NIH to open long COVID clinical trials to study sleep disturbances, exercise intolerance, and post exertional malaise – National Institutes of Health…

News Release

Wednesday, May 8, 2024

Part of the NIH RECOVER Initiative, trials will test four treatments.

The National Institutes of Health (NIH) will launch clinical trials to investigate potential treatments for long-term symptoms after COVID-19 infection, including sleep disturbances, exercise intolerance and the worsening of symptoms following physical or mental exertion known as post-exertional malaise (PEM). The mid-stage trials, part of NIHs Researching COVID to Enhance Recovery (RECOVER) Initiative, will join six other RECOVER studies currently enrolling participants across the United States testing treatments to address viral persistence, neurological symptoms, including cognitive dysfunction (like brain fog) and autonomic nervous system dysfunction. The new trials will enroll approximately 1,660 people across 50 study sites to investigate potential treatments for some of the most frequent and burdensome symptoms reported by people suffering from long COVID.

The group of symptoms these trials will try to alleviate are truly disruptive and devastating for so many people struggling with long COVID, said Walter J. Koroshetz, M.D., director of NIHs National Institute of Neurological Disorders and Stroke, and co-lead of the RECOVER Initiative. When people cant get reliable sleep, cant exert themselves and feel sick following tasks that used to be simple, the physical and mental anguish can lead to feelings of utter helplessness. We urgently need to come up with answers to help those struggling with long COVID feel whole again.

All four trials were developed using comprehensive feedback from the community and in close partnership with patient representatives, whose insights were especially important for the PEM trial. The PEM trial was developed to address concerns expressed by patient advocacy groups about patient safety, and to better understand how this study program may help improve PEM symptoms.

Structured pacing is currently the only intervention used to prevent post-exertional malaise, so we hope to test its effectiveness and determine how to best guide patients regarding activity management, said Lucinda Bateman, M.D., an expert in PEM and founder of the Bateman Horne Center, Salt Lake City, a facility specializing in treating people with ME/CFS, long COVID and fibromyalgia.

Diversity among trial participants is a high priority for the RECOVER Initiative. To support diverse and inclusive representation, study sites are chosen based on geographic location, their connection to communities, and track record for enrolling diverse research participants. Teams at the selected study sites will recruit participants from their health systems and surrounding communities.

Sites currently activated for each trial can be found on ClinicalTrials.gov (RECOVER-SLEEPNCT06404086,NCT06404099,NCT06404112 and RECOVER-ENERGIZE NCT06404047,NCT06404060,NCT06404073). New sites will be added to clinicaltrials.gov as they begin enrolling participants.

With the launch of these four studies, RECOVER is currently testing 13 treatments across eight clinical trials and continues to enroll participants. Those interested in learning more about RECOVER clinical trials should visit trials.recovercovid.org.

About RECOVER: The National Institutes of Health Researching COVID to Enhance Recovery (NIH RECOVER) Initiative brings together clinicians, scientists, caregivers, patients, and community members to understand, diagnose, and treat long COVID. RECOVER has created one of the largest and most diverse groups of long COVID study participants in the world. In addition, RECOVER clinical trials are testing potential interventions across five symptom focus areas. For more information, please visit recovercovid.org.

HHS Long COVID Coordination: This work is a part of the National Research Action Plan, a broader government-wide effort in response to the Presidential Memorandum directing the Secretary for the Department of Health and Human Services to mount a full and effective response to long COVID. Led by Assistant Secretary for Health Admiral Rachel Levine, the Plan and its companion Services and Supports for Longer-term Impacts of COVID-19 report lay the groundwork to advance progress in the prevention, diagnosis, treatment, and provision of services for individuals experiencing long COVID.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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NIH to open long COVID clinical trials to study sleep disturbances, exercise intolerance, and post exertional malaise - National Institutes of Health...