COVID-19 Emerging Recommendations Panel March 2020 – Transcript
Jeff Jellin: Hello, everybody. Let’s get started. We have an important session here for you, as you might expect. We’re focusing today’s discussion on the COVID-19 situation. I’m Jeff Jellin. The other voices you’ll hear are some of our advisory board members and some experts who are on the front lines of this pandemic. And of course, you’ll hear from some of our own editors. If you want to know more about any of the people I’m about to introduce, click on the tab that’s titled “Panelist Bios.”
Dr. Reid Blackwelder is professor and chair of family medicine at East Tennessee State University, and Reid is also a past president of the American Academy of Family Physicians. Dr. Andrea Darby-Stewart is a family physician and associate director of the HonorHealth Family Medicine Residency Program in Arizona. Dr. Andy Donato is a hospitalist and associate program director of the Internal Medicine Residency Program at Redding Health System in Pennsylvania. Dr. Steve Nissen is the chair of cardiovascular medicine at Cleveland Clinic and an internationally-recognized expert in cardiology. Dr. Doug Paauw is a professor of medicine at the University of Washington in Seattle, obviously one of the epicenters of the U.S. outbreak. Dr. Joe Scherger is a family physician and also a national leader in family medicine, education, and author of multiple books. Dr. Craig Williams is a clinical professor of pharmacy practice at Oregon Health and Science University.
In addition, we have a special expert joining us for this session, Dr. John Lynch. Dr. Lynch is associate professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington in Seattle. He’s also medical director for Harborview Medical Center’s Infection Prevention and Control Program. We’re very fortunate to have Dr. Lynch here with us to discuss how Harborview Medical Center is preparing for the expected surge of COVID-19 cases and what we can all take back to our practices to help patients in our communities.
From our own editorial team, we have Dr. Melissa Blair, our senior editor. Melissa will be looking for any questions that you might type in, and she’ll select some of your questions or your comments and present them to the panelists for discussion. Dr. Lori Dickerson is our Prescriber’s Letter editor. You’ll hear Lori leading today’s working group discussion. And Lori has several of our other editors assisting: Drs. Beth Bryant, Melanie Cupp, Sarah Klockars, Jeff Langford, Jennifer Nieman, Brea Rowan and Marlea Wellein.
If you want to ask questions or share your comments during this conversation, type them into the spot that’s called “Ask a Question.” You might hear your question or your comment discussed by the participants, or you might get a typed answer from one of our editors. Watch for those responses to show up in the “Total Answered Questions” section in the “Ask a Question” panel on your left. If you’d like to see more of the clinical resources related to this topic, click on the tab that’s called “Course Materials.”
And I want to wish you and your family and your colleagues the very best as you navigate these uncharted waters, and applaud you for the work you are doing to care for your patients during this very critical time. So, Lori, take it away.
Lori Dickerson: Thanks, Jeff, for those introductions. I’m going to start by going over some CME information. Today’s program is worth a max of 1 AMA-PRA Category 1 credit. Our program is also worth 1 hour of ACPE credit for pharmacists joining us today. And please note that in order to get credit for today’s session, you must be pre-registered for the course through the Prescriber’s Letter or Pharmacist’s Letter website. You must also have logged in with your specific login, so we have a record of your attendance. The course code for today’s presentation is 8617, and you’ll need this course code to get your credit.
To get us started, we do want to acknowledge at this moment that in our March 2020 issue we wrote about reinforcing infection control in light of coronavirus. At press time, the statistics we had comparing COVID to the seasonal influenza were appropriate and were vetted by our editors and our editorial advisors, including Dr. Anthony Fauci’s office at the National Institute of Health. But as we all know now, this perspective is rapidly evolving. Some of you have commented on our sites about this, and this is the very reason we’re doing the session right now. As you’re all aware, media reports are aplenty, but the medical data and literature are playing, and will continue to be playing, a catch-up game. So thank you for understanding. Let’s dig into our discussion.
The World Health Organization, of course, declared the COVID-19 outbreak a global pandemic on March 11th. And the U.S. declared this a national emergency on March the 13th. So, John and Doug, first of all, thank you both for joining us, while you’re in the middle of all this in Seattle. We’re so thankful to be able to learn from your experiences.
John, as of today, March the 19th, there are more than 207,000 cases confirmed globally with nearly 9,000 deaths. And we just pulled down the U.S. data. There are 11,442 confirmed cases and 150 deaths in the United States due to COVID-19, or the disease caused by SARS-CoV-2. I realize it’s very difficult, John, to predict, but based on the epidemiology of the disease from countries who are ahead of the United States in this pandemic, can you guesstimate when we might reach peak infection rates?
John Lynch: Yeah, thanks for inviting me to participate today. I really appreciate the opportunity to share some of our early experiences with what’s going on in here in Seattle. To get to your question really quickly, it looks like from models that I’ve been looking at through our own system and with our public health colleagues, that we’re probably a few weeks out from peak. We’re probably looking at the second or third week of April, depending on which dataset you use – the early-March versus mid-March data here in the Seattle-King County area. Either the low end or the high end of those numbers are both very, very challenging for our health systems, and have us all working extremely hard on how to address this.
Lori Dickerson: Go ahead, Steve.
Steve Nissen: Can I just jump in and say, doesn’t it depend really on the effectiveness of our social distancing, when that peak occurs? I mean, I would think that if we’re relatively ineffective, it’s going to peak quickly, and if we’re effective, we’re going to spread that out and the peak’s going to occur much later. Is that wrong thinking or is that reasonable?
John Lynch: Well, we think depending on the type of social distancing that’s implemented and how quickly and effectively it’s done, what you probably are looking at more is not the distancing of the peak, but the flattening of the peak. And this goes to the “smoothing the curve” sort of thing, the language has been out there. It’s that you’re not going to push it out farther. It’s just that your area under the curve is going to be distributed over a wider period of time. And the goal of that, really, as I think most folks on this call have heard, is to lessen the impact or slow the impact to the health care systems over time. So it may buy us time in big issues like, do we get to treatment faster? Do we get to vaccines, by the time that larger population later gets impacted? It probably doesn’t do much to the timing of the peak, but more how steep that climb is and how steep it is afterwards.
Lori Dickerson: That’s a great explanation, John. And we’re gonna talk some more about mitigation measures and social distancing in a bit. I do have a question from Craig Williams. Craig, you had a question about mortality rates. Would you like to ask that now?
Craig Williams: In February, the WHO renamed the virus “SARS-CoV-2,” which gets where this virus fits compared to other coronaviruses. And as we learn more about coronaviruses, there’s a huge range of mortality. I think MERS is about 35%. SARS was around 10% and this is going to be between 1 and 3%. And so, knowing what we knew about the kind of fatality and severity of infections with coronavirus, why is this one is different from SARS and MERS, so all of us can kind of take that back to all of our patients and concerned colleagues?
