Convalescent Plasma therapy, which uses anti-body rich plasma from a donor to help an infected patient recover from an illness, has been around for 100 years. Now, Baptist Health South Florida and other leading healthcare systems are having success using it to fight COVID-19.
Host Jonathan Fialkow, M.D. is joined by Samer Fahmy, M.D., chief medical officer at Boca Raton Regional Hospital, to talk about this promising treatment and answer questions about coronavirus tests on this episode of Baptist HealthTalk.
To learn more about coronavirus, including convalescent plasma donation information, please visit BaptistHealth-coronavirus.com
Convalescent Plasma therapy, which uses anti-body rich plasma from a donor to help an infected patient recover from an illness, has been around for 100 years. Now, Baptist Health South Florida and other leading healthcare systems are having success using it to fight COVID-19.
Host Jonathan Fialkow, M.D. is joined by Samer Fahmy, M.D., chief medical officer at Boca Raton Regional Hospital, to talk about this promising treatment and answer questions about coronavirus tests on this episode of Baptist HealthTalk.
To learn more about coronavirus, including convalescent plasma donation information, please visit BaptistHealth-coronavirus.com
Announcer:
At Baptist Health South Florida, it's our mission to care for you when you're injured or sick, and help you stay healthy and fit. Welcome to the Baptist Health Talk podcast, where our respected experts bring you timely, practical health and wellness information to improve your family's quality of life. An old idea is making new headlines as a promising treatment for COVID-19, plus helping to clear up confusion about coronavirus tests on this episode of Baptist Health Talk.
Dr. Jonathan Fialkow:
Hello, Baptist Health Talk podcast listeners. This is your host Jonathan Fialkow, and I'd like to welcome you to another special edition of our show, focused on the novel coronavirus. One of the things that makes COVID-19 such a serious threat is that there are no widely tested and approved medications available to treat it. Across the world, the race is on to find safe and effective treatments.
Dr. Jonathan Fialkow:
Here at Baptist Health, researchers have been finding success in trials of innovative therapies, one of which involves using the antibody-rich plasma of people who have recovered from COVID-19 to boost the immune response of critically-ill patients. It's called convalescent plasma therapy. It's not a new form of treatment. It's been used in the past to treat other viral outbreaks, such as Ebola, SARS, and even influenza. But it hasn't been used in the US for many years, and its effectiveness has not been shown scientifically in the past for other disease states.
Dr. Jonathan Fialkow:
So what's it about? How is it being used during the current COVID-19 pandemic? Baptist Health South Florida is one of the first healthcare institutions in Florida to use convalescent plasma therapy for its COVID-19 patients. And to tell us more about the convalescent plasma therapy and BHSF's participation in clinical trials is my guest Dr. Samer Fahmy, chief medical officer at Boca Raton Regional Hospital. Welcome to the podcast, Dr. Fahmy.
Dr. Samer Fahmy:
Thank you, Dr. Fialkow. I appreciate it.
Dr. Jonathan Fialkow:
So Sam, we mentioned quite a few words there. I do want to get to the convalescent plasma therapy, and specifically Baptist's role in the experimental trials, which is quite exciting. But for the listeners' purpose, let's talk a little bit about what is plasma. We get this quite a bit. We talk about donations of blood cells and plasma. Talk a little bit about just what is plasma, and what its purpose is in our body.
Dr. Samer Fahmy:
Sure. So the term convalescent plasma sounds pretty complicated, but when you break it down to simpler terms, there's definitions for each that make it quite simple. So the word convalescent comes from convalescence, which is the period after recovery from a disease. When you're recovering, you're in the convalescent period.
Dr. Samer Fahmy:
And the word plasma implies the blood that we can take from somebody. After it's spun down and you take all the red blood cells and the white blood cells out of it and you leave just the liquid behind, that liquid that's left behind is plasma. And that's rich in antibodies and other proteins that are floating around in the blood. And typically, those antibodies are generated from being exposed to a disease, an illness, an antigen we call it, that the body can target and produce antibodies that are specific for it. So that's convalescent plasma.
Dr. Jonathan Fialkow:
How is it obtained? How do we get convalescent plasma for our clinical trials?
