The National Institutes of Health said Monday it’s launching trials to test drugs and other treatments for long COVID, a mysterious condition that affects millions of people after they catch the coronavirus.
The phase II trials will focus on four impacts of the condition, including the virus’ long-standing jolt on the immune system and bodily organs; cognitive ability; sleep and daytime drowsiness; and systems like breathing and heart rate.
The announcement reflects the administration’s emphasis on stamping out COVID-19 and its medical consequences even though President Biden declared an end to the public health emergency around the virus in May.
It also shows that COVID-19 remains a potentially lucrative stream for pharmaceutical companies developing vaccines and therapies against the virus.
“The search for improved treatments for long COVID has come very late. But now that it is here, the clinical trial designs look very strong and should speed the discovery of new treatments,” said Lawrence O. Gostin, a global health law professor at Georgetown University.
The sheer number of Americans suffering from long-COVID offers a “huge market for the pharmaceutical industry,” he said. “And it could entail long-term treatments which can be particularly lucrative.”
The Biden administration estimates anywhere from 7.7 million to 23 million Americans have the condition.
Sen. Roger Marshall, Kansas Republican and physician, said trust in the NIH and Centers for Disease Control and Prevention took a dive during the pandemic so Congress will need to see that each stage of new trials is producing results before considering new funding.
“Until the NIH can be forthcoming about its role in funding risky gain of function research in Wuhan, China, where a preponderance of evidence supports the COVID-19 virus was leaked, I don’t think there is an appetite to funnel more money to this government agency without a laser-focused plan, first presented to us,” he said.
He also urged NIH to consider cheaper alternatives to expensive groundbreaking treatments.
Vaccine makers Pfizer and Moderna, which produce annual COVID-19 boosters, recently told Congress they will dramatically increase the list price of their shots now that the government is not guaranteeing purchases.
NIH researchers said the first plank of the phase II trials for long COVID involves testing a longer dose regimen of Paxlovid — the Pfizer drug that is approved to fight active infection in high-risk people — to see if it improves the symptoms of those with long COVID.
Long COVID affects an estimated 5% to 10% of people who get infected with the coronavirus in the U.S., NIH officials said, adding it’s difficult to pinpoint a total number of sufferers because definitions of the condition differ.
Officials said the incidence of long COVID seemed higher during the delta wave of 2021 before dropping when the omicron strain hit. Sufferers say the condition has made it hard for them to earn a living or enjoy daily activities.
“They can have trouble working, sleeping, taking care of their families and doing even basic physical activity, among other issues,” acting NIH Director Lawrence Tabak said. “Long COVID is preventing many from living their normal lives, and solutions can’t come quickly enough.”
Researchers said long COVID affects nearly all body systems and has produced over 200 symptoms, so they want to get a firm sense of which therapies will help people restore sufferers’ organ function and cognitive ability or restore normal breathing and sleep.
The trials will build on NIH’s RECOVER Initiative, which enrolled 24,000 people and collected millions of health records to examine why some people have lasting impacts from COVID-19. Each arm of the phase II trials will include 100 to 300 participants, though some might include more enrollees.
NIH said the trials will operate faster than normal and will be flexible enough to add new treatments as needed. The agency stopped short of comparing the program to Operation Warp Speed, the Trump administration initiative that developed primary vaccines for COVID-19 in record time.
“You can’t compare it to the Operation Warp Speed effort, which was focused on risk-manufacturing and distribution of vaccines against COVID-19. For vaccine development, the target was clear (SARS-CoV-2),” the agency said in response to an inquiry from The Washington Times. “We are facing a different challenge with long COVID. We don’t yet have a definitive understanding of the underlying pathobiology of the condition. Long COVID can affect many different parts of the body, and people can experience a wide range of symptoms. The RECOVER initiative’s approach was to first support research to gain some understanding of the biology of the condition before determining what types of clinical trials would potentially provide us with possible treatments that will work.”
The new initiative is divided into four categories, starting with a Vital category that looks at how the coronavirus lingers in some people, causing havoc on the immune system or the body’s organs.
This plank will deploy Paxlovid in a longer dose regimen.
A branch of the study called Neuro will see if there are ways to correct cognitive problems from long COVID, including brain fog, memory problems and difficulty with attention, clear thinking and problem-solving.
It will study a web-based training program called BrainHQ, developed by Posit Science Corp. in San Francisco, that trains the brain to improve cognitive function; and another web program known as PASC-Cognitive Recovery, developed by Mount Sinai Health System in New York City, to improve executive function.
Researchers will also test a device that deploys transcranial direct current stimulation and was developed by Soterix Medical Inc., based in Woodbridge, New Jersey. The device, which can be used at home, stimulates brain activity and blood flow.
NIH researchers said they plan to deploy at least seven more treatments or drugs in subsequent trials, once they are enrolled and launched.
A third, sleep-oriented plank of the initiative will see if two wakefulness-promoting drugs help long COVID sufferers combat daytime drowsiness compared to a placebo.
The final, autonomic branch of the initiative will test ways to improve body functions such as heart rate, breathing and digestion.
Researchers will target a condition known as postural orthostatic tachycardia syndrome, or POTS, which is marked by irregular heartbeat, dizziness and fatigue. Some people might be familiar with POTS as a common condition that causes dizziness in some people who get up after lying down for a while.
Researchers are developing a fifth section of the initiative that will look at exercise and fatigue.
NIH officials said the phase II trials are fully funded by Congress. However, the ability to fund trials into the late stages could depend on Capitol Hill’s appetite for continuing robust funding for NIH.
Dr. Tabak said his “crystal ball” isn’t giving him a clear answer on future support.
“I can’t really project,” he said.