 All right. Well, good morning everybody. It is eight o'clock and so we are ready to begin our weekly update on the coronavirus outbreak. My name is Donna Brasser. I am the Chief Clinical Officer here at the Patient Safety Movement Foundation and I'm joined here today by several others on our panel who are going to each address a different component of our preparedness for this epidemic. And so I'll go ahead and allow the panelists to introduce themselves and they're listed here on the slide in the order that they're going to be presenting. So please, if you'd like to go ahead and start. Good morning. I'm Steve Barker. I'm an anesthesiologist from the University of Arizona and also Chief Science Officer at Massimo Corporation and board member of the Patient Safety Movement. Thanks, Mike. I mean, thanks Steve. And Ed Kelly is our next presenter, but he is not on the line yet. I hope that he's still going to be able to join us today. He's a representative from the World Health Organization. And so hopefully he'll be able to join. Mike. Mike Durkin, currently Senior Advisor on Patient Safety at Imperial College London and until recently the National Director for Patient Safety for the NHS. Thank you. I'm a board member of the Patient Safety Movement. This is Mitchell Goldstein. I'm a Professor of Pediatrics at Loma Linda University School of Medicine. I am the Director of the Neonatal ECMO program here. Hi, this is Robin Betts. I'm the Vice President of Quality Clinical Effectiveness and Relatory Services for Kaiser Foundation. I'm sorry for Kaiser Permanente Northern California and I'm also a board member of the Patient Safety Movement Foundation. Hi, my name is Pete Dysart. I'm a pathologist. I'm Chief of Pathology at Baylor University Medical Center in Dallas and the Director of our residency training program. Good morning. I'm Art Kanowitz. I am an emergency physician founder of the Airway Safety Movement. I'm the Chair of the Patient Safety Movement Foundation's Airway Safety Work Group and Chief Medical Officer for Securities and Medical. Good morning. My name is Jerica Lem. I'm an Associate Professor at Chapman University School of Pharmacy and Pharmacy Practicing and Infectious Diseases. Excellent. Thank you so much and welcome to all of our panelists. We really appreciate you joining us every week and welcome to your Dysart. Thank you very much for joining us today. Okay, so as everybody knows, we are in our second week now of the COVID-19 pandemic. Steve, do you want to talk a little bit about what's happening in the world? Sure, thank you. What you're seeing here on the screen is the very excellent map that's maintained by Johns Hopkins University that was updated several times a day. And you've probably noticed that virtually all of the TV networks are using this now. Before I point out a couple of details, I want to give a warning. There were some internet rumors that the map contained malware and it turns out that apparently there was somebody malicious person making a imitation site. The map looked exactly the same. So be careful what you log into. The site you visit should be coronavirus.jhu.edu-map.html. We'll put that in our notes for you. But if you get any requests from the site you're visiting to download software, that's fake. Don't do it. Don't download software. So get into the map. The total cases as you see now is up to almost 250,000. The total death is over 10,000. The cases outside of China is where the greatest increase has occurred. That's up to 165,000. The deaths in China are up to over 3,000. But Italy, this is a very recent change, Italy has now passed China in the total number of reported deaths with 3,405. And yet Italy still has half as many reported cases as China, so that's something we should look at. Now we've all heard there are risk factors in Italy, a more aging population, but perhaps there are other things. Spain is rapidly increasing now and is number four in total cases and Germany is close behind. In fact, if you click on Donna, click on Spain over on the left-hand side, right, just click there. Yeah, do you see what happens when you click? It highlights where you're clicking and it shows you the total deaths for that country or region. Spain has 833 deaths. And if you compare it to Germany, which has 16,000 cases, almost as many cases, then yet click on Germany, please. There you go. Germany has almost the same number of cases, but only 44 deaths. So it brings up another point about looking at these data, which is when you see an increase in the total number of cases, you have to ask is that more actual people with disease or is it more testing? The number of testing kits is increasing rapidly. We're doing a lot more testing, especially picking up in the United States. And so you have to consider both of those US cases is now 14,000 deaths, 205. There are now, if you look at the slide over to the map on the US side. Oh, before you do that, notice that if you look at Europe and China, Europe and China, just look at the colors. They're both equally red now. That is a change in the last week. It used to be that China was by far the biggest red and Europe was well behind. They look about the same. Now scroll over to the US and if you can blow it up a little bit, you can click on the plus sign down on the very good. We're getting this down to a system. Beautiful. All right, so you can see the total number of US cases and you can also go see something new since last week and that is there are reported cases in almost all of the Caribbean islands. Those were, were spared. I think it's a matter of they're starting to do testing down there. Now the trends. The last thing I want to point out, if you, Donna, go down now to the lower right, the trend plot and click on the little box. There we go. Beautiful. Isn't that nice? So two curves I'd like you to look at the kind of orange curve with the early plateau. That's China. And you notice, first of all, we know that this disease started in China in, in, in at least December, but we didn't get any data or any word of it till January. You see the curve went up exponentially for a while and then in about February 13, it took a jump and then it plateaued and the number of I stress this reported cases in China has plateaued at about 80,000 for the last several weeks. We should really be asking why that happened. Is it a testing issue? And I