The Yale Listen Study Town Hall: November 2022

February 27, 2024

Information

Drs. Harlan Krumholz and Akiko Iwasaki discuss preliminary findings and answer questions from LISTEN participants.

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00:04Hi everybody.
00:05Welcome to the Listen Town Hall.
00:09Actually, I'm on a train right now,
00:10so let me just tell you,
00:12this is under unique circumstances,
00:14but everyone else is in secure
00:16locations where they'll be able
00:18to help in case I I bump off.
00:20But one, we wanted to really
00:23highlight how special this is.
00:26We're so thrilled to be able to
00:27have a meeting with people who
00:29are participating in the study.
00:30We're so appreciative of everyone's
00:32time and effort and the ways that
00:35they've been able to contribute
00:37the messages that they sent us,
00:39the information that's being provided.
00:41And we we can only do this through
00:46the approach that we're taking,
00:47which is that each of you is
00:48actually a member of the team.
00:49And we feel like we're just beginning this.
00:50I mean we're we're just in a point
00:52where we're able to invite people
00:54and and in and to start talking
00:55about the plans that we have.
00:57We've just reached 1000 people.
00:59The group includes people reporting on COVID,
01:02people reporting vaccine
01:03and people reporting both.
01:06Let me just say we're just
01:07starting to reach enough people
01:08to start producing insights from
01:10the surveys and medical records.
01:11We encourage all the listen participants
01:13to complete all the surveys.
01:15The more information that people complete,
01:17the more that we can use it together
01:20and to connect all the records without,
01:22without all those connections
01:23and without the surveys that
01:25we really don't have anything.
01:27So we've got to be able to pull together
01:29as much information together as we can.
01:31And we also appreciate if you can
01:33spread the word we're interested in,
01:35in.
01:35People with long COVID with vaccine
01:37injury also have neither,
01:38because ultimately we're going to
01:40need a controlled population,
01:41people who are not suffering from either.
01:43These things that we can compare
01:45to those who are to try to make
01:48useful scientific inferences and
01:49we're also working hard not just
01:51about describing this condition,
01:52but seeing whether or not we can
01:54test strategies that can help.
01:56And we hope that within a couple
01:57weeks we'll be able to announce the
01:59first clinical trial that we're going
02:01to be trying and we look forward
02:03to communicating you about that and
02:04and getting you in line and ready
02:06to dissipate and to be able to work
02:08with all of you in a way that that
02:10enables people to be part of it.
02:12But but I think the most important
02:14thing that we want to communicate is
02:16is gratitude and and thanks for being
02:18part of this and and in the course of this,
02:22we also recognize that you guys
02:24have joined a leap of faith.
02:25You've provided many of you've already
02:27provided information you've you've
02:29given us information that we hope
02:32to be able to turn into knowledge.
02:33We want to work with you to
02:35hear your questions,
02:36for you to hear what our plans
02:37are for us to work together
02:39as partners and to be able to
02:40make progress together.
02:41So we know that this has in some
02:43ways been frustrating in the
02:44sense that it's been started,
02:46but we haven't had any real
02:48meaningful findings yet.
02:48But we're we're just getting on our way.
02:50So I'm not going to tell
02:52anyone that patience with us,
02:53you should always be impatient with us,
02:55but we want to work with you as close
02:57as we can to help make progress.
02:58With that, let me turn and I
03:00apologize for being on the train
03:02actually that was unanticipated.
03:03So thank you for sticking with me on that.
03:05And let me hand it over to
03:07Akiko for some marks from her.
03:10Yeah, thank you, Harlan.
03:11Just to say, everyone,
03:12I'm Harlan Krumholtz.
03:13I didn't even say I'm Harlan
03:14Krumholtz and let me introduce
03:15the key code. It was time.
03:18Thank you, Harlan,
03:18and thank you for your dedication
03:20and joining us from A Train.
03:22Really appreciate it.
03:23And thank you to all of you
03:25from Listen for joining us.
03:27Delighted to be with you again.
03:30I've really enjoyed interrupting
03:31with you so far with the the last
03:34town hall meeting and Born Alley and
03:36I did a follow up because we had
03:39so many questions that we couldn't
03:40answer and during the meeting.
03:42So there is a video up on the Kindred
03:46site that if you're interested.
03:48Hopefully we addressed all the questions,
03:51but there may be others that we're,
03:53you know, you're welcome to submit
03:56to on the chat or question today.
03:59And we'll leave plenty of time
04:01at the at the last half of this
04:04meeting to have Q&amp;A sessions.
04:06So please do ask us questions.
04:09So yeah, just like what Harlan said,
04:12we're very,
04:12very excited to be able to
04:14work with all of you.
04:16And as I sort of presented last two times,
04:20I guess there are,
04:21there's a lot of work going on some of
04:24the work that I shared with you from
04:26the Mount Sinai Yale long COVID research.
04:29But also we're going to be expanding
04:32and extending those kinds of
04:33research to with the Yale lesson
04:36study to not only long COVID but
04:40for vaccine adverse events and
04:42people who had a combination of
04:44long COVID and vaccine adverse events.
04:47And one of the emphasis that I
04:50made last time was the remarkable
04:52similarities in the types of symptoms
04:55that people are experiencing as
04:57a result of those three different
05:00conditions as well as the pre-existing
05:03conditions and pre-existing symptoms
05:05that people have had in this three cohort.
05:08One of the things that we
05:10would love to do is to.
05:12So that was borne Alley's analysis.
05:14By the way,
05:14one of the things that that we
05:17are really excited to do is to be
05:19able to include control groups.
05:21So right now we have great
05:23participation from people with
05:25these three different conditions.
05:27But we do need people who are if
05:30we don't have these conditions
05:31in order to compare and contrast
05:34the types of symptoms that people
05:35are experiencing or pre-existing
05:38conditions that people may have and
05:40ultimately to compare the immune profiles.
05:43So we encourage people to participate
05:46even if you especially you know if
05:49you don't have these types of conditions,
05:51but are you interested in
05:53contributing to research,
05:54This is a very important thing to do.
05:56The other thing that we would
05:58love to do in Listen is to be
06:01able to collect symptom data,
06:02your own people with these
06:04three different conditions.
06:05So you know,
06:07I know that the Kindred Listen
06:10team has already distributed the
06:13questionnaire for the symptoms,
06:15but we'd love to be able to
06:17get into that data as well.
