NIH ME/CFS Advocacy Call, November 5, 2020

Ms. Margo Warren: Good morning everybody. I'm Margo Warren. I'm from the Office of Neuroscience

Communications and Engagement at the National Institute of Neurological Disorders and Stroke at NIH. Thank you so much for joining us for today's discussion. We want to welcome you on behalf of NIH.

Today's call is being recorded so if you have any objections to that please disconnect at this time. Dr. Walter Koroshetz, our director, will introduce all of the speakers and they will each make remarks after which we will invite you to have some questions. If you have questions, please put them in the chat box. You can submit them at any time during this meeting in the chat box.


We'll try to make our remarks brief so that there's time to answer as many questions as possible. So now I'm going to turn it over to Dr. Koroshetz. Thank you.

Dr. Walter Koroshetz: Hello everyone and it's a pleasure to talk to you today about the work that's been ongoing in the area of ME/CFS here at NIH and in the laboratories and clinics of our grantees. And as everyone knows we're in the midst of a very unusual situation, the pandemic.

And I'm sure that everyone on the call is wondering about the implications for ME/CFS of the current viral pandemic. So I just wanted to start out a little bit telling you about what we know so far and what the intersection with ME/CFS looks like and then lots of questions that are unanswered but NIH is really committed to try and understand them.

So the first thing I wanted to show you is, on this first slide is a study from Spain of people who were hospitalized for COVID-19 and this is 110 days later, so this is more than three months later and you can see that 55 percent of the people are completely.

Dr. Avi Nath: We can't see your slides.

Mr. Timothy Lyden: Walter, you have to share your screen again.

Dr. Walter Koroshetz: Okay, how about now? Do you see the slide?

Dr. Avi Nath: Yes, we can see it now.

Dr. Walter Koroshetz: Okay. Still see them?

Dr. Avi Nath: Yes we see them, but you need to switch the display. Currently we see two slides simultaneously. So if you go to display settings on top and click on that. Yes then that will just swap the other top, there you go this is good.

Dr. Walter Koroshetz: Okay, so the point here is that of hospitalized patients there is a large percentage of folks who are having trouble even three months later. And as you can see fatigue and memory loss poorly defined but certainly overlap with ME/CFS.

Dr. Avi Nath: Maybe it's just to me but the left quarter of your slide is cut off. Is that just my problem or is it, yeah it's just cut off a little bit but we can make out what you are saying.

Dr. Walter Koroshetz: The other symptoms in this group are difficulty breathing, sleep disorder, cough, and chest pain. Some of those things are certainly different than what you see in ME/CFS but clearly things that you might expect after COVID-19. There is another study from the CDC and that is looking at people who were not hospitalized. These are outpatients returning to two to three weeks later and 35 percent of those people have not fully recovered. So these are less-sick patients than were in the Spanish study. And you look at what the complaints were, you can see here, fatigue is certainly the most common symptom, cough is still common, headache is very common, pain, loss of smell, and then what they call confusion, which other people call brain fog.

And what was not reported is anxiety and depression, which is probably also a major component and I would say that just to compare this with say, influenza, a similar study would show that 90 percent of people with influenza would recover within two weeks of a positive test. So clearly we know with COVID that we're dealing with something that is lasting longer in some people and we don't know why, what determines that, we don't know how long things will take to get better, and we don't know if some people will have really long persistent problems like we've seen with ME/CFS.

But these are big questions that need to be answered and with COVID we have this opportunity to see people coming out all at once, we know what the virus is and so it's a special opportunity to try and understand it which is important for COVID but could also have some lessons for ME/CFS. The tricky part is that so many different organs in the body are affected and so it's going to be complicated and take a lot of work to try and understand what organ systems are the cause of the trouble that people are experiencing over the long run. With that, so at NIH there's going to be a workshop on these, this problem which is run by NIAID so I’d like to turn over to Joe Breen to just mention that workshop and what it's about.

Dr. Joe Breen: Thank you Dr. Koroshetz. My name is Joe Breen and I serve on the NIH ME/CFS Working Group as the NIAID representative and actually manage many of the grants at NIAID regarding ME/CFS and I'm part of an organizing committee that was put together for the workshop that Dr. Koroshetz just mentioned, which also has significant participation from other ICs such as NINDS and NHLBI and others, since this is obviously a multi-systemic problem with post-COVID in particular. The workshop will be held December 3rd and 4th and will be completely publicly available and viewable. The title is "Workshop on Post-Acute Sequelae of COVID-19".

