REPORT PART 2: NIH LACKS COORDINATED RESPONSE FOR LONG COVID RESEARCH

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The NIH is shaping research initiatives to study the long-term consequences of COVID-19 (long COVID), but it lacks the coordinated, outcomes-focused strategy necessary to deliver biomarkers and treatments to the people who need them.

Editor’s note: This is part of a series on what the NIH is (and isn’t) doing for ME/CFS and long COVID research. For our Report Summary see here. For Report Part 1: NIH is not Advancing ME/CFS Research see here.


The NIH is taking some important actions to fund and conduct research on the long-term health effects of COVID-19, which include but are not limited to symptoms characteristic of ME/CFS

While these efforts offer some hope, when we look below the surface we find a disturbingly familiar story: NIH leadership does not have a coordinated, outcomes-focused strategy for developing diagnostics and treatments for the many people who are experiencing debilitating symptoms months after developing COVID-19. While NIH Director Francis Collins is personally ensuring a coordinated, fast-tracked research strategy for the development of diagnostics, vaccines and treatments for acute COVID, research on long COVID is developing in a piecemeal, undirected fashion. Without a strategic, large-scale, treatment-focused research effort on par with the one being executed for acute COVID-19, a large number of those developing long COVID will likely remain ill indefinitely.

We appreciate the information that the NIH shared with us. Any opinions expressed are solely those of #MEAction.

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  1. There is no strategic plan to urgently address long COVID
  2. There is one expedited grant award pair at the NIH, which includes but does not necessarily prioritize the study of long COVID
  3. As of now, several studies within the NIH are investigating COVID-19 sequelae
  4. Some COVID-19 longitudinal studies, patient registries and data sharing efforts are taking place, inside and outside of the NIH
  5. It is too soon to tell whether COVID-19 longitudinal studies will consistently take ME/CFS into account, or measure it correctly
  6. Clinical trials on long COVID need to be prioritized

1. There is no strategic plan to urgently address long COVID

The NIH lacks a comprehensive strategic plan for addressing the looming long COVID crisis. The recently released NIH-Wide Strategic Plan for COVID-19 Research and the NIAID Strategic Plan for COVID-19 Research focus on the study of viral transmission and the development of diagnostics, assays and vaccines for the acute viral infection. These documents state a general plan to study the natural history of the disease. But they do not include an urgent, coordinated, outcomes-focused plan to address long COVID.

Congress is not improving this picture. While they gave additional funding to multiple NIH institutes to study COVID-19, the National Institute of Neurological Disorders and Strokes (NINDS), which leads the Trans-NIH ME/CFS Working Group and funds a significant portion of ME/CFS studies, did not receive any new funding, a serious oversight considering the mounting evidence pointing to neurological symptoms in COVID-19 patients. 

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2. There is one expedited grant award pair at the NIH, which includes but does not necessarily prioritize the study of long COVID

The National Institute of Allergy and Infectious Disease (NIAID), led by Dr. Anthony Fauci, is currently the only NIH institute that we know of that has released expedited R01/R21 grant opportunities to support research on SARS-CoV-2 and COVID-19. Investigators who apply should find out their score within 6 weeks of applying, with funding decisions to follow. 

One of seventeen “areas of high priority” listed in both grant announcements include “Studies to assess and characterize the natural history and long-term consequences of SARS-CoV-2 infection in various human populations including at risk populations.” Since the other sixteen areas of high priority are primarily focused on acute COVID, it is not clear how much focus there is on long COVID at the agency.

Aside from these awards, as far as we know, the NIH currently has no plans to significantly expedite the application review process for research that aims to understand and treat the complex sequelae developing from SARS-CoV-2 infection.

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3. As of now, several studies within the NIH are investigating COVID-19 sequelae

The COVID-19 Task Force, which Dr. Avindra Nath, the Principal Investigator (PI) of the current intramural ME/CFS Clinical Study, sits on, has received over 200 applications from intramural researchers who want to study COVID-19 in some form or another. While we do not know what portion of those focus on COVID-19 sequelae, defined as any condition that is the consequence of COVID-19, we do know that at least four intramural studies focused on COVID-19 sequelae have already been approved. 

