Still Here, November 22: Links and transcript

Summary

There are only two pediatric clinical trials testing drugs to treat Long COVID in kids — and only one of them is in the U.S. This week, reporter Simon Spichak speaks with podcast producer James Salanga about why there are so few of these pediatric clinical trials. Also in this episode: the latest COVID-19 numbers, disappointing results from the BC 007 clinical trial, REVERSE-LC recruiting participants, and more.

Find our podcast on Spotify, Apple Podcasts, Pocket Casts, Amazon Music, iHeartRadio, or listen below and jump to the start of the podcast transcript.

This podcast contains a promo swap with the upcoming podcast Public Health is Dead. Host, researcher, and public health advocate Daniella Barreto calls it “an anti-establishment field guide to surviving in the age of pandemics.” The first run of episodes is out on Nov. 29 on all podcast platforms.

Jump to a specific part of the transcript:

• Intro
• COVID-19 trends
• Lack of pediatric clinical trials for Long COVID
• Research
• Outro

Still Here is an abridged version of The Sick Times’ newsletter, which publishes weekly.

Mentioned in this episode (in order of appearance):

• The Sick Times: National COVID-19 trends, November 19
• CDC wastewater dashboard
• Biobot wastewater risk reports
• WastewaterSCAN dashboard
• CDC: Vaccination Trends | Respiratory Illnesses
• U.S. free COVID tests: COVID-19 Testing   
• The Sick Times: Why are there almost no clinical trials for kids with Long COVID?
• The Daily Beast: Stanford Medicine Long COVID Study Blows Up Because of Unmasked Staff 
• The Sick Times: Research updates, November 19
• REVERSE-LC website

Additional audio in this episode: 

• Rude Mechanical Orchestra: Which Side Are You On? (orig. Florence Reece) 
• Pixabay: Thunder and the beginning of rainfall

Your support helps The Sick Times continue to chronicle the ongoing Long COVID crisis. Our end-of-year fundraiser is going on, so your donations from now until Dec. 31 will be matched up to $1,000 thanks to NewsMatch and our generous partners.

Transcript

Intro (0:00) 

[Instrumental snippet of theme song, the Rude Mechanical Orchestra’s rendition of “Which Side Are You On?” begins playing.]

James Salanga: This is Still Here, a podcast from The Sick Times.

Miles Griffis: I’m Miles Griffis.

[Instrumental ends]

Betsy Ladyzhets: And I’m Betsy Ladyzhets. 

Betsy: We’re the co-founders of The Sick Times. 

James: And I’m James Salanga, Still Here’s producer.

Miles: Many public health authorities are ignoring the ongoing COVID-19 pandemic.

Betsy: But here at The Sick Times, we’re not. So we’re bringing you the latest Long COVID news and commentary each week.

Miles: Without pandemic denial, minimizing, or gaslighting.

James: This podcast is an abridged version of our newsletter. 

Betsy: And each week, we share the latest on COVID-19 levels in the United States. 

James: Then we talk about one or two of the stories we’ve published on The Sick Times website this week. In today’s episode, we’ll be talking about why there aren’t a lot of pediatric clinical trials for Long COVID treatments.

Miles: And we’ll also share some of what’s happening in Long COVID research. Today’s research updates are about two clinical trials. First, some disappointing results from a trial for the synthetic DNA compound BC 007.

And another NIH study is recruiting. REVERSE-LC will test an FDA-approved drug used for treating rheumatoid arthritis and COVID-19, among other diseases and conditions.

And a reminder, our year-end fundraiser is still going.

Your donations will be doubled between now and the end of December, thanks to [the] NewsMatch [program] and other supporters.

Thank you so much for everyone who has donated and shared our campaign so far.

James: We really appreciate you. Now, let’s get to our COVID forecast. 

[Sound of thunderclap and light rain]

COVID-19 forecast (1:41)

Betsy: Yeah, our COVID forecast continues to be kind of good, but feel kind of weird. [laughs] I think it’s the consensus from us at The Sick Times, anyway.

COVID-19 levels remain much lower than normal for this time of year and are still in kind of a plateau between surges. So it’s been essentially flat and at sort of a moderate position for the last month or so.

Typically, the late fall/winter surge has kind of started picking up at this point, but that really hasn’t happened yet this year, at least as far as we can tell from the available data.

