Two ground-breaking clinical trials have been announced by the National Institutes of Health (NIH) to evaluate potential treatments for long COVID. The trials, funded by the federal government, aim to address the long-term symptoms faced by COVID-19 survivors. The first study, called RECOVER-VITAL, will investigate the use of Pfizer’s antiviral pills, Paxlovid, which are currently approved by the FDA for early treatment of COVID-19. The trial, which will enroll up to 900 patients, has been modified based on feedback from the FDA to ensure optimal design and effectiveness. Another trial, RECOVER-NEURO, will explore three approaches to alleviate symptoms such as brain fog and memory problems. These include a brain stimulation device, as well as two web-based training programs. More trials are planned to begin within the next three months. According to the Centers for Disease Control and Prevention, around 5% of Americans continue to experience limitations due to long COVID. Symptoms of long COVID include extreme fatigue, brain fog, gastrointestinal issues, and loss of smell or taste. Dr. Larry Tabak, acting director of the NIH, stated that while the hope is for these treatments to be effective, it is also possible that some interventions may not provide relief. The announcement of these trials comes after months of planning, design adjustments, and regulatory approvals. The NIH has faced criticism regarding the pace of their research, but officials defend the process, emphasizing the importance of thorough planning and inclusivity. The Long COVID Alliance commended the launch of the trials but expressed concern over the timeline for results, suggesting that they may be over a year away. The future RECOVER-SLEEP arm of the trials will assess various interventions to improve sleep and wakefulness, while the RECOVER-AUTONOMIC arm will focus on treatments for autonomic nervous system dysfunction. The trials have been designed as adaptive platform studies, enabling flexibility in testing and the addition of new treatments. However, some potential treatment options, such as blood thinners, have not been included in the initial trials and may be considered in the future.
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