Why are RECOVER’s first round of Long COVID clinical trials failing?

Over an orange background, there is large white text that reads “Still Here” in the center of the image, and in smaller text in the top-right reads “The Sick Times” in a darker color. Behind all of that is an image of a National Institute of Health building.

The U.S.’s flagship Long COVID research program has received over a billion dollars in funding and had years of input from people with the disease. But its first round of clinical trials are failing, at least in the results out so far.

In this episode of Still Here, producer Melanie Marich talks to co-host and Sick Times co-founder Betsy Ladyzhets about the initial results from the NIH’s RECOVER trials, and why those results have left many patients and advocates in the Long COVID community disappointed.

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Intro
Interview with Betsy Ladyzhets
Outro

Intro

Melanie Marich: [00:00:00] Welcome to Still Here, a Long COVID news and commentary podcast from The Sick Times.

[Theme music begins]

In today’s episode, why are RECOVER’s first round of clinical trials failing?

Miles Griffis: I’m Miles Griffis.

Betsy Ladyzhets: And I’m Betsy Ladyzhets. We’re the co-founders of The Sick Times.

Melanie Marich: And I’m Melanie Marich, the podcast producer for Still Here.

Miles Griffis: Many institutions are ignoring the ongoing COVID-19 pandemic and trying to erase [00:00:30] the Long COVID crisis.

Betsy Ladyzhets: But here at The Sick Times, we’re bringing you the latest news and commentary that matters to the Long COVID community.

Miles Griffis: Without pandemic denial, minimizing, or gaslighting

[Theme music ends]

Melanie Marich: Hi folks, Melanie here. Today, I chatted with our co-host and Sick Times co-founder, Betsy Ladyzhets, about the latest in Long COVID research. In the United States, the National Institute of Health has been running the RECOVER research [00:01:00] program for several years now. We got a first batch of initial results.

It was not promising. Now, I’m not a scientist or a science reporter by training, so I wanted Betsy to help me understand where and how things have gone wrong and where there may actually be hope in all this. To check out all of Betsy’s reporting on the RECOVER trials and to learn more about anything we chatted about, you can find that in the episode description and on thesicktimes.org.

FYI, Betsy and I recorded this from [00:01:30] our respective homes in Brooklyn on a very loud

late spring day, so apologies in advance for any miscellaneous noise you might hear in the background. Okay, here’s the episode.

Interview with Betsy Ladyzhets

Melanie Marich: Betsy, I’ve got you in the guest seat today. You recently published a story on The Sick Times about the National Institute of Health’s RECOVER trials.

That’s the flagship research program for Long COVID in the United States, and you put it pretty bluntly, the trials are failing. And I know you to be a pretty measured person. You’re a [00:02:00] science journalist after all, so that felt pretty, pretty stark, pretty intense. Can you tell me a little bit about how you arrived to that conclusion?

Betsy Ladyzhets: Yeah. So the word, uh, failing or failed really has two meanings here. First is kind of the technical sense of what we mean when we say a clinical trial has failed, um, which is a term that is commonly used by researchers, and s- essentially what it means is that the trial did not meet its primary endpoint.

So when researchers design a clinical trial, they pick one measurement. It might [00:02:30] be a survey meant to assess people’s symptoms. It might be some kind of blood test. They choose one measure that they’re going to use to assess whether a treatment was either helpful for patients or not helpful compared to a placebo or a control.

And so if the treatment is less helpful on that primary outcome, on that pre-specified measurement than the placebo, then that means the trial failed. Like, that is just kind of the technical sense of how trials evaluate their results. Um, but these trials also failed in the [00:03:00] eyes of the Long COVID community.

So a lot of people who have Long COVID, people who are caregivers, family members, loved ones to people with the disease, uh, researchers who are outside the program, the healthcare workers outside of the program, a lot of these, uh, folks have been pretty disappointed by the first round of clinical trials from the RECOVER program.

Um, that’s for a lot of reasons g- going back to 2023. So I published a story back in twenty twenty-three when these trials were first [00:03:30] announced, essentially saying a lot of people are disappointed and they don’t think that these trials are going to advance Long COVID research very much.