Dr. Samer Fahmy:
So convalescent plasma, like you mentioned in the introduction, has been used for over a hundred years. The first documented use of it was back in the Spanish flu back in 1917. If you ever Google it, you'll find articles from back in that era by Dr. McGuire and others showing that they've tried taking plasma from some patients that recovered from Spanish flu and giving it to other patients. And even in that setting, they were noticing some promising results from it.
Dr. Samer Fahmy:
And like you mentioned with H5N1, the Spanish flu… Spanish flu pneumonia… Excuse me, I have to do that one over again. As you mentioned before, the H5N1, with another flu virus that was around, used convalescent plasma heavily. And H1N1 was the same way. These are all different types of flus. The medical community have used convalescent plasma when we had no other treatments to try.
Dr. Samer Fahmy:
So how is it obtained? It's usually a patient who had an infection, recovered from that infection, and they have the antibodies in their blood. They can go and either donate blood at a blood bank, or they go through a process called apheresis, where they can instead of donating the whole blood we're able to just extract the plasma and leave the rest of the blood products behind in their body. Either way, we can pull some of that plasma out, and we can test it for all the proper pathogens and then give it to a patient that's currently suffering from that disease.
Dr. Jonathan Fialkow:
It's good to know. So really, is a blood donation, the same type of processes as you'd be donating platelets or blood products. So for the donor, it's not an intensely painful or difficult process.
Dr. Samer Fahmy:
No, it's not intensely painful or difficult. But I'll tell you, when you're donating whole blood, it is a shorter process than if you're donating through an apheresis. So if you donating whole blood, it might take a half hour and it's one needle where they could take the blood from you. But when you're donating plasma, you can do it through whole blood, but we only get one unit of plasma as a product of that. If you end up going through this apheresis process, we're able to get two or three units of plasma from a donor, which is much more beneficial to more patients that are ill with the disease. So we still recommend the longer process. Although it's not much more difficult, it is longer.
Dr. Jonathan Fialkow:
It is. I donate platelets regularly. So it is a little longer, but it's certainly not painful, listeners. So let's go back to now the convalescent plasma trial. Can you describe the trial that we're part of in Baptist Health? And also it should be said, this is led by Mayo Clinic. So we have a relation with Mayo Clinic in the trial as well. Is that right?
Dr. Samer Fahmy:
Yeah. That's correct. So initially when we first started using plasma, we were one of the first health systems in Florida to start using this on a broad scale. And the FDA has criteria for which patients would be eligible to receive plasma when they're infected with the novel coronavirus, with COVID-19 disease. The FDA's criteria, as long as it's followed, they allow us to apply for an emergency investigational drug number through them, and be able to get a consent to use this treatment, even outside the setting of a clinical trial on many of our patients. And we did that.
Dr. Samer Fahmy:
We did that with about 50 or 60 patients to start, until we were able to join this larger Mayo Clinic, what we call an expanded access protocol. And that allows us to join a bigger group with an established protocol, streamline the process, and get plasma to our patients even quicker.
Dr. Jonathan Fialkow:
And in clinical trials, the more patients who are participating in the trial, the quicker and the more valuable will be our data. Correct?
Dr. Samer Fahmy:
Yeah. That's exactly right. Mayo Clinic to date has transfused more than 3,000 units of plasma to patients across the nation. So just to have that wealth of information of those outcomes, what happened to these people after they receive plasma? That was exciting for us to be a part of and to include our patients in those populations, to ensure that if the next virus rolls around, we have some sufficient data to say with confidence that, “Yes, this treatment will help our patients.”
Dr. Samer Fahmy:
And as you mentioned before, we haven't had clear scientific evidence in the past. It's been promising, and there's been lots of promising results with the multiple viruses, but there's never been that one solid trial that's randomized and we get people enrolled in either getting the medicine or placebo, and try to figure out whether it works or not. I think this Mayo trial is the first step towards that.
Dr. Jonathan Fialkow:
Thank you. To clarify the comment of my introduction, it wasn't that these have been shown not to be effective, we just have never really studied them in any kind of way to determine if they're truly effective. What can you say about our experiences here and your personal experiences leading these trials for Baptist Health South Florida? Any anecdotal experiences you're seeing or any trends in the data that we're able to report?