06:19And ultimately we will be asking
06:21some of you to join bio biological
06:25research analysis looking at immune
06:28phenotyping by collection saliva and and
06:33we will compare that to
06:35the different symptoms.
06:36So just to kind of recap what
06:39what we discussed last time,
06:41last two times, essentially we are
06:44finding immunological features that
06:46are clearly associated with long COVID
06:49such as increased in exhausted T cells,
06:52increase in activated B cells,
06:55reduction in circulating central memory T
06:59cells as well as reduced levels of cortisol.
07:03And that is the most uniformly and
07:06strongly correlated differences
07:08that we see in the long COVID.
07:10And then I also touched on the sex
07:13differences in symptoms and immune responses.
07:16That's a paper that we are currently
07:20working on to to try to understand what
07:23symptoms are different differentially
07:25felt experienced by people of different
07:29sexes as well as immune phenotype that
07:33are associated with those symptoms.
07:35So those are the some of
07:37the ongoing research,
07:39Some things that I that that we
07:41are starting to do, but it's very,
07:44very new are the micro clot
07:47analysis and platelet activation,
07:49phenotyping analysis.
07:51This is in collaboration with
07:54Professor Rizzo Pretorius who kindly
07:56came and visited us at Yale to
07:59show us how to do these analysis.
08:02And even though we only collected
08:05a few samples to do the analysis,
08:07we are seeing significant activation of
08:11platelets from people with long COVID.
08:14We haven't looked into the vaccine
08:18adverse event samples yet,
08:20but these are the some,
08:22some of the the new types of
08:24analysis that we'll be doing.
08:25And I know that the Professor Pretorius's
08:29group has reported significantly elevated
08:32activation of platelets and Michael
08:35microclots in people with long COVID.
08:38So that's something that we'd love to
08:41be including in the future analysis.
08:43So yeah,
08:44these are some of the current and
08:46new thinking that we we have and
08:49are planning to do with you all
08:51in the listen study.
08:53And we'd love for you to
08:54be able to participate,
08:55you know if you can and if you're willing
08:58for the biological analysis as well.
09:01And we'd love to be able to share
09:04with you some of the findings
09:06from these types of analysis.
09:08And of course,
09:09as with all research,
09:10we need to be able to do the analysis
09:12in a sufficient number first to be able
09:15to compare on these immune features.
09:17But once we have enough number
09:20and once we have confidence,
09:22we will be sharing those data back with
09:25you and we'll be thinking about it together.
09:28So that's very,
09:30very exciting for us.
09:32Yeah.
09:32So and I'd be happy to answer any
09:35questions that you might have in
09:37the last half of this program.
09:39But I'm going to turn it over to
09:41Barnalli to talk about what other
09:43measurements we're doing for
09:44the immune phenotyping.
09:47Thank you, Akiko. So I'll
09:48start by sharing my slides.
09:58I hope everybody is able to see it.
10:05So, so we have been receiving a lot
10:08of questions about you know what
10:10kind of surveys you are taking or
10:12also about biospecimen collection.
10:14So I just wanted to begin with the
10:16study design. So for everybody,
10:18this is important to know that this
10:20study is divided into two parts.
10:22The first part of the study is
10:24analysis of the surveys that you take,
10:27the Kindred surveys that you have been
10:29taking and also the medical records,
10:31which makes it very important that
10:33you also connect your medical
10:35records so that we can analyze your
10:37data in an unbiased manner to get
10:39correct results from our analysis.
10:41So this is the first part of the study,
10:43this part of the study,
10:45every participant from any part of the
10:47world can join this study and take the
10:50surveys and participate in the listen study.
10:53So this is the first part of the study.
10:55Based on the analysis of the surveys as
10:57well as going through your medical records,
10:59which we cross checked many a times,
11:02we will select initially select subgroups
11:05of participants for biospecimen collection,
11:08those who donate blood and saliva
11:09to us on the very same day.
11:11They are also asked to take a few
11:13more surveys which helps us find
11:16out their current symptoms.
11:17And we also go through their medical
11:19records to see if they have taken
11:21any tests so that we can correlate
11:22the surveys with them.
11:24So this is the basic study designed.
11:25The biospecimen collection portion is
11:28only including residents from mainland US
11:32right now with the funding that we have.
11:35And so this is how we have
11:37designed the study.
11:38So with this,
11:39I would next talk about immunophenotyping
11:41and to begin with the very beginning,
11:43some basic descriptions.
11:44I know many of you know a lot more
11:47than what I have in the slide,
11:49but I just wanted to begin
11:50with the very basics, sorry.
11:53So our immune system.
11:55When we talk about immunophenotyping,
11:57we're talking about interaction with
11:58the pathogen and the aftermath of it.
12:01So our immune system protects us
12:03from harmful substances and foreign
12:05microorganisms, including viruses,
12:07and comprise of different cell types.
12:09Monocytes mature to form macrophages,
12:12which can engulf and digest debris
12:15and invading microorganisms.
12:16Neutrophils are another kind of
12:18engulfing or phagocytic cells.
12:20Yesinophils can act on parasites.
12:24Other than that we have the
12:26dendritic cells or DCS,
12:27which engulf microorganisms and
12:29present their protein fragments on
12:31their surface to activate T cells.
12:33And when we talk about T cells and B cells,
12:36the different subtypes that have
12:38been spoken about and written
12:40about in our publication as well.
12:43These T cells and B cells circulate
12:46within the body and when they encounter
12:48foreign bodies or microorganisms,
12:51T cells develop into activated T cells
12:53which are people spoke about with many
12:56different functions involved in protection.
12:58T cells are of two types,
12:59namely CD4 and CD8 protein bearing types.
13:03B cells upon activation differentiate
13:05to produce antibodies or are
13:08called antibody secreting cells as
13:10well as they generate memory B cells.
13:13Our data has also touched upon double
13:16negative B cells which have been associated
13:19with inflammation and autoimmune diseases.
13:22And then we have the messengers or cytokines.
13:26Cytokines are small proteins that
13:28cells used to communicate with
13:30each other inside of our body.
13:32They quickly transmit messages to
13:34different parts of our body helping
13:36to moderate the behavior of different
13:39tissues and systems like the immune
13:41system and the nervous system.
13:43The cytokines may be mentioned here
13:44or in any of the reports that we
13:47will provide to you as Interferon
13:49Gamma TNF Alpha Illinois 6.