believe Mitch will talk more about that with other countries in a few minutes, but now compare that with the yellow curve, which is basically the rest of the rest of the world. And you see, first of all, it didn't get off the ground until about February 25. Then it went up kind of exponentially like the early China curve. It took a jump in slope at about March 12. And so maybe I'm using too much imagination here, but my question is, are we going to see a leveling off like we do on the China curve? I certainly pray that we do. And we'll have to watch that curve, especially over the next few days. Is it about start leveling off? Don't know. If you can go back now there, boy, we got this and go back to the, to the world picture. Just click minus a little bit. And okay, so there, there you see it. The whole world, you have the website. I watched this several times a day. And as I said, one question you always ask when you look at these cases, are we looking at more cases or are we looking at more testing? It's hard to separate those two. And we'll have further discussion of that. And that summarizes our situation today. Thank you, Donna. Thank you, Steve. I appreciate you are reviewing that great information with us. As I mentioned, we were hoping that we would have a representative from the World Health Organization to join us and let us know a little bit more about what the global perspective is lessons that have been learned from Italy and South Korea and China. But hopefully he will join later and we can come back to that. But in the meantime, Mike, Mike Durkin, can you tell us a little bit about what the European, the European perspective and what's happening in Europe? Yeah, thank you Donna. And I'm not going to go over the numbers. I think we can see the numbers for ourselves. What I'm going to do is just to talk briefly about the impact of those numbers and the strategies that are being put in place across Europe and obviously across the whole of Europe. Now, so as far as the waves are concerned, the UK is about, we think about two to three weeks behind Italy, but probably only one or two weeks behind northern Europe. The modelling that we have been doing over the last two weeks have started to reinforce the value of social distancing and the importance of social distancing. So now what we're now seeing both within countries and across countries, schools, colleges, all closing, home working becoming the norm, borders in fact being starting to be closed and transportation across borders becoming more and more challenging for those who need to need to cross borders and restrictions put in place for freedom to travel. Some countries have restrictions in place and requirements under law to have permission to travel either across borders, but actually now increasingly within countries. And we're now starting to see provinces within countries, but also towns within countries now across Europe starting to control travel in and out. All gatherings now are being curtailed to such a large extent and in some places again law being put in place to do this, otherwise it's down, hopefully down to sensibilities of local populations. An important element for a lot of European countries are places of worship. Places of worship are in the main staying open for individuals, but regular services are ceasing across many countries across Europe and I think we'll continue to see that. Mass transportation is also starting to scale down, both in terms of the need for it as people are now spending more and more time increasing their normal home working approach, but also on the basis of of trying to restrict travel and restrict movement. Interestingly, and we talked about it earlier for a few years, increasing an increasing use of data sharing platforms. So as we're using zoom, but also teams WhatsApp, blue jeans, so an increasing number of not just for business continuity and resilience, but for social continuity and resilience and particularly as we're asking now in the UK, we're asking all all those over 70 to stay at home, but particularly those with long term conditions and multiple communities. So the increasing use of these platforms is becoming the norm for book clubs for music for art for teaching. And so I think we do have also start to think about the the resilience of our service systems across across countries. Just wanted to close on a couple of elements. One is shopping and provisions for shopping are becoming increasingly difficult and there's no point in hiding that this is becoming an issue. And so in to a large extent now they were starting to be cohorts allowed in for shopping. Those in some countries there are restrictions to those who can shop. So the older the older age groups having access also restricting in many centers the numbers of the purchasing parts of the numbers of individual provisions you can access and buy and obviously the increased use of online online shopping. I just want to remind us of one more point before I move on. And that was the importance that a Vedic Donimadian put to some elements. So we knew that we know that structures and processes are important in any improvement strategy and we have to adapt that now. But then often not enough. And it's the ethical qualities of those who work within the system that are vital for success and and he outlined the importance of love being in that. And I think we're now starting to see that across many of our countries and not just within Europe but across the whole world. About the amazing acts of kindness that are supporting our individuals but are supporting our health care workers and are sporting that supporting those who are frail and at risk and I think that is the the conscious effort now that I think we all need to think about and use and demonstrate. So that's enough for me I think for the moment. Thank you. Thank you. It seems to be what's also happening here in the United States is we're starting to kind of develop a new normal. But there is a there is a discrepancy between how some states are handling it. You have states like California who now have a shelter in place order for all of the citizens of the entire state but then other states have not quite stepped up to that level yet. They have not yet banned large gatherings but that we imagine will be coming any any time now. Mitch would you like to talk about this this excellent website. Sure, absolutely. If