And indeed, you know, a couple of years later, as we’re starting to get results, that seems to be the verdict. So people are disappointed that, uh, most of the trials are not testing pharmaceutical interventions or drugs. Um, they’re largely testing behavioral interventions. Um, a couple are testing supplements.

Um, there was one electrical stimulation device that was tested, and one trial [00:04:00] that people really are unhappy with- Is one testing exercise as a Long COVID treatment. And obviously, you know if you’re probably listening to this podcast that exercise has a long history of harming people who have Long COVID, who have post-exertional malaise, or who meet the criteria for myalgic encephalomyelitis, um, and of course, a very, very long history of people with myalgic encephalomyelitis being harmed by exercise as a prospective, quote-unquote, treatment.

Um, so there’s just a huge amount of disappointment that with all of [00:04:30] the resources and all of the thought and consideration that has gone into RECOVER, that this is one of their clinical trials. I always try to remind people when I talk about RECOVER that it is an acronym. Um, it’s supposed to stand for Researching COVID to Advance Recovery, and of course, the acronym itself is RECOVER.

So, I think people really just feel so disappointed that a program that, called RECOVER, does not really seem to be moving the needle very much on actually finding treatments for Long COVID. Of [00:05:00] course, it’s a big program. Some parts are considered more su- successful or more helpful to the field than others, but, you know, when you look at specifically this first round of trials, uh, I think there’s just a lot of disappointment and a lot of frustration that this is what our resources were spent on.

Melanie Marich: So, I wanna break down the three of the five RECOVER trials that have recently started sharing their results because, like you said, they were all looking at different things, and then we’ll talk about some of their [00:05:30] commonalities. But like you said, this is a massive program. Uh, I think it’s worth getting into the nitty-gritty here.

So, let’s start with RECOVER VITAL, which looked at Paxlovid and viral persistence. Tell me a little bit about that trial and how that went.

Betsy Ladyzhets: Yeah. So Paxlovid is a COVID-19 antiviral, um, generally considered pretty successful. If you are infected with SARS-CoV-2, the recommendation is to try and get Paxlovid.

Some studies suggest maybe it can help prevent Long COVID if you take it during the acute [00:06:00] phase, although there are kind of varying data on that. Um, but it’s, it’s pretty successful as an antiviral for the acute phase, and so there has been a lot of, uh, interest in testing it as a Long COVID treatment.

Um, so RECOVER-VITAL is not the only Paxlovid trial for Long COVID. There have been a few. However, RECOVER-VITAL is much bigger than the others. It had nearly 1,000 participants, and it has some interesting aspects of its design. So one of these is that participants in the [00:06:30] trial were actually divided into three groups based on their kind of primary symptoms.

So for all three of the groups, all three of these primary outcome measures, the trial found that Paxlovid did not significantly improve people’s symptoms compared to the placebo. And I should clarify that, you know, we don’t have a full scientific paper for this trial yet. Um, the results that are available have just been shared on the clinical trial site, clinicaltrials.gov.

Um, [00:07:00] so what you can find on that website are essentially tables kind of showing the results numbers. Um, but we don’t have anything in terms of, like, the researchers interpreting their results or talking about the caveats and the limitations of the study. Still, with those preliminary data, it’s pretty clear that the study, you know, didn’t meet its primary outcome measure.

There’s this sort of side aspect of the trial that people are really interested in that we don’t have any data from yet, and that is looking at viral persistence with [00:07:30] Paxlovid. Um, so in addition to, you know, the symptom surveys and other kind of standard testing, like looking for any adverse events that people might have during the trial, um, participants, you know, did a lot of giving additional samples.

So people, uh, gave blood samples both before, during, and after they took Paxlovid or the placebo. Um, they gave saliva samples. Um, they answered, you know, detailed surveys. So there’s a lot of information that the [00:08:00] researchers can use to see, um, how Paxlovid is potentially changing the underlying biology of, um, people with Long COVID Um, and so there is a lot of interest, I think, from people who are patient advocates who I talked to for this story, people who are patient researchers, as well as outside researchers in just, like, getting that more detailed information that hopefully should come with a scientific paper in the future.

