 Good morning everybody. This is Donna Prosser with the Patient Safety Movement Foundation and we're excited to bring you another COVID-19 update today. Today, we are very excited to be joined by Dr. Ronan Kelly from Baylor Scott & White, Dr. Jerica Lamb from the Chapman School of Pharmacy, and Dr. Jeff Dunn from Redivist Health. And so I'd like to ask the panelists to, in order of appearance on this slide, if you would introduce yourself. Dr. Kelly, are you there, Dr. Kelly? Can you hear me now? I can, yes. Okay, great. My name is Dr. Ronan Kelly. I'm the Chief of Oncology at Baylor Scott & White Health, which is the largest not-for-profit health system in Texas. And I'm helping to lead our COVID-19 therapeutic task force across 52 hospitals in Texas. So I was invited to attend this webinar yesterday to give an update on some of our clinical trials that were offering patients across our system. Great. Well, we're excited to hear about that. Thank you. And Jerica. Good morning, everyone. My name is Jerica Lamb, and I'm an associate professor at the Chapman University School of Pharmacy. My involvement with COVID-19, the Patient Safety COVID-19 Task Force, I guess has been about over a little bit over a month now with Donna and the team. And I am an ID specialist, a pharmacist, basically specializing in viral infections. And today I'm just going to piggyback on what Dr. Kelly is going to talk about in terms of other clinical trials that are going on in the country as well as in other countries around the world. Great. Thank you. Okay. And Jeff. Hey guys, Dr. Jeff Dunn here, calling in from the middle of America in Kansas City. My background is I'm a hospitalist serving telehospitalist market right now for COVID-19. Also, I'm a physician entrepreneur that has decision support software. So happy to be here and thanks for having me. Great. Thank you for joining us. I really appreciate everybody being here today. All right, well, we'll go ahead and get started. As everybody is well aware, we are now into week six since the World Health Organization has identified COVID-19 as a pandemic. This is the most recent World Health Organization map showing the spread across the globe. You'll see here at the bottom of the page, there is a link to the situation reports at the World Health Organization. So this is really great information for everybody. Every 24 hours, they post another new report of what's been happening in the last 24 hours. So the great thing is that even though it has spreading, there hasn't been any new country or area who's reported the case since April 11. So that's great. But there's no shortage of information that's out there. There's so much information that I think that's one of the challenges is helping everybody to disseminate the information. That's really important. So what we've done here at the Patient Safety Movement Foundation, you'll see on this link here for COVID resources. It'll link you to our website so that you can see some of the different documents that we have assembled for you. I am trying to click on it right this second. There we go. Okay. So what you'll be able to see is that we now have these helpful resources that are dependent on each population. So for the general public, for the clinicians, hospitals, and for patients who are currently in the hospital, we have different information. So I invite you to go to those pages and find out more about what we're doing at the Patient Safety Movement Foundation to keep you updated on what's happening with COVID. And please share those pages on social media. I appreciate that. And so for today's purposes, what we do, everybody is well aware by now, we do an assessment every week to identify what it is that our network needs to hear the most. And this week, what we heard was that people really are interested in learning more about therapies and treatments and any clinical trials that are underway. So with that, I'm going to hand it over to Dr. Kelly, if you'll let us know about what the current clinical trials are at Baylor Staten White. Thank you. And so when this emergency happened, what we decided to do was to put together a multi-disciplinary team of experts across our system, which I'm sure every other group is doing. But because there's not one group of doctors that really is specifically caring for this, it's really a team approach. Our task forces comprised of infectious disease doctors, cardiologists, pulmonologists, oncologists, hematologists, intensive care doctors, emergency room physicians, and really everyone in between. It's to try to bring a true multi-disciplinary focus to trying to offer our patients the best available clinical trials that are out there. Now there's been an explosion in trials. There's been an explosion in the amount of publications. And so for one or two people to try to keep an eye on all the publications that are coming out would be impossible tasks. So this multi-disciplinary group meets every evening, tries to update people on what they found, and then we're trying to position ourselves to be able to offer our patients what we think are the best clinical trials that we can. And we utilize this network of doctors because each doctor may have a different contact in a pharmaceutical company. We reach out to different companies, and I think that way we've been very successful in getting as many trials open as we can really in record time. So we divided our group of trials into a number of different buckets or categories. And the first category is the antivirals and what, as we know, when you treat viral infections, you want to have an antivirus therapy which can try to stop the virus from dividing. So we only have one trial in that bucket. That's the Remdesivir study that everyone has probably been reading about overnight with stock markets are all up on the hope that this drug is working. We were one of the first to open this trial. We have it open in multiple centers. We have one of the largest enrollers in the U.S. And so far, you know, I can't really talk about data, but what we've seen published is in the New England Journal of Medicine last Friday, there was data on a small amount of patients which looked promising. All doctors in the world, however, will tell you we