The agenda is still in development, but I anticipate that the agenda and registration will be available by the end of the week. I know that the registration site is actually being tested right now. And it's an opportunity really, the goal is to bring in clinicians, patients, patient partners, as well as folks who are studying the virology of SARS-CoV-2 to really characterize the post-acute sequelae and identify key knowledge gaps that need to be addressed.

So really the goal is to identify knowledge gaps and identify opportunities and that is really important because as you might imagine NIAID and others at NIH have set up some longitudinal cohorts to study originally acute disease but now are transitioning that to follow on for, in order to measure long-term sequelae because now there's a recognition that this is a large problem and needs to be addressed.

And Dr. Fauci has been very upfront about that. He's been in the media as I’m sure you've seen and that a lot of that has stimulated this conference, which again will be December 3rd and 4th and we will distribute the registration information using the listserv mechanism that we use for ME/CFS, because there's obvious crosswalk as Dr. Koroshetz just described. Thank you.

Dr. Walter Koroshetz: I would also say that NINDS is funding a couple of grants now which are looking at large numbers of people who had COVID and looking for what their problems are, particularly in the cognition, fatigue space, exercise intolerance is clearly a big problem in post-COVID but heart and lung are also big issues. At NIH intramural program Dr. Nath who you've heard from before who runs the ME/CFS protocol at intramural could also mention about his protocol for post-COVID. Avi.

Dr. Avi Nath: Since we already have experience in bringing in patients with ME/CFS and already have a protocol with it, we decided to create another protocol very similar to that so we can bring in patients who may have ME/CFS from COVID and study them. At the moment we're doing all the telephone screening and interviews and stuff and then we'll start bringing in these patients for that purpose. And they will undergo the same type of investigation that the other ME/CFS patients are undergoing.

Dr. Walter Koroshetz: That will really be great because you've had so much and your team has had so much experience with ME/CFS so a great way to look for the overlap. Great, okay, so we're going to hear from some folks today. Dr. Nath will provide updates on the intramural study. Dr. Breen will talk to us about the consortium. Dr. Vicky Whittemore will talk about the Trans-NIH Working Group and the Interagency Working Group. And we're also delighted to be joined by Allison Kanas, administrative director of community outreach engagement at the Center for Solutions for ME/CFS at Columbia.

And she'll talk about this recently launched Community Advisory Committee, a bridge between the ME/CFS community and researchers in our Collaborative Research Centers. As always, we're eager to hear from you and so we'd like to keep our remarks brief before answering your questions. And I'd also say that we received 24 questions from MEAction yesterday. All good questions and we will compose responses and get back with those responses to MEAction. So thank you for coordinating that. We'll hit on some of the questions during the discussion today as well, we'll try to do that. All right, now I’d like to turn it over to Dr. Nath to talk about the intramural study update.

Dr. Avi Nath: I can give you an update. You know before COVID hit, we had enrolled 25 controls and 24 ME/CFS patients. Of those, 21 controls met our criteria and 17 were unanimously adjudicated as ME/CFS. And during the COVID time now we were unable to bring anybody to NIH, so we decided to start analyzing the data. We collected a lot of data on this and actually in a way that's a blessing in disguise because there are a lot of very interesting observations there that we are trying to put together and then we need to reconfirm and do additional assays on the samples we've collected.

I think that's actually come along beautifully and now we've initiated two COVID studies, one looking at all the neurological complications and the other which will be focused more on ME/CFS. But this time we can do a much more targeted investigation on the COVID ME/CFS patients that we bring in because we already have knowledge now from the previous study. So instead of doing everything, we can now do a targeted investigation and move that a lot faster, so that's our hope.

Dr. Walter Koroshetz: Thank you Avi. Joe would you be able to talk about the consortium and the data center?

Dr. Joe Breen: Sure, thank you. I'll keep these remarks brief so we have time for our guest and questions. I think the major update is we had an annual meeting in October where all three of the CRCs, as well as our Canadian partner called ICanCME, participated and the data management coordinating center, to really review scientific progress, talk about areas of collaboration, and try to move each other's ideas forward and I think it was a very stimulating meeting.