13:51These are just examples,
13:52one or two examples of that.
13:54Now moving further to study design,
13:57what I wanted to show you is
13:59what we are going to study.
14:01So of course you have already
14:03understood that we need your surveys.
14:05We need your survey responses to
14:08understand the disease better, right?
14:10We need those surveys because we
14:11are going to analyze the surveys.
14:13We are going to look into your
14:15medical records,
14:16which makes it imperative that we
14:18have that medical record connected to
14:21the Kindred or the Listen platform.
14:23Next,
14:24what are the different experiments
14:26that we are going to do?
14:28So of course we are going to look
14:30at the TCRS that we have so as to
14:32understand what are the pathogens
14:34against which they have been generated.
14:37That's one.
14:37Next there will be multiple
14:39Elisas that we are going to do.
14:41So what does ELISA do or what question
14:43are we going to ask from here?
14:45We will be looking for auto antibodies.
14:47We will be looking for antibodies
14:50against multiple analytes such
14:51as different kinds of viruses,
14:53bacteria,
14:53what kind of infections you
14:55have had in the past.
14:56We will look at it in multiple ways,
14:58which includes rapid extracellular
15:01antigen profiling read as well as
15:04serum epitope repertoire analysis,
15:06which can tell us what pathogens
15:08you have encountered in the
15:10past as well as at the present.
15:12And at the same time,
15:13we'll also look at autoimmune antibodies.
15:15Looking at viral antibodies is
15:17another thing that we will do.
15:19So SARS,
15:20COV 2 antibodies will be looked
15:22at for different parts of the S
15:25protein as well as other proteins
15:27and then we will also look at
15:29the efficacy at neutralization
15:31which these antibodies have.
15:33So that's another experiment
15:34that we are going to do.
15:36At the same time as I have
15:39spoken about the different kinds,
15:41so I have spoken about the
15:43different kinds of cells.
15:44So we also have a technique by which
15:47we will be able to look at what are
15:50the different subsets of cells.
15:52So how do we do it?
15:53The the different cells I spoke about
15:56actually these cells have different
15:58kinds of proteins sitting on their surface.
16:01On the basis of antibodies
16:03which can recognize those,
16:04we will be able to separate out
16:07different types of cells and calculate
16:09the numbers and give you a fraction
16:11calculated number of each of these
16:14cell types by doing a technique using
16:16a technique called flow cytometry.
16:18So other than that,
16:20as Akiko has mentioned,
16:21we are very much interested in
16:23platelet activation and we will look
16:25at microclogs and platelet activation
16:27using all the assays that have been
16:30designed by the different scientists
16:31that she has already spoken about.
16:33So this is what we are going to do.
16:35And I know all of you have lots
16:37and lots of questions regarding
16:39how to connect our medical records
16:41or which surveys have I taken,
16:42why haven't I received a survey?
16:44And we talk a lot about it,
16:46we exchange emails about it.
16:48So we thought there are two very talented
16:51people who are behind all the processes.
16:54They are both working for Hugo.
16:55One is Tanya, who is the product
16:57manager and the other person is Emma,
17:00who's the data engineer at Hugo.
17:02And we have both of them today to
17:04demonstrate how it should be done and
17:06also respond to all your questions.
17:08So keep your questions ready and
17:11I think I will stop sharing my
17:14slides and I will hand it over to
17:18Tanya so that she can walk with you
17:21through the process of connection,
17:23connectivity issues, everything.
17:24Thank you,
17:25Tanya.
17:27Thank
17:27you, Bernali. I'm going to go ahead
17:29and share my screen. Hello, everyone.
17:32All right, give me one moment.
17:36Can everyone see my screen? Perfect.
17:40All right, so this is nothing
17:43that you're unfamiliar with,
17:44but this is our Kindred platform and
17:47I wanted to just highlight a couple
17:49of items that may be confusing or
17:51people have questions around that
17:53I can definitely clear up for you.
17:54So you walk into the Kindred platform
17:57and the first thing that you're
18:00going to see is your active tasks.
18:02This is what Bernali is referring to as
18:05the surveys that need to be completed
18:07and how important that is for those
18:10to be completed to analyze the data.
18:12So I they open up right into the
18:16survey into a new tab in your browser
18:18or on your mobile device so that
18:20you would open up them up that way.
18:23And this is the structure of our surveys.
18:25The most important thing is to
18:29consistently complete the surveys
18:30because what when you complete a survey,
18:32it's then backed with another survey
18:34that is all based on the questions
18:36that you answered.
18:37So it's very,
18:38very imperative that you complete
18:40the surveys or any tasks that you
18:42have up in this task carousel.
18:44It really helps with the research
18:46and anything that we are trying to
18:49gather for all the data analysis.
18:51So that I wanted to definitely emphasize
18:54this carousel and the accessibility of it.
18:57I'm going to move further down.
18:59This is our content feed.
19:01So if you are in your are in the
19:04listen study in the COVID community,
19:06so you're going to get listen study
19:08articles that are extremely helpful.
19:11You can listen to any of our town halls.
19:14There's also Kindred contributors
19:15where they tell their,
19:17you know the vaccine injured or long COVID,
19:20they tell their stories.
19:21It's very informational,
19:23very interesting information that we post.
19:25So I encourage you to read those
19:27definitely as as often as you can.
19:30They are updated quite often as well.
19:32All right.
19:33So one more item that I want you guys to
19:36just take a look at within the platform,
19:38which I'm not sure if you guys
19:40know is accessible to you.
19:41Is this My account button up
19:43here in the top right corner?
19:45So if you go to My account,
19:48you are able to fill in your first
19:50and last name when you enrolled it
19:52did take the the city, state and zip.
19:54If it's not in there,
19:56you can you can add it in their phone number,
19:59date of birth and your communication
20:02preference.
20:02So if you have your phone number,
20:03you can choose to have your
20:06communication sent SMS, e-mail or voice.
20:08I wanted to let you know that whatever
20:10works best for you and that you can
20:13customize that within this My account page.
20:16What's also nice under this menu is
20:18if you have a question, if you can,
20:20contact support and it will take you
20:22to our frequently Asked questions
20:24and it'll help you guide.
20:26You through any you know problem
20:28or issue that you're
20:29encountering or any questions
20:30that you may have and we also have
20:33our privacy in terms of service.
20:34So I wanted to highlight
20:37the My Account feature.