Melanie Marich: Gotcha. Next up, let’s talk [00:08:30] about RECOVER-Autonomic. This is the trial that looked at dysautonomia. Uh, and as many of our listeners I’m sure know, a lot falls under the umbrella of dysautonomia. So how did that trial go?

Betsy Ladyzhets: Yeah. So this trial has a few different components to it. Um, it looked at two pharmaceutical interventions.

One is a drug called ivabradine, which is used to treat heart failure, but also has commonly been used for POTS, and the other is intravenous [00:09:00] immunoglobulin, globulin, or IVIG, and that is an infusion of immune system antibodies from healthy donors, and is also something that has been used for dysautonomia as well as for other conditions in the past.

And then the trial also included what the researchers call a coordinated care arm with some behavioral interventions. So these are things like checking heart rate and blood pressure regularly, having a high salt diet, which is often recommended for POTS, uh, [00:09:30] wearing a compression belt, regular phone calls with a care coordinator, and some physical activity, which I will talk about more later.

Um, so out of this kind of large, complicated trial, uh, what we have results from so far is the ivabradine portion of the trial. We don’t have results yet from the IVIG portion of the trial. So what this part of the trial found was that ivabradine by itself did help, uh, lower the heart rate of participants, but it [00:10:00] didn’t significantly improve symptoms on the primary outcome of this study.

So earlier, I was talking about how researchers choose one outcome to be the main outcome that’s going to tell them if their study has succeeded or failed. So in this case, the researchers used a dysautonomia symptom survey that’s been used in the past for, like, drug approvals with dysautonomia. So on this symptom survey, ivabradine by itself did not improve symptoms.

Um, however, ivabradine plus the coordinated care arm did [00:10:30] lead to an improvement in symptoms compared to the placebo. So this is kind of interesting to see, and I was able to interview Pamela Taub, who was one of the lead researchers on this trial. Um, and she was saying that this combination of a drug plus coordinated care, plus these things like eating more salt and wearing compression garments, um, are kind of in line with what she recommends herself as a clinician.

It seems like it’s, it’s very common in her experience to kind of prescribe different things together. Um [00:11:00] So that I, I think for her was kind of helpful to see. Um, however, the, the, a, a big caveat to this is that the coordinated care arm did include exercise. Um, and this is-

Melanie Marich: I’m, I’m feeling my heart-

Betsy Ladyzhets: Yeah

Melanie Marich: beat a little quicker even hearing that too. Yeah. So this is- So I’m sure folks had a similar reaction …

Betsy Ladyzhets: this is very, like, there’s some nuance to this. You know, I did ask Pamela Taub about this when, when I interviewed her, [00:11:30] and think she definitely recognized the fact that, as we all know, exercise h- has a history of harming people with Long COVID, people with myalgic encephalomyelitis, et cetera.

And so when she talked about this part of the trial, she described it as very tailored to people’s activity levels. Um, she described it having post-exertional malaise as a consideration. She was saying, like, she’s aware of the fact that cardiologists or physicians who are kind of treating POTS by itself [00:12:00] might just tell someone to exercise or might just tell someone to, like, get on a treadmill or, like, go for walks every day.

And, you know, she was recognizing that that is not necessarily the advice for a lot of people who have Long COVID, who might have PEM and other kinds of complications in addition to POTS. S- so a quote from her that’s in the story is, “A lot of the exercise has to be in a seated or lying position, and then they, participants, gradually work up over time to more upright exercise.”

Still, you know, f- [00:12:30] for some people who have PEM, even something very light or simple in the eyes of a physician can still cause harm, right? Um, and so personally, I would really like to see more information from the full results from the study in terms of, did people experience adverse effects? I noted as I was going through the protocol for this study that it does include measuring post-exertional malaise, so people were doing PEM questionnaires after their site visits.

But as far as [00:13:00] I could tell from reading through the protocol document, um, it wasn’t specifically, uh, assessed as an adverse event. Of the, like, coordinated care arm of the trial. Um, and in terms of the data that we have from the presentation that Pamela Taub gave at this conference, um, that didn’t include anything about post-exertional malaise, so we really don’t have a good sense yet of did anybody who participated in this part of the trial have a poor experience.