The NIH has publicly released little information on most of the studies, and it is unclear whether any of them — aside from Dr. Nath’s post-COVID syndrome study described below— will include much of the neurological, metabolic, proteomic, genomic, or other kinds of testing that may be necessary to study all those systemic issues related to post-infectious ME/CFS and other multi-system post-viral illnesses.

Dr. Avindra Nath is working on a protocol to study patients with neurological sequelae. He will be bringing 50 patients who continue to have neurological symptoms into the NIH Clinical Center, after they test PCR-negative. In the first phase of this study, the patients will come in for two days for workups that will include MRIs and a full battery of autonomic testing. There will be additional outpatient visits. The study will not be specific to ME/CFS, but ME/CFS will be one consideration among other neurological sequelae. Dr. Nath plans to enroll individuals who meet ME/CFS criteria and other study requirements into the existing intramural ME/CFS study. He is also prioritizing the enrollment of people of color in an attempt to reach proportional representation among study participants.

The other three intramural studies looking at COVID-19 sequelae are led by Principal Investigators (PIs) Dr. Michael Sneller, based in the NIAID; Dr. Anthony Suffredini, Director of the Intensive Care Unit Stat Laboratory; and Dr. Leighton Chan, Chief of Rehabilitation Medicine. Information about Dr. Sneller’s “Longitudinal Study of COVID-19 Sequelae and Immunity” can be found by clicking here

These four studies are being run independently but the researchers are trying to figure out how best to coordinate their work.

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4. Some COVID-19 longitudinal studies, patient registries and data sharing efforts are taking place inside and outside of the NIH

There are some new studies on the long-term consequences of COVID-19 taking place at universities and medical centers in the United States and internationally, some of which are funded partially or fully by the NIH. Researchers hope to use data from their cohorts to better understand COVID-19 disease progression and recovery, in order to help COVID-19 patients and those suffering long-term sequelae. Some of them are focused on only hospitalized patients. Many of them are focused on immunity; most of them are unlikely to capture the full range of information needed to comprehensively advance an understanding of post-infectious ME/CFS and other multi-system, post-viral illnesses. 

The National Institute of Allergy and Infectious Diseases (NIAID) wants to use longitudinal cohorts comprising mild, asymptomatic, and severe COVID-19 cases to understand the host immune response to SARS-CoV-2 infection. 

Outside of the NIH, multiple consortiums are being set up that will run longitudinal studies on COVID-19 sequelae, including some that are intended to be interventional in nature, and some that function as patient registries for improved data banking and sharing. 

The NIAID-funded IMPACC study was launched in May to look at up to 2000 hospitalized COVID-19 patients at ten research sites. The people in this cohort will be followed for at least a year after their release from the hospital. Originally most cohorts focused on hospitalized patients. In some instances that’s changing – through mobile blood draws and other methods, the original cohorts of hospitalized patients are broadening to include mild and asymptomatic patients, as well as hospital workers who were exposed. This is a positive development, as a significant minority of people with asymptomatic or mild acute COVID-19 are among those developing long-haul COVID symptomologies that overlap with ME/CFS. 

Another NIH-funded study, called LIINC (Long-term Impact of Infection With Novel Coronavirus (COVID-19)), will be following approximately 800 “individuals with prior SARS-CoV-2 infection across a wide spectrum of age, race, gender, and disease severity” for up to two years, and will include in-person study visits and biological samples.

There is an emphasis in the NIH-funded studies on enrolling cohorts that includes representative minority populations, particularly since they are being hardest hit. In additionmaking scientific and medical data publicly available is also a major emphasis for these studies, particularly to mitigate limitations posed by limited sample sizes, and by geographic site-based study enrollment. 

The only longitudinal study we know of that includes samples and is focused on the development of ME/CFS after acute COVID-19 is being funded by the Open Medicine Foundation. The study includes “collection of body fluid samples at frequent intervals, continuous health monitoring via wearables and symptom data recorded at many separate timepoints over the course of 2 years.”