However, that sort of “lower than expected” is still much higher than the true lows that we experienced earlier in the pandemic.

So there are still a lot of people getting sick. It’s still worthwhile to continue taking precautions, it’s just kind of good news to see that the winter surge hasn’t really started to pick up yet.

Some experts are suggesting that maybe the lows right now could maybe indicate that we won’t have as intense of a winter surge this year as we did last year or the year before, perhaps thanks to a combination of — this summer, we saw more cases than anticipated, and also, there’s not really a super competitive variant that’s emerged recently.

The XEC recombinant variant that we’ve been talking about for a few weeks now is still increasing, but it’s not out-competing other lineages as quickly as some people thought that it would.

And so it seems like a lot of people still have that kind of immunity from a recent infection from the summer.

Of course, it’s hard to say for sure what’s going on with COVID, especially as we have pretty limited data now compared to earlier in the pandemic.

But that’s kind of a hypothesis from experts I follow.

Respiratory viruses that are actually seasonal, unlike COVID — meaning the flu, RSV, and common colds — those are starting to pick up, as is anticipated for this time of year.

And with COVID, there was a bit of an increase recently in the Midwest, according to wastewater data and some hospitalization data. But cases seem to be increasing slowly so far, so maybe just like the very beginning of the winter surge kind of starting to show up.

Miles: You can find out more about the way we develop our COVID trends on our website.

Betsy: Meanwhile, speaking of flu, there continues to be concerning news about the bird flu, H5N1.

Recently, health officials in Canada announced that they had identified a case, a teenager in British Columbia, who is infected with bird flu, and is having fairly severe symptoms. This person is in an intensive care unit as of our recording this podcast on November 19th.

And so health officials are still trying to understand how this person was infected and also learning about the strain they were infected with. It’s a different strain than the one spreading in cattle in the United States.

More still to be learned there.

James: Also, I wanted to add that you can still get your four free rapid tests per household at covidtests.gov.

As part of a promo swap, we wanted to add that if you’re looking to hear more conversations that affirm the reality of surviving the ongoing pandemic, you can check out the upcoming podcast, Public Health is Dead.

Host, public health advocate, and researcher Daniella Barreto calls it an anti-establishment field guide to surviving in the age of pandemics. She’ll talk with researchers, public health advocates, and people living through public health’s failures — including people who live with and study Long COVID.

The show is meant to be an invitation to say together, we can map a different route through apathy and denial towards better health for all of us.

You can learn more at publichealthisdead.com and catch the first episodes on all podcast platforms on November 29.

And after a quick musical break, we’ll talk about clinical trials for treatments for Long COVID in kids.

[Instrumental segment of theme song plays]

Lack of pediatric clinical trials for Long COVID (5:45)

The Sick Times: Why are there almost no clinical trials for kids with Long COVID?

James: Nearly 6 million children in the U.S. are expected to be living with Long COVID.

That’s according to a review paper from the National Institute of Health’s RECOVER program published earlier this year.

But despite that, there has been little attention paid to acknowledging Long COVID in children from policymakers, media outlets, and pharmaceutical companies.

There are only two clinical trials studying potential treatments, and only one of those is in the U.S.

For The Sick Times, Simon Spichak reported on this lack of pediatric clinical trials.

I’m here with him now, and he’s going to share a little bit about how he found out that there were only two pediatric clinical trials looking at Long COVID.

Simon, good to have you here.

Simon Spichak: Thanks for having me. 

Everyone has strange hobbies. [laughs] I like Googling things and going through different databases. I do a lot of reporting for Being Patient, which covers Alzheimer’s and dementia news, so I’m really familiar with the websites like clinicaltrials.gov, which basically has [a] giant database of all the trials in the U.S. that people have registered onto there, as well as lots of trials from around the world.

So I decided to check out what’s going on in Long COVID, so [I] put it in [the search bar], “Long COVID”, I get a giant table of results.

And then the other thing I kind of spotted while I was doing that is that none of these trials are really looking at things in kids.

You know, I decided to Google that because I couldn’t be the only person asking this question, because we all know that COVID is still happening.

More kids are developing Long COVID. There’s tons of kids with Long COVID already.

So you would think that there’d be something out there at least testing for a treatment or a way to ease symptoms.

James: Right.

You spoke with a number of parents of children who have Long COVID to hear a little bit more about how they’re feeling about this lack of clinical trials.