we could load that screen. As we see these individual countries deal with the pandemic. It's helpful to have a more graphical view of what actually is happening. And as mentioned in the earlier slide looking at the world cases of coronavirus South Korea I think is an example of what can be done with effective social controls if we could go further down on that slide. That would be helpful so I can show some of the graphics here. Here are the total cases and you notice that within South Korea as you saw in the earlier world cases slide. This graph so really what's happened there since February 15 when they had their index case and you could see a leveling off effect as we go towards today. Go down just a little bit more please. This reflects the daily new cases and you can see here what they had was a peak that was right around the first part of March late February with kind of what looks like a tailing off save for the exception perhaps the last day here noted on the slide go down a little bit further. These are the active cases now so again you see also a peaking in the number of people who are in fact infected and as it goes down and as it approaches that a number of these people are recovering. You can see the effect most dramatically here. Let's go down a little bit more. Total deaths have scaled. You haven't seen yet a leveling off yet but again with the fact that you see fewer active cases the hope is that that will occur and a little bit further down. This is the daily new deaths in South Korea and then what I think is the most important slide go down a little bit more here. You start to see the new recoveries versus new cases and the green line representing the new recoveries. When that exceeds that of the yellow line or the orange line depending on the color of your screen. That's when you start to see the effects of the social controls social distancing and all the other measures that have been put into place by various governments in terms of helping their population recover or at least reduce the risk. And then going down a little bit further. This also dramatically indicates the effects of the effective programs for mitigating infection. And here you see that peak dramatically by the fact that the recovery rate and the death rate nearly meet in the middle. And then as we see fewer people getting the disease and as we see there being a relative more effective response to the disease. A dropping of the death rate and a recovery rate that as we can see here is now starting to approach 100%. Excellent. Can you want me to act out now? I think you're fine now. Okay, great. Thank you very much. That's great information. Kind of leading into our next discussion about recommendations for the general public. What lessons can we learn from South Korea about this and how do you think that people should change their behavior in other countries now? So one of the prime things that we've talked about from the onset is washing hands or using a hand sanitizer. And when you wash your hands, it's at least 20 seconds. There are various algorithms for how to do this. Some people recommend singing happy birthday twice or the alphabet song. But a good 20 seconds is very important to make sure that you really thoroughly clean the surfaces and get any kind of source of infection. So that you don't get any activity off of your hands. The other option is hand sanitizer. There's some confusion because there are a number of different hand sanitizers that are out there. But you want to make sure that the hand sanitizer that you're using has at least 60% alcohol. And this is what's deemed necessary to really provide the basic protection that you need. This leads to not touching your face and not touching your face is a very important thing. It's estimated that we all touch our face numerous times during the day. It's a conscious effort not to touch your face, especially your mouth and your nose, which represent vehicles for the virus to spread further. And again, because of various data that have shown that masks themselves can become ineffective after several minutes of use, wearing a mask unless you're sick or caring for someone who is sick during the immediacy of it may not provide the kind of protection that one would otherwise need. There are more extensive masks that are designed for situations that are extremely high risk, involving those people who are taking care of people who are doing high risk procedures such as placing a breathing tube intubation. And those masks, the N95 masks require special fitting and are not generally available for the general population. You want to go too far? No, I think you're fine. Okay. There are certain vulnerable populations that people have traditionally identified and asked questions about. Certainly, we're very concerned about the effects that this virus might have during pregnancy. And again, although there hasn't been a preponderance of cases with respect to pregnant women and the effects on pregnant women, the pregnancy state represents an immunosuppressed state and we can have and we can see situations where moms are compromised during pregnancy by this virus. This extends to lactating moms. Now, while there's no evidence of the virus passing through amniotic fluid or for that matter, breast milk, the point is that when you have a mom who's breastfeeding, that's a violation of most social distancing. And again, it's very hard to conceptualize the idea of moms putting distance between them and their babies. But in the instance of this particular virus and reducing the risk for spread, this is what is being recommended. And again, moms who have it during the period of time that they are in contact with their infants do need to mask. And again, there have been various recommendations. Again, if you look at the CDC site with respect to lactation, they have recommended that perhaps a non-affected caregiver help mom lactate so that the milk can be passed to the infant without exposing the baby to the risk of breastfeeding in terms of droplets from the mom. Newborns and infants in general do not appear to have as many manifestations of severe disease. But again, we have not had reports of this disease getting into neonatal intensive care units. Especially again, when you look at some of these babies who are extremely high risk otherwise from other things, extreme prematurity, or for that