HHS Secretary Xavier Becerra issued a statement announcing the launch of the Office of Long COVID Research and Practice to lead the long COVID response and coordination across the federal government and, in addition, the National Institutes of Health (NIH) launch of the Long COVID clinical trials through the RECOVER Initiative.
Mr. Becerra stated, “As our nation continues to make strides in combating COVID-19, it is crucial that we address the impact of long COVID and provide resources to those in need. Last year, President Biden called on HHS to coordinate the response to long COVID. The official establishment of the Long COVID Coordinating office and the launch of the RECOVER clinical trials solidifies this issue as an ongoing priority.”
“The Office of Long COVID Research and Practice will enhance efforts being undertaken across the U.S. government to improve the lives of those who continue to experience the long-term impacts of the worst public health crisis in a century,” said Admiral Rachel Levine, MD. “Bringing together the resources and expertise of federal, state, and local partners, patients, providers, researchers, and the business sector to answer the American people’s most urgent calls to action.”
The Office of Long COVID Research will be responsible for on-going coordination of the whole-of-government response to the longer term effects of COVID-19, including long COVID and associated conditions, and the enactment of the National Research Action Plan on Long COVID and the Services and Supports for Longer-Term Impacts of COVID-19. Currently, 14 federal departments are involved in long COVID, including over a dozen HHS Operating and Staff Divisions, with the intent to diminish its impacts by improving the quality of life for individuals living with the effects of long COVID and identifying and addressing related disparities.
Additionally, the NIH recently launched long COVID clinical trials via the Researching COVID to Enhance Recovery (RECOVER) initiative and announced enrollment for phase II clinical trials, which will evaluate at least four potential treatments for long COVID-19, with additional clinical trials to test at least seven more treatments expected in the coming months. These trials are a component of the NIH’s RECOVER initiative, which seeks to gain more information on understanding and treating as well as preventing symptoms experienced by those with long COVID. Treatments will include drugs, biologics, medical devices, and other therapies. The trials are designed to evaluate multiple treatments simultaneously to recognize the most efficacious therapies in a timely manner.
The phase II trials will focus on viral persistence and cognitive dysfunction in the RECOVER-VITAL and RECOVER-NEURO trials, respectively. The trials will use platform protocols, a term utilized to characterize the adaptive design of these trials.
In the RECOVER-VITAL trial, researchers will explore viral persistence and examine the impact of longer treatment intervals with Paxlovid in patients with long COVID-19. The first trial sites have been activated and are enrolling.
In the RECOVER-NEURO trial, researchers will explore cognitive dysfunction related to long COVID-19, including brain fog, memory problems, and difficulty with attention, thinking clearly, and problem-solving. As of September 5, 2023, clinical trial sites have been activated and are enrolling participants.
Additional trials will launch in upcoming months; however, platform protocols are still under review. More information can be found at: https://trials.recovercovid.org/.
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