Um, that’s just not [00:13:30] something that we have data on yet, but I’m ho- hopefully we get more information about that later. Um, and then also there’s the whole other arm of the study, which is the IVIG arm, where we don’t have any results yet, so we’ll, we’ll be looking out for those.

Melanie Marich: Okay, so this one, this arm sounds complex.

The results, as you’re describing them, make sense to me. They trialed this drug plus coordinated care in other ways. That combination proved effective for some people. All things considered,

Miles Griffis: [00:14:00] that

Melanie Marich: makes sense, and we’ll keep an eye out for the rest of the results. Let’s move on to the trial that’s caused the most, uh, hullabaloo , which is the RECOVER-Neuro trial, and this trial was looking specifically at neurological symptoms of Long COVID, as the name implies, except it didn’t test any pharmaceutical interventions.

So let’s, let’s talk about that. Why was that a big deal? How did it go?

Betsy Ladyzhets: Yeah. So I think this study [00:14:30] is really one of the chief examples that people who are disappointed with RECOVER, and specifically with these trials, point to in saying we are looking at cognitive dysfunction, which we know in Long COVID can be really, really significant, um, and did not actually test any drugs.

So the three interventions included in this study were a computer game program that’s kind of to help with cognitive function, a cognitive rehabilitation program, which is [00:15:00] kind of similar to cognitive behavioral therapy, but cognitive rehabilitation specifically is often used to help people who might have, um, like a brain injury or a stroke, something like that.

Um, so it’s, I, I think it’s a bit different than like a mental health therapy program, but still is, um, includes like coaching sessions and that sort of thing. Um, and then the study also included an arm testing what’s called [00:15:30] transcran-cranial direct current stimulation, or TDCS. Um, and this is a device that sends low-level electricity to the brain.

This is like a device therapy, so a bit more than behavioral, but still not like a drug. And so, yeah, there’s just people who I talked to about this study were very disappointed that, uh, these were the interventions tested among everything that researchers are interested in, among, uh, drugs that maybe could be repurposed for Long COVID and everything else.

Um, and I also was able to [00:16:00] interview David Notman, who is one of the main investigators of this study. And I pressed him on this, and he said that from his point of view, these were the most promising evidence-based interventions available to study at the time that they started the trial. He thought that it would be risky to test pharmaceutical interventions, uh, that had been suggested by community members, people who were patient representatives involved with the trial.

He was concerned about, like, the safety [00:16:30] of testing other interventions that- In his mind, didn’t have as much evidence behind them. But still, I think to many people who watched this happen or were even involved behind the scenes, this is very frustrating trial to watch go forward. You know, I talked to Hannah Davis, who is one of the co-founders of the Patient-Led Research Collaborative, and who has tons of experience, not only doing research herself on Long COVID, as someone who has Long COVID, um, and who’s [00:17:00] had it since early in the pandemic, um, but also she has served as a patient representative or given feedback on a lot of different scientific studies.

Um, and she was one of the people who was involved as a patient representative with this study, Recover Neuro. Um, and she said that for her, it was one of the worst experiences that she’s had, uh, as someone doing patient engagement for a study, which I think, coming from someone in her position who’s done this a lot, that is pretty [00:17:30] tough to hear.

Um, you know, she said that from her experience, the research team leading the study didn’t listen to people with Long COVID, you know, didn’t pick treatments that, uh, were really going to help advance the science, um, and it seems like just didn’t really, uh, address their concerns.

Melanie Marich: Yeah. That’s, especially from someone in her position who this is not her, this is not her first rodeo.

That’s, that’s a pretty intense statement. Yeah. So [00:18:00] I wanna make sure that I’m clear on all of these points. These studies from the National Institutes of Health, these massive studies that launched nearly three years ago to try and find Long COVID treatments and cures and symptom management, it cost hundreds of millions of dollars.

Um, these are the biggest results we have yet, and maybe I’m being harsh, but this doesn’t sound super promising. [00:18:30] So talk me down a little bit. What should I and other people who are unimpressed by these results, what should we be keeping in mind?

