July 31, 2023 – Enrollment is starting for 4 clinical trials evaluating recent treatments for long COVID, the National Institutes of Health announced at a press conference Monday. Additional clinical trials testing no less than seven more treatments are expected in the approaching months.
The trials are a part of the NIH's research effort often called 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 recent clinical trials are in Phase II and are designed to check how protected the treatments are and the way well they work.
However, some advocates fear that the method remains to be moving too slowly.
The Long COVID Alliance “is both encouraged and concerned by today's announcement from the NIH,” the group said in a press release. “We applaud the NIH's efforts to finally fund much-needed and long-overdue studies on Long COVID. … Today's announcement unfortunately leaves many important questions unanswered and appears to be riddled with the same lack of transparency that is all too familiar with RECOVER and its $1.15 billion budget.”
Patients with long COVID are increasingly frustrated by the dearth of effective treatment options. Some doctors are resorting to the off-label use of certain medications in treatment.
Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and co-leader of the RECOVER initiative, said the agency doesn't know exactly how many individuals have long COVID. “The answer depends on how you define the problem and which variant caused it. The incidence was higher with Delta,” he said throughout the briefing. Some estimates suggest that 5 to 10 percent of those infected develop long COVID. “I don't think we have solid numbers because it's a moving target,” Koroshetz said.
Here are the small print of the 4 experiments:
- RECOVER-VITAL focuses on treating viral persistence, which may occur when the virus persists and the immune system now not functions properly. One treatment will test a protracted dose of the antiviral drug Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID-19 to stop it from developing into severe COVID disease.
- RECOVER-NEURO goals to treat symptoms corresponding to brain fog, memory problems and a focus issues. Potential treatments include a program called BrainHQ, a web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a web-based program developed by the Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to enhance brain activity.
- RECOVER-SLEEP will study treatments for sleep problems, which may include daytime sleepiness and other issues. Koroshetz said melatonin, light therapy and an academic coaching system are among the many treatments being studied.
- RECOVER-AUTONOMIC will investigate treatments to alleviate symptoms related to problems with the autonomic nervous system. The first trial will goal a condition called POTS (postural orthostatic tachycardia syndrome), which may cause irregular heartbeat, fatigue and dizziness. It will test a treatment for an immune disorder and a drug currently used to treat chronic heart failure.
Timelines
The first study, taking a look at the persistence of the virus, has already began, said Dr. Kanecia Zimmerman, a senior researcher on the Duke Clinical Research Institute, the info coordinating center for the clinical trials. “We are actively working to start the second study on cognitive dysfunction.” Studies on sleep and autonomic function will begin in the approaching months, she said. A study can also be planned to look at exercise intolerance, which many individuals with long COVID report.
However, the Long COVID Alliance reiterated that the NIH plan lacks details.
“The NIH has not provided a timeline for results: They have stressed that enrollment will begin in the next few months, which likely means it will be at least another year before results are available that will help many millions of people with Long COVID,” the group said.
By that point, Long COVID could have been around for greater than 4 years, “an unacceptable wait time for patients to see meaningful results from this billion-dollar investment.”
Information on participating in long-term COVID studies may be found Here.