What did they tell you?

Simon: So kids are losing out on school and their childhood and a lot of their friendships.

I spoke with Matthew, who’s a 12-year-old kid.

And he was telling me that, basically, he likes to play baseball, and one of the things he does is he basically rests an entire day just so he can go out and have fun with his friends once in a while to do baseball.

Because if he doesn’t pace himself, he’s going to have a huge energy crash.

Other parents really talked to me about how it’s [Long COVID] affected their kids to participate in things like drama club or track and field now. That’s really sort of limited what they’re able to do.

Parents and kids are kind of stuck with this for a few years now and they want something that treats the symptoms.

Quite a few of them are aware of myalgic encephalomyelitis and there’s some overlap, especially with symptoms like extreme fatigue or post-exertional malaise, and they think it’s useful to take a look at what’s been done in that arena so that you’re not essentially recreating the wheel.

You want to run a trial that doesn’t suck because there’s been a lot of Long COVID trials that sucked. There was one trial I reported on for The Daily Beast, where some people dropped out of the trial because the researchers weren’t wearing masks.

And there’s very basic things parents want to be accommodated for in trials.

And they also want trials where some of their kids that are bedbound, are on the more severe side of things, they can’t spend a whole day doing various tests at a center far away, they want kids to still be able to participate in some way. 

Because you’re still going to have kids with the severe [Long COVID] symptoms. They get a lot of the brunt of losing out on their childhood and their hobbies and they really need a treatment as well.

You know, there’s been quite a few people I spoke with from Canada who are traveling to take part in the one U.S. study on Long COVID, just because there’s nothing else.

James: Speaking of that U.S. pediatric clinical trial, can you say a little bit more about the lessons it has about why there just aren’t more pediatric clinical trials for Long COVID?

Simon: Yeah, I think there’s two parts.

There’s a bit of serendipity involved, where you sort of get lucky in a sense where they [those running the U.S. pediatric clinical trial] saw kids coming in with MIS-C [multisystem inflammatory syndrome in children], and the kids also had high levels of SARS-CoV-2 spike protein in the blood and they had problems in their gut.

And there was a drug that was being tested for other gut conditions that was relatively safe that they were able to trial in kids.

But usually you’re not going to be testing something in kids first and then going to adults. That happens in the opposite direction.

So there’s the luck in the sense that they were looking at something going on in kids already.

And later, when they saw kids with Long COVID, they saw something similar with the spike protein in the blood and problems in the gut, where the gut cells, they had gaps between the cells in their intestine, which allowed some of the spike protein to leak in. There’s teeny tiny proteins that are supposed to keep stuff from slipping through between the gut cells.

But there was something off there in MIS-C and then again in Long COVID, and they already had this thing they were trying in MIS-C so they could move on to testing it in Long COVID in kids.

And you know, at the time, there weren’t a lot of trials early on looking at kids in Long COVID at all because sure, there’s a lot of denial with adults, but when it came to kids, there was even more denial that there was even, you know, the possibility of Long COVID in kids.

Some people didn’t think kids could even transmit SARS-CoV-2, which is kind of ridiculous in hindsight — ”you must be this tall to transmit this virus.”

James: Right. [laughs] 

Simon: I think the other thing that’s really interesting there with that trial is they look for kids that have elevated levels of spike protein in the blood. So they have a biomarker that they’re looking for.

Not all kids are going to qualify, and they’re testing a drug that sort of works to fix that pathology to see if it eases some of the symptoms.

And I know that RECOVER is planning to do clinical trials in kids. And they may take a similar approach where they look for very specific biomarkers and very specific outcome measures to try and have, you know, a hypothesis handy that they’re testing to see if it’s gonna treat the symptoms of Long COVID.

So, you know, the big takeaways: There’s some luck involved, the trial is happening because these researchers were looking at kids already, and the future trials might also take a biomarker approach to maybe identifying people who might benefit from a certain treatment.

James: Mmhmm. You know, you mentioned luck is a big kind of factor in this clinical trial even happening.

But another thing that you’re reporting mentions is that expenses in general are a huge hindrance to not just clinical trials overall, but ones that are specifically testing drugs to treat or mitigate the impacts of chronic illness in kids.

Why is that?

Simon: [laughs] In general, children are expensive, as anyone who has ever been around any children or has been a child in the past will know. 