Betsy Ladyzhets: Yeah. I mean, I think the biggest thing to keep in mind is that for two of the three studies that we’ve been talking about, um, we’re talking about preliminary results, you know, results that were shared on the clinicaltrials.gov website, results presented at a conference, and that’s a very different level of detail and level of explanation than what you get in a full peer-reviewed paper.[00:19:00]

Mm-hmm. So I think that will be helpful to see. Plus, even though it’s three out of the five kind of platform trials, it’s only, like, components of these trials, like we were talking about. We don’t have information yet from the IVIG arm of the RECOVER Autonomic. Um, we don’t have the persistence analysis that people are really looking forward to from the Paxlovid study, RECOVER Vital.

And there are two more RECOVER trials that we have not even really talked about. Of course, one of those, uh, includes testing exercise, so [00:19:30] that’s not particularly interesting or exciting to many people. Um, the other one is looking at sleep and is testing a few different interventions to try and address sleep issues in Long COVID.

And then on top of that, we also have the new round of clinical trials from the kind of newer aspect of the RECOVER program called RECOVER Treating Long COVID. So those studies, a couple of them are set to start this summer. Um, one of them was basically the NIH providing more funding to an existing trial, [00:20:00] uh, looking at an immune system modulating drug called ursodiol.

Um, so that trial is, like, already underway and has been recruiting for months now. Um, so all of these studies are, are coming, plus there are going to be continued research from the RECOVER program looking at the underlying biology of Long COVID, more research coming looking at Long COVID in children, which is just, like, a really important component of the overall program.

So there, there’s a lot more happening, I [00:20:30] think, from this program overall that’s not just these disappointing trials. I also wanted to bring up one thing that didn’t make it into the written story but was a point, uh, Miles brought up when he was editing it, which is that, you know, there is sort of a, maybe a silver lining to the RECOVER Neuro trial, which is that we do have this large, rigorous clinical trial saying that, uh, behavioral interventions for cognitive symptoms in Long COVID are not helping people’s symptoms in a meaningful way [00:21:00] or in a statistically significant way as identified by the parameters of this trial.

And so that is something that people maybe can point to in saying like, “Hey, we do need drugs to address these symptoms. Um, we do need something more than, uh, like a therapy program or a computer game program.” You know, I would wish that we didn’t spend tens of billions of dollars on this study to find that result, but, you know, sometimes it’s helpful to have a rigorous clinical trial to point to, to say like, “Hey, [00:21:30] I need a little bit more than Like therapy.

Melanie Marich: I can imagine that for a lot of folks who have been faced with a doctor who is encouraging them to try behavioral changes as opposed to working through any drugs. I think that’s a nice silver lining to think that they’ve got something that they can point to, to say, “Actually, uh, there is a lot of research to back up the fact that behavioral interventions, uh, are not gonna move the needle on this.”

So that does, that does calm me a little bit. [00:22:00] Um, so I appreciate that. Um, and just remembering that there’s, there’s still hopefully, knock on wood, lots more to come and lots more for us to do with this stuff. And so I wanna ask you, I mean, Beth, you’ve been covering Long COVID research for years now. What do you make of these results?

What do they tell you about the state of Long COVID research? Obviously, the RECOVER trials, they’re just one branch of this. They’re just one place that’s doing this. [00:22:30] Obviously, a very big one sponsored by the federal government, but where do you think that sits within the larger context of where we’re at with Long COVID research?

Betsy Ladyzhets: Yeah, it’s an interesting question because in a way, these trials or these results almost feel like a bit behind the times, um, in terms of, like, they’re comparable to trials that reported their results maybe a year or two ago. Like, if we look at the Paxlovid study, for example, a couple of the other Paxlovid clinical [00:23:00] trials that maybe started around the same time already shared their result a year or two ago and are now moving on to sharing more, like, in-depth analysis, looking at biomarkers with samples collected during these trials, things of that nature.

Um, so I think that kind of reflects overall the fact that it took Recover a long time to start doing clinical trials. The program initially focused heavily on observational research, which is something we’ve covered in detail before, you know, the [00:23:30] criticisms that people have of that, of that focus and of that kind of order of operations from what they were doing.