John Lynch: I have to say we’re learning a lot about this virus on a daily basis. When we entered into the outbreak here in the United States, the information we were getting from our Chinese colleagues – who are really now catching their breath and able to share a lot of information, and I think that exchange has been amazing – is that in general, the big numbers we say is about 8 out of 10 people will have a pretty mild-to-moderate disease manifestation of this infection. And so, ranging from very, very mild (and we can certainly talk about this later) to sort of a bad flu where you’re home and you’re feeling quite poorly, but still able to stay home.
About 20% of folks are going to require acute-level care or ICU-level care. And these are folks who are going to need oxygen supplementation, who are just too weak to eat or drink on their own. These folks tend to be older folks. You’ll see from our CDC colleagues, they say “over 60,” but where we really see the impact are folks in their 70s, 80s and above, and particularly those folks in that age category who have medical problems. So particularly, significant cardiac disease, significant lung disease, and probably some others. And so within that 20 percent of people who need medical care, in an inpatient hospitalization, probably what we’re seeing is something around 2 to 5% of folks are requiring ICU-level care.
We have to be very thoughtful about looking at mortality in those groups. We’re seeing in a skilled nursing facility outbreak that manifested here in my county, King County, we had a very serious outbreak and some really bad outcomes in patients that were probably hospitalized fairly late in their disease, but also in residents who are much, much older – people in their late 80s and 90s, and often with a lot of medical problems. And unfortunately, many of them required critical care, and a lot of them died. And that’s what I think you’ve probably seen out in the media.
Craig Williams: Just to clarify real quick, Lori, because I think that’s a great refresher of what we’re seeing with this virus. But since this one is so structurally similar to SARS, thus the renaming SARS-CoV-2, why does this one have a different mortality rate? What do we know about mortality rates of the different coronaviruses? And is it our immune response to it, is it the virus itself and its effect on the lungs or…?
John Lynch: You know, this is John again, and I’m not super qualified to answer that. I’ve been so deep in the operations and programmatic responses over the last six weeks that I haven’t been able to review all of the material. I do know that there appear to be similarities in the receptors that are used in the lungs. And there clearly are different manifestations of this disease versus others, and probably differences in transmission patterns as well. So maybe different populations are being impacted. There’s this really interesting and very curious manifestation in pediatrics. They really have no bad outcomes. It’s remarkable in the data coming out of China in the first 80,000 patients. No one under 10 died. Like zero. Nothing.
Steve Nissen: Let me comment on this issue of the mortality. In talking to our ID people and a lot of folks around the country, there’s this problem with cytokine storm, that some people get, triggering. Now, why some people get it and some people don’t, but that’s the real killer aspect of this. And these people just have an overwhelming cytokine storm. And that’s why there’s a lot of efforts underway to look at ways to block everything from IL-6 to other mediators, including IL-1 data. So I think that’s what’s going on here. And that’s the mechanism.
Lori Dickerson: Actually, Andrea Darby-Stewart had asked this question, wondering if there was any way to identify who these younger patients were who might be susceptible to or might develop this cytokine storm. And I’m guessing we don’t have those predictors, John, and this is another unanswered question that we’re going to have to learn over time. Would you agree with that?
John Lynch: I think you’ve seen in the media some reports of, particularly in Europe, a lot more people under 40 with bad outcomes, or severe illness. We so far haven’t seen that same pattern. We definitely have a small number of 20-year-olds who have required intubation as a result of this. I just actually saw one at one of our hospitals today who was able to recover and get extubated today, which is fantastic. But I think that issue of the cytokine storm is definitely something a lot of people are paying close attention to, and it’s informing some of the potential markers to track, like IL-6 and/or treatments that are potentially emerging.
Lori Dickerson: Okay, that’s great, John. We’re going to talk about some of the treatments, but I just want to back up a minute. And Doug, I want to call on you, if you could describe how these patients are presenting and what you’re seeing. We’re seeing the cardinal signs from the CDC: fever, cough, and shortness of breath. But could you talk a little bit about the quality of that fever, the type of cough, and in terms of symptom onset, how quickly are we seeing symptoms and how does that compare to the flu, Doug?
Doug Paauw: Well, it’s a challenge because there really is such an overlap with influenza symptoms. I don’t think there’s anything magical about how this presents. The patients I’ve seen and the many calls we’ve triaged that have turned out to not be. Fever occurs in most of them, but it doesn’t always occur as the first symptom. A dry cough can be persistent, but some of the patients that we’ve seen, that have been actually healthier, haven’t had cough as early on. The shortness of breath has really been the key symptom that has driven us to test people. And we have so many people that we just tell to stay home if they’re otherwise okay. They may well be COVID-positive, but we don’t ask them to come in and get tested.
I think John can touch on this, but some of our goal is to keep our workforce out there, but also to keep our patients isolated, not bringing everybody in who may have mild disease. But what I’ve seen is that those three are really, really important. One thing I just want to touch on – there’ve been some reports on GI symptoms and some people very early on can get nausea, vomiting, some diarrhea. And there is some fairly significant ability to spread this virus through fecal-oral means, probably. There’s one study that was looking at culturing bathrooms of people that were in hospitals with this. So I just throw that out as I’ve seen one one case like that, and just to keep your mind open for this in people that are getting sicker and sicker.
Lori Dickerson: Okay, good descriptions there. Andrea, were you going to jump in?
Andrea Darby-Stewart: Yeah. This is Andrea. So we have a couple of, well several, health care physicians out who are on our inpatient service right now, having treated people who are suspects and are now manifesting a couple minimal days of nasal congestion, then a fairly abrupt onset of cough and some shortness of breath. They’re pretty young. They’re not having fevers technically, although they’re all ranging in the 99 to low 100 range. And so they’re obviously out for appropriate observation. Is that a pattern that you’re hearing about or seeing or…? My suspicion is that sounds a little bit more like community spread, and I’m happy that these are younger people who might be a little bit healthier with their exposures.
Lori Dickerson: John, can you comment on that?
John Lynch: Sure. To be honest, every respiratory infection presenting in an outpatient and inpatient setting right now is a concern for COVID-19. Basically, just to sort of look at it from a different lens, 100% of patients admitted to my hospital and the other hospitals in my system who are presenting with symptoms consistent with a respiratory tract infection are being tested for COVID-19 on admission. We’re finding cases both in that population, and very interestingly, we’re seeing people come in – older folks who come in with a hip fracture and then you start doing an evaluation. You find out that they actually had a cough and some shortness of breath and then they get a chest X-ray or chest CT, and you find evidence of pulmonary involvement, and they get tested, and they’re positive. We’ve seen this in trauma. We’ve seen this in strokes as well. And it’s been very, very challenging.