20:38We also of course you guys have
20:40the Listen study which you can
20:42click into and it is only Listen
20:43study related and I'm sure that
20:45you guys are quite aware of that.
20:48But the biggest emphasis that I'd
20:50like to make is on data connections.
20:52So data connections,
20:54it is super important that we have this
20:57information of your medical records.
21:00It is the key contributor as to
21:03understanding the medical diseases,
21:05any current,
21:06any current events that have happened
21:08since the last time that you've been seeing.
21:10So I want to go ahead and go
21:13through AQ and A of anything that
21:15is confusing or about this process.
21:18So I'm going to go ahead and jump
21:20right into how to connect your records.
21:22OK.
21:23So what you would do is you would go
21:25ahead and just click this add my data
21:28connections and then it says that Kindred,
21:30it uses Hugo,
21:31how to safely and secure your records.
21:33We connect with hundreds of providers,
21:35so not only healthcare,
21:36we pharmacies,
21:37devices, applications,
21:39you know insure insurers,
21:42payers etcetera and that we only
21:44share your data with your permission
21:46you can manage and revoke at any
21:48time and I will show you how you
21:50can do that and press continue.
21:52So we all we do is we have a list
21:54of popular connections just to
21:55give you an idea of what kind of
21:58different clinical devices and
21:59pharmacies that we have to offer.
22:02But there's also this wonderful search field.
22:04So what I'm going to do is I'm
22:06going to go ahead and search
22:07for a provider in my area.
22:09I'm in the Bay Area,
22:09so I'm going to go ahead and and
22:12search Kaiser and you'll see that
22:14all the Kaiser locations pull up and
22:16that you can select which one you
22:19know you're you are affiliated with.
22:21So let's say that I'm affiliated
22:22with Baldwin Park,
22:24I would go ahead and press
22:25the button to connect.
22:27I would enter my Kaiser Permanente Baldwin
22:31Park credentials into these fields.
22:33You would check off this box that you
22:35were authorizing the use and storage
22:37of the credentials and your health,
22:38health data through the Hugo Connect process.
22:42I want to emphasize this as well.
22:44Your credentials are securely stored and
22:46encrypted in both in motion and at rest.
22:48When you with using a management
22:50system that is strictly controlled,
22:52credentials are never shared and
22:53are solely a part of your account.
22:55You can change or revoke access at any time.
22:58All right,
22:59so I'm going to go ahead and submit
23:02and there's this fun confetti
23:04page that shows you that you
23:06have submitted and that record.
23:07You can go on to add another.
23:09So let's go ahead and do so.
23:11Let's go ahead and choose a pharmacy
23:13this time and let's go with Walgreens.
23:18Same thing. You can go ahead and connect,
23:22put in your Walgreens
23:24credentials and submit some.
23:28Some of the pharmacies or providers or
23:31healthcare systems have an external question
23:33or an additional item that you need to,
23:35you know, you have to redirect to a
23:37different page or an additional question.
23:39This one happens too with Walgreens,
23:41so I'm going to go ahead
23:43and submit an answer.
23:44And this is all test data,
23:45so this isn't anything real,
23:47Just want to show you what it looks like.
23:49When you are all done connecting your
23:52records, you can click this button.
23:54You can see what you've already connected
23:57and if you click out of this box,
23:59it is now showing up under My
24:02Data Connections as connected.
24:04Now let's say that you would like to that
24:08this says it has it needs attention.
24:10Maybe the password that you entered
24:12wasn't correct or maybe you need
24:14to re authenticate yourself.
24:15You can go ahead and select this wrench
24:18here and go to repair connection.
24:21That will bring it this Baldwin Park
24:23Medical Center right back up so that
24:25you can re enter your credentials and
24:27hopefully have a successful login.
24:29If you'd like to revoke access at any time,
24:32the same applies,
24:34you would disconnect.
24:37You would receive this page to
24:38unlink the connection and this it
24:40states that you're unlinking the
24:42connection and this will prevent
24:44any of your connected services from
24:46accessing your data in the future
24:48and you can unlink that way.
24:51And so I wanted to definitely show
24:52you all the different types of things
24:54that you can search for any questions
24:57that you may have and and go from there.
25:06Anything that I didn't cover that
25:07you feel needs to be covered.
25:11So there's a question in the box.
25:14So when it comes to adding medical records,
25:17every time I connect to Facility
25:19portal it will connect but
25:21then connection will be lost.
25:23I also keep getting sent
25:25duplicates of assay survey.
25:27Sorry that I have already filled
25:29out and finished and I get
25:31emails saying need to complete.
25:33If I have already come completed,
25:35do I really need to fill
25:38out again if the serve?
25:40If you're still receiving
25:41survey emails then that means that
25:43there is a survey to complete still.
25:46So if you log into your Kindred platform,
25:49you should see a survey up in my
25:51active Tasks if you are still receiving
25:53an e-mail to complete a survey.
25:56So that means that it might be in
25:58progress but not fully completed
25:59because it will still show up in the
26:02carousel until it is fully completed.
26:04If it's in progress and you stop at a
26:06certain point, if you press the button,
26:08it will restart at the time
26:10that you stopped the survey.
26:13I hope that that helps.
26:16Yeah. Tanya, there's another
26:17question that a couple of people have
26:20asked is if none of the providers
26:21are linked, what is the process?
26:25None of the providers are linked,
26:28meaning you can't find
26:30the provider under. OK.
26:33So let's say you can't find the providers.
26:35So let's just search here.
26:37All right. So you can't find
26:39what you're looking for.
26:41Let us know here.
26:44And this is where you can go ahead and
26:46you can submit a request to us saying,
26:49hey, I can't find my provider and that we
26:51will do our best to go ahead and locate
26:54that provider and try to get that added.
26:56Does that answer that question Perfect.
27:00Thank you. You're welcome.
27:05So as you can see,
27:06this needs attention already.
27:07It updates rather quickly because
27:09I was using test credentials.
27:11So just to let you know why that
27:13says it needs it needs attention.
27:15It's just the test
27:16credentials that I was using.
27:17But in a in a normal situation
27:19it would be connected with
27:21the correct credentials. Enter
27:27any further questions that I am.
27:32So here is 1 from Sheila.
27:34I see that I signed up back in August
27:36for the survey but have received nothing.
27:39Can someone help me get into the pipeline?
27:43So I think Tanya there Talia has already
27:47sent out an e-mail ID where you can ask
27:52all of these questions and get a response.