need to see larger data sets and we need to see what we call these randomized phase. These where you compare what you think is a good drug to a placebo to make sure that there's not a lot of bias which can be introduced results. What I mean by that is we're patients on that drug just going to get better on their own. Or are they really getting better as a result of the drug? And so we do have that Remdesivir study. It's probably, if you were to categorize the drugs that we think are the most promising, that would certainly be at the top. But I think every doctor in the world is just waiting to see those larger data sets. We've been hearing so far, it looks good. We are seeing some people who are on ventilators coming off ventilators. We're seeing people who don't need to get that ICU stage getting better quicker. The idea for this drug is it tries to stop the virus from replicating once it gets inside the cells. And so if you can do that, you could try to stop the virus in its tracks. So shutting down its ability to replicate and to divide and to then infect another cell. That's how this drug works. So that's our top antivirus drug. And I think we'll see more data emerging on this in the next couple of weeks. If the larger data sets look good, we'll wait to see because every doctor will tell you we've seen some small studies that look very promising. And then when you give it in larger data sets, it's not as promising, but we're really hopeful this drug will be effective. And if it is, it could be the first drug we get FDA approval for. We'll have to wait and see, but that's our top antivirus at the moment. Do you want me to pause there or just keep going on the different trial categories that we have? Yeah, I think we would be very interested to know what all of you guys are working on there. Okay, so that's the antivirus category. Then everyone else has been hearing about convalescent plasma. What that is is patients who have recovered from this virus and people when they recover, they generate antibodies against the virus. And the whole idea of taking blood from those patients that have recovered is, can you harness the power of their immune system which is now fighting back against the cancer and take those antibodies which that patient has created in their blood and then give it to a more vulnerable patient to help them when their immune system is low. And so the hope there is that those antibodies that we can take from someone else and give to a different patient can help them in that critical time when they may be deteriorating and can you prevent them from deteriorating so they need to go to the ICU or need to go in a ventilator. So this is a technique which is not new in medicine. This is something that we've been doing for over 100 years. In fact, doctors in older days before the generation of antibiotics used to use this approach. Obviously we didn't have the technology 100 years ago that we have now, but it's an approach that was actually done in 1918. We've heard about the other pandemic that went through the US and around the world, the Spanish flu. It was an approach that was done there. In recent years we've seen small reports that it looked to be effective against other diseases like Ebola and like the SARS and MERS. We don't ever have huge amounts of data on this because those outbreaks were relatively small and they did tend to go away pretty quickly. So if people ask why don't we have large data sets on this approach? It's because the most recent pandemics were contained. So this approach is available now in the United States in three ways. The first one is the FDA have allowed doctors if they have a critical patient to give them what's called emergency use plasma. So if the doctors can get blood from a donating patient that's recovered from COVID-19, they can give the plasma to a patient and that's on an individual basis. It's not a clinical trial. It's called emergency or compassionate use where you can give this therapy to try to help a patient who's in desperate need. A number of our hospitals in Texas have done that but it is a little bit laborsome and cumbersome because you need to constantly be applying to the FDA for approval on a one-on-one basis. So I don't really see that as a path forward. So there's two other paths forward. There's clinical trials and I've written a couple of clinical trials on this already which we don't have open yet but we hope the FDA will approve this week. One is for patients in relatively early stage in the disease course. So if they need to be admitted to the hospital but they're not needing high flow oxygen or needing ventilators, we're going to give those patients this convalescent plasma in an attempt to keep them out of the ICU to keep them away from needing a ventilator. I hope that study can open in the next couple of weeks. We submitted it to the FDA by three weeks ago. They came back with a series of comments and we've made all the alterations that they asked us to and we've resubmitted it and I hope to hear in the next couple of days. You do have to compare though that to something which is not the plasma. So the current standard of care is the doctors treat patients according to what they think is the best way to treat it on April 17, 2020. So we're comparing that plasma in those early patients to what's called standard of care to see if it's beneficial because we don't know yet. And so that study is ongoing in Dallas and in Trader Hospital in Texas and hopefully in the next couple of days. And then the last way to do this is the Mayo Clinic have partnered with the FDA and they're creating what's called an expanded access program, which means the FDA has basically approved one protocol for the country. And doctors can sign up for this throughout the United States and the protocol has already been approved by the FDA. It's kind of regulated by Mayo Clinic. But you sign up online and then you can act that they can, there's going to be one, the Red Cross are participating, other blood banks throughout the country are participating and volunteer donors can go donate plasma if they meet all the correct entry criteria. And then there will be a pool of plasma, if you will, around the United States that if you're in Chicago