Dr. Samer Fahmy:
It's a bit early to tell. We are going through our data right now to be able to determine whether giving plasma to patients has helped them either stay on the ventilator less days, or be in the ICU less number of days, or hospitalized less number of days. And really, the outcome that everybody is worried about is, “Can it help people survive?” and, “Can those folks who are progressing towards a really bad outcome and possibly not make it, can they make it if we give them convalescent plasma?”
Dr. Samer Fahmy:
That's difficult to tell, unless you do a controlled trial. And what we were doing in the beginning is really trying to help as many people as possible. So we were giving the plasma without a controlled trial, just to get the treatment to the patients that need it.
Dr. Samer Fahmy:
Anecdotally, I think the results look promising. We were following several blood tests. We call them inflammatory markers. They're just a marker of how inflamed your immune system is in response to disease. And preliminary results show that there's less inflammation, that the body is responding well to getting convalescent plasma.
Dr. Samer Fahmy:
But one of the areas that has also been a hurdle is that we're not sure how much antibody is present in that plasma. So it's hard, anecdotally, without doing those tests before giving the plasma to say how effective the treatment is. And only over the last couple of weeks have we been able to get a true measure of these neutralizing antibodies, they're called, or how much antibody load are we really giving the patient that needs it? Some donors have a lot of antibodies and some have a lot less. And we weren't really testing for that routinely as a nation in the beginning, and only over the last couple of weeks have we started doing so.
Dr. Jonathan Fialkow:
So, still a work in progress. And again, we're optimistic that we might have a therapy to help patients, but still in clinical trial capacity. What about safety, though? That might be something to consider. Are we seeing any trends in risk to the patients we gave it to? As you said, initially for compassionate use, and now in the clinical trials. Is there anything popping up in terms of danger of using this therapy?
Dr. Samer Fahmy:
No, it seems to be extremely safe. As long as the blood products are matched from the donor to the recipient and you have the same blood type or a compatible blood type, then no, we have not seen any unexpected complications. And we've treated over 70 patients to date with no unexpected complications from any of the convalescent plasma treatments, which really gives us a little bit more motivation to keep doing it.
Dr. Samer Fahmy:
If there's even a small chance that this is helping folks and helping people recover, which we're encouraged based on the preliminary numbers that it is, and there's very little risk or adverse events, they're called, or side effects of giving this treatment, then why not try it? Why not give it to people and see if it'll work for them?
Dr. Samer Fahmy:
And what we've seen, something really exciting is that, usually when you have a coronavirus infection, a lot of times you see it in a cluster. So either multiple people in a family or multiple friends that were around each other would get infected. And what we're seeing is, so many family and friends have really stepped forward to try to be donors when they find out that a loved one is in trouble with coronavirus, is in ICU, or is not doing well. We've seen so much of that spirit, the desire and the spirit. Yeah, the desire to want to help each other. The donation hotline that we set up has been ringing off the hook. It's unbelievable how many people want to help.
Dr. Jonathan Fialkow:
So, are we still looking for donors? Would we want our listeners to inquire to participate as donors? I mean, I guess they had to be tested positive. So they had to be at some place, and I guess that's a limiting factor, but are we struggling to get donors or we're in pretty good shape in identifying people who can donate?
Dr. Samer Fahmy:
Initially, and going back to March when this disease was fairly new to South Florida, we were struggling to get donors because not too many people were infected with COVID-19 and were eligible. As time has gone on over the last two months, we've gotten a lot more donors. In fact, we used to run donation processing five days a week. We're down to one day a week now because we have sufficient quantities and there's nobody in our system that is waiting for plasma that hasn't been able to receive it.
Dr. Samer Fahmy:
And to help with that, too, is our local blood banks. OneBlood, our partner in this that's been working with us, has been able to catch up a bit more over the last two weeks, and general donations that are going straight to the blood bank are being processed. And occasionally, now when we enter an order, we find plasma available through our blood bank partner without having to recruit donors ourselves. So it seems like the donation has caught up a bit to the demand.
