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Patients with long COVID and their caregivers shared how the illness has impacted their lives, the treatments they've tried, and their hopes for clinical trials during a on Patient-Focused Drug Development for Long COVID hosted by the FDA on Tuesday.

Impacts on Daily Living

Jill Anderson, a patient participant, works for a behavioral health community services board in Virginia. Before developing long COVID, she had never had vertigo. Today, she's dizzy all the time.

"I would get up in the middle of the night and take a step out of bed and fall to the floor. It was terrifying how my world was spinning and out of balance," she said.

She has also experienced significant "brain fog," fatigue, and loss of appetite. Anderson currently works remotely on a reduced schedule and is worried she might lose her job.

Another patient participant, Heather Elizabeth Brown, a chaplain and corporate trainer in Detroit, said COVID impacted every major system in her body. "That includes my nervous system ... my reproductive system, digestive, lymphatic, endocrine -- any system you can name has pretty much been affected," she said.

She has had blood clots, lymphedema, fatigue, a stroke, COVID-induced diabetes, high blood pressure, and significant brain fog. During her initial infection, she developed pneumonia in both lungs and had to be on a ventilator for 31 days.

As a corporate trainer, her entire job is built around teaching and communicating, she said. "So having moments of not remembering what I was talking about could be very challenging."

Hopes for Treatment

During the panel discussion focused on treatments, Tammy Wilshire, a patient from the Appalachian Mountains of Pennsylvania, said she had "limited success" with a range of supplements -- vitamins C, D3, B12, and magnesium -- as well as beta blockers for tachycardia, and gabapentin for tremors and worsening fibromyalgia.

Physical therapy showed promise at first, she said, but as its intensity increased, she experienced "crippling fatigue" and a relapse of myalgic encephalomyelitis-chronic fatigue syndrome, a debilitating multi-systemic illness, which forced her to stop.

Angela M. Vasquez, president of Body Politic, a grassroots health justice organization, takes 15 medications, receives weekly infusions of diphenhydramine (Benadryl) and saline, and takes supplements to support "mitochondrial health."

After being reinfected with COVID, she took 15 days of nirmatrelvir-ritonavir (Paxlovid) and found that despite an "extended flare," the medication minimized, to a degree, her cognitive dysfunction and gastrointestinal problems.

Her symptoms also improved following her first vaccine, Vasquez said, and she's come up with a "strict pacing routine" that enables her to work full-time from home, though she has little energy for much else.

A third patient, Daniel Lewis, takes a beta blocker and midodrine for post-orthostatic tachycardia syndrome, and bupropion (Wellbutrin) for fatigue, but each has helped only "a tiny bit."

Asked about their ideal treatments, Wilshire said it would need to reduce her pain and fatigue. Vasquez urged scientists to focus on post-exertional malaise. And Lewis said his "most disabling symptoms" relate to exertion.

Lewis urged FDA officials to expand access to approved drugs that he argues appear promising based on early research, including antivirals, Janus kinase inhibitors, anticoagulants, antiplatelets, metformin, and others.

Other patients described success with Pilates (given the opportunity for strengthening muscles without being physically upright), methylphenidate (Ritalin) for brain fog, supplements, acupuncture, meditation, and other supports from functional medicine doctors.

Shaping Clinical Trials

"Anything that is in person is extensively more difficult, than anything that can be ... done on online," said Liza Fisher, a flight attendant and part-time yoga instructor. In-person clinical trials also add to the cost for participants, many of whom have lost employment and healthcare coverage.

Costs of participating in general are always a factor, Fisher said. In 2021, she contemplated participating in a stem cell trial, but was told by the Houston-based company running the trial that she would have to biobank her stem cells first, which would set her back somewhere between $3,000 and $10,000. Fisher, who was unemployed and receiving disability at the time, quickly dropped the idea.

Fisher also found she was ineligible for another trial because she is currently taking off-label steroids. She also noted that other exclusionary criteria included "activity ranges for vitals," which she said aren't sensitive enough for the long COVID patient population.

As for trials of medications with potential side effects, Fisher said, "To be perfectly honest ... every time I was read a list of side effects, I thought, 'oh, that's my Saturday.'"

When she hears of an intervention or medication in a trial that she thinks could potentially trigger an increase in her symptoms, Fisher considers micro-dosing and slow titration schedules to more carefully assess her reaction, rather than opt out.

As to whether she'd be willing to enroll in a trial in which she might be given a placebo, she said she would, as long as she knew that if the experimental drug or intervention was successful, then she would also have access after the trial was completed.

Another patient participant, Ryan, who chose not to share his last name, said he views a control arm as the most important part of a clinical trial. "Sometimes I'll see a study that's been trialing a medication for 6 months and they've seen moderate improvement, but that's my experience without medication," he said.

Ryan also stressed the need to track biomarkers, such as those measuring micro-clotting, endothelial cell dysfunction, and T-cell disturbances or cytokines, which are tied to immune dysfunction more broadly.

As a logistical matter, Ryan also avoids clinical studies that would require him to drive, because of his brain fog

He is currently enrolled in the at Mount Sinai Hospital in New York City, which is accessible by public transportation.

Asked by FDA officials about outcomes that matter most to patients, Michelle, whose daughter has long COVID and who did not share her last name, said that "being able to tolerate returning to school would be the most meaningful improvement for us."

Other patients, some of whom phoned into the webinar, called for more specific studies of long COVID and women's reproductive health. Others expressed concern over the loosening of mask requirements in healthcare settings, and the number of long COVID patients taking supplements, suggesting that more oversight was needed.

In closing the discussion, Michael Iademarco, MD, MPH, deputy assistant secretary for science and medicine in the Office of the Assistant Secretary of Health, noted that there was a great deal of diversity in the perspectives shared.

"It's a lot to pull together ... but at the end of the day, we have to pull it together, and make some steps forward in the right direction," he said. "And we may not always get it perfectly right, but that's what we're aspiring to do in HHS."

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