27:54Do you want to add any other suggestions?
28:01I would need to have more
28:02information to see what exactly
28:04this person's encountering,
28:05but I would be happy to assist
28:07or or stay after to to figure out
28:09what how that could be occurring.
28:11Yes, I want to hear and know
28:15about any possible, you know,
28:17disconnect or any any difficulties
28:19that anyone's having within the system
28:21other than finding their connection
28:23because there is a way to to submit
28:25that and we can try to obtain that.
28:27But yes, I can definitely follow up on that.
28:32So I also see that somebody is asking
28:35Angie here is asking how often
28:36should we check the app for surveys.
28:42You should be receiving emails for
28:44any new surveys that are assigned.
28:46So I would you know,
28:47it's it's always a great thing
28:49to visit the app, you know,
28:51a couple of times a week or as
28:52often as you'd like to see if you
28:54have any active tasks.
28:55But we will send e-mail correspondence
28:57when there is a task that needs
28:59to be completed and that would
29:01show up and whatever task we would
29:04send an e-mail about would would
29:06be up in this task carousel here.
29:08And there might even be one that
29:10says connect your health records
29:11And what you would do is you would,
29:13you know press on this on this arrow
29:15and then it would pop up this screen
29:17to encourage you to to to enter
29:20your medical record information.
29:25Thank you, Tanya.
29:26If there are any other questions,
29:28please type it and I can see many
29:31are being answered in real time. Now
29:36Bernal, if I could just jump in
29:38real quick and I wanted to explain
29:41a little bit about how our
29:43data collection works.
29:44A lot of the connections that we support
29:47are through an EMR provider called Epic.
29:50You'll notice that when you go
29:52to connect your credentials,
29:54a new tab will actually open and you will
29:57have to enter your credentials there.
29:59I'm seeing a question in the chat about
30:03if you have multiple Epic connections,
30:05do you need to sign up with each one?
30:07The answer is yes,
30:09because you are consenting on a
30:11sort of hospital basis to share your
30:13information and not the letter or
30:16the EMR basis to your information
30:20like that. And I just
30:21wanted to share how sort of
30:23new and novel this process actually is.
30:28We Well, not we, but if you guys are
30:32familiar with the Cures Act which was
30:34passed in 2016 that basically said that
30:38your healthcare providers need to share
30:41this information when you request it.
30:43And things like that actually take
30:47a very long time to get going.
30:50And you know, and then COVID happened
30:53and things kept getting pushed back and
30:55pushed back and we've reached this state
30:58where the deadline for full compliance
31:00is actually coming up pretty soon.
31:03It's the end of December 2022.
31:05So a lot of these processes that
31:08you guys are going through and
31:10almost sort of testing out for us,
31:12they're they're works in progress.
31:14So if you do see anything weird,
31:16you encounter a connection that
31:19you think should be there,
31:20that's not or you're finding that,
31:23you know, you connect and you
31:25keep getting needs attention,
31:26needs attention,
31:27needs attention.
31:28We encourage you to reach out to Kindred
31:31under score support at Hugo dot Health.
31:34The connection related issues
31:35actually tend to come straight to me,
31:38so I can get you going and make
31:40sure that we have everything working
31:41as smoothly as possible.
31:45I'm just going to check and
31:47see if there's any other
31:48questions that I can answer
31:50while I've got the floor here.
31:53Thanks so much, Emma. Yeah,
31:59I just tried
32:00reconnecting needs work account.
32:01How long does it take for a
32:03new connection to show up?
32:04So that's actually a great question because
32:07we get this one a lot in our support.
32:09It's not instantaneous.
32:10So the way it kind of works on
32:13the back end is once you finish,
32:15there's a message sent out to the rest of
32:17our system and it basically queues up a job.
32:19So it's like first in, first out type deal.
32:22So if there's a whole bunch of other
32:24people connecting at the same time,
32:26it may take up to, you know,
32:292-3 minutes for that new status to show up.
32:33So give it a little bit,
32:35maybe even refresh the screen
32:36in a minute or two.
32:38And if you're still seeing that
32:39needs attention,
32:39go ahead and reach out.
32:41How
32:47far back do
32:47you want My Health records?
32:49So when you first give us permission
32:52to go and access your records,
32:54we will pull basically everything
32:57that you give us permission to
32:59as far back as your electronic
33:01health record actually stores.
33:03And this varies based on different providers.
33:06I know my personal stuff,
33:07I can see as far back as I was born,
33:09but I was born in 1998,
33:11so some people might not have
33:13that same sort of longevity
33:14in terms of their records.
33:19And then what if our medical
33:20provider is a solo practitioner?
33:22Again, if you reach out to support or
33:27sorry kindred support at Hugo dot Health,
33:30we can you can send us your
33:32practitioners info and we can see
33:34if we could get you guys connected.
33:40Emma, there's a question I see
33:43are there hip hop protections in
33:45place when sharing medical records?
33:48This is also a really good question.
33:51So Hugo Health isn't what's called a
33:54covered entity under HIPAA protections,
33:57but we care greatly about your ability to
34:01share and protect your own health data.
34:04So we actually attest to and implement
34:06all of the HIPAA standards on our own,
34:10which you know, as someone who
34:12actually uses the Kindred platform,
34:13it's great because it means that there's
34:16less vulnerabilities when we're transferring
34:19your information to different places.
34:21It means that when it's stored, there's
34:24actually even more protections in place.
34:27Your information is actually
34:28completely de identified.
34:30So if there were a breach or
34:32something which not usually the case,
34:34they wouldn't be able to link any
34:37of that back to you whatsoever.
34:38And we really do believe in a
34:40test to HIPAA policies.
34:42There's also something,
34:43in case anyone's curious,
34:45called the Karen Alliance,
34:46which is an additional set of principles
34:50that different healthcare providers
34:52and health and information technology
34:54providers can attest to that have
34:57even stricter policies regarding
34:58sharing of data and all sorts of
35:01protections around that sort of stuff.
35:08Hey, Emma, can you hear me? Yes.
35:11Hi, this is Harlan. Hey Harlan,
35:17People do ask us about the issue about
35:20data staring in security and when they
35:22say we're connecting our records,
35:24what are we, what are we doing and
35:25what's going to happen with them?
35:26And I do think it's important to note
35:29the way this works on your behalf.
35:31Hugo's going, you may have just said this,
35:33that I just got bunked off.