or LA or Dallas or wherever you are, you can apply for this plasma and it can be shipped to your hospital and you can give it to your patient. So there are the three ways, the compassionate use, clinical trials, and then on this national expanded access program. So that's really where we are with the convalescent plasma. I'm also writing a study actually to give this plasma to frontline workers who are considered high risk in the attempt to try to prevent them from getting sick. So I don't have that protocol open, but that's something I've just submitted to the FDA and others are doing that around the United States. You know, that's an approach that we do in medicine. If frontline workers get a needle stick injury from a patient with hepatitis B, you can often get what we call immunoglobulins, which are again, and the bodies to try to prevent the patient, or excuse me, the frontline worker from getting hepatitis B. We also do this in other diseases like rabies and botulism. So it is an approach that we do to protect our frontline workers, so we're going to see if that also is helpful. So that's really bucket two. So the first bucket was the viruses, the antiviral treatment which was the remdesivir, then the convalescent plasma is bucket number two. We do have a number of other ways to try to prevent, help our frontline workers. We've been giving them hydroxychloroquine, which people will be familiar with. President Trump has mentioned this many times. It's a malaria drug. We're giving this to our frontline workers and we've enrolled about 150 frontline workers on a trial. So we're going to see, again, the control arm there is the frontline workers that decide not to get the hydroxychloroquine, but they do like to get the nasal swabs to see if they're infected. So we have a group that want to get the hydroxychloroquine and then a group of doctors and nurses that have decided they don't want to get the drug but do like to get the screening. So that study has been open for a few weeks and we're enrolling well and others, again, have that one. And then the last one we're working on just to protect our frontline workers is people have been hearing about BCG vaccinations. Again, you showed the map of the world there. The United States does not have a BCG vaccination for our children to prevent against tuberculosis, but many other countries around the world do. It's a standard part of their vaccine when the kids are growing up. There's emerging data that potentially giving this BCG vaccine may help against other diseases, not just tuberculosis, which it's designed to do, but to prevent against other infections and including some viruses. So in Australia, for example, they've just launched a phase three trial in a number of over 4,000 healthcare doctors or nurses and doctors where they're giving them actually BCG to adults, not to children. They're giving these frontline doctors and nurses BCG vaccines to try to boost their immune system to try to prevent them from getting sick with COVID-19. Now people will say, yeah, but it's not a vaccine against COVID-19. The answer is, yes, it's not a vaccine, what we're all waiting for against this new coronavirus. But it's an interim measure to give people a stimulated immune response. So our frontline workers who are exposed daily may be able to get some boosted immune system and it could fight the disease before it becomes a problem for them. So there are kind of things that we're doing in prophylaxis, as I said, just to summarize that it's the BCG type vaccinations, vandalism plasma and hydroxychloroquine. Then for patients as they get this disease, the other bucket we've been looking at is something called immune modulator. One of the problems patients get probably in the second week with this disease, and you've been hearing on the news, oh, he was getting better or she was getting better and then suddenly they deteriorated. And that's because what can happen with this disease is, believe it or not, our immune system gets turned on too much. And that can be bad in some instances when people, their immune system goes into overdrive. We call this cytokine storm, which basically means there's this flooding of chemicals, if you will, released from our immune cells which cause patients to have lung damage and start having severe respiratory difficulties and their oxygen levels can decrease. And it can be a almost like a vicious circle because once the lungs start failing then other systems can start failing including the kidneys and the heart and the blood pressure can drop. And so that's an important part for us to try to control that overstimulated immune response. Just so your viewers can be clear, we want the immune system to kick in very early on to try to prevent infection. But what's happening in some of these patients is as they get into the second or third week, that immune system can kick in too much and cause too many problems. So a lot of our trials are designed to try to dampen down that overstimulated immune response in those patients that are really quite sick and going towards ventilation. And so we have lots of drugs targeting different parts of that cytokine storm. In fact, we have about seven or eight different drugs that are targeting specific parts. I won't go through all the drugs, but they basically are all designed to do the same thing. If someone's immune system is too stimulated and is resulting in damage to their organs and to their body, and we dampen down some of that immune response so they don't run into all those problems. So that's another bucket that we're looking at. And then we have a number of other, what we call other. One of them involves mesenchymal stem cells, which again, not to get too technical, but the idea here is to give these these cells, which can migrate to people's lungs and can dampen down the immune response. We're also looking at other drugs that may help open up people's airways and people have been hearing about different ways to position patients in terms of turning them on their belly, which is called a prone position to try to help the lungs oxygenate better. But that's kind of just a snapshot of all the different trials we're doing in total. You know, we have trials that are constantly opening