A healthcare worker administers a Covid-19 test at testing site in San Francisco, California, U.S., on Monday, Jan. 10, 2022.
David Paul Morris | Bloomberg | Getty Images
The National Institutes of Health is rolling out one of the largest studies in the world to understand long Covid in a high-stakes effort to find definitive answers about a multitude of seemingly unrelated and sometimes debilitating symptoms that have plagued patients and confounded physicians.
The $1.15 billion taxpayer-funded study, called Recover, aims to enroll nearly 40,000 people by the end of this year. It will follow those participants over four years, comparing people with Covid to those who’ve never had it, with the goal of identifying all the long-term symptoms and finding out how the virus is causing them. The Patient-Led Research Collaborative said there were more than 200 long Covid symptoms across 10 organ systems, according to a study published last year in The Lancet.
It’s a massive undertaking, and expectations are high. The size of the budget, breadth, depth and scope of the study are rarely seen in scientific studies.
The study’s conclusions could play a pivotal role in developing diagnostic tests and finding treatments for patients who remain sick months after contracting Covid-19. If the scientists can produce clinical definitions of the various long-term illnesses associated with the virus, patients will stand on firmer ground when trying to convince health insurers to cover their treatments and getting disability claims approved.
Dr. Walter Koroshetz, who serves on Recover’s executive committee, said the study has been designed to investigate long Covid from every possible angle and provide definitive answers. But Koroshetz acknowledged that even a study this size will face major challenges in delivering on such ambitious goals.
“I’m worried that this is not an easy answer. The post-infectious persistent symptoms that go on to chronic fatigue syndrome have defied anybody’s explanation,” said Koroshetz, the director of the National Institute of Neurological Disorders and Stroke.
Enrollment and clinical trials
The Recover study aims to complete enrollment of more than 17,000 adults by September and 20,000 children by the end of the year, according to Dr. Stuart Katz, who is coordinating the nationwide rollout of the Recover study at its central hub at New York University Langone Health. The study will have research teams at more than 30 universities and medical institutions across the U.S.
As of this week, 5,317 adults and 269 children have been enrolled, taken together about 15% of the total population of nearly 40,000, according to Katz, a cardiologist who studies congestive heart failure. Katz caught Covid in December 2020 and suffered symptoms for about a year.
The National Institutes of Health is also planning to launch a “suite of clinical trials” on possible treatments in the coming months, according to Dr. Gary Gibbons, director of the National, Heart Lung and Blood Institute. Gibbons said NIH is in active discussions with the pharmaceutical industry on studying whether antivirals and other interventions can prevent or treat long Covid.
“These are exploratory with companies that have agents that may go before the FDA for approval,” Gibbons said. “There’s an interest both for public-private collaboration in this space and and we’re very hopeful that something will emerge in the next several months.”
However, Gibbons said NIH will likely need more funding from Congress for the trials given scope and complexity of the problem.
“We would anticipate to really fully do the clinical trial portfolio that patients with long Covid deserve, it probably will exceed $1.15 billion initial allocation that Congress awarded,” Gibbons said.
Unanswered questions
While the public uses long Covid for shorthand, the scientific name is post-acute sequelae of Covid, or PASC. Researchers believe it is not a single disease but several distinct illnesses…
Read More: U.S. scientists to enroll 40,000 in $1.2 billion Recover study