I think the kind of disappointment in, like, it took a long time, and now this is kind of all the results that we have, is very real. And that said, though, I think these results kind of reflect the fact that there have not been many successful long COVID clinical trials yet. Um, there have been a handful of successful, like, pilot studies, case studies, um, and of course many, many [00:24:00] treatments that people, like, in the community have tried and have found to be helpful or found to work in some cases or for some symptoms.

Um, but in terms of, like, large, rigorous randomized control trials, there are very, very few that have been successful. I was, like, trying to rack my brains before this interview, um, and I’m like, there’s one, there’s, like, one study out of Hong Kong that reported their results, and I think it was, like, late 2024, that looked at a microbiome-focused treatment, that this was, like, a [00:24:30] RCT that was positive result.

Um-

Melanie Marich: One study out of Hong Kong, and Betsy, it, it, to, to be abundantly clear, you’re the guy, you’re the person- I mean … who looks at long COVID. Like, this is what you

Betsy Ladyzhets: spend so much of your time doing. I, but I’m saying in the specific category of, like, randomized control trials, which are- Sure, sure … very expensive and, like, hard to set up, right?

Melanie Marich: Fair. Fair, fair, fair.

Betsy Ladyzhets: Um, there haven’t been that many of them. Sure. Um, but yeah, so there, there’s, there’s not much, but this research is very challenging. [00:25:00] You know, I always think back to, um, when I wrote this story last year about the drug BC007, um, from Berlin Cures, a German, uh, research startup, um, that also had an unsuccessful clinical trial.

For that story, I talked to this longtime ME patient researcher, Helen Brownlie was her name. So she gave me this great comment that I think about all the time, which is, like, randomized control trials are intended for when you have a well-defined treat… You have a [00:25:30] well-defined condition, and you have a treatment that you know works for that condition, and you’re trying to just, like, iterate and, like, improve it and trying to see, like, will something new be better than the existing standard of care?

And when you have treatments like, she specifically gave me this quote about myalgic encephalomyelitis. She was like, “For a disease like this, we don’t have a well-defined condition. There’s a lot of disagreements about how to even define ME,” um, or, like, who should count as a [00:26:00] participant in a, in, in an ME trial.

Um, we don’t have a well-defined standard of care. There are no approved treatments for it. Um, and we don’t really have a good understanding of, like, how to measure, you know, like we kind of know how to measure post-exertional malaise, but it’s not as though we have, like, a rigorous biomarker test for it.

Um, so this is very difficult. Like, designing these studies is very difficult and very expensive. Um, and I think that is part of the reason, [00:26:30] that’s a big part of the reason why we don’t have a lot of successful trials to point to. Um, and the researchers are iterating all the time. They’re learning from what’s been done before.

They’re trying to improve things. This is something that we’re always covering at The Sick Times is, like, how researchers are thinking about more smarter study design, um, looking for biomarkers that can eventually be used in clinical trials, um, and all of this stuff that really is gonna help kind of move us forward.

So it’s not just testing promising [00:27:00] treatments. It’s, like, everything around all of the what goes into a clinical trial.

Melanie Marich: When you put it like that, I think the fact that, you know, we’re this many years into the pandemic, uh, and still we’re not having such good luck with these trials, that context is important.

So I think one of the things that you’re raising that I do think is important for us to keep in mind is that it’s like we learn in science [00:27:30] class when we’re little, that failures still do teach us something. Um, and there is still a lot to be learned from these failed trials. But now looking towards the future, as new results come out, new trials begin, hopefully science continues chugging along, uh, what are you going to be looking out for?

What’s coming down the pipeline that you’ve got your eyes on?

Betsy Ladyzhets: Yeah, I think it will be exciting to have the RECOVER TLC, or RECOVER Treating Long COVID trials start, uh, this summer. Um, [00:28:00] hopefully this summer. That’s what they’ve said on the webinars. Fingers

Melanie Marich: crossed.

Betsy Ladyzhets: Um, they’re planning for this summer, so that’s going to include a study looking at low-dose naltrexone, specifically in children, um, which is exciting to have a clinical trial focused on children and young adults.