All the Centers had interesting results to present and as I've mentioned on these calls in the past you know we expect the productivity that you can see in the literature to increase as we're nearing the latter stages of the support for this segment of the CRCs and I think we are starting to see that. Actually, each of the CRCs have had publications in peer-reviewed journals in the last few months. From Columbia, a plasma proteomic profiling paper, from Jackson Labs, some interesting post-exertional malaise studies, and then Cornell, a fair bit about immunology and T-cell immunology earlier in the summer and then a more recent paper that's very interesting about extracellular vesicles and those are all publicly available.

 And the other piece I think that's important to note is that you know the two days of meeting included a community engagement panel that I think was also really productive to hear from our patient partners. That was led by Allison Kanas. And you're going to hear more from Allison about that. The data management and coordinating center has been building a project using informatics to collect the data from the CRCs that then would be publicly available and could for example help to find trends that wouldn't be easily seen in a single study and that project which you may have heard of and they've mentioned it in a few public meetings is called mapMECFS and another analog called searchMECFS, which will be used to find samples that are present in a repository that's supported by, a sample repository supported by NINDS, planned for launch in January.

So we're very excited about these two things and I think that they will show some of the productivity as well as benefit the community. And I think I'll end there so that we can have time for our guest. Thanks.

Dr. Walter Koroshetz: Thanks very much Joe and now if I could turn to Vicky Whittemore to talk about the Trans-NIH and the Interagency Working Group meetings.

Dr. Vicky Whittemore: Thank you, Dr. Koroshetz. The Trans-NIH Working Group meets monthly and what I guess some of the major things we're working on is, we had actually planned to launch a strategic planning process in the spring. That has gotten delayed because of the pandemic. Many of the individuals we were hoping to ask to participate on that panel have just been completely swamped, as we have, with working on post-COVID issues, but we hope to launch that towards the end of this year.

And we're also discussing what comes next after the five-year funding period for the current collaborative centers. They're in their fourth year of funding currently and so it's timely for us to be thinking forward about what the next steps will be and what that will look like. And again something else that got delayed, we had been planning a workshop to discuss clinical endpoints and outcome measures to be used in clinical trials on ME/CFS that we were hoping to have in the spring. But we're back working on that again and hope to have that workshop in spring of 2021.

The Interagency Working Group, the first meeting focused largely on post-COVID issues and from that meeting we have really been working very closely with some of the our interagency partners, primarily with NIAID, who's taking the lead on the workshop but staying in close communication with the CDC, who recently funded a very large grant to Nancy Klimas at NOVA to follow post-COVID patients and is doing quite a lot of work on epidemiology and other issues, other studies as well.

The next meeting of the Interagency Working Group is currently being scheduled to take place at the end of February and the CDC is organizing that next meeting, with a focus on workforce development and medical education. So we're in the process of developing that agenda and in the next couple of weeks and we'll get that out to the community as soon as that's ready. We likely will be developing smaller working groups going forward especially around some of the workforce and medical education issues following that meeting and so we'll be working with our patient partners and advocates to help us in that effort as well. With that I'll turn it back to Dr. Koroshetz. Thank you.

Dr. Walter Koroshetz: Thank you for that Vicky. And now we'd like to turn to our special guest today, Allison Kanas. As I mentioned she's the administrative director of community outreach and engagement at the Center for Solutions for ME/CFS at Columbia University. And I would say, you know in my career, there's a growing effort to include patients and people with lived experiences right into the design and operation of research. But it is something new and I think we have a lot to learn, but it's I think an incredibly promising effort and I'd love to hear what Allison has to say about this in the ME/CFS research community. So Allison can we turn it over to you?

Ms. Allison Kanas: Yes, hi. Thank you for that nice introduction Dr. Koroshetz.  Let me try to share my screen here. Okay so for those of you that don't know me, although Dr. Koroshetz gave me a nice introduction there, my name is Allison Kanas and I have been with the Center for Infection and Immunity at Columbia University for over 10 years and involved in the ME/CFS research that the center has been conducting since then.

Now I've taken on the role as the director of community outreach and engagement, which we have just recently launched a new network-wide initiative that I'm going to share a little bit about with you today.  Just to remind everyone that the distinction between outreach and engagement and today I'm going to talk a little bit about both of those things and including our community advisory committee that we've recently launched but I wanted to walk you through a little bit about what we've done in the past as the Center for Solutions and how it has evolved into the network-wide initiative that we've recently launched.