Dr. Jonathan Fialkow:
So on the one hand, that's not great because it means there's a lot of people who've had COVID-19 who are able to donate. On the other hand, at least trying to make something positive from that experience to be able to have these people donate for the potential benefit in the convalescent plasma trial is good news.
Dr. Samer Fahmy:
Yeah. Absolutely both ways. The donors, we're still recruiting donors through the Baptist system, but there's a designated donor. If it's a donor that's specifically going to one of our patients, we're still encouraging, “Come in. We'll do the processing on our end in our hospitals and get that plasma to the patients that need it.” But if we don't have a patient that currently is in need, we're sending those donors over to OneBlood to donate to them directly. So it can be applied to a general pool of donations, and any patient in South Florida can receive it.
Dr. Jonathan Fialkow:
That's the collaborative efforts that we participate in.
Dr. Jonathan Fialkow:
Well, again, I really appreciate your expertise and your leadership in this worthwhile and important program. With a few minutes left in the podcast, if we could switch gears for a little bit. And we keep talking about antibodies, antigens, let's talk a little bit about testing. I know I and others are constantly getting questions from people regarding the different kinds of tests, and should they get them? And certainly, the perspective of your role as a chief medical officer of an extremely large hospital within a large system will be worthwhile. Can you tell us the difference between viral testing, antigen testing, antibody testing, so at least when our listeners hear about testing in a newspaper, or article, in a conversation, they can at least identify what aspect we're talking about in this testing process?
Dr. Samer Fahmy:
Yeah. And I think most listeners will hear about those two types of tests first, the antibody test and the PCR test, they call it, or the viral test. That viral test is most-
Dr. Jonathan Fialkow:
Let me interrupt. The PCR is the viral test, as you just said.
Dr. Samer Fahmy:
Yeah.
Dr. Jonathan Fialkow:
I just want to make sure people see that. Yeah.
Dr. Samer Fahmy:
That's exactly it. The PCR is the viral test. And what you're trying to do with that PCR or viral test is you're trying to take a sample from the back of somebody's nose, all the way back to the throat. It's really quite deep, the nasal pharynx is called, but it's also at the beginning of the throat behind the nose. And if you swab that area and there's virus there, we're able to put it in a machine, replicate that virus multiple times so we're able to detect it, and then it tells us the virus actually exists in that area that you swabbed.
Dr. Samer Fahmy:
So that's the most common one that people have been receiving. And that's the one that we started with. And you hear a lot about the machines that are running it, like the Abbott device that can give us a really rapid result is being commonly used.
Dr. Samer Fahmy:
The experiences with that test, first, it's been a great help having those tests available to us. And it took a while to have those available to us. In the beginning, we didn't have as easy access to those as we would have liked. And we had multiple patients waiting for multiple days, waiting for a test to be resulted. But over time, we've been able to catch up. And even within my hospital, we're able to perform the test in-house and result it pretty quickly.
Dr. Samer Fahmy:
The accuracy of those tests has come under fire a little bit. But in our experience, if you're not sure about the result, if there's a doctor suspicious that their patient has coronavirus and the test doesn't come back with the result that you expect, typically running it one more time can improve that accuracy. So multiple results. If it's within 24 hours, running two tests. That usually gives us a valid enough result that we can rely on it, and we can say with fair certainty whether somebody has it or not. So that's the viral PCR test. We're continuing to do those, of course, for diagnosis and treatment of patients.
Dr. Samer Fahmy:
Now on the other side, and as it relates to the plasma, is the antibody tests. If I'm able to draw a blood sample from somebody and detect that they have antibodies to the coronavirus, this novel coronavirus, then I know they've previously been infected. Now, I can't tell if they still have it or don't, but I can tell based on certain antibodies that they've been previously exposed to that virus. And typically when the human body is exposed to one of these viruses, you produce antibodies. Those are the ones we're able to detect.
Dr. Jonathan Fialkow:
So the active virus, the viral test, the swab behind the nose, we've been told that sometimes people could test negative may because the swab didn't get all the way back. There might be some lack of reliability to test. Do we think, or I should better say do you think, we'll have advancements in the testing where we might be able to detect active infection and active virus, not with the swab in the back of the nose, would it be maybe something, a spit for saliva or something? Where is technology moving in that area?
