The slow enrollment has led to smoldering frustrations about the progress and potential of the NIH’s RECOVER initiative, the research consortium focused on studying post-acute consequences of SARS-CoV-2, or Long COVID, according to researchers and leaders of the initiative.
The RECOVER initiative was designed to support research into long-lived COVID in the United States, including all groups of people impacted by this poorly understood condition.
According to survey data collected by the US Census Bureau and reviewed by the CDC, more than 40% of American adults have reported COVID-19 infection, and 19% have reported having symptoms of a long-term COVID illness. Overall, the survey results suggest that nearly 20 million US adults suffer from these symptoms.
This far-reaching impact is one of the reasons the RECOVER initiative’s slow start, said Walter Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke and co-chair of RECOVER’s Senior Oversight Committee, noting that the initiative aims to casts a wide net as it begins to recruit participants for the many arms of the initial observational studies.
“We want to find solutions for the medical community. That’s the whole purpose,” Koroshetz said MedPage today. “But if it’s quick and easy, then someone else will get it quick and easy, and that would be fine. RECOVER was set up as if there was no quick, easy fix to this problem. And we now know that appears to be the case.”
Koroshetz compared long-term COVID to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), which occurs with other postviral infections like Lyme disease or Epstein-Barr virus that can affect people for decades.
“There’s a real chance this isn’t going to be easy, and it’s going to be more like what we’ve seen with ME/CFS,” he said. “RECOVER is put together in such a way that no stone is left unturned. So if we don’t find that out by the end of RECOVER, it’s not because we didn’t try. It’s going to be because it’s just too difficult a problem.”
Slow start of registration
Overall, according to Koroshetz, inclusion in the adult cohort of the study proceeded as planned. However, the initiative has encountered challenges for specific groups, including the acute infection cohort, the pediatric cohort, and the autopsy cohort.
The acute infection cohort hasn’t enrolled as quickly, largely due to a lack of awareness of the program, Koroshetz said, noting that most people with COVID-19 aren’t seeking treatment, meaning their healthcare providers can’t even recommend joining the study .
He explained that while this specific cohort has proven to be the most difficult to recruit, it is also one that the researchers like to monitor because it is important to “discover the differences in the recovery process from the acute phase to normal recovery.” to understand [with] no symptoms versus a pattern that leaves you with persistent symptoms.
The autopsy cohort faces a similar problem, as awareness of the need to participate is low, Koroshetz said. Researchers for this cohort need people and their families who are aware of the study and willing to choose to participate after their death.
The pediatric cohort is struggling to enroll, primarily due to paperwork delays, explained Lawrence Kleinman, MD, MPH, of the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School in New Jersey.
Kleinman, who directs the Center for Pediatric Studies at Rutgers, compared the RECOVER studies to a team trying to build an airplane as it taxis down the runway.
“It’s a complicated study in terms of enrollment. It’s a complicated study in terms of valuation. It’s a complicated study because we don’t have a comprehensive definition with details about this disease,” he said. “It is very difficult to study an emerging disease [when] You don’t have parameters… around it when you start.
Focused on the future
One cohort that has had no difficulty enrolling is the primary adult population, with some research centers more than half full. Sally Hodder, MD, of West Virginia University’s Health Sciences Center, said her research group enrolled more than 60% of the targeted 914 participants at its campuses, which include campuses in Maine, Puerto Rico, Hawaii and several states in the Midwest and South .
Hodder expects to reach full enrollment in her group by the fall, but admits their locations are only part of the study group of 17,700 adults. She noted that it is important to remember with RECOVER that it is a large observational study trying to understand how long COVID has been affecting all communities across the country.
“I think every study starts out as some kind of exponential curve,” Hodder said MedPage today. “You start and it slowly builds up, and then that registration curve gets a lot steeper, and that’s what happens with RECOVER.”
The more people are aware of the work they’re trying to do with RECOVER, the easier registration becomes, she said.
Researchers at multiple RECOVER study sites agreed that the slow recruitment was not unexpected, but they all emphasized that they are on track to collect the data necessary to better understand long-COVID.
“The RECOVER initiative is really trying to do a comprehensive study of this condition to get answers for patients, [and] to provide practitioners with the tools to reduce their suffering,” Koroshetz said. “I feel the frustration but I think this is the best thing that 10 years from now we don’t feel frustrated. This is the best chance of getting the answers.”