35:34I'll come back and say it again.
35:35You go on your behalf.
35:37It's getting your data to deposit
35:40into your secure cloud based
35:42account and grow your data assets.
35:44With your permission,
35:45that data goes into the study.
35:47With your permission,
35:48the data can be used in aggregate for us
35:50to create some summaries about what's
35:51going on for the Kindred community,
35:53but you will never be
35:54identified individually.
35:55Your data is not going to be
35:57sold or moved or monetized.
35:58It's about empowering you for your
36:00data to come in and for you to give
36:03permission for your data to be used
36:05in this way if you change your mind.
36:07If you decide you don't want to do this,
36:09you can.
36:10It's your data and Hugo, not Hugo,
36:13does not own your data.
36:14You own your data.
36:15And we're trying to create the the,
36:17the environment,
36:17the ecosystem where you can put
36:19your data to work.
36:20But we're also going to fight like heck
36:23to protect your data and protect your
36:24rights and help you to get your data.
36:27Again,
36:27it comes in the way we conceptualize
36:30and it's like we say B to C to
36:32R it's like from the businesses
36:34or organizations that hold your
36:36data to C to the consumer to you
36:38and then you're permission to go
36:40use it for R for the research.
36:42And then when it sits within
36:45the Hugo community,
36:46we're not doing any funny business
36:47or have anything like hey,
36:49because you're on this platform,
36:50we can de identify and move it around.
36:52It's yours.
36:53And So what we're working on
36:54is a permission based system
36:58in a sense of community together and
37:00trying to use the platform for the
37:02purposes of trying to empower people to
37:04be able to do things with their data.
37:06There has to be a business model with Hugo.
37:08I mean we want it to be sustainable.
37:09So in the transactions and partnerships,
37:11we're trying to make it so that there's
37:14enough revenue generated to be able to
37:16help support the platform to do this.
37:18But what we won't do is compromise
37:20on the idea that it's your data or do
37:22anything with your data in order to
37:24generate revenue that's not in the model.
37:27The model is working in partnership
37:29with you for things that that you
37:34if you want to be part of listen,
37:35that's great.
37:36We want you to be part of listening.
37:37That data then can be shared
37:38with the listening study.
37:39I wear two hats in that way.
37:40I'm on I'm on the Hugo side to
37:41try to help build the platform.
37:43I'm working with the Kiko on the
37:45listening side to try to help
37:47learn something with you about
37:50the conditions that you guys
37:51are facing and are challenging.
37:53And and our intent purpose is
37:55to move as fast as we can learn
37:57from you and to try to make this
37:59into something meaningful for the
38:01community not just our community
38:02but the world community who
38:04are facing the same challenges.
38:05But but I wanted to just say that
38:07because from time to time I see I
38:09see someone raise that issue and we
38:10just want to say it really clearly
38:11and loudly that the data is always yours.
38:14And we're trying to everything is is
38:16going to be based on permissions and
38:18that's just the way we'll we'll work.
38:24And there was one exciting
38:25piece that I wanted to show.
38:26If you don't if you don't mind
38:29there was one more thing that is
38:30in the works that is coming very,
38:32very soon and hopefully
38:34you can see my screen here.
38:36Give me one second. All right.
38:39So with the Hugo connect feature here
38:43what we're going to have coming soon
38:45is the ability to upload your records.
38:47So let me just move this bar real
38:49quick so you're going to be able
38:51these are the mock ups for it.
38:53So you're going to be able
38:54to have an upload feature.
38:56So if you can't find your your provider
38:58or if you just received something
39:00from the doctor or if you have
39:02notes that are you know no longer in
39:03your in your file or what have you,
39:05whatever you'd like to send
39:07to be a part of your record,
39:08we can upload that file.
39:10So it would be as simple as finding
39:12this within Hugo Connect and then
39:15just simply uploading and then
39:17adding a name to the file.
39:18We're going to have some categories
39:20of what type of file this is,
39:21whether this is an X-ray or your
39:23medical records, immunization records,
39:24etcetera and then you'll be able
39:26to date the form and continue.
39:29So I think that's another way to
39:31really try to get your documents
39:33and your information to to us to
39:35be able to use that for research.
39:37So I thought that was exciting
39:38way to kind of bypass not finding
39:40that provider at that moment.
39:42You can upload documentation as well and
39:46that's the that's what I had to share.
39:54Thank you, Tanya.
39:55So I believe everybody was able to
39:58get some answers to your questions
40:01regarding connection of records and
40:04also about how we protect the data
40:06and it's your data that remains there.
40:08I think next we will move on to listen
40:12to Say Sir and his conversation about
40:15more diversity in the population that
40:19we have or the community that we have.
40:23And many other aspects which are
40:24also important for this study.
40:26So say, Sir, it's over to you.
40:29Thank you, Hornali. Hi, everyone.
40:30My name is Ezra Caravaggio.
40:32I'm one of the research
40:33coordinators of the study.
40:35And I wanted to speak with
40:37you on a couple of things.
40:39First, regarding diversity.
40:40And we want to make sure that our
40:43group of participants is as diverse
40:46as possible because we want to
40:48be sure that we're capturing the
40:51experience of everyone or that most
40:53people are are experiencing in in the
40:56United States or whatever you are.
40:59So we are making efforts to improve
41:02the diversity of our participants and
41:04we I wanted to ask you if you have
41:07any ideas on what can we do better to
41:11improve the engagement of communities
41:13that have typically being under
41:15represented in in clinical studies.
41:18And we're open to it and we're open
41:20to feedback if there is something
41:22that AUS participant feel that may
41:25be a barrier for other people to
41:27to join the study where we welcome
41:29every comment that you may have.
41:32We want to have a rich and diverse
41:34population of participants.
41:36And so the idea behind that is that
41:40we can produce information that
41:42everyone can apply to themselves.
41:44So yeah, that's one point.
41:46If you have any ideas and
41:50feedback regarding our efforts,
41:52they are very much well received.
41:54The second point that I wanted
41:55to ask you as participants is
41:57that in some of the surveys,
41:59particularly in the symptoms surveys
42:02or in the diagnosis surveys,
42:04we found that a lot of you are
42:07clicking none of the above,
42:09meaning that of delays of symptoms
42:11or diagnosis that we're listing.
42:13You are not identifying the
42:15ones that you are experiencing.
42:17So I wanted to ask you too,
42:19if you think that we are keeping out
42:24some of some key aspects of your experience,
42:27please let us know.