So on that side, our bar is very low for testing. And the issue is that our testing is linked to our personal protective equipment, and our strategies around preventing infections of health care workers. On the outpatient side, it’s been everywhere. I have personally swabbed a patient who I – three weeks ago before things really kicked up here, we had a home assessment team, and I worked with public health and we went out to assess this patient. And I’ve been practicing ID for a while, and I’ve been doing medicine for even longer. And I said to this patient, “You have flu.” This came on like a ton of bricks the day before. She was driving home, all of a sudden felt sick. Fever, not hungry, but eating and drinking. And I was like, “You have flu.” And I was completely wrong. She had COVID-19, and it looked for all the world, like every other serious (but outpatient) respiratory infection. And so it’s all over the place. I could talk a lot about this.
We’ve gone out and done testing at skilled nursing facilities and found people with positive tests with very minimal symptoms in those age groups associated bad outcomes. We have a lot more to learn about this. And I would just recommend keeping your threshold as low as possible, which I recognize is a significant challenge with the barriers around testing.
Lori Dickerson: John, while we’re talking about transmission, I also wanted to ask you about the comparisons between transmission rates for COVID versus influenza. You know, we’re hearing that it’s 2-to-3 times more likely to transmit than flu. And that’s caused a lot of confusion, I think, in the media and in the lay personnel. Could you comment on the transmission differences or the rates of transmission?
Steve Nissen: R0, for flu versus COVID-19.
John Lynch: I’m not going to comment much on the R0 because of the complexities of that. But I will say that I am, as my younger daughter says “confuzzled,” (confusion of “confusion” and “puzzled”). We have seen devastating outbreaks in skilled nursing facilities, rapid transmission, and bad outcomes in patients. And these are in facilities that are used to seeing influenza. So if you don’t work in a skilled nursing facility, I’ll just let you know, these folks are used to seeing transmission of influenza. And some of these people are requiring hospitalization, some of these bad outcomes. We have seen devastating transmission in these facilities that happens quickly and leads to a lot of illness, a lot of morbidity, a lot of hospitalizations and deaths associated with it.
But at the same time, we’re seeing people working together, so like business people working in groups and in meetings, and out of 10 of them, 3 of them will get infected. But at the same time, in my health care worker population, where I have documented exposures, where we do testing of any symptomatic individual, we’re not seeing transmission. It’s remarkably unclear how this bug is moving the way it does. I know there’s lots of discussion around asymptomatic spread, and pre-symptomatic, and post-symptomatic, and that could be a whole discussion unto itself. But this is a respiratory droplet transmission. I lack clarity around super-spreaders, like there are with SARS-CoV-1 and also the role of direct droplet, like inhalation to mucosal membranes and fomite transmission. Again, a lot more to learn that will help inform this question.
Lori Dickerson: Okay. Go ahead, Steve.
Steve Nissen: I was going to ask, have you seen fomite transmission where you were pretty sure that was that was the route?
John Lynch: Well, it’s hard to know because I’m really looking at examples where I look at transmission patterns in different groups, and so I don’t, not having been in those situations…I know that we’ve had small groups where there’s been transmission from people who became symptomatic that night. And these are often people who aren’t like, direct clinical people, so they’re not engaged in hand hygiene the way that many of us are in healthcare environments. And so fomites may be a much stronger part of this process compared to direct transmission with droplets. But, you know, in the work we’re doing in hospitals, environmental cleaning, hand hygiene, the PPE that we’re using – all intervene in both the direct transmission, but also importantly, that fomite transmission with the environment. So, again, a lot more to learn. I’m sure there’s experts in virology who know a lot more about this. But from my perspective, I think fomites are probably an important part of that transmission pattern.
Andy Donato: Hey, John, this is Andy Donato. You brought up something very great in our pre-session about quarantining groups in hospital wards. Could you bring that back up again with that comment of fomites? Because I think that was really important for everybody to hear.
John Lynch: So are you talking about health care workers, Andy?
Andy Donato: No, no, sorry, I’m talking about patients, about keeping everybody on a ward and keeping that ward locked down. If you would bring that comment up again, that was great.
John Lynch: Yes, sure. So I’m a big advocate of this. There’s a lot of ways to do this, but I’m a very strong advocate of cohorting, where possible, people who you’re evaluating – so pending tests and who have positive tests for COVID-19 on specific wards. And there’s a huge number of reasons for this. One, I think it serves patients really well to have all of the same type of health care workers work with them. Health care workers who are trained on use of the PPE, where you can track PPE – because let me tell you the supply chain in this is incredibly important and central to this process.
Two of the most important things in this whole process are turnaround time for your test, and your supply chain. And that’s where I spend most of my time dealing with things. So having a close eye on your supply chain, having a dedicated health care workforce that are trained and comfortable in that environment, having an environment that is, if you can get to it, negative pressure at the unit level, but also at the room level, are really important. I think these are all really good ways of using resources as efficiently as possible and keeping people safe.
Lori Dickerson: Thanks, John, for that explanation. I’m going to move us on to our next part of the discussion. And Doug, I think you actually had a comment you wanted to make. Was it on what we’ve already covered? Go ahead.
Doug Paauw: Yeah. I just wanted to get back to the influenza-versus-COVID discussion because so many people bring it up. And a lot of this sort of national pooh-poohing – you’ll get people saying it’s just the flu. And I think transmission is different. One of the reasons is that the earlier studies out of China, and certainly some of the ones on the people from the cruise ships, have shown that people carry this 14, 21 days and they may be shedding for quite some time. And influenza does not last that long as far as, our infectious period, may be a lot less. The other thing that I think is important around this, too, is I suspect there are people that are really efficient spreaders of this because you see some of these reports of 15, 18 people getting transmitted from one contact and then you get families where there’s no transmission, even though there’s significant exposure. So there’s so much we don’t know about this. I just want to comment, and John can comment on this, but I think that the length of time that this virus, without any natal immunity in our own systems, is available to be transmitted is a lot longer than other viral illnesses.
Lori Dickerson: Thanks, Doug, for that. I’m going to move us on to our mitigation strategies a little bit more now. We’ve talked a little bit about social distancing. But, John, I wanted to call on you about masks. And I know, of course, that we have a national shortage and many, many issues and many health facilities not being able to get the masks that they need. But asymptomatic people are still wanting to wear masks, and that’s causing a shortage for the symptomatic people. And so just to reiterate the role of masks, if you could please, for asymptomatic versus symptomatic patients, that would be helpful.