and closing because some of these studies are relatively small. And some of the larger studies are on a competitive basis, which means every system is trying to enroll patients on these trials. So part of our strategy is to have an eye on the future to try to understand, okay, if that trial is going to close, and we open another trial so that the next generation of patients have an opportunity to participate in some trials as well. So it's constantly trying to keep trials open and having an eye on the future. Well, that's, you guys are doing some amazing work there at Baylor Scott and Wayne. Thank you for that summary. I do, there is a question that we have from from the audience. The question is about whether or not the clinical trials are primarily focused on high risk patients versus those that are considered potentially low risk. Can you address that in terms of how you're choosing which patients are in the studies? Yeah, it's a great question. In fact, some of the trials are just for what we call moderate risk and some are for high risk. And the way we divide it up is depending on how well a patient is doing. So if a patient is early in their disease course or is not is having maybe a slight difficulty breathing but is not having to need high levels of oxygen. And their their their breathing rate is not too strained. They would be considered in the moderate risk. And then if someone, you know, is their oxygen levels are decreasing, they've gone to the ICU, they're on a ventilator, they're at the severe risk. So some of the trials are categorizing patients in the moderate risk and some are putting them into that high risk. What we actually think is these drugs will work better earlier in the disease course. It kind of makes sense to try to intervene at an early stage before someone gets really sick. And so as I said, I would almost think of this as three different categories, right? So you've got the prophylaxis category, which is try to prevent someone getting sick at all in the first place, which is what we hope a vaccine will do. But until we get that vaccine, as I said, we have a couple of different categories, including an interim vaccine with a BCG type approach. We have convalescent with hydroxychloroquine. Then the next category is, okay, someone gets sick and we intervene straight away. You know, if they thought maybe they could ride this out, they're at home, but then they get too sick and they come into the hospital, but they're not needing high levels of oxygen. So that's the moderate risk category. Let's give them medicines there to try to make sure they don't need to go to ICU. And so some trials are definitely just looking at that group of patients. But then there is obviously some that, no matter what we do, they get worse. And, you know, we spend a lot of time, how do we rescue those patients? How do we help them in their time of need? And so that's, I really think that's those immune modulators. That's the category of trying to shut down their overactive immune response. And so that's why we have a lot of trials in that category as well. Great. Well, I know that you have to jump off here at before 830. So we just have one more question that I hope you can address. The question is regarding the plasma trials that you were talking about. Is there any evidence or does anybody have any understanding of how long folks may have antibodies for and how well those antibodies are truly protective? So that's another great question because that's something that we think about a lot right now. You don't want to just give plasma to someone and not know what what what we call the antibody tighter level is. So what that means is how much antibodies has a donor created. So if you had 10, 10 people that have recovered from this disease, you know, you may have a category of a couple of those individuals would have recovered very well would have a high level of of antibodies in their in their blood when they may be able to help those vulnerable patients. But then some of those other people that have recovered, they may have recovered and not really generated a huge amount of antibodies. And so if you give their plasma to a patient may not help them a huge amount. So one of the things we're all working on right now is to be able to measure what we call the antibody titers, how many antibodies are in a donor's plasma so that we would only give plasma to vulnerable patients. If we think it's going to work by making sure that the highest amount of antibodies are in that plasma. In terms of how long does a patient or excuse me how long does a person who recovers from this disease remain with high antibodies, we just don't know that yet. There's a lot about this disease we don't know. We don't know if people can get reinfected. If they've recovered. So I think it's almost we're all in this together we're going to learn this over the next couple of months. We just don't know we don't have answers to all those questions but I hope I was able to help answer the first part of the question in that you want to make sure when you give plasma to a patient that it's the antibody levels are a certain threshold and we want to make sure we can measure those before we give it to a patient. Great. Well thank you so much for joining us today I know that you have to go. There are a few more questions but I think that for the audience for a few more minutes if you need me to. Okay, well we we can keep going then with with some more information about recommended medications and other trials that may be happening out there. And then I think as we go through the some of the next few slides, we're going to answer some of the questions that have been coming through but please keep your questions coming. All right Dr. Lam, do you want to tell us a little bit about about the recommended medications and other things all coded. Yes, thank you very much Donna. So, so basically what what has been percent earlier was very comprehensive and very, very, very nice and I just wanted to allude to the patient safety movement foundation COVID-19 treatment summary that we've created as a as a team here. And this just summarizes again, we all agree that the treatment to the therapeutic trials are ongoing and information