Lori Walsh: As Americans reach for a sense of normalcy during the pandemic, scientists and medical professionals search for the kind of insight and solutions that could create breakthroughs, large and small, in the fight against the novel Coronavirus. Kevin Post is chief medical officer with the Avera Medical Group, he joins us now with an update on research and clinical trials.
Dr. Post, welcome back, thank you for being here.
Dr. Kevin Post: Yeah, thanks Lori. I'm happy to be here.
Lori Walsh: You know, in the early days of this, when you and other healthcare professionals and leaders came and talked to us on the show, I just remember we had that sense of uncertainty that we'd still be talking to each other, weeks down the road, because we never knew who was going to get sick and who wasn't. So, it's a moment to just say, thanks for still being here, we appreciate that you're healthy and well, and still doing the leadership work that needs to be done. I want to start with that.
Dr. Kevin Post: I was going to say, thank you. My colleagues and I were just reflecting on that yesterday, how we felt two months ago when we had initially seen the projections and numbers, compared to the feeling now, when we probably feel more prepared, and that we know somewhat more about it, although there's still a lot of unknowns.
Lori Walsh: Yeah. I want to remind listeners, because we're talking about clinical trials and research for therapeutics or treatments, not necessarily a vaccine right now. But, remind people why we don't already have proven treatments for this disease?
Dr. Kevin Post: Yeah. Why we don't have that is that this is a new disease, it is a new virus, although many things are similar to the common virus. There is just not a specific remedy for this one. So, although some of our anti-viral medications are showing promise, there are still some limitations to them, and we have to make sure they're safe before we're rolling out.
The other thing that sets Coronavirus apart is there's just a general lack of immunity among our community because we haven't seen this before. So, our bodies haven't recognized it, we don't have our own antibodies. That really underscores the importance of why we do need to head into research, so we can find better treatments available, to better protect ourselves. Both for this outbreak, and what may occur in the unknown future.
Lori Walsh: All right, let's talk about some of that research, and some of those treatments. I want to start with what's happening locally, and what is showing promise. If I asked you what's showing promise, what would you bring up first?
Dr. Kevin Post: Yeah, definitely for that what I would first bring up would be the convalescent plasma therapy. Avera's been very involved with that, it was a study developed by the Food and Drug Administration. Then, it is then driven through Mayo. Avera was one of the early adopters, as one of the sites through Mayo for the convalescent plasma therapy.
What that is, is basically, people who have become infected with Coronavirus, their body responds by making antibodies. Approximately four weeks after you have an active infection, you do have high enough levels of antibodies that we can test to see if you have had a past infection. In those that have had it, we can then have them donate their plasma, which is a portion of their blood, that we can then transfuse, or give into the selected patients that are suffering from an active Coronavirus infection, who are quite ill, and hopefully can use another person's antibodies to help stave off, or fight that person's infection.
It's been a very beneficial therapy. So far at Avera, we've transfused 56 total patients, and usually starting to see improvement within sometimes up to approximately three to five days. On average, patients can be discharged six days after receiving the therapy.
Lori Walsh: Let's walk through some of how this works. When do people donate the plasma, the people who have recovered from COVID-19? How are those selections made, and how much do you get to store up, or have in a bank for donations?
Dr. Kevin Post: Well yeah, the storage is really not the issue, that can be stored easily. But, what we need, and fortunately and unfortunately, we're far enough into this now where we have had more positives, where people are now about four weeks out from their acute illness. At about one month, or four weeks out, is when you typically can collect from people who are willing to donate their plasma. That plasma is then stored, we go through all the normal testing and treatment, safety measures you would, just like you would with a blood transfusion. You can then administer it into someone with an active infection.
So, to receive the therapy, if you were going to be the recipient for it, you need to be over 18 years of age for the study. Then, we really are focusing on patients who have developed severe symptoms, or patients who are very high risk for developing severe symptoms, such as those with severe chronic health conditions, problems with their immune system, there are medications that may suppress their immune system. So, we're trying to carefully select which patients we use it on until, of course, we get our storage built up so we can treat more this way.
The encouraging thing about this, Lori, is that as we do have more people infected in the area, we will have more donors available as well. So, it should be a therapy that, hopefully, is available while we wait for a vaccine.
Lori Walsh: Somebody sitting at home right now, they know they had it, they were tested and it was positive, and they just took care of themselves at home, and they recovered. Should they call their doctors and ask fi they're a candidate for donating plasma?
Dr. Kevin Post: Yes, that is the perfect route is to call your primary care provider, they know your medical history best, your medications best. That would be the correct route to take, and it would be much appreciated. It's a nice way to give back to others, give back to the community, and so I do encourage the public to do that if they're able and willing.
