WASHINGTON (AP) — The National Institutes of Health is beginning several studies to test possible long-acting treatments for COVID, an eagerly awaited step in America’s efforts against the mysterious condition that affects millions of people.
NIH’s Monday announcement of $1.15 billion RECOVER project It comes amid the frustration of patients who have struggled for months or even years with sometimes disabling health problems, with no proven treatments and only a few rigorous studies to test possible ones.
“This is a year or two late and smaller in scope than one would expect, but nonetheless a step in the right direction,” said Dr. Ziyad Al-Aly of Washington University in St. Louis, who is not involved in the NIH project. but whose own investigation highlighted the long toll of COVID. Getting answers is critical, she added, because “there are a lot of people exploiting the vulnerability of patients” with unproven therapies.
Scientists still don’t know what causes long-term COVID, the umbrella term for some 200 widely varying symptoms. An estimated 10-30% of people have experienced some form of prolonged COVID after recovering from a coronavirus infection, a risk that has decreased somewhat since the start of the pandemic.
“If I get 10 people, I get 10 answers for how long COVID really lasts,” said US Health and Human Services Secretary Xavier Becerra.
That’s why, so far, the RECOVER initiative has tracked 24,000 patients in observational studies to help define the most common and bothersome symptoms—findings that are now shaping treatment trials on multiple fronts. The first two will see:
— Whether taking up to 25 days of Pfizer’s antiviral drug Paxlovid could alleviate long-term COVID, based on the theory that some live coronaviruses, or their remnants, can hide in the body and trigger the disorder. Paxlovid is normally used when people get COVID-19 for the first time and for only five days.
— Treatments for “brain fog” and other cognitive problems. They include Posit Science Corp.’s BrainHQ cognitive training program, another called PASC-Cognitive Recovery from New York City’s Mount Sinai Health System, and a device from Soterix Medical that electrically stimulates brain circuits.
Two additional studios will open in the coming months. One will try treatments for sleep problems. The other will target problems with the autonomic nervous system, which controls unconscious functions like breathing and heartbeat, including the disorder called POTS.
A more controversial study on exercise intolerance and fatigue is also planned, and the NIH is seeking input from some patient groups concerned that exercise may do more harm than good for certain people with long-term COVID.
The trials are enrolling 300 to 900 adult participants for now, but have the potential to grow. Unlike typical experiments that test one treatment at a time, these more flexible “platform studies” will allow the NIH to add additional potential therapies on an ongoing basis.
“We can pivot quickly,” explained NIH Dr. Amy Patterson. A failed treatment can be abandoned without finalizing the entire trial and “if something promising appears on the horizon, we can plug it in.”
Flexibility could be key, according to Dr. Anthony Komaroff, a Harvard researcher who is not involved in the NIH program but has long studied an equally mysterious disorder known as chronic fatigue syndrome, or ME/CFS. For example, he said, the Paxlovid study “makes a lot of sense,” but if a 25-day dose shows only hints that it works, the researchers could extend the trial to a longer course instead of starting from scratch.
Komaroff also said he understands people’s frustration with waiting for these treatment trials, but believes the NIH appropriately waited “until some clues about the underlying biology emerged,” adding: “You have to have goals.”
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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Science and Educational Media Group. The AP is solely responsible for all content.
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