matter, other types of respiratory infections and the risk of co-infection with other viruses including RSV, rhinovirus, flu, and others exist as well. We haven't yet seen, I think, the full effect. And again, case reports continue to come in. Children and teens also can be affected. And again, the data doesn't necessarily support that there is a perhaps increased prevalence here. This is very different from H1N1 flu that was 10 years ago that we were all very much worried about. However, in these populations, there have been reported deaths. There has not been as much attention, as much concern as the population though, however, that are elderly or frail or who have other chronic health conditions in the adult populations. Great. Thank you, Mitch. Well, let's move on then to talk about hospitals. And there's a lot of things that hospitals are dealing with right now, a lot of uncertainty about the future. But we've received a lot of specific questions about ventilator management and PPE stewardship. So Steve, tell us a little bit about what's happening with ventilators right now. I know that we don't have a lot of data worldwide right now. You're just seeing the U.S. data, and we'll continue to work on getting back. But your thoughts on this, Steve? Sure. Thank you, Donna. As I mentioned, I'm an anesthesiologist and the ASA, the American Society of Anesthesiologists, had a webinar last night. And ventilator management and preservation was the top subject. Of course, the concern is that a lot of these patients, the ones that get very ill, will deteriorate rapidly, be short of breath and require ventilatory assistance, either by intubation and mechanical ventilation or other means. The first consensus I'll tell you from the ASA is that these people, we have to remember, they're not only very sick and they need help breathing, but they're still very contagious. So the ASA is not recommending using non-endotracheal forms of airway management, such as what's called the combitube or other extra laryngeal airways. So they should be intubated and placed on a mechanical ventilator. How do we make more of these mechanical ventilators available? Well, the main thing we can do is postpone elective surgeries. Of course, the other thing we can do is make more ventilators and companies are working on that right now. But in the meantime, we have about one million total hospital beds in the United States, for example. Each of those has probably a hundred or more ventilator beds, including ICUs, intensive care units and post-op care units or recovery rooms, what we call the PACU. So if we postpone elective surgeries, we can make more of those PACU beds available for COVID patients who need ventilation. And that was the main thing discussed. However, the question of what's elective and what's not is not as easy to answer as you might think. I mean, sure, plastic surgery is elective, but is dental surgery purely elective? If you postpone it, eventually the patient develops an abscess and can get septic. So the term elective has to be a clinical judgment. So the ASA is behind the idea of postponing when possible elective surgery, but that has to be done carefully. The other important thing we discussed is how to protect the care providers. And Mitch mentioned that. I want to just add a couple of things. The N95 mask is a very tight fitting and highly protective mask, much more than the standard throwaway surgical mask. And the ASA does recommend that we use those masks when possible if we are intubating, endotracheally intubating, and infected or highly suspected patient. The problem is there's a shortage of those masks. And so we probably don't have enough to use them for every patient. And the other thing is we don't have enough that we can throw them away every time we use them. So they're not intended to be reused, but they frankly, they can if you protect them. And the ASA actually suggested wearing some kind of protection over the N95 like a face mask or even an ordinary throwaway surgical mask. So there were discussions on how to clean the masks. I won't get into that level of detail. I'd be happy to give any of you more detail on this if you want, including talk about how to best clean an anesthesia machine or ventilator once it has been used in a COVID patient. That is a significant problem because as you know, these viral particles are very small. They're down in the micron size. The last thing I will throw in is it was brought up at this meeting that there is actually no zero clinical evidence that NSAIDs, non-steroidal anti-inflammatories such as ibuprofen or motrin are in any way bad for COVID patients. And this has been all over the news and the internet. This recommendation has apparently been removed by the WHO. I'd like to hear from them. But you've all heard about this probably on the news and the internet. Apparently there is no clinical evidence that ibuprofen is bad. So I'll end with that and happy later to answer any questions on ventilators. Thank you, Donna. Thank you, Steve. Yes, and I think Jerica is also going to be addressing that later on. So thank you. All right. And then Robin, can you tell us a little bit about what we can do in hospitals to flatten the curve and the struggles folks are having with PTE? Yeah, thank you. This is kind of an example of how we can flatten exposures. We take measures such as social distancing that in the hospitals we need to follow isolation precautions where we're working in an environment of known potential exposures. So you can go to the next slide. As we know, this is just kind of a reminder of the type of virology we're managing. So it is transmitted by droplet. And so to preserve, as Steve was talking, those N95 masks and other protections for those high risk procedures, we really need to make sure that we are using the appropriate protection when we're in the room and not overutilize resources that should be reserved for high risk procedures where you can what they call aerosolize a droplet virus. So I think last week we showed you kind of the image where, you know, these, this virus is heavier than such as a measles virus that can kind of hang out in the air. You know, on dust particles where this really does drop to the surfaces. So I won't spend a lot of time here, but we do again reserve the N95's and what are called cappers and pappers for that process. The cappers and