Solve ME’s You+M.E. Registry now includes a COVID-19 questionnaire in their survey dashboard to track the impact of COVID-19 on people with pre-existing ME/CFS. In addition to doing direct outreach via social media, they are partnering with existing COVID-19 registries and apps to refer those who have developed ME/CFS-like symptoms after COVID-19 to the You+M.E. registry.  

Many pre-existing longitudinal cohorts have joined the COronavirus Pandemic Epidemiology (COPE) Consortium, and members of the cohorts can track their symptoms in the COVID Symptom Study app, which has been downloaded more than four million times.

There were several pediatric cohorts started last year to study influenza immunity and now these same cohorts are adding COVID-19 patients, some including mother-child pairings. Emerging reports indicate that children with COVID-19 are also experiencing long-term sequelae, in addition to MIS-C. Children must not be forgotten in any strategic research planning.

One data-sharing platform that is particularly important for tracking COVID-19 sequelae, including ME/CFS, is part of the National COVID Cohort Collaborative at the NIH’s National Center for Advancing Translational Science. Their COVID-19 Analytics Platform will collect data on people tested for COVID-19 from 35 medical centers across the country for five years so researchers can use it to accelerate COVID-19 research, improve clinical care and identify potential treatments. It is not given that ME/CFS symptoms and diagnoses will be captured accurately by clinicians and tracked in this or other data platforms. That is an area that will require ongoing work and diligent monitoring. 

For a list of some registries and studies looking at COVID-19 sequelae click here. We will continue updating this list over time. 

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5. It is too soon to tell whether COVID-19 longitudinal studies will consistently take ME/CFS into account, or measure it correctly

Although we don’t know how many of the researchers applying for funding from the NIH will get a chance to speak with NIH program directors familiar with ME/CFS, these staff are in touch with investigators at hospital groups that are tracking individuals who are post-COVID-19 infection. The program directors are connecting them with health care providers and researchers to advise them on measures of fatigue and ME/CFS symptoms, and to ensure that ME/CFS is part of the researchers’ considerations post-infection. 

While this is good news, it is not systematic. A set protocol for measuring ME/CFS and an accountability system for ensuring these measures are being used in all COVID-19 longitudinal research is necessary for consistent, high impact in this area. Consistent, validated instrumentation is central to ensuring that ME/CFS is accurately diagnosed and that studies can be compared to one another. 

The NIH is not planning to require researchers to use specific instruments or tests, but it is developing a protocol for ME/CFS measures that all investigators of COVID-19 longitudinal studies (across the relevant institutes) should use in their studies. They plan to use the ME/CFS Common Data Elements (CDE) oversight committee and other knowledgeable clinicians and researchers to develop this protocol. We have asked for knowledgeable members of the ME/CFS community, and specifically people with ME, to be involved in every phase. If properly designed and instituted, a set protocol for using ME/CFS measures across all COVID-19 longitudinal research could have a significant positive impact. But at this stage, that outcome is not a given.

This effort to establish a new protocol does not replace the urgent need for the NIH to fund and support a meeting of ME researchers and clinicians to reach consensus on patient selection methods and criteria for research, which ME activists have been demanding for years.

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6. Clinical trials on long COVID need to be prioritized

The central goals of research into multi-system, post-viral illnesses developing from COVID-19 should be the rapid development of treatments and preventive mechanisms, as is the case with research on acute COVID. Dozens of readily-available, symptom-reducing on and off label treatments are currently prescribed by ME/CFS expert clinicians and should be evaluated for safety, efficacy, and subgroup relevance in clinical trials. They could benefit people with a range of complex, multi-system long COVID illnesses and symptoms, as well as those with ME/CFS. NIH leadership needs to prioritize clinical trials that could help the many people developing multi-system, post-viral illnesses after COVID-19.  

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This is part 2 of a two-part reporting series by #MEAction on research at NIH. 

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