Lori Walsh: What are we learning, Dr. Post, about the timing for giving those infusions, and what is effective? Because you said, severe symptoms is where the study is focusing on right now. From everything that I've read, this can become pretty severe pretty quickly, so what are we learning about the timing of administering the convalescent plasma therapy?
Dr. Kevin Post: Right. As more becomes available, I think we're becoming a little more aggressive on our timing. It's not so much the number of days that you have been ill from it, it's more of the progression of the illness. So, if you start to see, over a period of one to two days, where people are declining rather quickly, that is definitely a time you want to try to proactively get ahead of it, and get the transfusion on board. In addition, we are being more proactive with those that have high risk medical conditions, that we're just very concerned in this population, or this patient type, they're likely not going to do well with Coronavirus, then we may try to get ahead of the curve by transfusing the antibodies.
If we had an unlimited supply, I think you'd be able to use it more aggressively, but as we get more donors, I think that will become more available. It's an exciting study, it has shown some benefit. Of course, it's just one tool in the total picture of how you treat a Coronavirus infection.
Lori Walsh: Right. Are people making that decision? Are patients making the decision to be part of the study, or they're choosing between one study and the other? What does it look like for people when they get sick and they're in the hospital, as far as making some of those informed choices?
Dr. Kevin Post: That's a very good point, it is definitely with the engagement with the patients. It should always be a physician and patient decision, that's shared together. Patients always know, they are given the outline of the study, what this is, what are the risks and benefits of receiving this, so it is very transparent, it's open, and people do have the option to participate or not.
It is one of those situations where, I think, you look to the physician whose treating you for their recommendation, who knows you best, and knows how your course through the illness is progressing.
Lori Walsh: Yeah. Are there risks inherent in convalescent plasma therapy?
Dr. Kevin Post: There are, and it's very similar to receiving a blood transfusion when it comes to risk. There's always the risk of infectious disease that didn't get caught in the screening process, that is very low, transfusions are all very safe. Usually, the benefit outweighs the risk, and we always look at that.
There can be other things, like you always can have an allergic response, or a true anaphylactic reaction, which is a severe allergic reaction. Then, you can have the normal side effects when you have a transfusion, such as a low grade fever, itchiness, things like that. But, we can try to give medications, if possible, to pre-medicate to prevent some of them.
There's always risk to everything we do. In this case, this is fairly low risk, as long as we follow our normal safety precautions, which we always do.
Lori Walsh: . How fast is the data coming in, as part of this Mayo Clinic study? We're still talking about convalescent plasma therapy with Dr. Kevin Post from Avera, if you're just tuning in. You're listening to In The Moment, on SDPB Radio.
This FDA study through the Mayo Clinic that Avera's participating in, all that data is going back into that study even as most people who are listening are concerned about the health of their loved ones, and the immediate results of that. But, this is part of this bigger study. How quickly is this process moving forward, as there are so many people across the country who are ill, and are part of the study?
Dr. Kevin Post: Yeah, it's moving forward fairly quickly. Fortunately, for the Midwest anyway, we are somewhat behind the curve of the nation. So, other areas like the coast, they have been able to have many more patients engage more early, just because of the sheer nature that they're ahead of us in this pandemic. That has allowed us to somewhat learn from them as well.
I think, last I looked, there was 1004 and sites who were contributing, so we are collecting a lot of data rather quickly. Our affiliation with Mayo, it's been very responsive, and we are in contact frequently to get updates.
Lori Walsh: Let's talk about some of the other studies. Of course, most people in South Dakota have heard about hydroxychloroquine because there is a state wide clinical trial underway. Then, we hear about other medications, like Remdesivir. Let's shift from convalescent plasma therapy, and talk about some of the other research efforts.
Where would you like to go next? Which one is worth talking about now?
Dr. Kevin Post: Yeah. I think Lori, like you said, hydroxychloroquine is heard frequently on the news, and people wonder where we are with that.
There has been a nice collaboration between the state, Monument Health, Sanford Health, and Avera, to try to bring better therapies for our patients. With hydroxychloroquine, and we were just on a call this week, all of us together again, we're looking at very closely. This is a prevention study, with hydroxychloroquine, so it's not for the active infection. But, I think what we're watching so closely with hydroxychloroquine is there has been mixed messages out in the media and in research, about the effectiveness and side effects of it, so we are very carefully weighing, as we develop this study, how do we proceed very carefully for the sake of patient safety. There's a lot of cardiac or heart side effects with this, a lot of interactions with other medications.