You have a lot of things going into the trial — you have to compensate parents or caregivers for taking time out of work. There’s extra regulatory requirements that help keep kids safe during trials that, you know, adds cost to designing the trial and training up the staff.

There’s a longer and more involved process to get consent from the parents to let the kids participate in the trials.

You might want to study how different drugs work across different age groups.

Then you have to, like, recruit people into the trial. Some people may be hesitant in putting their kids through an experimental drug trial.

And then there’s also like — sometimes you just need kiddie-sized gear, because kids are smaller than adults.

So like, for example, if you need to measure blood pressure, you might need to buy special blood pressure cuffs that you might not have on hand.

So all those costs pile up.

James: During your reporting, you talked to Megan Fitzgerald, who’s a researcher-advocate, and she mentioned that funding is a big obstacle to these trials actually happening.

Besides that, what other kinds of support did she say are still needed to do these trials?

Simon: It’s very simple. You just need to talk to the families and kids and ask them what they need of a trial. So that might include supports at the trial site, especially if they’re spending a whole day there. It might mean breaking up when certain tests are being done so that people don’t experience fatigue.

You have a lot of parents and caregivers that also have Long COVID or other chronic conditions. So you have to accommodate that. And then there’s also looking at compensation.

You want to design trials with patients in mind.

So you don’t want to do something that’s potentially harmful, like graded exercise therapy, or try to convince patients that their disease is all in their head because then they won’t want to enroll in the trial. 

Because you can basically design the perfect, most statistically rigorous, most beautiful trial ever put to paper. But then if none of the parents and kids that are actually affected with Long COVID or other infection-associated chronic conditions want to participate, that’s a problem that should have been addressed earlier.

So I think the key thing for these trials is to talk to the parents, talk to the kids, talk to the caregivers to figure out exactly what accommodations you’re going to need to get a representative sample and to test something that patients, whether they’re the kids or the families, actually want to see.

James: Well, we’ve been talking a little bit about some of the reasons, right, why there’s only these two pediatric clinical trials and only one in the United States.

What’s next for their future? Is there anything else for parents, for kids to be hopeful for in terms of next steps for future pediatric clinical trials?

Simon: Yeah, I spoke with other researchers from RECOVER as well who didn’t make it into the final piece because I only have so many words.

But the thing that people were emphasizing was RECOVER has a lot of this really great data from kids through their observational studies.

They really took a look at symptoms and how they differ between different age groups. That’s going to really help them target and design clinical trials in kids and that there might be some low-hanging fruit that they go for, and these are going to be trials that they’re going to design and recruit for.

Unfortunately, none of those trials are currently up or recruiting yet. But that’s something to look forward [to] in the very near future.

With Dr. Lael Yonker’s trial [the one pediatric clinical trial for Long COVID in the U.S.], it’s set to end in 2025 and then there’s — they take some time to crunch the numbers, see if it works, and then they have to design a larger confirmatory trial if it’s successful.

I also think with the trials, it’s really important to say that you’re going to want to have more trials instead of less trials because most clinical trials in people are going to fail.

That’s OK. They’re all learning lessons.

Some of the trials fail because you didn’t measure the right thing or there’s a problem in the types of people that you recruited that aren’t really a fit for the medicine that’s being treated.

Some trials will fail because the treatment doesn’t work. Something might work on paper, it might be great in cells — heck, it might also work in animals, but for whatever reason, it’s not going to work in humans, and that’s OK. And that’s going to be a huge chunk of all the trials. 

But there’s also going to be treatments that are successful.

The treatments that do work probably won’t be a silver bullet.

But these drugs, they might help a slice of the population substantially with some of their symptoms, and that’s the importance of having a lot of these clinical trials.

This is why we need a more urgent push for these trials and figuring out the treatments. And even studies that find certain treatments don’t work really help advance how much scientists know about these diseases.

James: That’s it for me. And thanks again for coming on the podcast and just sharing a little bit about your reporting. 

Simon: Thanks for having me.  

James: So that’s our top story for the week. And next, we’ll hear from Miles and Betsy about two other clinical trial updates.

Research (18:28)

[Miles’ voice echoes the word “Research” accompanied with a party horn sound]

Miles: Yeah, in this week’s research update, we have two announcements on bigger clinical trials.