is constant rapidly evolving as we know on almost a daily basis. So what Donna is showing to you right now is a table of the various drugs that are being trials throughout the country as well throughout the world in many, in many areas, you know, in terms of medical centers, as well as private sectors too. And what was touch upon were hydroxychloroquine, as well as gram disavir, which I heard on the news today that it does have some modest promise. And so we just need to have more, more a larger sample size to determine its true efficacy. But that is a drug that people are crossing their fingers and hoping that there might be some hope down the road in terms of an antiviral treatment against the COVID-19. What I want to add on to what was talked about in terms of vaccine was another vaccine that's actually started in the United States actually around March is the mRNA, messenger RNA vaccine, the 1273. There was a collaboration between Moderna Company and Kaiser and the site was held in Seattle, Washington State. And right now, phase one trial is currently going on, and it has about 45 healthy adult enrollees in that trial. Phase one vaccine trial is just to test the safety of this messenger RNA vaccine, just to see if the volunteers who are receiving different doses of this vaccine are found to be safe. So the vaccine actually is different from traditional vaccines that have been created is that it is actually a synthetic synthesized version of this SARS-CoV-2 virus. And it actually looks at, it encodes this pre-fusion spike protein that actually what we are learning more about this virus, the coronavirus, is that it uses a spike protein to enter the epithelial lung cells. So this mRNA 1273 vaccine is used to basically trigger an immune response in these healthy volunteers to see if it can block the entry of the real coronavirus into their lungs. So this is again an open label small trial that's going on, and it's been conducted for about almost six weeks now. So hopefully we'll get preliminary data sometime maybe towards the end of this month. But I think more realistically sometime in May that we'll get some preliminary data from the phase one trial. Another trial that has been touched upon as part of an immuno-modulator class is the Toxi-Lizumab, which we've heard about at TEMRA. And this is an immuno-modulator, what Dr. Renner has referred to in terms of targeting the various cytokines, as we understand is that there's also the cytokine storm, the surge of cytokines that actually is released when patients are severely ill with COVID-19. And so, I think several days ago we've heard that there was an ER physician from Seattle, from Washington State, who has recovered from receiving Toxi-Lizumab or ect. And he was near death's door and basically he received this infusion of this medication and he recovered and he's actually a testament of the novel therapies that are being used by a lot of clinicians and scientists. And so, there is a trial that is going on right now in the United States and just to let you know, there are many strategies to attack this virus. It's not just one strategy, but many multi-prome strategy. And so, I am very encouraged that hopefully, maybe by the end of this year or early next year, we'll have some form of therapeutic treatment before the vaccine actually gets approved sometime in 2021. So, as what Donna has alluded to in sharing that table, what we're going to do as a task force, a COVID-19 task force, is to update this to reflect the current trials that are ongoing, as well as potential future treatments that are being tested against COVID-19. And this is available on the webpage as well for everyone to use and access. And we are welcoming feedback to this table and this summary page so that we can educate and inform everyone about what is going on, because we're all in this together to make sure that everyone gets factual information, as well as evidence-based science behind what is going on in terms of treatment. Great. Thank you, Jerica. That's fabulous. There is a question about related to trials. Do you have any advice, and this would be either to Dr. Lam or to Dr. Kelly, any advice for people who might be interested in participating in trials? Who can apply and how do people go about being in a clinical trial? That's a good one. I would defer to Dr. Kelly who has more experience in this. Well, you know, it's a good question because, you know, it depends on where people are living and their geographic area. Clearly, not everyone needs a trial, right? I think that's important. A lot of most people will recover from this disease, staying at home, and, you know, we know that everyone hears those stories every day. But if you do need to go to a hospital, you would certainly encourage, certainly ask them if you have any clinical trials available, because remember, there's no FDA-approved treatment for this disease as yet. So all of these treatments that we talk about have to be done on a clinical trial. You know, it's a typical question to answer because I know your listeners are from everywhere and I'm not able to really comment on what different hospitals and different states have. You know, a lot of these are going up on hospital websites. You know, you can contact the hospital and see if they have trials. But as I said, a vast majority of people hopefully will never need a trial. They can get this and ride it out at home. But if you do go to a hospital and ask them, you know, if they have trials available and if not, you know, I don't know, maybe your website may be able to put up where trials are available. There is a website, of course, a national website called clinicaltrials.gov. So that's an NIH sponsored website. It's a government sponsored website, www.clinicaltrials.gov. It's not the easiest to navigate in terms of it can be a little bit overwhelming when patients type in COVID-19 trials and they may see a whole explosion of trials because there's now hundreds. But it may be somewhat helpful if someone has time to identify their particular geographical area and to be able to see which hospitals in their state have trials ongoing. And so, you know, then if you were going to get sick, you may have a preference to go to one hospital over