So as you'll see, outreach is really one, unidirectional communication and that's communication we see it as from the research centers or the Collaborative Research Centers to the community. And engagement is real bidirectional communication and partnership with the ME/CFS community. So as I said, I've been the one working on the various administrative capacities on the ME/CFS research that we've done at Columbia since we started with the XMRV research in 2011 and then we had the Chronic Fatigue Initiative that we worked on for a few years as well, with more pathogen discovery focused work.

And around that time when we were working on CFI we were approached by a dedicated group of patients that wanted to help us raise more funds to expand the work that we were doing. I was the primary liaison for the communication and partnership with this group of people living with ME and this was proven to be extremely successful. They were extremely grateful for the partnership that we had with the Microbe Discovery Group project and they helped us raise, which really you know highlights the dedication of this community, they helped us raise over $220,000 from microdonations, thousands of microdonations globally.

And really helped us to be well positioned for as we know when these, when the RFA for the CRCs came out, a component of it was engagement and partnership with the ME/CFS community so the fact that we had this long-standing partnership with this patient community group, really well positioned us for being competitive for this work. Once we were awarded, so thank you to all of them, all everybody that helped us get to where we are because we were then competitive and won the clinical one of the clinical research coordinating sites.

With that we had some engagement and outreach components built into that structure of the award. One of the things we first did for the communication component and the outreach component of the Center for Solutions for ME/CFS was we developed our website it's you know again working on outreach, which is just communication and transparency and a lot of the criticism that we get and NIH gets about you know when we're awarded these centers, it takes quite a long time for a paper to come out and that leads to some frustration within the community and others that we are not really knowledgeable of the progress of the work that's going on.

We started with our website, which explains who we are and explains the projects that we're working on, also gives information about our partner groups, and other resources available to the community. And then we also worked on developing our Facebook and our Twitter accounts, which was great. I mean it was a wonderful way to start our communication and our outreach. However as anyone who works in communication and communications knows what you communicate is only as powerful as the audience that you can reach.

We had these two sites and our website but our traffic was pretty low and how we had to be more creative with how we engaged with the community. So we sat back and said to ourselves, okay so we have this website that explains what we do, we have Facebook, we have Twitter, we give little bits of information because you know like I said research is slow and incremental and we're really only used to sharing findings once a paper is published.

We really then sat back and said well how can we achieve the goal of outreach and engagement and break down this barrier between the community and the researchers. We decided to come up with the strategy of the Ask Our Researchers Video Q and A series. What we did was solicit questions through our social media sites solicit questions after we had the website developed and it explained what we were doing, we solicited questions from the community that they wanted our researchers to answer.

And we were really excited that we had such positive feedback on that and questions really came flying in left and right and that helped us you know, gain more traction in our communication and outreach component of our work so once we did that we developed our YouTube channel and this was very successful as well. We were able to pull out some researchers from our annual meetings and we had the questions ready for them and they recorded answers during our annual meeting.

And as you see, you know from here, from September to October of 2019 we'll have about 1200 views. But then once we launched our Q and A series more broadly you'll see that really broadened our reach quite significantly. If you see the 567 percent increase of followers and that just expands our impact and reach so much more broadly. So then we, that also helped expand our Facebook following. We have 800 followers and that's a fairly decent metric for success here and our Twitter we're thrilled to have 1300 followers. So our reach is getting that much broader.

However then we said, then we once we had the Q and A series then we have more of an established following we then decided to dig a little deeper and started our Center for Solutions for ME/CFS blog, which delves more deeply into specified topics and also is another outlet for engagement because there's you know, you can comment and we can respond and things like that. So you know and one of the things that we just recently did on there, we had you know this proteomics paper that Joe was talking about, was really quite dense so we asked one of our researchers, Dr. Komaroff, to kind of explain it in more layman's terms and was able to dig more deeply into the implications of these findings for the community.

And then more recently Dr. Komaroff also did a blog posting about the post-COVID long-hauler syndrome and we're thrilled to say that we have, I was very impressed of the following that we now have on our blog, which is 7,500 views. And if you see we have 62 countries that we reached, which you know really had an impact on me about the global reach, the ability for this type of communication. So at the same time we were developing our outreach and communications approach, we also we also knew that we were committed to forming a Community Advisory Committee and honestly that was a bit of a struggle for us.