pappers can be reclaimed. So those are kind of nice, but they're, I would say they're not as comfortable to wear. And also, when you're doing actual the lab sampling, they recommend using a N95 mask. However, this does bring there's a lot of concern about PPE availability, personal protective equipment. So some of the things that organizations are doing around the world is reducing the number of patients going into their hospitals. So really imposing visitor restrictions, you don't like to do that people feel vulnerable. However, our visitors have have to also abide by our isolation precautions. So they use up resources as we protect them. They also may have been exposed by a patient who's also, again, really restricting that we are providing a sample of visitor restrictions from an organization that that will be available to you if you want to look at what are other people doing. And we also through cohorting patients, so patients putting them together on a single unit or ward, so that just you limit the number of healthcare providers that are providing care to patients with these symptoms or under investigation for COVID or actually have COVID. So cohort them in those two groups, and then it limits the number of care providers doing them. In our organization, we even might have care providers do additional procedures that they normally would delegate to another ancillary service such as they might have a nurse draw the labs instead of having lab go in and draw the lab. So really reducing the number of people that need to go in and out of the room and use PPE where possible you can maximize your telemedicine services. Some organizations who are fortunate with strong technology, they might have telecritical care services and so can be another set of eyes in the room and instead of somebody going in or being a second double check instead of having another person go in the room. The other tele-services you might have roving tele-services for, tele-stroke in the ED and you can use those tele-services to again increase eyes on the patient where they're really critical in a remote way. I think really knowing what your inventory is, go and sweep your buildings for all the protective equipment that you have and centralize it and distribute it so that you are clear on your days remaining and you can work on your creative ordering if your usual resources aren't available. And then Steve talked about extending the use of equipment. The CDC has provided some great guidelines for how you can reuse and re-clean or reuse between encounters the same equipment to reduce overuse or limit the use so that our supply lasts a little bit longer. Let me go to the next slide. You should though anticipate, you know, crisis levels and so, you know, some of the things that you'll find on the CDC is really using those N95 respirators beyond the manufacturer designated shelf life. So they have an expiration, but the CDC is saying, look at them for the integrity. Is there anything wrong with them and if not use it? There are other guidelines around. I already spoke to this extending the N95 use and reuse by the same provider. And then, again, we've talked about limiting to high risk procedures. You might want to begin gathering from creative resources. My own organization, we have a command center and within our command center, we've created a new workgroup and we are accepting all creative ideas for PPE should we lose our normal resources. And it's been amazing. You know, many medical centers offer universities to have nursing students or medical students come and participate in their hospitals to get their clinical hours. Our nursing schools and our science departments from those universities have donated goggles and masks and their PPEs since their schools are closed right now, probably through September. Veterinarian offices are another great place. We've gone to hotels and electrical companies who have sent over their face shields, their gloves and things like that so that we have those. And we are creating a warehouse of backup supplies. We actually have a carpenter company who have mocked up a face shield that is very, very good. Our infectious disease doctors have looked at it, provided feedback to them. And they are beginning to produce face shields for us. Our organization is purchased a 3D printer to start producing some face shields as well. So there's, there's also patterns and for some churches are sewing their daughters and sons are home and so they have them sewing face masks. And it's the last resort because you know the, the, the resources we use now are really designed to certain specifications but something is often better than nothing. So, it's been really exciting to see the community start to rally and to also see the creative ideas of our teams as they bring forward alternative sourcing opportunities. And also through Israel and other places that we have normally ordered from we're getting supplies from them. So it's been, it's a wonderful journey and it's wonderful to see the community rallying around this work. That's all I have. Thank you. Yeah, thanks Robin. No, that's fabulous because there are lots of questions coming in about PPE. There's a significant amount of concern and hospitals that they're not going to be able to get that equipment. So those are some really great tips on what we can do to mitigate in the meantime. Thank you. Yeah. Thanks. And Pete, you want to tell us about testing and where we're at with with coronavirus testing in the United States and if you know anything about what's happening internationally we'd love to hear that perspective as well. Okay, thank you. I'll see if I can kind of hit some points relative to testing that probably have not been really discussed a lot in the media but to give you some insight or kind of where we are and where this testing is going. First of all, the early deployment of what is now the approved test is under the control of the White House largely through the major and traditional vendor manufacturers like Roche. Roche meets with pence's team daily along with representatives of the largest commercial reference labs and other large health systems prioritizing around the disbursement and deployment of that technology that would have the maximum impact to the largest segment of patients in this country. So those machines and those reagent lots are just now hitting the ground, so