another, but that's the only way I can really tell on clinical trials doctors. Yes, I wanted to add to that. That's a very good point, Dr. Kelly. Donna, if you go and click on the treatment summary, the clinicaltrials.gov. Actually on that table, I've listed, if you scroll right there, yes. So there are clinical trials that I've actually taken out from that website and posted on the summary page. So whomever is interested, whether they're living in Turkey, Brazil, China, the U.S., these trials are currently going on or the investigators, principal investigators are asking for volunteers. So if you click on the hyperlink, it will route you to that after a trial on the clinicaltrials.gov site. And if you scroll all the way down onto that page for the particular clinical trial, there is a contact person that you can either give them a call or email them. They do have contact information there. So that's a helpful resource, too. If you know of someone who really needs to be enrolled in a trial, and many of these trials are placebo randomized controlled trials. Some of them are smaller trials and they're open label trials. But this web page is, or the summary page is meant to offer some guidance for those who want to be involved as well as perhaps maybe find more information for collaboration and partnerships. Thanks. Thank you so much. You know, I was trying to click on this and it's not going to that page. So for everybody on the call, just know we're going to check that and make sure that those links are working this morning. Thank you. Yes, thank you. All right. Well, let's move on and talk a little bit more about about actual treatment. You know, most of our hospitalists and our intensivists these days are working around the clock to care for these patients and hospitals. So Dr. Jeff Dunn, we've got with us today who's a hospitalist. So Dr. Dunn, you want to tell us a little bit about what people need to do to care for these people right now. Yeah, absolutely. So first I want to say that being a hospitalist we are termed with knowing a little about a lot. And I can tell you that this disease, there's a lot of fluid stuff going on with us. So from our perspective, we couldn't do it without our nurse colleagues, respiratory therapists colleagues or our critical care colleagues and managing this disease. It's very much a team sport. So I'm just going to talk a little bit about some of the bullets of taking care of these patients. What we have seen is along with the common symptoms of cough, fever, shortness of breath, many times these folks are having GI symptoms as well as loss of taste or smell. What we're seeing also in the timeline of when they become symptomatic, many times after that seven days is when the patients get in trouble. So from our perspective from being a hospitalist when you admit somebody to the hospital that needs a small requirement of oxygen, our ears spark to perk up when those oxygen needs start to go up. And I would say that that three to four liters of oxygen is usually a sign that that patient may need maybe at high risk of decompensating and may need to be put in the ICU for further observation. So to talk about the second bullet, usually we see sepsis from a bacterial pathogen and many times the sepsis bundle is, you know, IV antibiotics, lactase, labs, IV fluids, etc. This cytokine dysregulated response is from a virus this time. I will tell you that many of the treatments that the other panelists have been talking about have showed some promise. But the one thing that we would like to know more about is when these patients get really, really sick, what's working with those folks, the people that are on a ventilator or a ventilator plus hemodialysis. So we are putting quite a few folks on empiric antibiotics because these folks look like severe sepsis or septic shock at times and it's hard to decipher whether they are co-infected with a bacteria as well. The last one I'll talk about is the ARDS syndrome and Dr. Kelly talked about the cytokine storm. Some of these folks are having five lobe embolt rates that look very dense on a chest x-ray. Some of them have disproportionate hypoxia as well, where the hypoxia is disproportionately to what their chest x-ray looks like. So I will tell you that not everyone has a bad looking chest x-ray and a lot of the sites, they're not following the chest x-ray, it's more following the amount of hypoxia. So let's go ahead and go to the next slide here. And the treatment modalities, just to talk really generalistic from a hospitalist perspective, hemodynamic support, people do have shock syndrome with this that's much like septic shock. We are using norepinephrine as our first line, vasopressin as a second, and unlike bacterial sepsis where you rapidly and aggressively fluid resuscitates, we are using a very cautious IV fluid protocol with these patients. You don't want, obviously, to put too much in the tank with these folks. The other thing with the amount of cytokine dysregulation, we're also considering that there might be a micro thrombotic phenomenon going on with these patients that's, you know, a cause or an etiology behind that disproportionate hypoxia. So the other thing to watch out is everyone needs DVT prophylaxis. We've had some folks in reports of patients getting clots as well with the more severe COVID response. Obviously, with the ventilator support, we are counting very much on our critical care folks to be able to manage those. And Dr. Kelly talked about the proning, et cetera, the high peep, low tidal volume that you typically do with ARDS. But to further kind of talk about that disproportionate hypoxia to the chest X-ray as well. And lastly, those three things that were eloquently talked about by the other panelists about hydroxychloroquine remdesivir trials, we do have one of the academic centers that's doing a hydroxychloroquine trial here at University of Kansas. And the promising results from remdesivir that has recently come out. And I think that for my standpoint, we need to have tempered expectations on even remdesivir and need more of a sample size to be able to say that this is going to be a very successful and impactful drug here. And then lastly, plasma from survivors, which we have not given, but