42:28You can type in the chat or you can
42:30e-mail us to Yale. Listen, study.
42:32Sorry.
42:33Yeah,
42:33listen,
42:34study at yale.edu and we'll be
42:36happy to modify what we're doing
42:39to better capture your experience.
42:42I will type in the e-mail in the chat
42:44so you can have it and that's it.
42:47Thank you.
42:51I think now we can. Yeah,
42:52we're not. Go ahead. Sorry,
42:54no. Say Sir, are we taking questions now?
42:57Leave it to you. Yeah, I'm. We'll
42:59be more than happy we start answering
43:03some questions that people may have.
43:05We can go over the ones that are
43:07still open or if you have any at
43:10this point please feel free to
43:12talk with. So what I have is a list
43:15of 10 and we can have a few more maybe
43:19from the list which are still open.
43:22I believe Akiko and Harlan are both
43:24here and we can start. Yeah, perfect.
43:27We can start with a few questions
43:30and then say Sir, you can add a
43:32few more from the open questions.
43:37So I'll start with the 10
43:38that I have on my list.
43:40Akiko, there are a few for
43:41you which I will start with.
43:43So the first question that we have here,
43:47will there be any efforts towards
43:49correlating immune features
43:50with symptoms, example,
43:52distinguishing patients presenting
43:54with dysautonomia versus not?
43:58Yes, absolutely.
43:58That is our ultimate goal
44:00is to be able to link the
44:03symptoms to the immune features.
44:05We've already started to do some
44:07of that with the Mylon COVID
44:09study and found for instance
44:11select number of people who have
44:15autoimmune auto antibodies to
44:17certain type of G protein couple
44:20receptors and sodium ion channels
44:22were associated with the tinnitus.
44:24So there is some sort of features
44:26that are coming up to be
44:28associated with specific symptoms,
44:30but we also want to do the reverse as
44:32the question the questioner is suggesting,
44:34which is to take a particular symptom
44:37or syndrome and then go back and look
44:40at the immune features to see if
44:42there's anything unique that's coming up.
44:44So that's ultimately the goal.
44:47Thank
44:48you, Akiko. So the next question
44:51is can you speak to whether in
44:53the initial findings you have
44:55seen this Autonomia in many long
44:56COVID and backs injured folks.
44:58It seems to be common.
45:01Yes, dysautonomia is definitely happening.
45:04I mean we haven't studied the
45:06vaccine injured people yet,
45:08but we are hoping to do
45:10that with the lesson study.
45:13But certainly with the myeloma and COVID,
45:15there are people with dysautonomia
45:18and Doctor David Petrino,
45:20who really specializes in diagnosis
45:23and treatment of various symptoms,
45:25including dysautonomia,
45:28is our partner in this.
45:29So he's also a partner in the
45:32Yale lesson study as well.
45:33So we're very excited and
45:35fortunate to have an expert like
45:37him on board to help us with it.
45:41Yeah. And I'll just say quickly that
45:44just as Akiko said that the hope is to be
45:48able to provide a almost like an Atlas,
45:50a map of the different kinds of
45:52manifestations that people are facing.
45:54See who's similar,
45:55who's different and then see whether
45:57or not we can reflect this in the immune,
46:00what we're calling immune signatures,
46:01the the unique ways that that the immune
46:05system seems to be signaling us around the
46:08different features of the immune system.
46:10And so just what you're asking
46:11is exactly what we're hoping.
46:13Can we get large numbers of people
46:15with similar clusters of symptoms and
46:17then see whether they have distinctive
46:19biological signals which can serve
46:22both for diagnostics and therapeutics,
46:24help us be able to identify and monitor
46:26and then ultimately find targets
46:28to treat for each of these people?
46:30Because I think both of us, Akiko,
46:32believe that that this is more
46:34than one disease.
46:35It's it's actually different people
46:36are being affected in very different
46:38ways and that's why they're manifesting
46:40with very different symptom complexes.
46:41And it's up to us to sort of find the clues,
46:44crack the case,
46:45understand what it is that's causing
46:48this vast spectrum of symptoms.
46:50And for different clusters of people
46:52who are experiencing similar ones,
46:54can we find common mechanisms.
46:56And so that that's really the hope.
46:57And that's why we need large numbers
46:59of people because we want to.
47:01I I think of it like an Atlas.
47:02And it's almost like who lives
47:03in your neighborhood?
47:04This is an unfortunate neighborhood
47:06because everybody's afflicted by a
47:08sort of similar cluster of symptoms.
47:09But if we can get large enough people
47:11together as opposed to what's happening now,
47:14or somebody goes to the doctor
47:14and people say,
47:15I've never seen this before or I
47:16don't know what this is, you know,
47:18that we start getting large numbers
47:19of people who saying, like, yeah,
47:20I'm not alone.
47:21There are a lot of people like me there.
47:25There are a lot of people like
47:26me in the world.
47:27And if we can start bringing those
47:29people together and looking whether
47:31they have similar biological signals
47:33that that that help us understand
47:36mechanism and lead us to produce
47:39diagnostic and therapeutic advances,
47:40that would be wonderful.
47:41And that's the hope with this.
47:46Thank you. Harlan.
47:47There's another question
47:49which I will just present.
47:51So here is a person who's
47:54suffering from vaccine adverse
47:56events and this person is asking,
47:58will you be contacting us to
48:00participate in the biological sample
48:02collection or should we let you know?
48:04We are interested.
48:07Absolutely. So as I mentioned,
48:09we're very excited to expand our studies
48:12to vaccine injured people and Bornelli,
48:18Cesar Harlan and I meet every week to
48:22discuss the type of participants that
48:24we we would like to recruit first.
48:27We don't have the resources
48:29to recruit everybody.
48:31We'd love to, but we don't have the kind
48:33of resource needed to to analyze everybody.
48:36But we will be starting with a small
48:39subset of people and then expanding
48:41that as we hopefully raise enough funds
48:44to be able to look at immune features.
48:47But definitely our first a set of vaccine
48:51injured samples will be coming shortly,
48:53right, Bornelli?
48:55OK, great. And
48:57and by the way, I think this is a really
48:59good idea that we could talk about,
49:00which is do people want to express
49:02interest in, in being part of the
49:04biological part of the study.
49:06Then we'll have a long list of people
49:08who've already expressed interest.
