from the pathobiology studies in selecting the biomarkers that TLC is going to be looking at. I was curious if you could share more about how that’s going to be embedded into these trials, and also how the samples and data might be available for other researchers in the future, like I know the RECOVER 1.0 studies have been doing?
JB: Obviously we want to make all the data and any samples collected available. That’s part of our operating principles. RECOVER [1.0] is doing that, and we will as well.
We had members of the pathobiology committee join the protocol groups’ meetings on several occasions. Sometimes they were actually already integrated [with the same people in both groups] … Cliff Rosen, who is part of the pathobiology leadership, helped us develop the specific biomarkers that we should really be thinking about, based on what’s going on in the RECOVER pathobiology studies. We’re trying to utilize as much data as possible.
For the core biomarkers [which will be tested across all three TLC trials], we did a literature review to try and make that sync up with what others are doing all across the research community. And then we got as contemporary a view as we can from the pathobiology members to give us input. Those biomarkers, the core and each of the trial-specific ones, are on the FNIH website, so we’re trying to be transparent about it. We may have to adjust based on where the field goes. The systems biology data that we’re anticipating could change some of those choices over the next year. But we can’t wait, we have to keep going based on what we know today.
BL: You and I talked at this meeting last year, and you said at the time that there might be room in RECOVER-TLC’s budget for additional clinical trials on top of these three plus the support for REVERSE-LC. Are you able to share any updates on that?
JB: We are still taking in interventions [in the portal]. And we are still — two years ago and last year, we said, we’re scoped to do a number of trials. We still have some support to do additional trials. Whether that will be mechanistic or something larger — that’s a balance of resources, frankly. But also, where the field is, what pathways and what interventions are available.
Maybe we need to do something that’s even closer to phase 1, we need to be really open-minded about that. Or maybe one of these preliminary results [from the trials already started] would mean we need to pick something a little further ahead. So we’re open to that, and we do plan on proceeding and supporting additional trials. Just like we had to start this program before the RECOVER wave one trials were done, we’re anticipating we probably can’t wait to see the results of these, we’re going to keep moving ahead.
It’s a balance, to be honest, because obviously these trials are planned, we have budgets. But that’s a plan. We need to move forward, get these launched, see what our resources are. And then, at the same time, keep our eyes on the literature and hearing from the pathobiology folks as to, where is there another opportunity?
JP: I think the last part of what Joe said is the most important. It’s not just a matter of resources. … It’s also, where does the evidence support another intervention? And in what kinds of patients would those interventions hypothesize to be most valuable? Because given the different presentations of Long COVID, some interventions might be helpful in some kinds of patients and not in others. If we don’t study the right intervention in the right kind of people, it’s going to look like it doesn’t work when we just basically missed the target.
Given the different presentations of Long COVID, some interventions might be helpful in some kinds of patients and not in others. If we don’t study the right intervention in the right kind of people, it’s going to look like it doesn’t work when we just basically missed the target.
John Powers III, NIAID
BL: On that note, I noticed that Penelope Markham is going to be presenting on BioVie’s results tomorrow. And when they had their press conference a few weeks ago announcing the results initially, I believe they mentioned potentially applying to RECOVER for funding. So I was curious if that’s something you can speak on, or just any comments on those results, because I think that was a really exciting moment for everybody following this space.
JB: We are still evaluating, and we actually re-reviewed a number of ideas that came in when we got additional data that might change the calculus.
We were also excited by [BioVie’s preliminary results] and that’s why we invited them [to this meeting]. Even though they didn’t meet their primary outcome, they still had efficacy signals that I think are important for us to consider. And we would certainly, and we will, encourage them to put whatever data they are comfortable sharing into the portal, so we can consider that for whatever level of support is needed for the next step. That’s a good example of how things could change over time as these early trials read out.
BL: I also wanted to ask about the connections with other infection-associated chronic conditions. I know Dr. Bhattacharya in his remarks this morning specifically mentioned ME, chronic Lyme. Rivka [Solomon] obviously was just talking about ME. So are there plans at this point for studies that could build on RECOVER and include more of those patient groups, or other ways that you foresee this program directly translating into these other related areas?
JB: I’m hopeful that where there is overlap, there will be benefit. Where there’s not, it’s going to be harder.
Dr. Rao mentioned that those with ME/CFS post-COVID are eligible for the GLP-1 trial, while I don’t believe that people with ME/CFS symptoms are eligible in the baricitinib trial [REVERSE-LC]. So I think we are trying to learn from the harsh, hard lessons that community has learned, and people like Rivka are helping us.