there are reports that this is doing wonders for some really, really sick patients. So that's kind of a generalist update on COVID and the telahospolus phenomenon. Great. Well, thank you. That's fabulous information. We do have several questions that are coming in from our audience. So lots of questions about hydroxychloroquine. Is it, there was a clarification about whether or not this is being used on ventilated patients or patients who are more stable? Yeah. So from my perspective, hydroxychloroquine, you know, I think that this drug is better suited for folks with mild disease rather than severe and critical disease. Again, we don't have a lot of patients that are on this. This is for the clinical trial folks. We can use it with the help of our infectious disease colleagues. But anecdotally from what I'm reviewing is this one probably isn't going to move the needle as much as the others when it comes to those critically ill patients that are on a ventilator or a ventilator with hemodialysis. But I'd defer to Erica or Dr. Kelly on what the clinical trials are actually showing. I would agree. This is a treatment that will work better in early stage patients because the mechanism of how we think it works is it inhibits the virus from entering the cells. And it also is changing some of the acidification in part of the intracellular machinery that the virus needs to replicate. So what I mean by that is if someone is at the towards the latter stage where they're in the ICU, the virus has already got in and it's multiplied by billions, right? So it's not really going to work that well. You want to give this earlier in the disease course to try to minimize the ability of the virus to replicate. So anything that we're seeing is that this treatment will be better in the early stages of the diseases rather than the latter stages. Great. So then can it be inferred then that somebody who's already taking hydroxychloroquine for another disease process may have an additional layer of protection? Well, so that question has come up because this drug is approved for patients with rheumatoid arthritis and lupus and there is data sets emerging. But again, you know, whenever you're in a pandemic like this, it's hard, you know, there's a lot of small data sets emerging and it's only after the fact where we really get the hardcore data that we can truly believe in. But what we have seen is that those patients are made to slight protective effect in that group of patients that have rheumatoid arthritis and lupus. However, those are also a little bit more vulnerable because they're immunosuppressed. Certainly the rheumatoid arthritis patients are. So I think we need to see more data. But to answer your question, we think there may be a hint of activity in those groups that already take it. Excellent. Dr. John, I wonder if you could talk about the use of ECMO in these patients. Are you finding that that is common practice with COVID-19? I would say it's not common practice, but ECMO reports are suggesting that some of the younger patients that are critically ill from the disease, they are actually being plugged into ECMO therapy. So I haven't seen it done in my practice yet, but there are reports suggesting that there are some places that are pretty cutting edge that are using this as a treatment modality for really sick patients. Okay, great. And then there's a question regarding race or climate. We know we've heard a lot about racial disparities and that our minority populations are being affected more than others. But what are you seeing in terms of clinical trials and treatments? Is there a difference in the response based on race or geographical location? Is that for me or for somebody else? Oh, I guess probably Dr. Kelly, have you noticed any differences in the trials? Well, again, I think it's going to depend on where you live in the US and what the breakdown of the population is. You know, what I can tell you is some of our data sets in Dallas, we've been seeing more Caucasians having this than African-Americans or Hispanics. But I think that's going to depend on where you live. And certainly you're right. In some of the larger cities like New York, they've seen a difference in the outcomes in patients according to what their background is. I think there's a lot of work that needs to go into this. I don't know if there's a particular genomic difference. I would be surprised if there was. I mean, we actually think there may be a slight difference between men and women. And, you know, we can get into that a little bit, you know, but in terms of 2X chromosomes versus an XY chromosome and the amount of receptors that are available for the virus to enter. But so there's a lot of data, you know, is there a difference between men and women? Is there a difference between Caucasian, African-American, Hispanic? I don't think we know the answers yet. You know, we've heard, you know, every evening on the government responses, you know, they talk about, well, potentially some groups in our population have more comorbidities and more diabetes and more high blood pressure and other illnesses that are going to impact how well they do. And so I think we need to tease all of that information out. We also need to tease out the information about the ability to social distance. And in some cities that are more populous, they've not been able to do this as well as some of the more open areas in the country. So, you know, I'm kind of avoiding the question a little bit because I don't want to give any misleading information. We just don't know yet. I don't know yet. Great. And Dr. John, I wonder if you could describe the plasma treatment a little bit. Is it just a standard plasma transfusion or is there a special technique? I'd probably defer that to Dr. Kelly to be perfectly honest. We haven't treated any of our patients with plasma yet, but he's probably the one to talk to about that. Dr. Kelly? Sure. So the process here is you need to make sure, if you follow the FDA guidelines, someone needs to be, before you can donate and go to your local Red Cross or in Dallas, we have what's called Carter Blood Care, you need to be 28 days, you know, post symptoms you've recovered for 28 days. If it's 14 days since you've