to speak. In our case in North Texas, for example, quest facilities literally made their first runs this morning and made the testing available to health systems like ours. We're the largest not-for-profit in Texas. We've had an in-house test available. We've been utilizing for the last 10 days or so but the volumes and throughput of those kind of technologies are very small compared to the larger scalable platforms from companies like Roche. Roche had 110 platforms in China was the principal testing platform they used and is also the dominant platform in Europe. So in spite of what you may read in the media right now, we are still a long way away from having rapid turnaround time for COVID testing and the challenge that represents is really on the hospital side of the equation where I'm situated. Our ED has patients under investigation occupying rooms. We've had to create additional negative pressure rooms upstairs for those patients while we await test results. And then of course we have the sequestered unit where we have test positive patients for COVID. So we are a ways away. A little bit about the test itself right now, obviously in short order from the time of recognition for the test development, all the tests currently available are focused on recovering the viral RNA. There are not any simple test people that might be familiar with associated with influenza, for example, that use antibodies to test for a specific set of proteins on the outside of the virus. All of the tests available now are reverse transcriptase PCR reactions and they're looking for the viral RNA. All of the machines that I'm familiar with right now have an on machine time of about two to four hours depending on the platform. So once a lab gets it in hand, it's going to take three to five hours for them to actually produce a result. So again, back to that urgent situation of what we do with hospital inpatients, we're still a ways away from having a rapid test. Will there be additional methodologies looked at? Absolutely. But I'll frame that in a larger context now around not only is the challenge doing the test, but but clearly there's an interesting set of clinical parameters that are going to drive the performance of this test, which is part of it. I think I'll really focus on now that you don't really see discussed in the media, or at least I haven't seen it discussed. So let's assume we've got a really good test, but it takes a while for the test to get done. There's a paper out of Germany, which I can send the reference on published last week from from Munich, where they profile the ability to recover viruses in relation to clinical symptoms and prodromal symptoms. So first of all, the specimen right now used by all these platforms is an oral or nasopharyngeal swab. This virus unfortunately is not present in blood, is not present in urine, and it's only variably reported to be present in stool. So that means by nature there is some technique required to actually get an adequate clinical sample. And there is a finite number of swabs that are approved by the FDA for use in doing these tests, which brings to surface one of the next big issues. And that is there, while you may have the test, you may have the platform, you could either be constrained on reagents, or like we are, you're running out of FDA approved swabs to do these tests, and you're having to improvise. So there's a technique involved in some of the false negatives with this test are probably related to improper technique and improper training for obtaining a proper nasopharyngeal or pharyngeal swab sample for the testing to begin with. There are also some fairly prescribed criteria for the way that you must maintain the specimen before you start your testing on it. Now looking at the pathophysiology of the disease, the viral load peaks in the oral pharynx and in the nasopharynx before day five of symptoms. So if you have somebody that's sitting around and they're doing okay and all of a sudden they start doing worse, depending on when they come in the relative sensitivity this test could be impacted by the decline in viral replication in the oral pharynx, as well as in the nasopharynx. And it appears now that quite honestly, there is a significant viral load present in the upper respiratory tract prior to the appearance of any symptoms at all. The papers range from two to three days before any appearance of symptoms. But in terms of recoverability, the patients actually may be at peak much earlier in the progression of the disease than we know today. Now, taking the next look beyond day five of symptoms, the diagnostic sensitivity of these assays starts to decline. And depending on which paper you read, some people would say there's 50% false negatives after day five in some of these patients, even though they have clinical symptoms. And it's just thinking about it logically is this virus moves from its primary source of replication in the upper respiratory tract down into the lungs. Then the replication in the upper respiratory tract starts to go down and it starts to progress at the ACE2 inhibitor level in the lungs. The other relevance of that fact is so you could have a negative swab in the patient in the presence of somebody with symptoms. They appear to be getting better. They all sudden clear their symptoms. But guess what? The virus is still being detected at significant rates in sputum, which has huge implications for discharging patients. And where do you discharge them to once they clear their fever as well as once they're ready to go home? Do you send them back to isolation? And that's the current set of recommendations. When you look at the seroconversion of this virus and thinking about, well, could we have an antibody test? Seroconversion really doesn't happen until the second week of the illness. So if you're looking for a rapid antibody test during the first week of symptoms or early presentation, probably not going to be very good. It may not even be better than any of the flu tests now, which predicted value in some cases at 50%. So I think it's going to be a while before we have an easier, more rapid platform based on the seroconversion rates in these patients. The other thing is when we do get seroconversion, you do not see the precipitous drop in the viral load in sputum. The viral load starts to take a rather slow decline after seroconversion, but it can