John Lynch: Yeah, sure. I think there’s both a micro and macro answer to this. And listen, I also want to acknowledge that some countries have successfully had mass mask use in their population as part of their response strategy. But I want to emphasize, those have been one part of a much larger group of strategies used at the national level. And so knowing that we don’t know all the data, we don’t understand everything that some countries have used this as part of their response, I want to say that when we think about mask use, and where we have data for that, it’s at the micro level. When we are going into a patient room with influenza, we wash our hands. We put a gown on. We put gloves on. We put a mask on. We put eye protection on. We do our patient work. And then as we leave that space, we remove all that PPE and then we wash our hands, right? So there’s a whole context where the risk assessment is built into the signs we have on the door and that test. That’s where we have evidence of the utility of these things. So that’s the micro.
So when someone’s out in the world wearing a mask, they’re not doing a risk assessment. They can’t do a risk assessment as they move through their day. And what you normally see is people moving their masks up and down, sideways, for some reason – like eating lunch in a cafeteria, isn’t perceived as being the same as walking down the sidewalk, when in fact, the cafeteria is probably much more risky than walking down the sidewalk. And they’re touching their mask, they’re moving it up and down. And the mask may be contaminated. Now, they’ve got contaminated hands and they’re not wearing eye protection, which I believe is a really important part of preventing transmission. So that’s the sort of micro issue around all of this. There may be some small benefit, but I think that the additional benefits of this compared to hand hygiene, environment, social distancing, is not significant.
The macro issue is that every time someone’s using a mask – and I’m telling you, this is for anybody who’s not dealing with this outbreak right now and soon will be, the mask issue and supply is very, very, very significant. And it is a very serious challenge. And we need to, at a national, at a regional level, we need to be thinking about where these masks can best be utilized. And to be honest, the best utilization of a mask right now is for health care workers. We need to keep that group of people safe, healthy, intact and feeling confident in their work. And I really, really worry about if all the people outside of health care are using masks, we are not going to have enough for the people at the bedside who are not only taking care of patients with COVID, but are also doing surgery, trauma, oncology care, everything that we do normally. And so that’s my concern. I’ll be the first to recognize that we don’t know everything. I don’t have all the clear answers. But right now, the pragmatic issues outweigh the lack of data.
Andy Donato: John, this is Andy again. Are you reusing masks?
John Lynch: Right now… So we don’t reuse. There’s a couple different ways to think about this. So when I say masks, I’m referring to the simple surgical masks. These are the ones with like, ear loops or something similar. Our mitigation program for those masks isn’t reuse, but what we call “extended use.” So, for instance, in our OR for surgery, they get one mask before lunch and one mask after lunch. And these are the ones that tie behind the neck so you don’t have to contact the front of the mask. And they’re not dealing necessarily with infected people. So they can kind of drop it and bring it back up again.
We are looking at potentially extended use of these types of masks for our EVS personnel. So people who have to clean environments where they have no idea what the fomites are like. And there’s, to be honest, a lot of barriers to access for information for folks in our EVS community. In my particular area, for a lot of our custodial workers, English is a second language. They might not have easy access to the Internet and other fora to get information. So we really want to address their concerns and keep them safe. The other group, though, where reuse is much more likely, is at the respirator level. So when you think about respirators, you think about N95s – those are the masks that you had in the picture there, that white mask, which are used typically for places where aerosolization is a risk, or PAPRs or CAPRs, where you have this shroud with a machine that filters air. You can clean or mitigate both of those. For shrouds, you can clean them and reuse them. And for the N95s, you can reuse them, and the CDC has published guidelines about how to do that. So we haven’t had to move that way yet. One of the tricky parts with N95 reuse as a mitigation plan is that the way you do that is you actually put another mask, a simple surgical mask over the top of it, which means now you’ve burned through another mask, and that could be a problem for your supply.
Andrea Darby-Stewart: Have you had anybody in the community start actually making masks, cloth masks, things that can be reuseable/washed to put over the N95s in order to be able to extend the N95 life?
John Lynch: Yes. So we should be getting about, either today or tomorrow, 5000 cloth masks, just like – for those who are old enough – remember from M*A*S*H? Ours are more colorful and we’re going to work with our laundry and they’re going to be able to launder them. And those will be predominantly for our OR.
Andrea Darby-Stewart: Okay. So you’re using it for people who are in the OR, not necessarily for coverage of N95 in order to kind of use, throw in a baggie, wash everything at night, come back.
John Lynch: That may be a good strategy actually. I haven’t actually thought about using… That’s a good idea. We’re predominantly using for our procedural areas where they could wear one like over the course of a day.
Andrea Darby-Stewart: My mom’s quilting group is ready to go.
John Lynch: Well, that’s great. Our laundry said they can make like 2,500 in a weekend. So it’s amazing. Yeah.
Lori Dickerson: That’s amazing. That’s a great exchange of ideas there. John, many of our viewers and many of our subscribers are community pharmacists who are interacting with tons and tons of patients every day in the community pharmacy and a question that’s coming in from one of the pharmacists now is, should the staff in the pharmacy be wearing masks in their day-to-day activities? If they stay behind the counter, maybe not. What if they have to go out to help people in the OTC aisle? Well, maybe you haven’t thought about this question, but I’m wondering what your gestalt might be.
John Lynch: Yeah, this is super hard because I want to be thoughtful and I recognize the concern. And I want to acknowledge that concern. It’s good. It’s real. I understand it. So let me frame it just a little bit. And that’s that I work in a hospital, predominantly, and that’s different than a community clinic, or community pharmacy, so I want to first recognize that. I’m not an expert in that area. But the issue is that everyone focuses on hospitals, because that’s where you first see the cases and they’re first diagnosed. But within a week or two, it’s in your community and it’s probably been circulating your community for weeks prior to that first hospitalized case or that first death. Almost definitely. And the issue is that if you are out in the world, in our community, you are being exposed whether you know it or not.
And so when you’re at work in a community pharmacy, probably the more important things are to do all the social distancing things, look at other ways to get people their prescriptions rather than relying on a mask that only actually is for one part of your life. The only way to mitigate that really is to wear a mask all the time, like with your family, with everyone. All the time. Or lock yourself in a room when you’re not at work. And so it’s that balance of recognizing that there’s transmission going on in your community from people with minimal symptoms. Doug mentioned earlier, a lot of people do get symptoms, but I’m telling you, a lot of people get minimal symptoms. And they probably transmit a lot less because they’re not coughing and sneezing on you, but they’re still potentially transmitting virus. And so that risk assessment sort of on a person-by-person level is really tricky. And, is it my work? Is it the grocery store? Is it when I’m stopping to get gas or…? They probably all have similar risks and so it becomes very challenging to start, to say, “Well, I’m going to use masks and that will make the difference.”
Craig Williams: I think people are coming to pharmacies disproportionate compared to the gas stations or a grocery store. I think it impacts the mainstay for pharmacists who want to wear a mask. It’s not unreasonable, but I understand where you’re coming from. But obviously it’s generally a sicker population coming to a pharmacy than some of those locations you’re mentioning.
