National Institute of Health
The National Institutes of Health in America has launched and is opening enrolment for phase 2 clinical trials that will evaluate at least 4 potential treatments for Long Covid, with additional clinical trials to test at least 7 more treatments expected in the coming months. Treatments will include drugs, biologics, medical devices and other therapies. The trials are designed to evaluate multiple treatments simultaneously to identify more swiftly those that are effective.
“We know that when patients are suffering, we can never move fast enough,” said Acting NIH Director Lawrence A. Tabak, D.D.S., Ph.D. “NIH is committed to a highly coordinated and scientifically rigorous approach to find treatments that will provide relief for the millions of people living with Long Covid.”
“Hundreds of RECOVER investigators and research participants are working hard to uncover the biologic causes of Long Covid. The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, M.D., director of the NIH’s National Institute of Neurological Disorders and Stroke, and co-lead of the RECOVER Initiative. “Recognizing that more than one solution is likely needed, we’ve taken the lessons learned from RECOVER participants to design rigorous clinical trial platforms that will identify treatments for persons with different symptom clusters to improve their function and well-being.”
The trials that launched on Monday will focus on viral persistence and cognitive dysfunction using “platform protocols,” a term used to describe the adaptive design of these trials.
RECOVER-VITAL will initially focus on a treatment targeting SARS-CoV-2 persistence, which could occur if the virus stays in the body and causes the immune system to not function properly or damage to the organs. The first intervention will test a longer dose regimen of the antiviral PAXLOVID (nirmatrelvir and ritonavir) than is used for treating acute COVID to see if it improves the symptoms of patients with Long Covid. PAXLOVID is provided by Pfizer, Inc., New York City, and is currently approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The first trial sites have been activated and are enrolling.
RECOVER-NEURO will examine accessible interventions for cognitive dysfunction related to Long Covid, including brain fog, memory problems and difficulty with attention, thinking clearly and problem solving. Interventions under this protocol will include a web-based brain training program called BrainHQ, developed by Posit Science Corporation in San Francisco, that has been used to improve cognitive function; PASC-Cognitive Recovery, a web-based goal management training program, developed by Mount Sinai Health System, New York City, that has been used to improve executive function; and a device used for home-based transcranial direct current stimulation developed by Soterix Medical, Inc., Woodbridge, New Jersey, which has been demonstrated to help brain activity and blood flow. Trial sites are currently being activated.
Additional trials, based on the below platform protocols still under review, will launch in the coming months:
RECOVER-SLEEP will test interventions for changes in sleep patterns or ability to sleep after having COVID-19. A trial for hypersomnia, or excessive daytime sleepiness, will test two wakefulness-promoting drugs compared to a placebo control. A second trial for sleep disturbances, such as problems falling or staying asleep, will test other interventions designed to improve sleep quality to learn if these interventions may help regulate sleep patterns in adults with Long Covid.
RECOVER-AUTONOMIC will examine interventions to help treat symptoms associated with problems in the autonomic nervous system, which controls a range of bodily functions including heart rate, breathing and digestive system activity. The initial trial will focus on postural orthostatic tachycardia syndrome (POTS), a disorder with a number of symptoms including irregular heartbeat, dizziness and fatigue, and will have multiple study arms. The first arm will evaluate a treatment used for immune diseases versus placebo. The second arm will evaluate a drug currently used to treat chronic heart failure in people with an elevated heart rate versus placebo. Participants within each arm will then be randomized to receive either more intensive coordinated care that does not involve additional medication, or usual care.
A fifth platform protocol, focusing on exercise intolerance and fatigue, is under development with input from the patient community and scientific experts.
All trials are designed to individually and collectively accelerate the identification of safe and effective treatments for some of the most debilitating symptoms of Long Covid. Study interventions were reviewed by teams of scientists and patient representatives and approved by NIH leadership based on ideas submitted through a May 2022 request for applications.
“Clinical trials to test effective treatments and interventions are a core component of the whole-of-government response to Long Covid,” said Adm. Rachel L. Levine, M.D., Assistant Secretary for Health, Department of Health and Human Services. “Coupled with adequate supports and services, access to clinical care and up-to-date information on what we know about Long Covid, we can work toward relief for individuals and families impacted most.”
Link to Washington Post article: https://www.washingtonpost.com/health/2023/07/31/long-covid-treatment-studies-nih/
Link to ABC News article: https://abcnews.go.com/Health/wireStory/brain-fog-long-covid-symptoms-focus-new-small-101870322
NIH launches trials for long-COVID treatments: what scientists think: https://www.nature.com/articles/d41586-023-02472-1