extend out to at least two weeks after seroconversion. So that's relevant back to the point I made a minute ago, and that is patients can still have a significant viral load in their sputum, even though their symptoms appear to be cleared and they appear to be getting better or well. Unfortunately, all the assays we currently have available now are qualitative assays, and any of the data that's been generated to date about relative infectivity uses viral culture media in order to just basically recover and grow the virus. And you need to have a viral load of less than 100,000 viral particles per milliliter sputum to be considered safe, but unfortunately we don't have a way to quantify that today. And I'll just reiterate a couple of more points and then I'll stop and we can take questions. Again, the virus is not present in blood to any significant degree, which is great for our blood supply. It's not present in urine, which means we can't get an easy urine sample to test for. We have to stick with these nasopharyngeal swaps as we go forward. And then the last thing I will say is, and this is more of a question than a comment, is right now we're trying to use this test in the role of being a diagnostic test. In other words, somebody who has risk factors or has a clinical symptom presentation. The challenge and the thing I'm worried about is when we shift priorities as an institution because we're now beginning to recognize patients that have no symptoms at all or have subclinical symptoms actually have a very high viral load and stand a chance of transmitting the virus. And that mode, the role of this test shifts from being a diagnostic test to a screening test. In fact, I think there'll come a time in my institution where the request will be made to screen all surgical patients and possibly all hospital admissions. And that's going to put a great strain on laboratories because you're going to need a very accurate and you're going to need a rapid turnaround test and I'll stop there and we can ask questions at the end. Wow. Wow, that's we had not thought about that. Thank you for bringing that to our attention. Great, great summary of what's happening with testing and we are going to get to questions and answers very shortly here. Go ahead and type your questions into the chat function or into the Q&A function. And then Art, you want to tell us about a little bit about what we can do from a telemedicine standpoint to mitigate this crisis. Yeah, thank you, Adana. So CMS is now going to temporarily and the key is temporarily under the pandemic, pay clinicians to provide telehealth services, which will allow seniors to communicate with their doctors without having to travel to a healthcare facility. Obviously, this is very consistent with our social distancing guidelines and hopefully will help limit the exposure and spread of the virus. This is now allowed because on March 13, the president announced an emergency declaration under the Stafford Act in the National Emergencies Act and then consistent with the president's emergency declaration. CMS then expanded their Medicare healthcare telehealth benefits under the Social Security Administration's 1135 waiver. This is a very important waiver and there's several things that it entails. Previously, prior to this declaration, Medicare only paid clinicians for telehealth services in certain circumstances. They had the number one live in a rural area and they had to travel to a local rural medical facility. It was not done at home and it wasn't done allowed in urban areas. Under the new presidential announcement and the 1135 waiver, Medicare patients can now visit their doctor by telemedicine from their home. That's the key to social distancing. However, in addition to using this for helping with COVID-19 diagnoses, the telehealth can be used for other purposes other than directly COVID-19 diagnoses again to help take care of these patients and keep them at home. Under the new waiver, the range of clinicians that will be able to provide services include doctors, nurse practitioners, clinical psychologists and licensed social workers. And now it can be done in the doctor's office and hospitals and nursing homes and rural health clinics and again most importantly at home. In addition to these maneuvers which are around CMS and obviously applied to Medicare patients, the elderly, the president has called for all insurance companies to expand and clarify their policies around telehealth. And obviously this is all meant to facilitate CDC guidelines for practicing social distancing. And there's a fact sheet that there's a link for at the bottom of that page. Going to the next slide, this 1135 waiver that I'm talking about also affects amtala and HIPAA requirements and related sanctions. So as you all know, amtala normally requires healthcare facilities to perform an appropriate screening evaluation and stabilization prior to transfer. During the pandemic and 1135 waiver, individuals can now be directed or relocated to another location without the necessary screening evaluation and stabilization. Obviously we have to use common sense on when those screening evaluations and stabilizations are necessary prior to transfer, but when it when it seems reasonable, you can do it without fear of sanctions. The 1135 waiver also relaxes some of our HIPAA privacy rules under the pandemic. Waiver requirements to obtain patient agreements to speak to family and friends or opt out is waived. It also waives requirements to distribute a notice of privacy. And in addition, it waives the patient's right to request privacy restrictions on communications. The other important thing that the 1135 waiver includes is that now healthcare professionals that hold a license to practice in any state in the United States can now practice across state lines. They don't have to hold the license in the state that they perhaps are practicing, and that perhaps will allow us to use and redistribute some of our professional resources. That's what I've got. Awesome. Thank you. I appreciate that. Yes, I think telemedicine is really going to change the way we deliver care moving forward. Sharika, would you like to tell us a little bit about what we can do to treat some of these patients that we have in our hospitals? Yes. Thank you, Donna. So there are currently several drugs being studied as possible effective treatments against