49:09Like Akiko said, we're by the way,
49:10we're constantly looking for resources to
49:12be able to expand and do more of these.
49:14But you know, I think it might be a good
49:16idea based on this comment to think that
49:18we can create a waiting list of people
49:20who are interested in in that way.
49:22We know that, you know,
49:24these are people who are really
49:25eager to participate in this part.
49:27So that's a really good comment.
49:28Thank you.
49:31Yeah, it would be great Harlan if Kindred,
49:34I mean so they listen site can
49:36have some sort of marking to say
49:39that if people are interested in
49:41donating their blood and saliva,
49:42it would be easy for us to just
49:45sort of cross check that with the
49:47participants that we we want to recruit.
49:49So maybe it's it's something
49:51that you can work on for us.
49:57Thank you Akipo and Harlan.
49:59The next question is about the recent
50:01MDPI article which has shown that
50:04persistent spike protein in brain
50:06and heart of a patient who died
50:09three weeks after third vaccine.
50:11How will you be assessing for
50:12persistent spike protein that may
50:14be triggering an immune response?
50:17Yeah, that's an excellent question.
50:20We'd love to do tissue level analysis
50:23but obviously taking biopsies from
50:25brain and lung and you know places that
50:28are difficult would not be possible
50:33possible we are you know so so the
50:35autopsy studies and other studies
50:37are are coming out where people are
50:39starting to look at these issues but
50:41even with the COVID samples this
50:43is sort of been a difficult thing.
50:46With the recover though they are having
50:49a an entire sort of you know funding
50:53for a collection of autopsy samples
50:56from people who who've had long COVID.
51:00I I I don't think they are including
51:02vaccine injured people and not group.
51:04But aside from having a tissue sample,
51:08which is maybe difficult in some cases,
51:11but there are some efforts to look at
51:16circulating spike and circulating antigens
51:18at least that's easier to collect.
51:22And we are actively working on looking at
51:25circulating spike from people with long
51:27COVID and and people with vaccine injuries.
51:30So that's just a proxy for something
51:33that may be happening elsewhere,
51:35but that that's sort of what we are
51:38you know immediately planning to do.
51:40Thank
51:41you, Akiko. The next question is
51:43about a recent Swedish study found
51:46antibodies for latent viruses in saliva,
51:49but not always in the blood.
51:51The saliva be tested for
51:53reactivated viruses as well in
51:54case it's missed in the blood.
51:57Absolutely, and that's why we are including
52:00blood collection in the Listen study.
52:02So with the Mylon COVID study with
52:04Mount Sinai, we didn't have access to
52:07the saliva and we really wish we did.
52:09But in the Yale Listen study,
52:11we will be asking participants to
52:13to donate their saliva and blood
52:15so we can look at both mucosal
52:18and systemic immune responses.
52:20And in fact we are planning to
52:22look at viral genome as well as
52:25antibody reactive to virus antigens
52:27both in saliva and in circulation.
52:32So the next question is
52:34about auto antibodies.
52:35So you have mentioned not seeing
52:37elevated GPCR auto antibodies in those
52:40of long haulers compared to controls.
52:42Can you comment on that please?
52:46Right. So as I shared with you last time,
52:49we are collaborating with Doctor Aaron
52:52Ring's laboratory here at Yale who
52:55developed a technology called rapid
52:58extracellular antigen profiling or REAP.
53:00And according to that analysis which
53:04looks at over 6000 different antigens
53:07that are expressed on the surface
53:10or are secreted from human cells,
53:12we do not see a consistent, first of all,
53:16we don't see a public or universal
53:18antigen that people are reacting to.
53:20So it's not like you have a specific
53:23antigen that everyone is responding.
53:24That's definitely not the case.
53:26We also don't see elevated levels
53:29of auto antibodies against the
53:326000 plus auto antigens in long
53:36COVID patients versus the controls.
53:39So there there's no unique pattern.
53:42There's no increase in auto
53:44antibody reactivity and intensity.
53:47There are of course you know
53:49various different auto antibodies
53:51that all of us carry.
53:52That doesn't mean that we
53:54are going to have disease.
53:55It's just something that B cells make,
53:58but it's just sort of quiescent auto antibody
54:00and that we are seeing in healthy control,
54:03convalescent control and long COVID.
54:05But that doesn't mean that there doesn't
54:08exist auto antibody that actually
54:10causes disease in a subset of people.
54:12So I I already mentioned
54:14about the sodium ion channel,
54:15but there may be other auto
54:18antibodies against intracellular
54:19antigens or nuclear antigens,
54:20who knows that could be causing disease
54:24and that we're not dismissing those.
54:27About the GPCR,
54:28yeah,
54:28there are many different ways of us
54:31saying although anybody has GPCRS
54:33and depending on the sensitivity and
54:36specificity and having the right
54:38kind of control groups to compare.
54:40That's what I was emphasizing last
54:42time and if anyone has studies that
54:45have included the proper controls,
54:48please do send it to me.
54:49I may have missed that,
54:51but so far I haven't seen great
54:54controlled studies to compare auto
54:57antibodies to GPCRS in various different
55:00conditions with the controls and
55:03and so that that that was sort of
55:05related to what what I said last time.
55:08Thank you, Akiko. I think I'll pass
55:10on to Cesar now so that he can ask
55:13a few more questions over to you.
55:17So I think it's almost time meant
55:18to be respectful of everyone.
55:20So I'm, I know that there
55:21are a lot of open questions.
55:23I'm sorry that we won't be
55:24able to cover them all.
55:26Maybe we can do something similar,
55:28put together a document after the
55:30town hall and answering most of them.
55:34But yeah, I don't think we have
55:36time for more questions, Bernali.
55:41OK. So I think we can list the
55:44questions and maybe put them
55:46up like the responses later.
55:48Yeah, sounds like a plan.
55:51If there is nothing else to respond to,
55:54we are already running short of time.
55:55I think we will thank all of you,
55:57the panelists and the
55:58participants who have joined us.
56:00Please ask questions,
56:02write to us, please,
56:04like finish the surveys whenever
56:07you receive an e-mail and also
56:09connect your medical records.
56:11These are all very important for us
56:13and we would love to have controls
56:16we did not have long COVID who do
56:18not have vaccine adverse events
56:20to report or neither together,
56:22and we need these controls in
56:24order to compare and contrast.
56:27Thank you all for your presence here today.
56:29Thank you. Thank you so much.
56:32See you again soon.