John Lynch: Yeah. And I think but there’s still things we need to lean on, you know, working with our Medicaid teams at the state level, work with Medicare around getting easier access to prescriptions, getting longer durations of prescriptions. That’s a big thing that we were able to change. I’ll just tell everyone. Never let a crisis go unappreciated because we may be able to get so much changed at the legislative level around rules and regulations that I think serve our patients and our healthcare workers, that it is astounding. Things are moving so fast that you wouldn’t believe it. And so we really improved our ability to take care of our patients in so many ways.
Lori Dickerson: Steve, you had a question?
Steve Nissen: You know, what I was going to comment on is I walked by our pharmacy today, one of our outpatient pharmacies, and there was a whole row of little windows with people standing in the windows, you know, providing prescriptions to patients. None of the pharmacy techs or pharmacists had masks on. The number of people they would be interacting with in the course of a day is staggeringly large. And I actually called up our ID people. I said, “This is a potential problem.” And I think we probably need to all be cognizant of the fact that that pharmacy techs and pharmacists see a lot of people. And that’s not social distancing there. These folks were a lot closer than six feet from each other. They were handing credit cards and they were doing all kinds of other things.
John Lynch: Yeah. To me, this is a great time for innovation because I totally hear what you’re saying. But our ER doctors are seeing people with more symptoms. And we’re not having them wear masks the whole time. The nurses are doing it, again, because as we started doing this, you’re going to burn through these masks so fast that you’re not going to be able to keep up. And 2 weeks or 3 weeks down the road, you’re not going to be able to keep your inpatient nurses safe. It’s a real problem. And so for instance, if you need to put a bag on the counter and the pharmacist steps back and they take the drug. And there’s the teaching, the education is on FaceTime on their phone. We need to be thinking about innovative ways that haven’t been possible before. but make sense, to sort of mitigate that hazard.
Lori Dickerson: Great discussion, but I want to move on. We have so much to cover. Melissa, I wanted to call on you now. We’ve talked about – well actually in this session yet we haven’t talked about hand-washing, but we’re familiar with the importance of hand-washing, soap and water, 20 seconds. And the other part of hand cleanliness, of course, is using hand sanitizer, and hand sanitizers are nowhere to be found on any shelves anywhere. And so many people and lay people are trying to compound their own and pharmacies are trying to compound their own. And lots of different recipes have been flying around on the Internet. So I wonder if you could just comment briefly on the status of where we are with compounding hand sanitizer.
Melissa Blair: Well, and Lori, I completely agree with you that there is lots of information on the Internet, some of which maybe we should believe and some of which maybe we shouldn’t. I also agree that what we found is that there’s really no, as far as for our patients, there’s really no vetted formulations. So we really need to continue to tell them to stick with the hand-washing for 20 seconds and singing “Happy Birthday” or “Baby Shark” or any of those other Broadway songs or popular songs that you’re seeing on social media, whatever. You know, since you’re going to be doing it so many times. Just pick a couple songs that you really like.
The most popular formula that we have seen is mixing two parts of isopropyl rubbing alcohol with one part of aloe vera after-sun gel. But you can’t find those, either on the pharmacy shelves, or anywhere. There have been recipes that are popping up using things like vodka. It’s important and I think Tito’s has come out with this, I think most of us probably know, but just reminding our folks that that doesn’t provide a high enough alcohol content, that you need to have at least 60% alcohol. What I have noticed here recently and even where I am in North Carolina, there are some distilleries that are manufacturing high-potency alcohol as a hand sanitizer and distributing it that in their communities. So even if you have that, just make sure that you can help with the safety of that. A lot of them are putting things like tea tree oil or things so that people don’t want to drink the high-alcohol-content alcohol from the distillery. But those are some things that folks have been able to do.
There are a couple of different recipes. The FDA and World Health Organization have produced guidance. And yesterday, the USP provided guidance for pharmacies and health care institutions. The USP actually has three different formulations on how to make 10 liters of sanitizer with a beyond-use date of 30 days, and that can either be using 80% ethanol or 75 or 60% isopropyl alcohol. So I would recommend that if you’re looking to do that, there’s still some questions about, can you sell it? But definitely for internal use, those are available. So I would send you to those websites to get that.
I do want to make sure, though, that one of the things that we probably need to be telling our patients is, because there’s such a shortage and people are so scared about this and are trying to make sure that their families are safe and that they’re safe, that a lot of times they’re making up their own cleaning supplies with what they have at home. And there’s a lot of things that don’t mix well together. And so you can see on this slide, having some information about what not to mix together that could cause problems, I think would be very helpful. So just to kind of summarize, there’s some information on USP, FDA and the World Health Organization sites about how to make sanitizer for internal use. And again, if you get questions about this, just remind patients that hand-washing with soap and water for that 20 seconds is really the most important thing to do, and that hand sanitizer should really only be used when you don’t have access to that hand-washing.
Lori Dickerson: Great overview, Melissa. Appreciate that so much. You know, when we went to press with our March issue, we had really only focused on hand-washing and masks because social distancing really hadn’t even been brought into the discussion yet. But now, of course, you know, we’re seeing the hashtag #flattenthecurve all over social media. And I know all of us probably are personally struggling as a family with, how we do social distancing with teenagers in the house and all of that. So actually, John, can you give us a little bit more about how social distancing can impact that peak and duration of the COVID-19 pandemic? And you mentioned it previously, but now that we have our slide up here to describe that, it would be helpful to give that a quick discussion.
John Lynch: I just want to follow up on that last comment. I agree with everything about the alcohol-based hand-rub and soap and water. But just like we talked about supply before, we’re running low on soap too. So this is the challenge, and our pharmacy is making alcohol-based hand-rub and dispensing it in our facilities. And thank you, Andy, for the offer to send toilet paper. Our Costcos are empty. That happened to us like weeks ago.
So, the social distancing measures. So this is a really, really useful curve, and if you haven’t seen it, it’ll probably burn into your brain over the next few weeks. The big issue here is in that yellow part, or the orange part of that curve, that’s going to be a typical outbreak, where you see a steep increase in cases. This is particularly true going back to another person’s comment around the R0 of a new infectious disease that occurs in a population with no immunity, which is what’s true for this SARS-CoV virus. So you see a steep rise, very high peak, and then usually as people either die or get sick, develop immunity, you see a steep decline and there’s variations in this. But that’s the general curve.
The big issue that we’re trying to address is that big, steep curve with this particular infectious disease and the population it preys on has the incredibly high potential to devastate the health care system, to basically bring hospitals to their knees. And as you bring hospitals to their knees, and you run out of PPE, and you put health care workers at risk, you actually end up creating – the hospitals become areas where you transmit, you actually amplify transmission. You see lots of pictures of what happened in Wuhan, and you see these people in these big tieback suits and gloves and masks, and everything. And as you probably well know, they weren’t changing those between patients. That was 100 percent about saving health care workers. And it really didn’t address the concern about transmission. So that’s a big issue.