Um, one looking at stellate ganglion block, which is a procedure that, uh, some people have found helpful for Long COVID. Um, and then one looking at, uh, a GLP-1 drug. Um, so I think there’s some interest in [00:28:30] those. I mean, people have kind of mixed feelings about these trials, too. You know, um, Hannah Davis, who I mentioned previously, kind of gave me a comment saying that, like, in her view, even TLC is still not testing the k- the most promising, like, cutting-edge treatments.

Um, but still I think to a lot of people, there’s a lot of improvement, uh, in this kind of component of RECOVER from the first round of trials. Oh, and then another thing that hopefully soon we’ll maybe start to see is combination trials. So looking [00:29:00] at, uh, multiple treatments at the same time. Um, this is something that, you know, is kind of a growing area of interest, both among patient advocates, patient researchers, and, uh, other researchers.

Um, John Douglas, who’s a Long COVID patient researcher, wrote an op-ed for us, um, last year that we published, I think, in September, kinda arguing in favor of combination trials. Hopefully we see one, like, actually start, or at least be formally announced, [00:29:30] like, this year.

Melanie Marich: That makes so much sense to me because, I mean, everyone I know who is getting Long COVID care, uh, is not just trying one thing, and especially with a multi-system disease that Long COVID is, 200-plus symptoms, uh, that we know of, that, that makes sense.

Um, so that is exciting. And I know we’re, I know we’re, we’re really yapping it up, but I do, I do wanna ask you as we’re talking about this, I’m curious what you think. I mean, a lot of what we talked about today [00:30:00] is the structure of these trials and how there are issues with the structure of these trials.

From where you’re sat, from the sources you’ve talked to, researchers, patients, advocates, I mean, what would it take to have trials that move things along better, more efficiently? Like, what does, what would a version of this that’s smoother even look like?

Betsy Ladyzhets: Yeah, it’s a good question. I think some of that is [00:30:30] what we’ve already been talking about, like this aspect of pairing potential biomarker research with a clinical trial, and using the opportunity of seeing a treatment in a controlled environment, somewhat controlled environment, um, to see, like, is there something measurable that we can find that is changing?

That is a really important component. Obviously, one important component is having patient engagement, like having people who have Long COVID or, and/or who have related diseases [00:31:00] like ME or POTS, uh, consulting on trials and helping researchers find the best outcome measure, um, because randomized controlled trials are designed in a specific way where you do have to pick one measure to sort of stake your claim on, um, and tell you whether you succeed or fail.

And that is a very, very challenging thing to do. It’s something I’m always asking researchers about, and it, it’s a very difficult decision sometimes to pick one. And, you know, when you have people who have lived experience consulting on your trial and [00:31:30] helping out, they can help say, like, “This is something that would capture a change in my symptoms.”

Um, and then I think there are also, like, more ways that researchers could be getting creative in running trials more quickly. There, there’s a lot of interesting stuff going on in this kind of realm of study design, um, that could be kind of brought into the Long COVID space more.

Melanie Marich: And hey, your mouth to the NIH’s ears.

Betsy, thank you so much for breaking this story down for me. There is a [00:32:00] lot to get into, and I definitely feel, uh, more informed and a little less outraged than I was at the onset. So thank you, as always, for being here.

Outro

Betsy Ladyzhets: That’s all for this week’s episode.

Miles Griffis: In the meantime, we’ll continue reporting the information that you need.

Betsy Ladyzhets: Solidarity with everyone still here.

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Melanie Marich: This podcast and The Sick Times are supported by you. You can help us keep this work going by donating on our website. Still Here is a production of The Sick Times, a [00:32:30] nonprofit newsroom chronicling the ongoing Long COVID crisis. Our theme song for this episode is The Rude Mechanical Orchestra’s rendition of “Which Side Are You On?”, originally by Florence Reece. I’m Melanie Marich, and I produced this episode. Our engagement editor is Heather Hogan. Sophie Dimitriou designed our podcast cover art. And Miles Griffis and Betsy Ladyzhets are your co-hosts and The Sick Times co-founders. Thanks for listening.

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