the coronavirus and these include hydroxychloroquine, kevzara and remdesivir. And I'll just go over them very briefly. First is hydroxychloroquine, which is receiving a lot of buzz in the media as a potential treatment for COVID-19. It actually stems from an unpublished, non-randomized trial based on the French COVID-19 patients that have shown that the drug has promised against the virus and patients were recovering from that small trial. And right now in the United States, hydroxychloroquine is currently being studied at the University of Minnesota and has enrolled approximately 1500 patients in that trial. Just as a background, hydroxychloroquine is very similar to chloroquine. It is a hydroxylated version of chloroquine and it is also considered as an anti-malarial. However, it is used primarily for its anti-inflammatory effects to treat lupus as well as rheumatoid arthritis and other autoimmune diseases. What we found out is that in terms of how hydroxychloroquine works, and this is again a hypothesis in terms of its mechanism, clinical investigation have shown that there are high concentration of cytokines detected in the plasma of critically, critically ill patients infected with COVID-19. So, suggesting that there is a cytokine storm occurring in these patients accelerating their disease severity. And as a result, what the scientists and healthcare professionals are doing is using hydroxychloroquine as an anti-inflammatory agent because it has been shown to be effective in suppressing certain cytokines in autoimmune diseases. So that is the angle that a lot of the researchers are taking in using this drug against COVID-19. The second drug that's being studied is Kevzara and it is different from hydroxychloroquine in terms of it is a human monoclonal antibody that inhibits interlupin-6, which is a pro-inflammatory cytokine. And it was approved also for rheumatoid arthritis and right now it's currently being used in Phase 2-3 clinical program. It is being tested against 400 patients who are severely hospitalized with severe COVID-19 in 16 sites in the U.S. One thing I want to emphasize is that Kevzara is not a vaccine, it is a human monoclonal antibody. And the proposed mechanism of this activity is that this drug is aimed to help the lungs from triggering an overactive inflammatory response. The third medication that is also getting a lot of hype from the media is remdesivir. We've talked about this from last week's webinar. We know that this is a nucleotide analogue that was studied in Phase 3 clinical trials for the treatment of Ebola two years ago. And right now what remdesivir is being used is being used in actually five clinical trials around the world. In the U.S. right now it's being used at the Nebraska Medical Center and also internationally it's used in China. And in China seems to have the biggest patient population enrolled about 1,000 patients. So we're hoping that remdesivir will have some results in the upcoming weeks. And let's segue into the vaccine trial. This is the first vaccine trial that is using a messenger RNA sequence of the virus. And as we know it actually the trial was started this past Monday. It was funded by the National Institutes of Health and Moderna Pharmaceuticals in collaboration with Kaiser Permanente Washington Health Research Institute in Seattle. This vaccine is basically different from traditional vaccines. Just as a historical perspective traditional vaccines were produced by using the virus itself. In contrast mRNA1273 is using just a small the genetic code of that of the coronavirus. So the vaccine is designed to direct the body cells to produce an antibody and to spur up a robust immune response against the virus. And it's being shown promise in several animal studies. And what I also want to highlight about the vaccine is that its aim is to target the coronavirus spike-like proteins. And the spike-like proteins or S-like proteins are the ones that allow the virus to enter the epithelial cells of the lungs. So you know further data is forthcoming from that study. As Dr. Steve Barker has mentioned earlier about ibuprofen. So it's getting it was receiving a lot of social media simply because it was sparked by a tweet by the French Health Minister who actually had warned people not to take ibuprofen or NSAIDs because some French COVID-19 patients had experienced serious side effects. Subsequent to that the European Medicines Agency including the WHO has issued a statement in the middle of this week saying that there is currently no scientific evidence establishing a link between the use of ibuprofen and the worsening of COVID-19. And many infectious disease experts also confirm that that statement as well. So the conclusion from ibuprofen use is we can use it as an antipiratic in addition to acetaminophen as well. There is no harm at this point for the use of ibuprofen or NSAIDs unless if someone has underlying kidney disease and other conditions as well. And I also wanted to update one last thing about the FDA recent update from the Daily White House Coronavirus Task Force. And the Trump administration is pushing the FDA to eliminate barriers to using hydroxychloroquine as well as other drugs from Europe and Japan. And one last thing about what the FDA is aggressively doing is looking into convalescent plasma taken from recovered COVID-19 patients as a possible treatment based on antibody therapy. That's all I ask Donna. Thank you very much, Jerica. That was very helpful. And we are at the top of the hour. We do have some questions that have come in and there's not that many of them. So I think that what we can do is we will summarize all of the questions and we will send them out to everybody on this webinar with the slides as we do every week. And so we welcome your continued questions. Please, if you did not get an opportunity to ask your question during the webinar today, feel free to head to the Patient Safety Movement Foundation website and you can send us a question from there. And we will continue to take these questions and we'll use this information to determine what our topics are going to be for next week. Well, thank you very much everybody for joining and thank you to all of our panelists today. I really appreciate your participation and we will be back here next week, Friday, 8am Pacific Standard Time. Thank you everybody. Thanks. Thank you, Donna. Bye bye.