Judith Aberg, MD, provides an overview on convalescent plasma research for the prevention and treatment of #COVID19 . Dr. Aberg discusses the difference between convalescent plasma and hyperimmune globulin. She discusses some of the advantages of hyperimmune globulin, as well as the research being conducted at Mount Sinai to determine the most effective dosage and frequency, and whether it is an effective prophylaxis postexposure.
I'm Dr Judy A. Burgum, chief of infectious diseases for the Mount Sinai Health System And at the Icahn School of Medicine. Um, also, Ah, the George Bear professor of medicine here. Thank you so much for having me today. So convalescent plasma, hyper immune, uh, immune globulin of both prepared from convalescent plasma. So these air from patients who have had covert 19 have recovered, and we've identified that they have high tigers of antibody in their blood. And then we're able to collect this plasma that subsequently would be transfused into people who are sick with co vid. And these interventions have been used in the past to treat many infections when there was no vaccine or any drugs available to treat many of these infections. You may be familiar with, like the theory of pneumococcal pneumonia, hepatitis A and B, mumps, measles, chicken pox. And these are all different conditions where we have shown in the past that convalescent plasma may be effective as well as's hyper immune globulin. Now, convalescent plasma is generally thought to be very safe and well tolerated, but you can have sometimes adverse events can occur, and it has to be blood type specific. So symptoms that have been reported a similar to reactions that may occur with any type of blood transfusion, including having fevers, chills, allergic reactions. Um, sometimes it can be more seriously transfusion related, um, reactions that people get. Furthermore, in convalescent plasma, it's it's more than just the antibodies. It has other factors, including things like blood clotting factors which may not be the best for people who are having covert and maybe already experiencing types of blood clots. So therefore, there's an advantage of looking at hyper immune globulin and essentially hyper immune. Globulin is taking that same convalescent plasma, but it's pulling multiple units together, and they do a process that we call Fraction Nation, where they can actually extract and have the just purified antibodies. So the immune globulin G that therefore contains a standardized amount of the antibodies directed to the organism SARS. Kobe to the virus that causes co vid. So compared to convalescent plasma hyper immune globulin, it's it is not blood type specific, so it's much less likely that someone would have a transfusion reaction, although you still could have a reaction. And so that's important to remember that you still could have an allergic reaction, or that there could be, um, just like with convalescent plasma. When you have a needle in your arm, you could have swelling or pain and potentially even an infection. Um, the other is advantage. That hyper immune globulin has is that you're preventing the transfer of these potentially harmful blood clotting factors. I mentioned that a president of plasma so overall again, when you think about hyper immune globulin compared to convalescent plasma, it's prepared in a more consistent manner so that you can have more control over the amount and the amount of antibody concentration that is being given to you. We have multiple research studies that we're gonna be looking at the first that needs to be done. Our studies that we call Pharma Co Kinetic and Phar Maco dynamic studies on what these are studies that we can do that helps us determine what the appropriate dose and how often that hyper immune globulin may be given. We are working with the National Institute of Health Thio be using the hyper immune globulin products in their treatment trials, both for people who are hospitalized with covert and people that are home or what we call ambulatory and able to go back home after they could get a infusion of the hyper immune globulin. In addition, we're going to be launching a very large study to look at. It's used in something we call post exposure prophylaxis. This study will recruit about 500 patients across multiple sites across North America. And the intent of this study is to assess the efficacy of this hyper immune globulin as post exposure prophylaxis in people who are currently negative for co vid but have had an exposure. So you may ask, Who is that? So those individuals who had a prolonged close contact with one or more individuals who turn out to have confirmed cove it on DWI wanna recreate these individuals 48 hours before they would have any symptoms so 48 hours within 48 hours after that exposure. So these maybe people that you've had contact with who were not wearing face covering or face mask um, it maybe healthcare workers that are present in the room, and especially doing procedures that could be generating lots of aerosols that may put them at risk. It may be a household member or one of your partners who you've had a close contact with, meaning less than 6 ft for prolonged period of time. Or it could be that you're caring for somebody who has confirmed Cove in 19 infection. So anybody who has had a really prolonged exposure to somebody with covert could be eligible to go on this study. And hopefully what we would show is that patients who receive the hyper immune globulin would have a decreased risk of of acquiring covert. This study will be done so that it's in what we call a randomized fashion. That's like a flip of a coin. And for every five people, two individuals will get the hyper immune globulin at a specific dose. Another two will get a different dose, and then one person will get placebo, which will be like saltwater sailing that we normally, um, infuse. And and again. What we'll do is we will follow individuals doing frequent monitoring and testing, um, over the course of 29 days to see if who may have acquired Cove it and again to show that the hyper immune globulin actually is effective in preventing that. Furthermore, we're going to be working with emergent and the military for a pre exposure prophylaxis study, so this would be one where you would have repeat dozing at a set interval. So this is to prevent you from getting coverted. Not that you've had a known exposure yet, but that you could be at risk for having exposures. And so, in this case, hyper immune globulin. When you receive it, you're receiving antibodies. Those antibodies only last for a set time. So maybe three weeks of four weeks, and then you would need to be dosed again. So we have. As you can see, we have a really broad range of studies that we're really excited about. That can help both prevent people from getting covert as well as treat individuals who have co vid so hyper immune. Globulin is often viewed as a bridge until we have an effective vaccine again, as I just mentioned, hyper immune globulin is infusing antibodies. Ah, vaccine. You're given a substance and it could be part of its RNA DNA in a fragment. It is a substance that you would be injected with that triggers your own immune system to make antibodies, and it takes time for your body to make antibodies. So, like in the study I just mentioned in post exposure prophylaxis, there isn't time for a vaccine toe work, so hyper immune globulin would really be an effective use. And in fact, what we frequently do with other conditions is we use hyper immune globulin in conjunction with vaccines to prevent covert. So, for instance, someone may have an exposure, as we just discussed, and you would want to provide immediate antibodies with that hyper immune globulin. And then you would want to follow up by a vaccine to allow you to produce your own antibodies so that would last longer and give you ongoing immunity. And then there are people who may be allergic to components of the vaccine, and there's certainly people who do not want to take a vaccine. So while hyper immune globulin most often is used as a bridge, there may be other conditions where we will continue to use. And in fact, we would use all three of the therapies that I mentioned that the studies they're gonna be ongoing. And while these studies are ongoing, as I mentioned, they will have placebos, and so some some individuals may up to receive convalescent plasma until we really have a licensed product that we can offer people either hyper immune globulin or vaccine as appropriate.
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