Long Covid Research Trials Near but Patients Want Swifter Action

Research trials for potential long Covid treatments are on the way from the Biden administration, but patients say the process lacks urgency and fails to take their needs fully into account as much of the country moves on from the Covid-19 pandemic.

In the coming months, the National Institutes of Health’s RECOVER research initiative into long Covid will launch its first clinical trials, in which multiple therapeutics will be tested against various symptoms associated with the affliction. Officials with the Health and Human Services Department, which oversees NIH, declined to provide a specific start date. But Adrian Hernandez, director of the Duke Clinical Research Institute, which is coordinating the trials, said they will launch this summer.

Clinical trials have the potential to improve the lives of Americans living with long Covid symptoms like heart palpitations, brain fog, and chronic fatigue, as well as people who may develop the affliction in years to come. The Centers for Disease Control and Prevention reported that in June 2023, 11% of those who had ever had Covid said they were experiencing long Covid symptoms.

Long Covid sufferers are optimistic about the administration’s efforts, though skeptical of execution and disappointed in its pace. They say research thus far has been too slow, focusing too much on symptoms and not enough on underlying causes, and taking second looks at treatment options already adequately researched.

“We’re three years in and have very little answers to give to someone who develops long Covid right now. There’s no treatment specific for long Covid,” said Lisa McCorkell, co-founder of the Patient-Led Research Collaborative, an outfit of long Covid patients who are also researchers. McCorkell, a long-Covid patient, has worked alongside RECOVER as a patient advocate.

“It was clear from the Covid pandemic that we have the capacity to and the ability to invest significantly into a large response for therapeutics and drug development generally, so why are we not doing that with long Covid?” she said.

$1 Billion in Funding

The NIH announced RECOVER in 2021, following a $1 billion-plus infusion from Congress. RECOVER is supporting research at over two dozen universities and hospitals, focusing on adults, children,and pregnant people. Over 20,000 people have been enrolled in observational studies.

However, critics like Michael Sieverts, a patient advocate and member of the Long-COVID Alliance, say RECOVER’s work has largely focused on long Covid symptoms without “shedding much light” on the underlying causes. They also contend RECOVER has lacked transparency and been slow in launching trials.

In August 2022, Duke University announced its Clinical Research Institute would serve as the data coordinating center for NIH’s long Covid clinical trials.

Clinical trials were supposed to start earlier this year but “keep getting pushed back,” Sieverts said, noting that some already floated by the agency, like exercise therapy, are particularly frustrating, as there’s “very solid research” that it doesn’t help people with an illness like long Covid.

The NIH didn’t provide information on the numbers of trials and patients they hope to enroll.

McCorkell said she’s “overall disappointed with how the Biden administration has handled long Covid, largely because of the lack of urgency.”

“We have really needed something like an Operation Warp Speed for long Covid, given the huge amount of people that are impacted and how severe they can be impacted,” McCorkell said, referring to the Trump administration effort that sped up Covid vaccine development.

‘Appropriate Response’

Administration officials see the pace of their efforts differently.

The development of Covid vaccines “was based on foundational work that took 20 years. It isn’t that they started from scratch on mRNA vaccines,” said Rachel Levine, assistant secretary at the HHS.

Levine’s office will oversee the upcoming Office of Long Covid Research and Practice, which will serve as a coordinating arm for long Covid efforts across the Biden administration.

That office will formally launch soon, with no specific date set, Levine said. Her office has already been playing that coordinating role and doing related work since last year, and has held 10 long Covid coordinating council meetings since April 2022.

Those bring together various factions of the HHS that grapple with long Covid, such as the NIH, CDC, Health Resources and Services Administration, and the Food and Drug Administration, as well as outside agencies like the Departments of Defense, Veterans Affairs, Labor, and Education.

Levine said that for long Covid treatment, “fundamental research is occurring.”

“It’s hard to put a date on when breakthroughs occur,” she said.

Typically, clinical trials can take five to seven years to organize, while cures for unknown conditions like Covid-19 generally result from research over decades, an HHS spokesperson said. The spokesperson deemed criticisms that RECOVER clinical trials have been delayed “a mischaracterization.”

Better Data

Clint Wright, director of the Division of Clinical Research at the National Institute of Neurological Disorders and Stroke, who is working on the Covid clinical trials, said “RECOVER has been trying to get better data,” particularly on what long Covid is and isn’t.

Research published in Lancet EClinicalMedicine with McCorkell as an author found that over 200 symptoms are associated with long Covid. The World Health Organization said studies reveal that about 10-20% of people with the SARS-CoV–2 virus could get symptoms eventually diagnosed as long Covid.

The long Covid clinical trials have a design in place. Wright described it as five different “platforms,” each of which allow researchers to test multiple therapeutics.

The first platform will aim to answer questions around viral persistence, striving to determine whether Sars-Cov-2 is still replicating in long Covid patients and whether there’s a way to intervene. The other four platforms will focus on symptom clusters like autonomic dysfunction, fatigue, sleep, and cognitive dysfunction.

McCorkell says patients are excited about the prospect of testing things like antivirals to target viral persistence, but she wants trials to avoid things debunked by other trials like cognitive behavioral therapy and exercise therapy—and for the NIH to move faster.

“It’s just been very, very frustrating for patients to have these longstanding symptoms and not have clear treatment options,” Wright said. “That’s what we’re trying to address.”

Hernandez agreed: For people who have long Covid, things are “never fast enough.”