NIH Announces New Long Covid Study

Press Release from the National Institutes of Health.  The NIH is opening enrollment for phase 2 clinical trials.

 

 

Monday, July 31, 2023

NIH launches long COVID clinical trials through RECOVER Initiative, opening enrollment

People 18 years of age and older who are interested in learning more about these trials can visit https://www.trials.RECOVERCovid.org(link is external) or ClinicalTrials.gov later [July 31, 2023] and search “RECOVER” for details, including enrollment sites.

Today, the National Institutes of Health launched and is opening enrollment for phase 2 clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven 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. Part of the NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative(link is external), the trials were informed by findings from other RECOVER research over the past two years and focus on several of the symptoms described as most burdensome by people experiencing long COVID. With its complementary research efforts, RECOVER has positioned NIH to design and conduct trials that have the potential to provide long COVID patients who experience varying symptoms with relief sooner than any individual study can alone.

“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.”

RECOVER is a large, nationwide research program designed to understand, treat and prevent long COVID, which is marked by long-term symptoms following infection by SARS-CoV-2, the virus that causes COVID-19. The initial stage of the initiative involved launching large, observational, multi-site studies examining and following people through their experience with COVID-19 to learn why some people develop long-term symptoms while others recover completely. These studies are ongoing and have recruited more than 24,000 participants to date. Researchers also are analyzing 60 million electronic health records and conducting more than 40 pathobiology studies on how COVID-19 affects different body tissues and organs. Data gleaned from these efforts helped shape the development of the phase 2 clinical trials, which test the safety and effectiveness of treatments typically in groups of 100-300 participants.

“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 today 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.”

RECOVER is committed to enrolling a study population that is inclusive and representative of the communities most affected by long COVID. Study sites will partner with local communities to raise awareness about long COVID and offer opportunities to participate in the RECOVER clinical trials. Researchers developed the trials with extensive feedback from patient representatives, experts in the symptom areas and proposed interventions, and after reviewing hundreds of proposals.

A Data and Safety Monitoring Board made up of an independent group of experts will monitor participant safety throughout the trial and provide recommendations.

“Our patient and community representatives have provided critical input to help us ensure that the results of these trials are applicable to people across the country and become available as soon possible,” said Kanecia Zimmerman, M.D., Ph.D., M.P.H., principal investigator of the RECOVER Clinical Trials Data Coordinating Center, Duke Clinical Research Institute, Durham, North Carolina.

Trials will continue to launch and enroll participants on a rolling basis. Enrollment will take place at clinical research sites located throughout the United States. A track record for enrolling diverse participants was a key criterion for site selection. These trials will follow a traditional clinical trial recruitment strategy in that sites will contact their patients and residents in their local communities to enroll in the trials.

Those interested in learning more about RECOVER trials should visit https://trials.recovercovid.org/(link is external).

About RECOVER: The National Institutes of Health Researching COVID to Enhance Recovery (NIH RECOVER) Initiative is a $1.15 billion effort, including support through the American Rescue Plan Act of 2021, that seeks to identify how people recuperate from COVID-19, and who are at risk for developing post-acute sequelae of SARS-CoV-2 (PASC). Researchers are also working with patients, clinicians, and communities across the United States to identify strategies to prevent and treat the long-term effects of COVID – including long COVID. For more information, please visit recovercovid.org(link is external).

HHS Long COVID Coordination: This work is a part of the National Research Action Plan(link is external), a broader government-wide effort in response to the Presidential Memorandum(link is external) 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(link is external) report lay the groundwork to advance progress in the prevention, diagnosis, treatment, and provision of services for individuals experiencing long COVID.

www.nih.gov.

 

Chronic Pain

 Noted:

 NY Times article on brain signals of chronic pain:

https://www.nytimes.com/2023/05/22/health/chronic-pain-brain-signals.html?smid=nytcore-ios-share&referringSource=articleShare

 

Pain Management

 

See this very interesting interview on pain:

https://www.nytimes.com/2023/02/21/opinion/17eks-ezra-klein-podcast-rachel-zoffness.html?smid=nytcore-ios-share&referringSource=articleShare

Ezra Klein interviews Rachel Zoffness, author of The Pain Management Workbook.