Dr. Samer Fahmy:
Yeah. That's the hope is that that test with the swab in the back of the nose is extremely uncomfortable for patients, and it can cause what we call aerosolization or some little tiny particles of virus to float in the air and be inhaled by somebody else in the area. So it could create a danger for others. So that's what we're trying to move away from that nasal swab test and go towards the spit test or saliva testing.
Dr. Samer Fahmy:
If we do go that route, one of the routes to being investigated is what's called antigen testing. This antigen testing is you're really putting that spit in a machine that tells you whether there's proteins on there that are produced by the coronavirus. And those antigens are what the body targets to make antibodies.
Dr. Samer Fahmy:
It can get a bit confusing, but the spit test is one of the ways that we're looking at to detecting whether somebody has an active infection, just like that nasal swab would tell you if somebody has an active infection. And that's different than the antibody, which tells you about previous exposure.
Dr. Jonathan Fialkow:
So our Holy Grail for testing would be, I can spit in something, and within a few minutes know if I'm sick. And if I'm sick and I'm home, I can quarantine, and we can take care of people differently. Wouldn't that be nice?
Dr. Samer Fahmy:
Yeah. I mean, that would be amazing. And that's really what we're looking for is something where people can test themselves at home. We know the key to reopening society and making sure everybody can get back to work and school safely is if we can test, test, test. We need to test as many people as possible. We need to trace those contacts of people that have the infection, and make sure that we isolate those folks so the infection doesn't spread further. And the key is easy testing.
Dr. Samer Fahmy:
If we can develop a reliable antigen test through saliva, through spit, that can give us a result and help us quickly identify people who are infected, that would take us a long way in preventing this disease.
Dr. Jonathan Fialkow:
So a quick question now on the antibody testing. If people have active disease, you get the viral test, we just talked about the PCR and hopefully a different technology down the road, the antibody testing is for people to determine if they've had the infection. Correct?
Dr. Samer Fahmy:
Yeah. The antibody is what your body produces in response to an infection. So yes, if it's somebody that's several weeks out or maybe even several months out, you can check their blood. And if they have these antibodies, you can tell that they've been exposed to the virus in the past. Now there's two types of antibodies; one of them that tells you if you were recently infected, and one tells you whether you were infected a bit longer ago. And both of them can be detected with some of the antibody tests that we have on the market today.
Dr. Samer Fahmy:
So those are becoming much more commonly used to determine whether somebody had the coronavirus infection and didn't know it because there was a lot of asymptomatic people out there that had the disease, or it's being used for plasma donations. For those who never tested positive, because in the beginning we were telling people to just go home and quarantine, unless you feel short of breath then you would present to the hospital for testing, that's when testing supplies were a bit limited, some of those folks are eligible plasma donors, and we can detect them by doing an antibody test. And if they have those antibodies, other people may benefit from their plasma.
Dr. Jonathan Fialkow:
So other people may benefit from the plasma, but we're not ready to say, “You're immune. Don't worry about it. You can be exposed to people who have the virus because you have antibodies.”
Dr. Samer Fahmy:
We're not ready to say that with any high level of confidence. If we're looking at the examples from other viruses that have presented in the past, we can say with a moderate level of confidence that once you have an infection with this type of virus, you should have some level of immunity to it. But there has not been any scientific studies to clearly demonstrate that you are immune to COVID-19 once you've been infected once. A lot of the sentiment in the medical community is that that should be the case, but we just haven't proven it yet.
Dr. Jonathan Fialkow:
So that might help for healthcare workers at risk if we can get a pool of people who are immune, we might feel more comfortable having them take care of people who are sick so they won't then get subsequently infected. What about to that end? And I'm almost done with my question, Sam, and I'll let you off the hook. What about the false results we can get with antibody testing? What's the likelihood? As per the limitation, if we test someone and they test that they have antibodies but they really don't, is that at all possible such that we might be telling someone you're immune and you're not?