We did release an application to the community. We put it out through our social media platforms and we received over 40 applicants and accepted about eight members. And where our plan for engaging the work the Community Advisory Committee was to assign the working groups and to schedule a schedule of activities and really engage the Community Advisory Committee. Now that is when we kind of, where we were stumbling a bit and I'll be the first one to say that we were, we were struggling a bit with the challenge of how best to engage a Community Advisory Committee in scientific research and somebody just alluded to this too.

This is, I think it was Dr. Koroshetz, this is a novel approach for us and in basic research and research institutions we're not, it's not second nature for us to engage and partner with the patient community.  So this is where I, then in June 2019, when I presented to our center meeting the work that we had done to build our outreach and communication and explained how we were struggling a bit with how best to engage the Community Advisory Committee.

After that meeting is when Vicky and others approached me and said, well you know we like what you're doing with outreach and we're wondering if we can potentially expand that for the network and at the same time you know determine how best to engage a Community Advisory Committee so we went back and forth about how best to do that because one of the things that was limiting our ability to efficiently, effectively engage a Community Advisory Committee was the internal resources, the funding, and personnel resources to be able to manage an advisory committee.

If you have something large enough that's a pretty significant commitment of a individual or two at a research institution that is not used to doing work like this. So that's when we started to talk and develop a strategy and then again in October of 2019 we had our full network meeting, which has representatives from all the Clinical Research Centers and our clinical, I'm sorry, Collaborative Research Centers and our clinical partners and advocacy organizations so we discussed it a little bit more there.

And from October 2019 we went back and forth a few times with multiple iterations of a proposal that would be responsive to what the NIH is interested in funding as well as responsive to the community needs and how best to shape a Community Advisory Committee and what type of information we wanted to be able to disseminate. And you know so that went back and forth for many, many months and then in December or January, December 2019, in January 2020, we came up with a strategy and approach that we were all quite happy with.

This is the expanded approach that we, this is the outline and structure of the expanded approach for doing our outreach and engagement work to be a network-wide research resource. NIH then you know increased our funding to be able and gave us an administrative supplement to be able to have more resources available to expand the work to be a service for the entire network. The Center for Solutions serves as a conduit between the NIH CRCs and performing these activities on behalf of the network, not just on behalf of the Center for Solutions anymore.

And then COVID hit. So we're still very  dedicated and committed to moving the initiative forward and we will, we were still working in the background to launch this but the you know NIH and NINDS and NIAID you know were really fully occupied with and even us at Columbia were occupied with our COVID research so we were still committed to doing this work but it was just a bit delayed. So I'll start with explaining here a little bit about how we expanded our outreach and communications and then I'll get into more of the engagement approach.

And you'll see that the engagement approach includes an expanded video Q and A series for the researchers throughout the network as well as a Community Advisory Committee that will serve the entire network. I'll start with the outreach and communication. So when we evaluated what, how we could broaden our reach and communicate more broadly to the ME/CFS stakeholders, we said we evaluated how many different online platforms each of our partners and partner organizations and institutions had. And it was you know over 25 different outlets.

So we said if we could somehow you know join forces and establish, what we wound up doing was establishing a communications hub. So this is housed on Slack and we identified either administrative or communications representatives from each of our partners. You'll see here that's and we have a representative from all of our partners on the Slack channel so this helps us in any time to align our message and broaden our reach.

So anytime there's a paper that comes out of any of our sites, a meeting or a presentation that one of our researchers or affiliates are doing or any newsworthy item that we feel would be helpful for the community to be able to share and reach so broadly we put it we warn each other and alert each other to upcoming information and help with the language for posting on all of our social media sites. So that's we you know we have really just started with this.

We have everybody identified and we are housed on a Slack channel and you know it has worked pretty successfully. None of us are really used to this way of doing things, so we are continually working with each other to remind each other to share this type of data, this type of information to be disseminated. So then that leaves me with ending with our Community Advisory Committee.

Like I said we had accepted I think it was eight members of the community to serve on the Community Advisory Committee and during the summer and during the pandemic lockdown we reached out to everyone that was originally accepted, now it had been a long delay so that was not something I was looking forward to, having to do my mea culpa with everyone I  about resurrecting our work but the fortunate thing is I was able to explain how we would now be expanding the scope of the Community Advisory Committee to serve as a network-wide resource so that really got people excited and I've gotten a great response to wanting to participate and being willing to participate.