So if we are going to move forward on this, we need to do so cautiously, and never at the risk of our patients.
Lori Walsh: Yeah. Do we have people participating in it now? Are we looking for new patients? What are some of the numbers look like about the study? Or, is the study itself being developed still?
Dr. Kevin Post: Yeah, the study is still being developed, yes, at this time. I think right now, we're trying to form the inclusion criteria, those that we'd be excluding. And, we're really being cautious because after a few weeks ago, it came out from the FDA about the study done at the Veteran's Administration, the VA, where there was some concerns for hydroxychloroquine. So, we're very carefully looking to make sure it's safe to proceed. And, if we do, how do we do it in a way that's most safe?
I think, again, this underscores the need for good research, in general, and I'm happy that our state and our health systems are being involved in that so we can help, hopefully, the patients of our area, as well as the nation.
Lori Walsh: I want to go to the very basic level right now, for people who are tuning in. This is something that is done through a medical professional. People were concerned about the politics of this kind of study, and you're telling me that Monument, and Avera, and Sanford are working very closely together, on the science of this, not influenced by politics at all, that part of the study. Say more, a little bit, about how researchers, in general, as a standard practice, eliminate financial pressures, or political pressures, to make sure that they're focusing on the science? And, the ethics of that, which are pretty well established, in clinical studies.
Dr. Kevin Post: Right. I would really like to thank our state of South Dakota as well, because their Department of Health experts and representatives have been phenomenal to work with in this process. Up front and foremost is always patient safety, the ethics of it, is this the right thing to do is what we are constantly asking ourselves. That is, I think, what we're called on when we do research.
As physicians, first, do no harm to our patients. So, we always lay that, "If this patient were my family member, if it were me, would I want to be in this study? Would I feel safe being in this study?" Those are questions we actively discuss on these calls, to make sure we're following the close safety standards, and doing what is ethically right, and following our mission.
Lori Walsh: Let's talk about Remdesivir, that's something a lot of people have read about in the national news as well. What is that?
Dr. Kevin Post: Remdesivir is an anti-viral medication. Like you think of antibiotics, such as Penicillin, to treat bacterial infections, Remdesivir is an anti-virus. Basically, it's a medicine you would take to fight off a viral infection. Often anti-virals are maybe not quite as effective as antibiotics, but they can help, in some cases prevent, and in other cases slow the progression of a disease. Remdesivir, again, has also seen some mixed results in different studies, but overall there's definitely enough of a trend there that there may be some positive value, that we'll continue to explore it.
One limitation with Remdesivir right now is that the distribution of it, nationwide, is somewhat limited and being conserved to certain sights, so we do not have widespread access to it yet, at this point. Our treatment specialists, our infections disease doctors, are watching this closely, and we're hopeful that if there is ongoing benefits shown, that we can find the best place to use this in our treatment of the Coronavirus.
Lori Walsh: Yeah. Tell me a little bit about antibody testing, we're hearing a lot about that as well. A lot of what we're hearing is the inconsistency of it, and tests that have been rushed to the market without FDA clearance and approval.
First, start with what is antibody testing? What is the potential for helping us understand our fight against COVID-19?
Dr. Kevin Post: Yeah, antibody testing is a very important topic right now. It's another tool that we can use to help see if people have had the infection, or to track how we're doing as a community, or a region.
What it is, it's basically a blood test you draw, and you get a result back that says if you have had the Coronavirus infection in the past. It's a positive or a negative test, it doesn't give you a quantity or a number to it, so it doesn't tell you how much, what level of antibodies you have in your body, just whether you have antibodies to it or not.
There's many things we don't know about this. We don't know, if you have antibodies, how well you could fight off another infection, if you're susceptible to another infection or not. It should likely help prevent you from getting another one, or not having as severe of an illness, but to say that you can go back without any protection, things like that, we don know yet for sure.
Where it is very valuable is you can use it to monitor ... At Avera, we're pushing patient safety, we're making it safe for our patients to come back in, so we're wearing our personal protective equipment, and we have all of our safety measures. You can use it to measure how well you're doing, compared to the general public, that's a tool for it. We're looking at using it, can it be a tool for our employees, for returning to work, situations like that.
I do think, like you brought up, Lori, we have to remember there are limitations to what the test tells us and how we can best use it. I think all of us healthcare professionals are looking at how we best use this, both in our own health systems, our communities, and nationwide, as we try to return to the new normal, and live with COVID.
Lori Walsh: Is it being deployed in healthcare scenarios yet, across the nation? Or, in South Dakota, where healthcare workers, and emergency room doctors, and nurses, for example, are using the test, yet? Is there a study going on, what's it look like right now?
