By Clare Banaszewski, Nicole Barrick, Mike Bilik, Addie Davis, Mia Delli Gatti, Ellie Hayes, Roman White
We are a group of 53 individuals with Long COVID from across the U.S., including healthcare workers, students, educators, parents, and professionals, ranging in age from 19 to 60. In 2023, we joined a Long COVID clinical trial for Vyvgart (efgartigimod), a drug approved by the Food and Drug Administration (FDA) for the autoimmune disease myasthenia gravis. We joined trial sites nationwide, and are now connected by a shared experience. Together, we make up roughly 25% of the clinical trial population.
All of us have also been diagnosed with postural orthostatic tachycardia syndrome (POTS), a type of dysautonomia. We use the term “Long COVID POTS” to describe patients who developed POTS following a SARS-CoV-2 infection.
The study, run by the biotech company Argenx, was a double-blind, placebo-controlled phase 2 trial. For six months, one-third of patients had received a placebo while the rest received the actual drug. This was followed by an open-label extension, in which the remaining people got access to Vyvgart. For many of us, the treatment, an infusion administered weekly, changed everything.
Sarah, who had been bedbound with Long COVID for months, started Vyvgart and steadily regained her life. “I could be out in the sun doing manual labor for eight hours. It was incredible to feel so much closer to what I used to feel like.” Stories like Sarah’s echoed across the group: People returned to work, resumed school, exercised again, and reached milestones we thought we’d never see again.
Then, without warning, Argenx canceled the trial in June 2024. The company cut off the drug, buried the announcement in an investor press release, and left us without a transition plan, access to our data, or viable alternatives.
Most of us have now relapsed. But we’re not just grieving what we lost; we’re demanding change. Long COVID research must evolve. Without urgency, patients like us will continue to suffer — not for lack of promising treatments, but because of systems that refuse to meet the moment.
We call for two urgent actions by RECOVER-Treating Long COVID and/or Health Secretary Robert F. Kennedy Jr.’s Long COVID Consortium:
- Hear our stories of how Vyvgart helped us and critically examine what went wrong in the original trial design.
- Collaborate with medical research institutions and pharmaceutical partners to launch a redesigned clinical trial of Vyvgart for people with Long COVID POTS.
In a recent review paper, researchers estimated that about 36% of people who had documented COVID-19 cases worldwide developed Long COVID. Another 2024 study found nearly six million children have had Long COVID in the U.S. Recent studies have also found that nearly one in three Long COVID patients is diagnosed with POTS, and about half of people with Long COVID meet diagnostic criteria for myalgic encephalomyelitis (ME), which often overlaps with POTS and dysautonomia.
Despite these staggering numbers, Long COVID does not have any FDA-approved treatments. Senator Todd Young recently stated at a hearing with Health Secretary Kennedy, “If we assume, conservatively, that it takes 12 to 15 years to develop acceptable therapeutics for Long COVID, and then another 18 years for them to reach clinical practice, people my age — and yours — will have passed before they get help. We need to accelerate this.”
We agree. Accelerate Long COVID research and treatments now!
What Vyvgart did for us
Many participants saw life-changing gains. Ellie, a geologist, resumed field work without fearing she would pass out. Nicole, a nurse who contracted COVID-19 while working on a COVID-19 unit, began working part-time again. Mia, a college student, took a full course load while holding a job.
Nicole said, “My body finally started to work again. My symptoms decreased and my activity levels began to improve. After six months in the open-label phase, my tilt table test results had improved, indicating I no longer met the clinical criteria for a POTS diagnosis.”
Clare, also a nurse, said that Vyvgart significantly improved her tachycardia and lessened her post-exertional malaise (PEM).
“The open-label stage of the trial completely changed my life for the better,” shared Roman, a former firefighter. “I no longer qualified for POTS criteria when tested. I felt great, and pretty much all of my symptoms were gone. I was about to get a gym membership when the trial was canceled.”
Michaelene shared, “I was five months on the open label. I did not meet criteria for POTS when the trial was abruptly canceled.”
Judith, an award-winning producer, added, “While I was on Vyvgart, I had begun to go back to work. I started to feel like a real person again. I went from being mostly house-bound to being able to travel to a friend’s wedding. My tilt table results began to indicate that I was no longer clinically eligible for POTS.”
Clare and Addie, both previously unable to work, experienced major symptom relief, even if not a full return to baseline. Mike, a lawyer, didn’t see improvements in the blinded stage but made rapid progress during the open-label phase.
We saw consistent patterns of improvement. We believed others would benefit next. That made the cancellation even more devastating.
While I was on Vyvgart, I had begun to go back to work. I started to feel like a real person again. I went from being mostly house-bound to being able to travel to a friend’s wedding.
Judith, trial participant
The trial design missed what mattered
The trial relied heavily on subjective symptom surveys like COMPASS 31 and Malmö POTS. While commonly used in clinical trials, these tools failed to capture the full extent of our recovery. They ignored the most meaningful changes: our ability to stand, walk, work, and perform daily tasks again.