So I thank everybody for their patience and sticking with us, but we're excited that we have a pretty solid approach to this and we're looking forward to the work that we're just starting together. So you'll see we have an advisory committee and we broke it out into working groups which is you know, information dissemination to increase communication, study feasibility to help inform study design, to increase research participation and inclusivity in the participation of research of clinical research studies and then we were able to add a CAC research priorities which will recommend future pathways for ME/CFS research.

And recently with the conversations that we've had with everybody we really saw a need within the network and within you know the broader ME/CFS community to expand CMEs. And we're not in the business of developing new continuing medical education formats and courses, however there is a lot of information out there so this committee will be determining what CMEs are available and helping us figure out ways that we can get them released and used within our network institutions. We'd love to get them through Columbia and Cornell and Jackson and other places like that. So the goal of our working groups for information dissemination is you know increased communication and transparency and study feasibility is to increase research participation and research priorities is to you know accelerate the pace of research with the overarching goal of finding real solutions to ME/CFS in the near future.

We're proud that we have, we were able to assemble a 14 person committee, with representatives from MEAction, Solve, our Canadian partners at ICanCME, Bateman Horn Center, folks with Jax and Cornell, as well as caregivers and other non-affiliated people living with ME. And we were excited as Joe said, we had our network meeting last month and we had what I thought was a, and others as well from the feedback I received, thought what is a very productive conversation. We had a panel discussion with all 14 members on Zoom. We were hoping to have it in person but this is a new time, and as well as representatives from NIH and researchers and clinicians and we really had a productive dialogue that I feel like broke down a lot of walls between these communities and which was really the first step to establishing trust in a relationship and partnership here.

We're really excited to be, the current status of this is we are designating the appropriate folks to the working groups. We're also working with our partners at the Canadian, at ICanCME, to develop a terms of reference, which is kind of like a bylaws for how a Community Advisory Committee operates. And then we're going to be setting, once the working groups are designated, we will be meeting and setting timelines and milestones and goals for the next two years of our work together.

We're really excited about this new initiative. We see ourselves as you know bridging the gap between ME/CFS stakeholders, the caregivers, advocates, and people living with ME and the researchers, clinicians, and sponsors here. We feel like we're well positioned to make some real progress in this realm. So that's all I had at this stage. Does anyone have, I don't know if we're taking questions right now.

Dr. Walter Koroshetz: I think it would be great if there's any questions for Allison.

Dr. Vicky Whittemore: Yes, so there are some questions for Allison. I'll be moderating the questions. We have several questions that have come in. I'll start with those to Allison and then move to the rest of the panel. So Allison, Whitney Fox is asking how can patient advocates help your efforts to increase engagement and in turn increase stakeholder involvement.

Ms. Allison Kanas: I'm sorry can you repeat that?

Dr. Vicky Whittemore: How can patient advocates help your efforts to increase engagement and in turn increase stakeholder involvement?

Ms. Allison Kanas: Well I mean that is why we've established this Community Advisory Committee because we do have patient advocates, caregiver advocates, advocates from Solve and MEAction represented. If this person is wanting to become involved more directly with our Community Advisory Committee they could reach out to me directly and we can establish some kind of arrangement. I also encourage you, if you haven't, to work with Solve and MEAction directly. I hope that answers that question.

Dr. Vicky Whittemore: Yeah, thank you Allison. And another question from Scott Simpson who comments that in the HIV community patients needed to develop the meaningful involvement of people with AIDS in order to move beyond tokenism. Many AIDS service organizations signed on research organizations to a much lesser extent but it was effective in integrating the patient voice and the question is perhaps do you think this type of a tool could help advance the ME voice.

Ms. Allison Kanas: That's exactly what we're trying to achieve with the work we're doing here and the HIV AIDS model has, you know, proven to be so successful with this so that is the work we're hoping to build upon and incorporate into this approach.

Dr. Walter Koroshetz: Allison, I'm just wondering whether, one silver lining to the COVID epidemic is that we all work by Zoom now and what I can imagine, you know, that might have some advantages, particularly in people who have, you know a lot of trouble going to meetings and person-to-person stuff. Do you want to comment on how you think technology has changed things.