Dr. Kevin Post: Yeah, right now I think health systems are just starting to use the test, and figuring out how to best use it. What a health system might do is use a small pilot group, a test group, say, for instance, one department, to try to track what the numbers look like, what we would do with those numbers if we rolled it out system wide, and how we can best use it to help us without adding to any confusion. Especially, what you don't want to do is give people a false sense of security. Say, I myself tested positive that I had the condition, what you don't want is that I now feel secure going out in public, not practicing the normal, typical safety measures that are so important as well.
Lori Walsh: What I'm wondering specifically is if people are having those tests, are we collecting data from that, to help us understand more about that antibody test?
Dr. Kevin Post: If they are collecting the data, I specifically don't know of any studies going on right now. I would suspect there are, I just do not know any of them personally, or any in our area. I suspect as that rolls, since the antibody testing is a little bit of a later phase, I think as we get through this first acute rush of the Coronavirus, I think we'll start seeing a lot heavier focus on antibody testing, and how it is best used. It's almost a phase two of this pandemic, we're now moving into this type of testing and how we can best implement it.
Lori Walsh: Yeah, we're also moving into this time when we have more tests available, we especially see with Smithfield workers, is some larger scale testing. Governor Kristi Nome has said repeatedly, "Watch the numbers of active hospitalizations." That number, right now, is up to 76 active hospitalizations throughout the state, up from 70 yesterday.
Tell us a little bit, Dr. Post, about getting ready for the surge? Because this is all part of the same conversation that we've been having for weeks, now, that it's very, very important not to overrun any individual hospital or community hospital. When we talk about research, and clinical studies, and the antivirals, and the convalescent plasma therapy, how does it tie all in to this notion of surge preparation for our hospitals?
Dr. Kevin Post: When it comes to surge preparation, I just want to take a moment here and really thank our listeners and the public for everything they did with our medication efforts, for staying at home. In our area, we have seen a nice flattening of the curve, and a lot of that is due to the cooperation of all of us here in the Midwest, so thank you for that.
What that has done, it has allowed us to slow the number of cases so we don't overwhelm our healthcare system. That includes things such as having enough protective equipment for our patients and our employees. It looks like we may have enough hospital beds, ICU beds, ventilators, and other equipment that's a necessary.
The other thing that has been very beneficial here in the US is we have been able to decrease the length of the hospital stay. So, we can then turn patients over as well, more quickly as well, so you don't get quite the backlog of patients we were first expecting.
If I look back, like we talked about earlier in the show, if I look back to two months ago, I'm much more optimistic that our health systems in our region will be able to handle the load of the patients. However, that will hinge upon how well we do, as a public, just being wise and responsible. I think our Governor has given us a lot of liberty, but we have to handle that liberty with responsibility. Thankfully, we haven't had to go down in lockdown, and I think if we continue to be responsible, and to do our part, we can come through this okay. I think if we get reckless, and careless where we aren't watching ourselves, then we may see a rebound in the surge. Due to the economic reasons, we really don't want to go back into mitigation efforts as well, because the economic impact of that is also staggering.
Lori Walsh: Yeah. Tell us a little bit, because when we talk about ventilators, and we talk about the 31 deaths in South Dakota, and 76 active hospitalizations right now, when you go into the hospital ... What I'm getting at here, Dr. Post, is encouraging people to be proactive with their symptoms, because we are hearing about people who are, really, dealing with that fear of I don't want to be intubated, I don't want to go into the hospital, this is a scary place to be. A lot of this treatment is not getting to the ventilator stage, right?
Tell us a little bit, and we have about a minute left, of how people should be proactive about their symptoms, and about getting the treatment that they need? Even if that is calling your doctor and saying, "I think I need to go to the hospital."
Dr. Kevin Post: Yes, you're exactly right. If you do have health conditions, we are ready to see people again, we have the equipment ready. I urge you not to wait, because the uncontrolled diabetes, heart symptoms, those cannot wait because we are seeing the fall outs of people not coming in when they're having heart attacks, strokes, and letting conditions go. We are now ready to see people, we have the equipment ready, we have measures in place to keep you safe when you come in. So, the risk of staying home is, actually, going to be much worse that coming in.
I understand how the perception may have gotten there through this, but we are prepared to see you safely.
Lori Walsh: All right. Dr. Kevin Post, thank you so much for being here. We will continue to wash our hands, and keep distant from each other, and use those really smart things in hopes to keep everyone safe. We appreciate your time.
Dr. Kevin Post: Yeah, thank you, Lori.