recovered, you need to have another test that shows that you're now negative. And things will evolve over time. We've had a problem, of course, throughout the country with testing. We all know that. But the ability to do rapid amounts of testing will evolve over the next couple of weeks and months. So I think we will help improve the testing issue. But then if you're confirmed that you can go, you go to your local blood banks, they do the normal things. They have to check you for other infections, like HIV and hepatitis and all these other things that we always check when we're giving blood transfusions to patients. And then they also make sure that your blood type matches the blood type of whoever will receive your plasma. So those things are routinely done in blood banks. And then they take the plasma from you. It's done over, you know, a period of time. It's pretty easy to do it in any blood transfusion service or any blood bank. And then they take the plasma and then they can freeze it or send it to the local hospital. And then the hospital can really give it at any time. It can be frozen and stored for a period of time. Or if a patient needs it straight away, you give it, the nurse can hang it as an infusion. And we really are, well, in my protocol, we're recommending that we give it less than 500 mils an hour. So we give it relatively slowly, but anywhere from 250 mils to 500 mils. And it's just you follow normal infusion guidelines. All nurses, all doctors, all hospital administrators, we have blood transfusion guidelines. So you just give it as you want any other blood product. You slowly infuse it over a period of time. And then you just watch the patient and make sure that they're doing okay. Great. Is there anyone on the panel who has any information about the passing of the virus from mother to fetus? That was a question. And I don't, I'm not sure if anybody would know that on this panel thoughts. Yeah. Well, we're in the new in the Journal of Medicine about that. I think last week. I don't know if my colleagues on the panel have seen that. People are looking at that right now. Great. Well, we will definitely follow up on that and make sure that we add that information to our website for the person who asked that question. And then the last question that we have is related to testing. I know we just talked a little bit a little bit about that. And so, you know, I wonder, Dr. Dunn, how do you decide in a hospital, you know, as a hospitalist, how do you decide which patients get that test and which ones don't? Yeah, I would, I would tell you it's changed quite a bit. So I'm on the kind of the state line between Kansas and Missouri. I would tell you that Kansas in general has has had a lot more limited testing than Missouri has at this point. So early on in this disease process in the March, mid March, late March, even up to early April. We were testing the very focused subset of patients that had essentially interaction with another COVID patients, shortness of barats, hypoxia, fever, etc. It is those guidelines are loosening up a bit. So if we believe that patients has one or two of those criteria and particularly hypoxic, those patients are getting tested right now. And I can tell you the turnaround time from the testing when we started was about five to seven days. You can imagine people are sick on ventilators at times, not knowing whether we had COVID positive that has shrunk down to considerably to a day or two at this point. So I would tell you that testing is we are testing more and more people that we have clinical suspicions on. They don't have to fit every single four or five criteria at this point, because I believe that it makes the healthcare workers and staff safer knowing that if a patient has positive COVID or not. And then we also had another question, Dr. Dunn regarding ventilation when you're determining ventilator settings and ventilator strategies. How do you decide on that. Well, I can talk as a generalist here I'm typically not the one that's managing the ventilator that's the critical care folks. But typically what we're hearing and seeing from the pulmonary critical care folks is like Dr Kelly mentioned some of the pruning strategies that are coming out they're still running some strategies and protocols regarding the pruning. But typically these folks that have the ARDS syndrome. High peak, low title volume strategies, typically, you know, a typical ARDS patient is is what the pulmonary critical care folks are using right now. Excellent. And, and what about going back to testing very, very briefly. Have you noticed any trends in terms of false negatives. That's a good question I think some of the data that that we've received is about 70% of true positives with the test. Still there is some, you know, folks that have the disease that are not coming up positive with the test. So, I haven't seen recently what the what the data suggests, but there are some folks that have disease. And if the clinical suspicion is there, they're covered 19 positive less, less proven otherwise. Yeah. Well, we are right about at the top of the hour so I am very grateful to all of you today for joining I do believe we've answered most of the questions there were a few a few outstanding questions that we will address on our website moving forward. Thank you very much to Dr Kelly, Dr lamb and Dr done for joining us today and to everybody on the phone, and on the webinar. As I mentioned earlier, we're going to continue to to maintain our patient safety movement foundation resources page, and we'll be adding to that. Over time, additional video interviews and, and other webinars and such for you to join. As I said today is going to be the last of our weekly webinar series, we will continue to bring you webinars and we will continue to bring you interviews with real time information. But we rather than waiting for eight o'clock on a Friday morning we will will try to get to it as fast as possible so more to come you'll see it all of that coming through our website and through our email distribution. But my thanks again to the panel. I very much appreciate your participation today. Thank you very much Donna. Thanks for having me. Thank you so much. Everyone have a wonderful weekend.