Ms. Allison Kanas: Sure, yeah and thank you for prompting me on that because one of the things that we incorporated into this approach which I didn't mention is that the Community Advisory Committee is primarily housed on the Slack platform because we know that so many folks have, first of all we have people from many many different time zones and people go through different phases of wellness or disability, times that they're not able to participate at certain times so the Slack platform is, I'm not sure if you're familiar with it, but it's a instant messaging centralized platform for communication that can be broken out into topics and channels.

So each working group has their own channel and it allows for folks to be able to comment and read on whenever they, whenever they're most available to do so. So yes that is one that technology has been has been a cornerstone of how we've designed the Community Advisory Committee. And yes I think you're right, specifically with the network meetings that are open to our Community Advisory Committee and our advocacy partners, I think the Zoom platform really has helped with that.

I do want to say that we did have our folks participating in this last network meeting and it was, while it was wonderful that they could be participating, it was as you know nearly two day meeting with a lot of dense information so I do think going forward if we have the ability to record these meetings and share it with our with our partners that would really go a lot farther too. Because there's just so many limitations of you know first of all people's time for more than a day meeting but second of all, the stamina to be able to stay focused on, it was tough for me so I can't imagine how it was for other people suffering with this, so yeah.

Dr. Vicky Whittemore: I'll jump to a question for Dr. Breen. When will the database, this is from selinl, when will the database from the center grants be available to other investigators and how and where do we access it?

Dr. Joe Breen: That planned launch will be in January 2021, where that information will be publicly accessible through what's called mapMECFS, which I'm sure we will promote broadly when it is, it's being tested now, and when it's launched I think it should be available to all. Did I answer all that question? Did you have a second question in there Vicky?

Dr. Vicky Whittemore: Yeah, so the link to, Joe's right, we will blast out when it's launched and work with Allison also to announce the launch and there will be links to mapMECFS from the website that RTI has developed for the collaborative centers. The other thing we'll be launching in January as well is another tool that the data coordinating center has developed which is called searchMECFS, which will allow investigators to search a biorepository that we've brought in from a CFI-supported study that's now being housed at the NINDS-supported biorepository called BioSend at Indiana University. So the ability for investigators to search what's available both in the clinical data and the associated biospecimens and to request access to those biospecimens, that will also be launched in January. And I'm sorry Allison were you?

Ms. Allison Kanas: No, that's fine thank you. I just wanted to add what Joe and you both alluded to as, yes this is one of the things that we're excited to be now be working through our communications hub and our new outreach and engagement expanded video Q and A series. When the site becomes available, we will be pushing it out and promoting it through all of our channels, but we were also planned to be doing and we got Matt Schu, the project lead over there, to agree to do a video Q and A, so we'll be soliciting questions from the audience, from the community, once it's released and available and folks have a chance to take a look at it and Matt will be able to answer some questions and do a video that we will release to the community as well.

Dr. Vicky Whittemore: Thank you so there's a lot of questions about post-COVID studies. I guess I'll direct these questions to Dr. Nath, Dr. Koroshetz, and Dr. Breen. So first is, are the studies on, this is from Sonya, are the studies on post-COVID also tracking post-exertional malaise and sort of a related kind of question from Eric is for those with post-COVID who meet criteria for ME/CFS, why aren't you telling these patients they likely have ME/CFS to consolidate the research. So who wants to take those questions?

Dr. Avi Nath: I can take those questions. So yes we will be looking at post-exertional malaise as an important component of the ME/CFS patients that we bring in with post-COVID and then what was the second one, sorry.

Dr. Vicky Whittemore: Yeah so individuals who are post-COVID who meet the criteria for ME/CFS. I guess the question is are they being told that they have ME/CFS. Can we sort of leverage it and build on the post-COVID research to benefit ME/CFS.

Dr. Avi Nath: Yeah of course. These patients are a little bit complicated because they have multi-organ involvement. So they get kidney involvement, heart involvement, muscle involvement, from the infection itself. You do have to investigate them thoroughly to make sure there isn't some underlying condition that could be contributing to their symptoms. But once you can exclude them then there's no problem in diagnosing them as ME/CFS if they meet the criteria. I think all the neurologists I know of are aware of these situations and that's the way they're planning to do it.

Dr. Walter Koroshetz: The other thing to mention is that most of the people coming out are still a fairly short time period since their infection so you really have to wait and see too.

Dr. Vicky Whittemore: There's again a lot of questions about the post-COVID studies. Andy is asking are there plans to investigate physical abnormalities found in post-COVID, long-COVID cohorts and in ME/CFS cohorts so patients who receive a diagnosis of ME/CFS tend to have very little physical, scans, exams so there may be missed issues.

