USA: The RECOVER Initiative - Long Covid research

https://twitter.com/user/status/1866543043882434658
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There's mention of Recover VITAL, a trial of paxlovid and ritonvair. It's an odd clinical design.
Treatment 1 - 25 days of paxlovid
Treatment 2 - 15 days of paxlovid and 10 days of ritonavir +placebo
Treatment 3 - 25 days ritonavir +placebo

There's no proper control.

I think there will be 300 people with 'exercise intolerance', 300 with cognitive dysfunction, 300 with autonomic dysfunction.

https://twitter.com/user/status/1866543600185622931
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The outcomes seem a bit hopeless. For example, the primary outcome for autonomic dysfunction is given as 'Orthostatic hypotension questionnaire'. The primary outcome for exercise intolerance is a modified DePail Symptom Questionnaire - PEM. And the secondary outcome is an endurance shuttle walk test. If that is the 6 minute walk test, then that does not show sufficient discriminating power in mild ME/CFS.
 
NIH Director Dr. Bertagnolli at NIH ACD today in kick-off welcome speech portion:

"To put it simply, we need to evaluate more potential treatments for Long COVID. This is a pervasive & very challenging disease. In this process, we're ensuring that patients are meaningfully engaged as our true and equal partners in research. To put it quite directly, we cannot succeed without having patients at the forefront, particularly of these clinical trials. The only way to design and carry out effective research for Long COVID. Our goal is to address the needs of those suffering from Long COVID by being very transparent in our approach, flexible and responsive to a changing landscape that they are living everyday."

https://twitter.com/user/status/1867229731219030244


https://twitter.com/user/status/1867249845574004849
 
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12/12/24: 'NIH adds funds to long COVID-19 research, advances work on new clinical trials'

'NIH recently received approval to reallocate $147 million to support ongoing efforts of the RECOVER Initiative'

'This allocation is in addition to the $515 million that NIH announced earlier this year, bringing total new funding to $662 million.'

'RECOVER will allocate approximately $300 million to RECOVER-TLC clinical trials'

'Long COVID is a complex and debilitating chronic condition affecting people’s ability to work, attend school, and participate in their regular activities. Alleviating the suffering of so many individuals, their families, and their caregivers is a priority of NIH. We look forward to further advancing our understanding of long COVID and advancing prevention and treatment.'
 
12/10/24, 'A Frank Conversation with Long COVID Research Leader Janelle Linton, MPH'

'Linton, MPH of NYU Langone is the Assistant Program Director for Community Engagement in the Long COVID study called RECOVER'

Linton: "We're fighting every year to make sure that we keep getting funded to do this work."

"The public is waiting - they're waiting for results - they want to know, especially since we are a billion dollar study."
 
Nath seems openly still only interested in early intervention/ prevention and seems to be happy, as probably lbh many are if unchallenged, to just write the damaged, long term with ME/CFS off
, ie reducing ME/CFS research funding, despite saying ME/CFS has a damage that’ll be harder to treat.
 
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12/17/24 - 'RECOVER’s tissue pathology (autopsy) study makes unique contributions to Long COVID research'

“The main activity for the study, which we hope to be launching in the very near future, is called ‘Pathology of PASC...we will be inviting specially trained pathologists from across the country to examine the RECOVER biospecimens."

“We want to know if viral persistence can cause Long COVID. If it can, we want to know where the virus remains in the body. We want to know which Long COVID symptoms are due to reversible changes that can be targeted with treatments to relieve those symptoms, and we want to use this information to design clinical trials that deliver positive results.”

– Dr. James Stone, Principal Investigator, Chair, RECOVER Autopsy Cohort Coordinating Committee
 
'Long COVID and sleep: an urgent call to action' by Dr. Elizabeth Benge, Harvard (RECOVER PI)

'Long COVID underscores the urgent need for a multidisciplinary approach to post-viral care. Patients deserve a medical system that validates their experiences, invests in research, and provides effective treatments.'

'At the same time, we must advocate for research funding and collaboration to address the gaps in our understanding of long COVID.'
 
12/29/24, MDPI by Leonard A. Jason: 'Methodologic and Policy Efforts to Improve a National Long COVID Study'

Abstract:

'Researching COVID to Enhance Recovery (RECOVER) is a National Institutes of Health initiative to improve our understanding of recovery after SARS-CoV-2 infection and to prevent and treat Long COVID. For almost two years, I worked with a RECOVER Task Force called Commonalities with Other Post Viral Syndromes, whose scope was the overlap of Long COVID symptoms and possible pathways with other post-viral syndromes, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and other dysautonomias.

In this article, I review how I was selected to be on this Commonalities task force, and my role as chairperson of a subcommittee that accomplished some specific goals, such as being able to introduce ME/CFS-specific symptoms and ways to assess them in the adult and pediatric RECOVER battery. An effort to have a study funded to collect an independent sample of patients diagnosed with ME/CFS before the pandemic was not successful. This commentary outlines the process of working with this Long COVID task force, including steps such as questionnaire development, protocol design, reviews, and policy initiatives. The outcomes of this task force and subcommittee are reviewed, and lessons learned are presented for those with an interest in working toward policy and structural change.'

8. Unsuccessful Policy Initiatives

'As mentioned in the above section, our subcommittee endorsed the idea of recruiting an ME/CFS cohort that had become ill before the pandemic. We recommended that among controls for RECOVER, 200 patients with ME/CFS be recruited for comparison purposes. We recommended that among controls for RECOVER, 200 patients with ME/CFS be recruited for comparison purposes. This would allow us to determine the extent to which ME/CFS and Long COVID share similar pathobiology (e.g., cytokines, NK cell function, and markers of neuroinflammation).

Our group spent a year obtaining approvals from multiple RECOVER committees for this proposal, including the Ancillary Studies Oversight Committee. Even though approval for this sample was obtained, funding was not provided for this initiative, so the study was not launched.'
 
NIH Statement from Monica M. Bertagnolli, M.D., on ending her tenure as NIH director

Quotes:

I am announcing today that I will step down on Jan. 17, 2025, as the 17th director of the National Institutes of Health (NIH).

...

Recent events have brought far greater understanding of the threats that we all face from infectious agents. The COVID-19 pandemic has brought great suffering to the world, and even after recovery from an acute infection too many people experience prolonged harm. To further bolster research efforts to find treatments for long COVID, NIH launched a new component of the Researching COVID to Enhance Recovery (RECOVER) initiative(link is external) called RECOVER-Treating Long COVID (RECOVER-TLC). We convened a workshop to hear from more than 1,400 patients, advocates, health care providers and scientists to help inform this next phase of long COVID clinical trials. These trials will also be informed by extensive data from 40 pathobiology studies, review of 60 million electronic health records, and eight existing phase 2 clinical trials testing the safety and efficacy of 13 treatments that include drugs, biologics, medical devices and other therapies.

So, while I leave NIH unable to see these initiatives and more through to fruition, I am optimistic that they will continue under new leadership.
 
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