July 31, 2023 – Enrollment is opening for four clinical trials to evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing Monday. More clinical trials to test at least seven other treatments are expected to launch in the coming months.
The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are phase II, meant to test how safe the treatments are and how well they work.
But some advocates are concerned the process is still moving too slowly.
The Long COVID Alliance “is both encouraged and concerned by the announcement today from NIH,” the group said in a statement. “We welcome the NIH’s efforts to finally fund much needed and long overdue trials on long COVID. … Today’s announcement unfortunately leaves many important questions unanswered and seems fraught with the same lack of transparency that has become all-to-familiar with RECOVER and its $1.15 billion budget.”
Long COVID patients have grown more frustrated about the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.
Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and co-lead of the RECOVER Initiative, said the agency is not sure exactly how many people have long COVID. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta,” he said during the briefing. Some estimates suggest 5% to 10% of those infected get long COVID. “I don’t think we have solid numbers as it’s a moving target,” Koroshetz said.
Here are details of the four trials:
Timelines
The first, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance reported by many with long COVID.
But the Long COVID Alliance said, again, that the NIH’s plan is lacking in details.
“The NIH has not presented a timeline for results: They have highlighted that enrollment will begin over the next several months, likely meaning that results to benefit many millions with Long COVID are still at least a year away,” the group said.
By then, long COVID will have been around for more than 4 years, “an unacceptable wait for patients to see meaningful results from this billion-dollar investment.”
Information on how to join long COVID trials is here.
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