Dr. Walter Koroshetz: I think that's a great question because it offers the possibility that we'll learn something from studying the post-COVID patients that's a clue to ME/CFS. So we don't have any idea what it's going to be but it could be, like there's a report of iron metabolism abnormality in post-COVID that came out yesterday, you know three months after the infection. So that would certainly, you would want to say well does that occur in ME/CFS patients who haven't had COVID? Probably not, but those kind of things will come out. There's, you know, MRI of the heart is showing evidence of inflammation in the heart in people with COVID, even football players who were asymptomatic, young college football players. So no one would ever think of doing that, but if it holds then those things might actually inform the study of ME/CFS.

And the last thing I wanted to mention which I put in the chat box is everybody understands that patients with ME/CFS have a hard time finding care. There aren't people who are expert in this area but the post-COVID clinics are going to train people to be very astute in this area and I'm hoping that will kind of spill over to improve the care of ME/CFS patients around the country because these post-COVID clinics are everywhere. I just wanted to throw that out as a potential another silver lining.

Dr. Vicky Whittemore: Thank you both for those answers. There's several questions about clinical trials for post-COVID and for ME. So Courtney's asking how we can move treatment trials for ME/CFS and post-COVID urgently and Jen the same, how can we address rapidly executing clinical trials. Joe maybe can we start with you and maybe you could talk about the COVID clinical trials that are underway now and then thinking about how we can move some of that information over to and move clinical trials on ME/CFS.

Dr. Joe Breen: The clinical trial networks that NIAID has are very, very heavily engaged in COVID vaccine trials as well as therapeutics. And it's actually an NIH-wide effort, but certainly the clinical trial sites are very engaged in that, so I think that's where a lot of effort is right now. But I think even given that, we're always open to proposals that could, as Walter said, you know there is an opportunity here to look post-COVID and look at symptoms that are consistent with ME/CFS.

So I think that's what we're trying to, one of the outcomes of the workshops to get a picture of sort of a landscape of what is being seen clinically across all these systems and then try and come up with a follow on, would be like what should we be building what kind of cohorts should we be building.

So that we can study those and then test them which is what this question is really after but I think we need to understand a little bit more of the landscape of what is being seen and I think that unfortunately we do have many patients who are expressing that and are as the numbers that Walter showed in his in his presentation, so I think it will come but on a sort of a local issue it's like the clinical trial sites are really quite busy with these, currently testing vaccines and therapeutics.

I think that's the short answer. I think the mid and long answer though will be that we would certainly entertain those kind of connections and it may fall out that we have an opportunity here to understand ME/CFS, study and test additional modalities but we don't know that yet.

I think we need to take in a little more data at this workshop for example, hear from the community and then move forward, but as you know Vicky, we're always open to discussing these ideas and how we might support them. That's part of what we do.

Ms. Margo Warren: I just wanted to give you a heads up Vicky if we could take one more question, we're running a little behind.

Dr. Vicky Whittemore: I'll take Rivka's question here. What are you all doing to ensure racial diversity in the patient cohorts you are working with? Walter would you address that or Avi?

Dr. Avi Nath: Yeah, we've established collaborations with several institutions where a lot of these patients are being seen so that we can get appropriate referrals. People who call us by phone and stuff or by email, its very hard to know what their racial background is. But collaborations with these hospitals hopefully will help us in that regard. It's not easy.

Ms. Margo Warren: Well thank you everybody, thank you so much for joining today's call. We'll have a transcript of this call on the NIH ME/CFS website quite soon. And i just wanted to remind you about our list serv. If you're not already on it, just go to the website and join our list serv at the bottom of the page. Thanks again for coming and making this a successful conversation.

Ms. Allison Kanas: Thank you for having me.

Dr. Avi Nath: Margo there are a lot of questions still in the chat box, I'm happy to address them at some point. Can you keep a record of that or something? How can we access these?

Mr. Timothy Lyden: Yes, I have all the questions Avi.

Dr. Avi Nath: Oh okay, good. So the ones that are relevant to me, if you can send them to me, I'm happy to answer them.

Dr. Vicky Whittemore: Great thank you everyone.

Ms. Allison Kanas: Thank you, take care.

This page last reviewed on December 2, 2020