So this is a disease that preys on that population, on what I call “the utility of health care” – so, the utilities like gas and water and electricity. So what we need to do is that, we’re not going to decrease the number of cases because we do have a population that has no immunity to this virus. So it is unlikely that we’re going to stop this virus cold and not let it go through our population. So what we’re trying to do is actually what I refer to as “managing the introduction of an epidemic,” and that’s this “flattening the curve.”
So the idea is we use public health measures. Everyone talks about testing. But what we really need is to use public health measures to slow the introduction of this epidemic as much as possible. And the reason we need to do that isn’t that we’re going to save people from getting infected. Although, over a long period of time, if we could do this for months and months and months, or a year, we can get to a vaccine, and that could definitely save lives and infections. But in the short term, what we’re looking at doing is slowing the introduction of the epidemic, the spread of the epidemic into our community, so that our health care systems can absorb those patients both in the ED and in clinics, but also most importantly, in the acute care and ICUs.
We are not capable in the United States of surging in the ways that that first orange peak would require. Taking 50%, 100% more patients is very unlikely in most settings around the country and in places where this is going to be a big impact, particularly in metropolitan areas. It’s not possible. And so what we’ve got to do is to use these social distancing things where we basically just separate people, reduce that direct droplet transmission, reduce the interactions with those surfaces that are fomites and contaminated. And the tools, are, as has already been mentioned: here in Seattle, all the schools are out, the university’s out. Bars and restaurants only do takeout now, and delivery. There’s a whole host of these things. A lot of companies started allowing people to telework, if they could do their job that way.
But we have to recognize that those things don’t help us in hospitals. And so we’re really relying upon everyone in our area to take these things seriously. So, again, slow that epidemic peak, just decrease it or flatten the curve so that we can eventually continue to absorb patients over a longer period of time. So there are pharmacists – you guys love AUC, right? I love AUC and I’m an ID doc. So the AUC’s here’s not changed. The area under the curve is the same. It’s just that it’s over a much longer period of time.
Craig Williams: It’s a different peak. Pharmacists will understand that.
Lori Dickerson: That’s right. Good.
John Lynch: Yeah, different peak.
Craig Williams: As a brief follow-up, Lori, can I ask real quick on that – John, as we do start having patients recovering from this and other countries are ahead of us, what do we know about re-infection or protection once you’ve had it once? Can we say anything about that?
John Lynch: I don’t know if anyone else has heard. I’ve seen case reports of people being re-infected with the same virus. But at the population level, it doesn’t appear to be an issue. But we’re not sure yet. We know that other coronaviruses can re-infect, right? You’ve got to remember there are 4 human coronaviruses that cause colds, and I think they can re-infect you. I think people do develop immunity, but I don’t know if it’s long-lasting. So maybe, is it more like the flu? Or is it more like something else? Unclear.
Lori Dickerson: Okay, one question about social distancing, too. Again, from our community pharmacists who are used to giving immunizations every day in the pharmacy. What are your thoughts on whether that practice should be continuing during this period of time or if that should be held off if possible?
John Lynch: Oh, that’s a super hard one. You know, I am a passionate advocate of vaccination, and I am so deeply appreciative of my pharmacy colleagues making that accessible to people as easily as possible. Oh, boy. Ugh.
Lori Dickerson: It’s a tough one.
John Lynch: That’s a really tough one, because vaccination is so important. You know, again, I live in Seattle. I live in Washington State, where we had a mumps outbreak last year. We had a measles outbreak last year. We’re having a coronavirus outbreak this year. Oh my goodness. We don’t want to get in the way of vaccination, but I guess, my gut reaction is if we can hold off for a couple of months, that may be the right thing to do. But I’m not a public health expert, you know, in the way that a real public health doc is.
Lori Dickerson: No, I understand and I appreciate you giving us your gut feeling there. And I think it is certainly an individual decision that pharmacies are going to have to make and let their patients know. For the sake of time, I’m going to skip us ahead through some of our content and we’re going to transition from mitigation, which has been very interesting and a very important discussion. But we have so many questions about the medications that are being studied and being touted and patients are asking tons of questions. So I do want to skip ahead to that. And actually, I’m going to call on you, Steve, to get us started. There have been lots of rumors about meds that exacerbate COVID-19 infection. And one of those, of course, are the ACE inhibitors and ARBs. What are your thoughts on this rumor, Steve, and how we can help our patients continue to take the medications that are important for them?
Steve Nissen: Very briefly, this is exactly what it is. It’s the worst thing that happens in these kinds of situations. Frankly, The Lancet was irresponsible by publishing this kind of research letter. It’s theoretical. It’s never been shown to be true. It comes from the fact that people with hypertension seem to have a little bit higher mortality rate. But of course, those are also people who have other comorbidities. Multiple cardiovascular organizations have come out with very strong statements saying that patients should not stop ACEs or ARBs out of fear that they would somehow be worse off from the coronavirus. This is just not solid science and we need to stamp this out as quickly as we can. These people are going to stroke. They’re going to stroke.
Lori Dickerson: Right.
Craig Williams: Also briefly. It’s that same kind of receptor from that Lancet article that brought up the concern about NSAIDs. And there’s no data for that. And the FDA just released a statement about an hour or 2 ago saying they’re not aware of any data that NSAIDs pose risk for patients concerned about COVID.
Lori Dickerson: Thank you for that, Craig.
Doug Paauw: Quick word about NSAIDs. You know, I actually like that rumor only because I think many of these people, I don’t like them taking NSAIDs. You know, you’re 85-year-old or 75-year-old with a high fever loading up on an NSAID when they’re volume-depleted. So I think my feeling on that is certainly acetaminophen is a preferable drug in many of our complex medical patients when they get a fever. But I agree with this theoretical issue of the angiotensin II receptor and the effects of NSAIDs and ACEs on that is unproven and shouldn’t change our recommendations.
Lori Dickerson: Excellent. I hope we’re able to convey that message to the patients who are asking. We are also, John, hearing that hospitals are restricting the use of nebulized meds such as bronchodilators in favor of using metered-dose inhalers. We’ve also been hearing about albuterol MDI shortages perhaps due to this shift or simply maybe because patients are stockpiling inhalers at home, in case they develop symptoms. Can you comment on how nebs are being handled at Harborview Medical Center?
John Lynch: Yeah, sure. And again, you see all these little supply chain issues just continue to percolate. People are smart. They know what they need and they’ll take action. So around this issue of nebulizers, yeah, I totally agree. At our hospital, for those who are big believers in CDC guidelines and are following those right now, I would just argue that those are unrealistic and won’t work. And we’ve adopted what’s called standard droplet contact for our patients who aren’t in the ICU and don’t require aerosolizing procedures like nebulizations. So the issue of these aerosol-generating processes like nebulizers is really important because we think that those aerosols potentially persist in the air for a bit longer.