Pain and Glia Research

 An interesting article in the NY Times regarding pain and glia.

https://www.nytimes.com/2021/11/09/well/mind/glial-cells-chronic-pain-treatment.html?smid=nytcore-ios-share&referringSource=articleShare

 

 

 

Another Way Benefits Are Denied

 

Despite spending at least $250 million to modernize its vocational system, Social Security disability programs still rely on 45-year-old job titles to deny thousands of claims a year.  So stated a recent story in the Washington Post.

 

The article noted that: “The jobs are spelled out in an exhaustive publication known as the Dictionary of Occupational Titles. The vast majority of the 12,700 entries were last updated in 1977.”

 

To mitigate the existing system, it is crucial for anyone applying for Social Security or SSI (Supplemental Security Income) disability benefits to hire an attorney or non-attorney representative who is a member of the National Organization of Social Security Claimants' Representatives and/or the National Association of Disability Representatives and who is familiar with vocational publications such as, Social Security Disability Advocate's Handbook by David Traver and David Ferrari.

 

The newspaper report was probably correct when it observed:

“Social Security’s delays in updating the database of job titles are rooted in conflicting political considerations, shifting leadership, and the drift that can bedevil large federal projects . . . .[And] many advocates believe the agency is motivated to delay the project so it can deny more claimants benefits.”

https://www.washingtonpost.com/politics/2022/12/27/social-security-job-titles-disabled-applicants-obsolete/

Long Covid 19

“Roughly 18 million American adults (7 percent of the adult population) have at least one symptom [of Long Covid 19] that has lasted 12 weeks after infection” according to an article October 31, 2022, in the Boston Globe. The most common symptoms people report are “fatigue, shortness of breath, difficulty concentrating, and muscle aches.” Some people with these symptoms say that their daily activities are limited; 4.5 million describe their limitations as “a lot.”

The recommendations of Katie Bach, a writer on the economic impact of Long Covid 19 and David Cutler, an economics professor at Harvard University, include expanded access to affordable treatment and more research. As to work issues, they urged accommodations where possible. For those workers, “whose jobs are physically demanding and ineligible for remote work,” for whom accommodations are not sufficient, they listed the following short-term disability proposals that Congress should address:

“[F]ederally funded short-term disability insurance to allow long COVID patients early in their disease to rest and, hopefully, recuperate; adjusted Supplemental Security Income/Social Security Disability Insurance guidance and expedited review processes for infection-associated illness patients, who need a different standard of “proof’’ of disability and for whom early rest may be crucial to recovery.”

Bach and Cutler also noted that the 24-month Medicare waiting period for those on disability should be waived.

https://edition.pagesuite.com/popovers/dynamic_article_popover.aspx?artguid=b2ce9c75-fb3e-4e8e-96fe-0e9b6637d7c6

Comfort TV

Brian Broome wrote an article Monday of this week (https://www.washingtonpost.com/opinions/2022/07/25/comfort-tv-golden-girls-escape/) about turning off “the strife” in our relentlessly cruel, crazy world. His solution is to watch comfort TV, and he listed his favorites.

He said: “And I watch them over and over. I long ago memorized all the dialogue and every twist and turn that these shows and episodes will take.”

Broome noted that, “You might even engage in this soothing ritual alone . . . .[because you] just can’t deal with the outside world. . . . We are supposed to ignore those nagging feelings of worry, angst and helplessness . . . .”

Broome’s article resonated with me because I also watch comfort and escape shows and also because this is also something that disabled people sometimes do. See my blog post of October 1, 2019: https://disabilitydisability.blogspot.com/2019/10/do-you-watch-tv.html

As I pointed out in that blog, taken from my book on how to apply for Social Security & SSI disability, claimants for disability benefits actually have to explain their “watching television” so as not to be denied benefits.

Social Security disability administrative law judges are trained, when questioning about memory issues, to ask claimants, “Can you follow the story on TV[?]”

Television comfort shows, as I have written, serve many purposes:

“In reality many people leave a television on as background noise or to offset other noise in an apartment building or on the street outside, as a way to block out intrusive thoughts and/or as company when lonely and depressed. Many people identify with the characters portrayed in television series—they become almost like real friends. Many people will doze off for brief periods when watching television particularly people who are in constant pain and people who are unable to sleep through the night. Perhaps a claimant may be able to concentrate on television programs, and that while watching TV, his pain is somewhat dulled.”