The U.S. National Institutes of Health (NIH) has finally launched its Long COVID trials to explore potential treatment options after considerable delays sparked intense criticism of the agency.
“Today, the National Institutes of Health launched and is opening enrollment for phase 2 clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven more treatments expected in the coming months,” the agency said in a July 31 press release.
“Treatments will include drugs, biologics, medical devices, and other therapies. The trials are designed to evaluate multiple treatments simultaneously to identify more swiftly those that are effective,” the agency said.
Long COVID trials are part of NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative—a $1.15 billion effort supported through the American Rescue Plan Act of 2021 seeking to understand, treat, and prevent Long COVID.
It aims to demystify as to why some infected individuals develop long-term symptoms while others recover completely.
NIH has been facing criticism for delaying Long COVID studies.
Congress allocated $1.15 billion to the NIH for studying Long COVID back in December 2020. Two months later in February 2021, NIH announced the RECOVER initiative.
Until now, more than two years later, the agency has failed to conduct any trials. Instead, RECOVER only focused on observational studies during this period. Trials were initially scheduled for fall 2022, which was delayed to the end of 2022, and then to the first quarter of 2023.
“Certainly, we are attempting to fast track these trials, but we do know that there are a lot of things that have to happen for trials to launch,” she said.
“Some of those things are the development of the protocols, agreement, we’ve had a number of different people who’ve been involved, from patient communities to experts in the field, even understanding long COVID itself,” she said.
“So far, I don’t think we’ve gotten anything for a billion dollars,” Ezekiel Emanuel, a physician, vice provost for global initiatives, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania, said to STAT media outlet in April. “That is just unacceptable, and it’s a serious dysfunction.”
Ignoring Patient Input
Ms. Stiles told CBS that she is “glad NIH is finally funding much needed clinical trials on Long COVID, which has left millions of Americans severely disabled.”However, she is concerned that NIH has “largely ignored” patient input regarding research priorities and trial designs.
“For example, to study cognitive impairment, which research shows is related to reduced blood flow to the brain when standing, inflammation, and coagulation problems, NIH chose to study what is essentially a computer game, not a treatment that actually addresses the underlying biology that is causing cognitive impairment in Long COVID. This is a huge let down for patients,” she said.
“NIH was late to start the clinical trial planning process, and then once it started in fall 2022, there was so much pressure to get these trials launched quickly that patient input was often sidelined,” said Ms. Stiles.
The NIH announcement came the same day the U.S. Department of Health and Human Services (HHS) announced the formation of the “Office of Long COVID Research and Practice.”
The task of the new office would be to “lead the Long COVID response and coordination across the federal government and, in addition, the National Institutes of Health (NIH) launch of the Long COVID clinical trials through the RECOVER Initiative,” the HHS said in a July 31 press release.
Mental health symptoms and conditions linked to Long COVID include depression, psychosis, and anxiety, the HHS stated.
While the HHS is insisting that Long COVID is a real phenomenon, some experts have questioned these claims.
In an article at the Wall Street Journal in December, Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine, said that the Long COVID issue is being exaggerated so as to “scare low-risk Americans as our government gives more than $1 billion to a long COVID medical-industrial complex.”
Dr. Makary cited a December 2022 study that found that patients who have had COVID-19 reported better long-term outcomes compared to those who had suffered from other respiratory infections.
In an interview with NewsNation, Dr. Monica Gandhi, a professor of medicine at the University of California in San Francisco, criticized a study by the U.S. Centers for Disease Control and Prevention (CDC) which claimed that around 20 percent of COVID-19 infections result in Long COVID.
The RECOVER Trials
The initial stage of NIH’s RECOVER plan involves “large, observational, multi-site studies” of people who have had COVID-19. Over 24,000 participants across the country have been recruited into these studies which are still ongoing.Researchers are also going through 60 million electronic health records and conducting over 40 pathobiology studies to understand how COVID-19 affects various organs and body tissues.
Data from these studies help shape the phase 2 clinical trials that will now test the safety and efficiency of treatments. The trials will be conducted in groups of 100–300 individuals.
Among the four treatment trials, RECOVER VITAL will seek to resolve the issue of the COVID-19 virus remaining in the body and causing damage to internal organs or disrupting the functioning of the immune system.
RECOVER-NEURO will examine interventions for cognitive dysfunction related to COVID like memory problems, brain fog, and difficulty with attention.
RECOVER-SLEEP aims to resolve alterations in sleeping patterns or sleeping difficulties among patients with Long COVID.
RECOVER-AUTONOMIC will examine interventions for treating symptoms linked to problems in the autonomic nervous system, which is responsible for several critical bodily functions like digestive activity, breathing, and heart rate.
“Hundreds of RECOVER investigators and research participants are working hard to uncover the biologic causes of long COVID. The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, director of the NIH’s National Institute of Neurological Disorders and Stroke, and co-lead of the RECOVER Initiative.
React19 is an alliance dedicated to supporting individuals affected by long-term COVID-19 vaccine adverse events. The survey was conducted among 450 individuals who identified as vaccine-injured.
The top five commonly reported beneficial therapies in the survey included pacing strategies, an anti-inflammatory diet, brain retraining, and a gluten-free diet, all of which are classified as lifestyle changes.