I think many of you have probably seen the article from The New England Journal that was published yesterday, that aerosols can last for quite a while and that they require a higher level of personal protective equipment. And those are the respirators I was talking about before. And the big problem is that those respirators are going to be short supply, right? They require additional training. They have extra risk because health care workers aren’t used to wearing them. The N95 mask, people think, “Oh, it’s just another mask.” But if you take it off, even correctly, with a trained observer, the risk for that thing turning around and bouncing in your face or vibrating right as you take it off is actually quite high. And it takes some practice to do it well. And then every time you practice, you’re wasting a mask, and so it becomes this real challenge. So anything we can do to avoid aerosolizing-generating procedures like nebulizers and other similar procedures is good, mostly because of the impact it has on risk to health care workers with aerosolization, and the impact it has on PPE usage.
Andy Donato: Hey, John, this is Andy. Does that same thing go for C-PAP and BiPAP? I’m hearing people say, “Just go right to intubation, and don’t do things that aerosolize like that.” Could you comment?
John Lynch: Yeah. So for folks with COVID-19, talking to my intensive care colleagues – and Doug Paauw may have come comment on this as well – the real push for those folks is: don’t mitigate, don’t do a half-a-step. Don’t do the high-flow nasal cannula. Just intubate the folks. If they’re doing poorly, they’re probably going to continue to do poorly and get worse, and all these middle things like BiPAP, C-PAP, high-flow nasal cannulas probably just create aerosols and create risk for health care workers, and they should just probably get intubated. Which honestly is probably the safest situation, because in my facility, 100% of my ventilators are filtered. And just, again, another supply thing, we’re running out of filters too. So it just goes on and on.
Steve Nissen: That’ll work if we have enough ventilators.
John Lynch: Yes, that is true. Just to give people one more little note – I don’t want to talk too much for this crew – but my state is actively having statewide conversations, and certainly the hospitals have conversations around what’s called “crisis standards of care.” And if you work in health care, this is probably something that as we’re moving in this epidemic, you should at least have some familiarity with. “Crisis standards of care” is when you start changing your standard of care. And that’s things like, in the extreme, “How do I triage who gets a ventilator?” Right? But that’s an extreme part of it. But there’s many, many other parts to that that you’re seeing manifested in Italy right now. So that’s when you change what we normally do, which is not where we are in Seattle, not by a long shot, but if we had, you know, twice as many or 3 times or 4 times as many patients. We are actively engaged in those conversations right now so that we have – the idea is, “What can we do now so we never get to that situation?” But we have to be able to have that conversation now to be prepared.
Joseph Scherger: Before we sign off, Lori, can we talk about chloroquine and hydroxychloroquine?
Lori Dickerson: I was just going to let the group know: we do have the ability to extend, and I want to talk about meds. We’re at the top of the hour, so we’re going to go for probably another 10 minutes or so. For those of our viewers out there in the audience who do need to leave, I want to remind you that the course code for today’s discussion is 8617.
But now I do want to dig into the investigational approaches. We’ve had so many questions about the meds that are being studied to treat patients with acute COVID infection, including those that are investigational, others that are commercially available for other indications. It’s really, really important to make it clear that it’s too soon to make recommendations about which approach to follow. And the data are being published – nearly every single day there’s something new coming out. Just this afternoon, you’ve likely heard about the FDA fast-tracking antivirals for COVID-19, and we’ll discuss a little bit about that.
So a few things that I wanted to just share with you. You’ve probably heard of remdesivir. This is the drug that was developed in the U.S. to treat Ebola. I believe now it is in 5 clinical trials, including 1 by investigators from the NIH, looking at treating some of the cruise ship passengers who contracted the virus. So we do have some data on remdesivir. And then yesterday, you probably heard about the new “Japanese flu drug” or favipiravira, with encouraging outcomes in clinical trials in Wuhan and Shenzhen, involving 340 patients. And in that study, again, very preliminary – a lot of this stuff is getting out there without much peer review – but preliminary data showing decreasing viral shedding and improvements in X-ray findings.
Of course, today in The New England Journal of Medicine, you may have seen the data about one of the existing HIV meds, Kaletra (lopinavair/ritonavir). The study in The New England Journal today showed no benefit compared to standard care in terms of clinical improvement or mortality with it, in about 200 adults hospitalized with severe COVID. So those are some of the antiviral data. Melissa, can you share with us some of the data about chloroquine and hydroxychloroquine?
Melissa Blair: I am happy to. And we have, of course, gotten (as I scrolled through a lot of the question and answers) a ton of questions about this. So what we can tell you today, which might change, you know, in the next week or two, is that most of the background data about using chloroquine or hydroxychloroquine is in-vitro research. And it’s thought that it may work to interfere with the ability of the virus to replicate by keeping it from going into the host cell. So that was all of the background data until yesterday.
Yesterday there was an early report out of France – again, has not been accepted for peer review publication. The study authors felt it was important enough that they needed to make it available, so they put it out online and on YouTube. This was in 20 patients. 20 patients versus 16 controls and the 20 patients received hydroxychloroquine, 200 milligrams three times a day, plus or minus azithromycin, depending on whether they thought there was a bacterial component in addition to the COVID-19. And they received that for 10 days or until hospital discharge. This was given mostly to patients who had upper respiratory tract symptoms. There were some that had lower respiratory tract and some that were asymptomatic, but had a positive COVID-19 test. So where all this came from, and where everybody got really excited about, is that, by day 6 there was about a 70% virologic cure rate, not symptomatic cure rate, in the hydroxychloroquine or the hydroxychloroquine plus azithromycin, versus 12.5% in those control patients.
Now, again, when we start to look into this data, it becomes very difficult because we’re only talking about 20 patients. It did seem to work better in patients that had symptoms versus those that were asymptomatic. Again, we’re only talking about like 6 people that were asymptomatic that were tested in here. There is a trial in Spain administering hydroxychloroquine to close contacts of positive tests, but we have no idea what that information is.
And I think all of this led to what happened today, where during a White House press briefing, it was mentioned that that there would be a fast track. And I think the words were actually “FDA-approved for COVID-19,” which is not true. The problem is, I know that what I have heard and have seen is that, basically within an hour of that press briefing, there was already a shortage of chloroquine and a hydroxychloroquine, and now pharmacies can’t get it from wholesalers at all anymore. So it’s a problem, because we use hydroxychloroquine for a lot of other things. And our lupus patients and our RA patients aren’t necessarily going to be able to get some of their chronic meds because we’ve had this big influx of prescriptions in a hope of either preventing symptoms or if somebody – and we see this a lot with health care workers – is writing prescriptions for themselves in case they are exposed to somebody so that they can start to take it.
