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After almost three years, NIH has finally launched its first clinical trials for long COVID treatments. However, both health experts and patients have criticized the agency's long-delayed research efforts, calling them "too little and too late."
NIH to begin clinical trials for long COVID
In December 2020, Congress allocated roughly $1.2 billion to NIH to fund research into long COVID, including to test potential treatments for patients. Although the agency has planned several clinical trials on treatments since early 2022, several delays have pushed back the research.
Earlier this month, nearly three years since the allocation, NIH announced it will start enrolling patients in clinical trials to test at least four potential treatments for long COVID. According to the agency, trials to test at least seven more treatments will also be implemented in the coming months.
One clinical trial, called RECOVER-VITAL, is testing a longer regimen of Pfizer's antiviral COVID-19 drug Paxlovid to see if the drug can help alleviate long COVID symptoms. The trial will include 900 patients who are split into three groups. One group will receive Paxlovid for 25 days while the other two groups will receive more limited treatments.
In another trial, called RECOVER-NEURO, researchers will test several different treatments on patients who have neurological issues from long COVID, such as brain fog and memory problems. Some of the treatments include a device that delivers low-level electrical currents to the brain and two web-based training programs.
Other trials plan to address sleep issues, using modafinil and solriamfetol, two wakefulness-promoting drugs, and heart rate, breathing, and digestive activity symptoms using intravenous immunoglobin therapy and ivabradine.
According to NIH's acting director Lawrence Tabak, the trials, which will receive funding until their completion, are "a significant milestone" and will be conducted by institutions with records of attracting diverse participants.
"Long covid is preventing people from living their normal lives, and solutions can't come quickly enough," Tabak added.
Health experts, patients criticize NIH's long COVID efforts
According to some health experts, the launch of NIH's clinical trials is an important step, but the agency will need to show tangible progress and results to ensure patients that their concerns are being taken seriously.
"The fact there were no trials until this point has been highly discouraging," said Eric Topol, EVP at Scripps Research. "The community of people suffering are desperate and want to see the investment by NIH bear fruit."
In addition, there are concerns that NIH may not have enough funding to conduct additional clinical trials in the future. Based on an investigation from STAT and MuckRock earlier this year, most of the $1.2 billion allocated to NIH for long COVID research has already been spent, with almost 47% going to observational research instead of clinical trials. Around 15%, or $171.5 million, has gone to clinical trials.
David Putrino, director of rehabilitation innovation at Mount Sinai who studies long COVID, said that NIH's funding "has largely been wasted" and that findings from the initiative have not added new insights to the field.
Patients have also expressed disappointment with NIH's clinical trial plans, with Devin Russell, a patient advocate, calling the current trials "too little and too late."
"Nobody in the patient community or the research community thinks this is going to be sufficient to solve the problem," said Charlie McCone, a long COVID advocate and patient representative for the RECOVER initiative. "And there's been no indication that there will be funding for further trials."
"I don't know that it's [NIH's slow research pace] going to cost lives," said Ezekiel Emanuel, an oncologist and bioethicist at the University of Pennsylvania. "It's going to cost suffering."
Why more treatment research is needed
According to patients and experts who have reviewed NIH's plans, most of the treatments being tested are "underwhelming," STAT writes. In particular, several patients said they were disappointed that relatively few drugs were being tested compared to other interventions.
"We need pharmaceutical treatments because there's clearly something wrong with the patients," said Ursula Hofer, editor in chief of The Lancet Infectious Diseases. Basic therapies and other interventions targeting behavioral changes don't "fix the underlying issue" of long COVID, she said.
In addition, Julie Moore Vogel, a scientist at the Scripps Translational Institute who has long COVID herself, said many patients have already experimented with many of the treatments being tested, as well as several others, which range from over-the-counter medications to yoga and meditation.
"I'm really anxious to see pharmaceutical interventions because a lot of patients have tried all of the other things that you might try," Vogel said.
One potential treatment that could be tested is low-dose naltrexone, which is an addiction drug that some patients with long COVID and similar conditions say has helped alleviate their symptoms. Another potential treatment is blood thinners to treat tiny blood clots that some researchers believe may be an underlying cause of long COVID.
According to Putrino, long COVID patients deserve fast answers, not "incremental innovation." Going forward, Putrino said he expects researchers receiving private funding will be able to test treatments and return results much more quickly compared to NIH.
"They [NIH officials] don't have the sense of urgency they needed to have," said Ziyad Al-Aly, director of the Clinical Epidemiology Center at Washington University School of Medicine in St. Louis. "There is a lot of time lost. I want RECOVER to succeed, but I also want them to have a sense of urgency around it." (Ladyzhets, STAT, 8/9; Tin, CBS News, 8/7; Kozlov, Nature, 8/1; Johnson/Goldstein, Washington Post, 7/31)
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