Dr. Samer Fahmy:
With the right antibody test, it should be less likely to do that, but there's always a risk because coronavirus is a family of viruses. And this family of viruses, they have some similar features. So there is a risk of one of the more common types of coronaviruses that were here way before COVID-19, causing just a simple cold or a simple cough that you would get over. There's a chance that some of our antibody testing may pick up some of those more benign coronaviruses and give us a positive result. And I think that's why as a medical community, we're hesitant to say that if you have this antibody, “Yes, you're safe,” and, “Yes, you're immune.”
Dr. Samer Fahmy:
Even the World Health Organization came out several weeks ago against this concept of immunity passports that people can get if they test positive for the antibody. That's because there's a degree of cross-reactivity between these coronaviruses that we're still not clear about yet. So until we're sure about that, we don't want to tell somebody they're immune and expose them to any kind of harm.
Dr. Jonathan Fialkow:
So scientifically, if someone has the antibody test because they feel they may have had an infection, and it should be positive if they have been exposed, and the tests scientifically should give them a level of immunity, we just haven't felt able to establish that with certainty just yet. But hopefully, we're moving that direction to be able to give some recommendations based on that.
Dr. Jonathan Fialkow:
And going back to the viral testing again, my last question. Should an asymptomatic person, who's been quarantining as much as they can or staying at home as much as they can, could they just say, “I'm curious. Let me get the viral test because it's available,” or would not be person that would really want to be using the tests on yet? Again, down the road, you have a box in your house, you can test it regularly. But right now, would that be the person that will look into getting tested?
Dr. Samer Fahmy:
Like you said, Jonathan, down the road, ultimately, that's what we're hoping we're able to do is to have a test at home that tells you whether you're infected or not. At this point in time, though, I would not recommend that somebody get tested for with this nasal swab unless they show symptoms. If you're showing symptoms of fever, or cough, or a sore throat, or difficulty breathing, of course that's somebody where we highly recommend that you go, you talk to your healthcare provider and you get tested immediately to make sure it's not COVID-19.
Dr. Samer Fahmy:
But if you don't have symptoms, the more beneficial test for you if you think you may have been exposed is to get the antibody test. And that antibody test will tell you, have you been exposed in the past or not, because you don't really need immediate treatment for it. I think that would be the better test to do if you don't have symptoms.
Dr. Jonathan Fialkow:
And where can one get the antibody test?
Dr. Samer Fahmy:
So the antibody test is becoming much more available now. In fact, at Boca Regional Hospital, we're offering it as an outpatient test. You can come into our lab and get your blood drawn if your doctor writes an order for it, and you'll have those results within two days.
Dr. Jonathan Fialkow:
That's great. That's great. And maybe for our program notes, we'll have a couple of links where people can get the testing with a doctor order if it's appropriate. Any final comments, any final thoughts, Sam? You've been a very helpful guest, an informative guest, both in terms of convalescent plasma, which is something that people may have heard about but certainly they're experts in now, and the differences between the testing out there, and its benefits, and its potential as well as some of its present limitations. Anything you'd like to add?
Dr. Samer Fahmy:
As a final comment, the last two to three months have been a really trying time for the medical community and the nation as a whole. And watching the teams involved in these projects, whether the convalescent plasma, or the teams that were in charge of testing or supplying our staff with personal protective equipment, PPE, come together, it's been a joy to be part of it. And to know that all these efforts are focused on helping our community and our patients get better, and a tremendous amount of progress in a very short amount of time when you consider from March until now the progress that we've made.
Dr. Samer Fahmy:
It's really great to be a part of a community like this that steps forward and comes together. And the number of donors that we have for plasma is just one example of the people that stepped forward to help others. It was just really encouraging to be a part of that and then to see that in our community.
Dr. Jonathan Fialkow:
Well, I thank you. You have been, you are, and you will be an important part of our leadership team in Baptist Health South Florida. And it really has been inspirational to see the incredible work in very short notice, and under very trying circumstances to be able to keep our community safe as well as educate our staff and our community as well. So thanks again, Sam, and thank you to our Baptist Health Talk podcast listeners. As always, any ideas, any comments, any thoughts of future topics, please email us at baptisthealthtalk@baptisthealth.net. Stay safe, folks, and stay home.
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