Steve Nissen: Let me jump in a second before I get off, because, as some of you know, I do talk a lot with the FDA. Frankly, there is a little bit of a war going on between the White House and the FDA over these issues. The White House wants the FDA basically to just not require randomized controlled trials or other controlled experience. And FDA senior leadership is really appalled. And so they’re not buying into it. And I don’t know how it will all get resolved. But, you know, my view is that politicians shouldn’t make these decisions. Scientists should. And I’m worried about it. That French data, was it a randomized controlled trial or was it…?
Melissa Blair: It was not. No.
Steve Nissen: That’s what I thought. And, let me just tell you, I’ve been doing this for a long time. When you don’t have RCTs, you make terrible mistakes and you end up giving a drug that has toxicities to people, that turns out not to work. And I would be very careful about this until we get at least a small, well-conducted, randomized controlled trial.
Andy Donato: I agree with everything Steve’s saying. I would just add that if there are people that are on death’s door, there’s a “We’ve got to try something” thought. I completely agree we should not be having docs writing this stuff and treating themselves. Reminds me of the anthrax outbreak when we couldn’t get Cipro for about six months.
Lori Dickerson: Right. And Doug?
Doug Paauw: Yeah. So the chloroquine/hydroxychloroquine: the first thing is it’s a scary situation when you can’t get hydroxychloroquine because there are many patients that are using it and need it for their diseases. I also like think chloroquine/ hydroxychloroquine both can have issues with cardiac rhythm, which is important with this disease, when we’re not sure how much myocarditis and other problems. There’s certainly noise from the outbreak at Evergreen that the patients – many of them were dying of – they were getting an improvement in their symptoms and then had unexpected cardiac arrest and there were concerns about that. So I can’t echo enough what Steve says, the importance of trials that really show, “Is this beneficial?” so we don’t harm people.
The other thing is the whole steroid issue that comes up, on giving steroids. And I think from SARS and MERS, we have pretty good evidence that it was not a helpful thing. And the early information out of China really doesn’t look like systemic steroids are good. They actually have a randomized controlled trial that hasn’t been published yet that I think will give us some guidance. But I suspect it will be a trial that will come out and say we shouldn’t do it. Inhaled steroids: I think if you have a reason to give it for other diseases, but I haven’t seen any data on it being a positive. And we worry about the increased pneumonia risks that we’ve seen in the past with use of inhaled steroids. So I would not choose that.
Lori Dickerson: Doug, I just wanted to jump in too, before I go back to you, Melissa. The international asthma organizations have come out today saying patients with asthma should not be stopping their inhaled steroids. But I hear also what you’re saying in terms of COPD and increased risk of pneumonia. So a little up-in-the-air there. Thanks for those comments, Melissa. I think you were going to quickly discuss some of the cytokine blockers, too.
Melissa Blair: Yeah, and I certainly was. But, to reiterate what Steve and Doug and everyone have said, it’s really important that we get good data about using these investigational meds, even if they’re already available in the setting of a clinical trial, so we really know whether it works or not. And so people just going out and getting them is not helpful for the larger population because it doesn’t help us figure out whether these work or could potentially be harmful. And we have lots of examples where really small trials showed great benefit, and then when you actually looked at it in a larger population, there wasn’t one or it was harmful.
So the other big one that we have seen about, especially in those patients that are very ill, is using Actemra, or tocilizumab (which is an IL-6 inhibitor), and it’s thought that this might help with that cytokine storm that people were talking about, which leads to ARDS in those really, really sick patients. And for those of you that aren’t familiar with that, it is indicated for rheumatoid arthritis and there is some preliminary data out of China that does support its use. Again, preliminary. Today, the manufacturer announced that they are working with the FDA to start a phase 3 trial for those hospitalized patients. They’re going to hope to start enrolling in early April and are hoping to find about 330 patients to be able to do that.
So, again, you might hear if you’re working in a hospital, people trying to use these meds and so trying to figure out the best way to get the patients enrolled in a clinical trial, if possible, to help figure out whether these medications are really going to work versus the small scale trials that are happening. But again, as Andy said, when somebody’s at death’s door, the thought process is to kind of throw anything that you can at them. And so we certainly understand that that happens as well in those situations.
Craig Williams: If we’re looking for silver linings here, we can probably sum up treatment by saying there’s no known treatment we should be doing at the moment. But as people have been coming, and calling, and we’re interacting with lots of concerned patients, one thing we’re asking them is if they got a flu shot. Hopefully for next year, we can do better than 50% penetration of the population for the flu shot because people are certainly very aware of communicable infectious diseases now. And hopefully maybe we can get much closer to 100% of flu shots next year, than the 50% we’ve been kind of stuck at for a while.
Lori Dickerson: Great point, Craig. And certainly, one of the overwhelming messages that we do want to reiterate throughout this epidemic, is the importance of the flu shot. And just to touch briefly on the investigational vaccine that’s being studied now for COVID-19, you’ve probably heard that the first dose was given a few days ago at Kaiser Permanente Washington in Seattle, through a phase 1 clinical trial, again, through the National Institute of Allergy and Infectious Disease or the NIH. They do plan to enroll 45 healthy volunteers over approximately 6 weeks and of course it’ll take a year or 2 to determine the outcomes from that trial. So just a brief smattering of some of the information that we have, changing minute-to-minute.
We are really just trying to bring you what we know as of this moment, and we’ll continue to try to bring you some more of that information. I do want to close and get everybody back to their patients and get everybody back to their families. This has been a really fantastic discussion.
We want to thank our audience for all of their fantastic questions. We really can’t thank our panelists enough, particularly Drs. Lynch and Dr. Paauw. Dr. Lynch actually had to sign off. He had a patient care issue and he had to leave us about 10 minutes ago. But thank you so much to both of you and Doug, as one of our regular panelists, for bringing Dr. Lynch to this group and being able to have this discussion. We appreciate sharing all those experiences with our editorial team and with our subscribers in the midst of the cases that we’re facing, that you all are facing in Seattle right now.
As a reminder, the course code for today’s discussion is 8617. Please make a note of it as you’ll need this course code to get your credit. An email will be sent to you in about an hour with more instructions on how to get your credit. Also, a special note about quizzes. You must complete the quiz for this presentation within 30 days in order to receive your credit. And we’d also like to invite our listeners to join us again for our next Emerging Recommendations Panel webinar. It will be held on Thursday, April the 23rd at 8:00 p.m. Eastern.
And as a final note, please keep in mind that our nation’s blood supply is low. Encourage friends and loved ones to donate blood if they’re healthy and able. And from all of us at TRC, thank you all for everything that you do on the front lines each day to care for your patients and their families. We are thinking of all of you and are honored to support your critical role as health care professionals in this time of crisis. Good night.