The first was the highly anticipated phase two clinical trial for the synthetic DNA compound BC 007.

Betsy, do you want to say more on that since you are reporting a bit on this?

Betsy: Yeah. So BC 007 is a treatment that was originally developed for heart disease, I believe, and researchers in Germany, where the company developing it is based, found that it might be useful for treating Long COVID since it works on autoantibodies, which are one of the underlying biological processes that may be involved with causing symptoms.

And so they had a phase two clinical trial, which is intended to, you know, really find out if a treatment works or not.

And the company announced last week that the trial did not have successful results.

It was a very brief press release. It was like three sentences, so they didn’t give a lot of information.

They basically just shared that the main outcomes measures of the trial did not show BC 007 was effective compared to the placebo that was tested, and they also added that the company has been dealing with financial issues and is going to have to stop all further research.

So it’s unclear as well if they’re going to be sharing more data from this trial or what’s going to happen next with this potential treatment.

So I’m working on a story aiming to better understand kind of what happened here and maybe what’s next.

If you are somebody who participated in the trial and you happen to be listening to this, or if you’ve been closely following it and you have comments, or if you are a researcher, you know, who might have input on this treatment, on the study design here, anything along those lines, please reach out.

You can email me at betsy@thesicktimes.org or I’m pretty easy to find on social media.

Miles: And then in slightly more hopeful news, there’s a new clinical trial launching.

The NIH REVERSE-LC is now recruiting.

REVERSE-LC is not a part of the RECOVER-LC initiative, but is being funded by the NIH. It will test the FDA-approved drug Baricitinib for Long COVID.

We previously reported on the trial when it was first announced earlier this year — that was in March.

Baricitinib is an immunomodulatory drug used to treat rheumatoid arthritis and COVID-19, among other conditions and diseases.

The trial aims to enroll 550 people with long COVID to assess how the drug affects quality of life, as well as brain, heart, and lung function.

The study has enrollment sites in four states, California, Georgia, Minnesota, and Tennessee.

You can find out more about it and enroll at the REVERSE-LC website, reversinglc.org.

I felt like when we reported on this in March, it was, like, about to get off the ground, but it just shows how long clinical trials can take.

And this is just now recruiting almost a year later, like nine months later. So, yeah, I’m hoping that this has great results. Unfortunately, it doesn’t look like they’re going to be available for another year or two.

It just shows how slow these things can go and how important it is to get them started and get them started early.

James: You know, just, future reporting that we do, I know will deal with what it means to be somebody participating in a clinical trial.

So hopefully, you know, that will provide more insight for folks who are asking, you know, why are these things taking so long?

Which is a very fair question, especially given the promises that, especially, the NIH made, you know, around urgency.

Betsy: Well, for the NIH, things taking less than like 10 years is urgent. [laughs wryly]

A lot of my reporting on RECOVER, you know, like they’re constantly defending themselves by saying, “Well, this is faster than we how we usually do it.”

And it’s like, “Well, okay, you have like, you still have millions of people who are sick with no approved treatments.”

Like, okay, great, I guess. But like do better, [laughs] you know. 

Before we wrap this week’s episode, I also wanted to remind folks that our end-of-year fundraiser is currently going on.

Any donations that you make between now and December 31st will be matched up to $1,000 per person thanks to the NewsMatch program at the Institute for Nonprofit News, which we are participating in, as well as other supporters who are helping us out with this fundraiser and will be making sure people’s donations go further.

Anything you can give will be doubled.

And if you are not in a position to donate, you know, sharing the fundraiser, sharing our articles, sharing this podcast, rating and reviewing the podcast, sharing our stuff on social media, anything you can do to help get the word out [is helpful].

Outro (23:18) 

James: Yeah. And on that note, that is all we have for you this week. You can stay up to date with the Sick Times newsletter, our coverage, and find ways to support us at thesicktimes.org.

[Instrumental theme song excerpt plays underneath the rest of the podcast]

Miles: We’ll continue reporting the information that you need to better practice care. 

Betsy: Solidarity with everyone still here. 

James: 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 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 Reese.

I’m James Salanga and I produced this episode. Our engagement editor is Heather Hogan, Sophie Dimitriou designed our podcast cover art, Miles Griffis and Betsy Ladyzhets are your co-hosts and The Sick Times’ co-founders.

Thanks for listening.