Many of us saw improved tilt table test results — the gold standard diagnostic tool for POTS — reduced PEM, and increased physical capacity. But despite including this test in the trial, the study didn’t use this result as a primary endpoint to measure if the drug was successful. When researchers overlook real-world improvements, they risk discarding treatments that work.
Future trials must include objective metrics such as autonomic testing, exercise tolerance, biomarkers, and patient quality-of-life indicators to determine trial efficacy. The current tools aren’t enough — and people with Long COVID should not be collateral damage of poor study design.
This isn’t just about Vyvgart. As The Sick Times reported in its Long COVID clinical trials series, other trials have made similar mistakes. The Berlin Cures trial, which also assessed a treatment that may work best for people with POTS following COVID-19, failed to capture meaningful progress because its endpoints didn’t reflect patient experience. We see a pattern: trials that exclude the sickest patients and rely on narrow metrics.
The effect on our lives
When the trial ended, we all knew that we were on limited time before the drug stopped working.
We braced ourselves for the painful reality of losing our health and energy all over again. Most of us have regressed to pretrial baselines and are once again debilitated by Long COVID. The treatment that helped us — already FDA-approved for another condition — is now financially inaccessible. Without access to our trial data, we cannot advocate for insurance coverage. Requests for compassionate use have been denied. We are left with no other viable treatment options. We have been left with anger, disbelief, and hopelessness.
For Clare, her symptoms became more severe again and caused her to be mostly housebound.
Michaelene reported, “Unfortunately, the gains I made did not hold up, and I returned to baseline.”
Roman shared, “The end of the trial has had an enormous impact on my life. Besides the obvious health decline, my mental health took a massive hit. I had to turn down a job that would have paid $20,000 more a year.”
Similar to Roman, Nicole shared that she missed out on returning to her job in the operating room. “I felt like that opportunity was being ripped away from me for a second time.”
Judith shared, “The end of the trial had a devastating effect on my life. Since the end of the trial, my health has been worse than before the study started. I am no longer able to work a consistent job and have had to move home with my parents, as I’m no longer able to care for myself. I’ve completely lost my independence, my income, and my social life.”
For those living with Long COVID, every ounce of hope is hard-won. This isn’t just about physical symptoms. It’s about the emotional toll of being given hope — and then having it taken away.
We need better-designed trials that use appropriate, functional outcome measures and include patients in the design process. And we need reliable, long-term government funding that makes these trials possible.
This isn’t just about physical symptoms. It’s about the emotional toll of being given hope — and then having it taken away.
Our calls to action
The recent whiplash of proposed funding cuts and eleventh-hour reversals is terrifying for patients whose lives hinge on research. For instance, in March, the Trump administration canceled up to 45 grants for projects studying the underlying biology of Long COVID, POTS, and other post-acute infection syndromes under the National Institutes of Health’s RECOVER program. But after pushback from patient advocates and some federal lawmakers, these grants were restored.
As patient advocates, we call on the following:
For researchers and drug developers:
- We call on RECOVER-TLC and Secretary Kennedy’s Long COVID Consortium to join forces with pharmaceutical partners, medical researchers, and patients to collaboratively relaunch a trial of Vyvgart for people with Long COVID POTS.
- Researchers could also launch an investigator-initiated trial for Vyvgart.
- Use trial endpoints that reflect quality-of-life indicators such as PROMIS Global Health and objective data such as autonomic testing, exercise tolerance, and biomarkers — not checklists that simply ask about presence or absence of symptoms.
- Focus on inclusion criteria that identify the right patient populations.
- Enable data sharing and unblinding so patients can advocate for continued care.
- Provide compassionate use and off-label access for effective treatments.
For grant funders and policymakers:
- Protect and expand federal Long COVID research funding in the billions.
- Prioritize trials with high potential for impact and patient-centered design.
For fellow patients and allies:
- Contact your representatives. Demand stable, long-term investment in Long COVID research.
- If you’ve participated in a trial, consider sharing your experience publicly or with advocacy groups. Patient testimony shapes the future of research.
Vyvgart gave us something we hadn’t felt in years: hope. For the first time since becoming ill, many of us saw glimpses of the lives we used to live. That hope shouldn’t end with us. Millions of others with Long COVID and Long COVID POTS deserve the same chance at recovery.
We’re asking the medical community, pharmaceutical industry, and government leaders to step up: Support continued research, fund better-designed trials, and help ensure access to promising treatments like Vyvgart.
Those we’ve spoken to who worked directly on this trial believe in the science and don’t think this study was a failure. We agree. The only thing missing now is the will to act.
Those we’ve spoken to who worked directly on this trial believe in the science and don’t think this study was a failure. We agree. The only thing missing now is the will to act.
We are a group of patient advocates living with Long COVID and POTS who participated in a groundbreaking clinical trial testing what could become the first FDA-approved treatment for our condition. Now we are speaking out together to demand progress.
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[…] This article from USA (2025-10-10) is written by a group of 53 long haulers who made up about a quarter of a […]