The ENERGIZE trial, I think, is another crossover. I think we’ll learn things in that trial that will be amenable to being utilized in the ME/CFS community, people that have [pre-2020] ME/CFS as compared to COVID-derived ME/CFS. I think this is the way it’s going, that because there’s a large population of people who have diagnosed ME/CFS post-COVID, I hope that there’s overlap. We’ll have to see how much there is for other things, like other infections.
It’s a balance. This money is appropriated for COVID. … But we can certainly try to leverage it, and physicians who take care of ME patients as well as patients have been incredibly generous to help us design these trials to be accurate, inclusive, in terms of PROs [patient-reported outcomes], and to the extent that we can, even mechanisms. So that if we have an effective mechanism in the symptom area that covers something that may have been initiated with Epstein-Barr virus, versus SARS-CoV-2, we hope that there would be benefit. Right now it’s just a common goal.
BL: Definitely we have a lot of readers at The Sick Times who had ME pre-pandemic, and people are always asking these kinds of questions and wanting to see what the lessons are going to be for them out of some of these trials that are happening.
[Editor’s note: John Powers III became available on the phone again here after more technical difficulties.]
BL: I had wanted to ask you about the new Vaccinology and Immunology Center that was announced a couple of weeks ago, that’s going to be studying chronic symptoms both from infections and from vaccination. How do you anticipate that the new center might intersect with RECOVER or learn from RECOVER, and/or are there any other updates that you can share about it following that announcement?
JP: The protocol for that study is still under development and review. So I think it would probably be pretty premature [to give further updates]. The one thing that is clear is, we’re not limiting that clinic to just COVID or Long COVID. For instance, we know that people, after influenza vaccination, can get Guillain-Barré syndrome. So we’d be looking at a wider array of diseases other than just COVID in that particular clinic.
We would hope that we would measure some of the similar things in that clinic that we’re doing for RECOVER and for other studies. That way, we can compare across those studies as well. That’s the way I would think about them dovetailing together. We should probably be looking at similar immunological correlates of disease across all these studies, so then we can make some comparisons across different types of patients from study to study. I think that’s probably the best connection. But it’s going to be a lot broader — it will include people with Long COVID and post-COVID vaccination [syndrome], but it’ll be broader than that.
BL: I was also curious about, so over a year ago now, HHS [Health and Human Services] Secretary Kennedy had a roundtable event on Long COVID. He talked about, and the other speakers at that event talked about, efforts to spearhead more Long COVID research, better partnerships with pharmaceutical companies, more public awareness. I’m curious if there are other efforts that have been happening either at the broader HHS level or at the other health agencies that are connecting with RECOVER or connecting with these trials?
JP: There have been meetings at the HHS level. But I’m not going to comment on what other agencies are doing, that’s above my pay grade. It’s best to talk to them about those things. But we are trying to coordinate with those other agencies in terms of the kind of work we’re doing.
We have a very different remit than those other agencies, right? For instance, CDC [Centers for Disease Control and Prevention] does more surveillance and epidemiological things. We do the research piece of this. AHRQ [Agency for Healthcare Research and Quality] and HRSA [Health Resources and Services Administration] are doing other things related to provision of care, and FDA is obviously the regulatory review piece. Should we get to the point where we have a trial that looks successful, then we would hopefully you know take that to FDA. But we’re not there yet. I wish we were.
BL: The last main question I had is, looking at funding. So where does the RECOVER-TLC funding stand? I mean, you kind of answered this earlier with saying there’s still more available for other trials. But I think people among our readership at The Sick Times always want to know what they can do to help in terms of pushing for further funding, pushing for more support for research.
JP: Obviously, we’re not allowed to lobby Congress for this stuff, and whatever Congress decides to send our way for this, we would use those resources wisely. And we’re working with the available funds that we’ve been provided with to date. So it’s up to other folks if they want to talk to people to try to get more funding applied to the research end of this.
JB: This program has been well supported, and we’re still at this stage where we’re supporting these trials, and we’re still planning to initiate others. … We’re still trying to meet the objectives of the current program.
This program [RECOVER-TLC] has been well supported, and we’re still at this stage where we’re supporting these trials, and we’re still planning to initiate others.
Joseph Breen, NIAID
Read The Sick Times’ full live blog of the 2026 RECOVER-TLC workshop here.
The Sick Times will continue covering NIH RECOVER and other U.S. government-funded efforts to advance Long COVID research. Send us tips at editors@thesicktimes.org, or reach Betsy on Signal at @betsyladyzhets.25.
