Mayo Clinic experts review recently authorized therapies for COVID-19, including monoclonal antibody treatment and other novel therapeutics.
Moderator: Amit K. Ghosh, M.D., M.B.A. , consultant, Division of General Internal Medicine; professor of medicine
Featured Expert: Raymund R. Razonable, M.D. , vice chair, Division of Infectious Diseases; program director, Infectious Diseases Fellowship Program; professor of medicine
Featured Expert: Ravindra Ganesh, M.B.B.S., M.D. , consultant, Division of General Internal Medicine; assistant professor of medicine
Featured Expert: Larry Lutwick, M.D. , consultant, Division of Infectious Disease, Mayo Clinic Health System — Eau Claire; professor of medicine
Featured Expert: Lori L. Arndt, P.A.-C., Division of Infectious Diseases, Mayo Clinic Health System — Eau Claire
Featured Expert: Richard Arndt, Pharm.D., R.Ph., senior manager, Pharmacy Clinical Services, Mayo Clinic Health System — Eau Claire; assistant professor of pharmacy
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The views and perspectives shared in these resources are presented based on information available at the time of recording.
Welcome on behalf of the Mayo clinic School of continuous Professional development. I'd like to welcome you to the Mayo clinic, monoclonal antibodies and other novel therapeutics and Covid 19 treatment webinar series. I'm Whitney Pruitt your host for today's webinar On updates on recently authorised therapies for COVID-19. This webinar is accredited by the Obama for 1.5 credits. Here are the disclosures for this activity and we'd like to thank eli lilly and company for their support of this educational activity. Before we get started, we'll cover a few points. The first is how to claim credit. If you'd like to clean credit after the webinar, please visit ce dot mail dot e d u forward slash covid 04 to eight. You'll need to log into the site and if this is your first time visiting, you will need to create an account profile After you've done this and logged in. You'll see an access code box you'll want to type in today's code which is COVID 04-8. This will allow you to access the course to complete a short evaluation and then you'll have the ability to download or save your certificate. The link and code will be dropped into the chat box throughout today's webinar. The second item is how will facilitate questions. You'll see at the bottom of your screen the chat and Q. And a function. If you have any questions during this webinar for today's presenters, it's important that you drop them into the Q. And A channel rather than the chat box. This will help to ensure that the panel can see your questions. There's also a helpful up vote button so that you may have the questions answered that you would like to see if you're experiencing any technical issues during this webinar. Please use the chat feature to share so that our support team can assist. We'd like to introduce you to our panel moderator for today. Dr ahmed Gosh dr go she's the consultant and professor of medicine within the division of General Internal Medicine at Mayo Clinic in Rochester Minnesota. And with that I'd like to hand it over to Dr Gosh, thank you Brittney. Uh welcome ladies and gentlemen all over the world. This is an important topic we're going to discuss today, where the world is challenged with Covid like we have never seen. Some of the countries are going through the worst period at the present moment and our entire support is with them joining us today is a panel of highly distinguished speakers who have been with the Covid situation and been dealing with them Right from day one and introducing five members who have played uh absolutely fantastic role in our understanding our care delivery and the knowledge that we have the Mayo clinic. Our first speaker is going to be Raymond dr Raymond Resin. Apple is vice chair division of General Medicine and also program director of General medicine of of infectious disease. Second speaker is going to be dr Ravinder Garnish, who's an assistant professor of medicine at the division of General Internal Medicine. And he leaves the and he actually led the uh covid frontline care team which was the main phase of how he managed the outpatient care of current. The next presenter is Professor Larry Ludwig stanford trained infectious disease specialist, whom we were fortunate to uh recruit and he works for the Mayo Clinic health system in Oakland. Uh Claire Wisconsin, he's a professor of medicine and uh specialist in infectious disease. Next line and then is Miss Lori, aren't? She's she's also worked in the infectious disease. She has been instrumental in managing a lot of outpatient logistics and delivery of of this novel therapies which we're going to talk at the Mayo Clinic health system at our Claire Wisconsin next life. And finally we have Mr Richard Aunt, who's assistant professor of pharmacy, is a senior manager for pharmacy clinical services in Mayo Clinic health system, declared all these speakers are extremely adept at management and and delivery of this complex situation that we are facing it which requires all these therapies. I will now hand over the presentation to Dr Raymond reasonably thank you so much Doctor Gosh um and welcome to everybody. Uh The learning objectives of this webinar is to explain the effect of neutralizing monoclonal antibodies on SARS. Called to explain how wonderful antibodies Fit in the paradigm of outpatient therapy for COVID-19. We will explain the country indications to monoclonal antibody therapies and how to manage reactions and complications related to treatment. We will also address logistical requirements for the administration of monoclonal antibody therapies, identify individuals at higher risk of clinical disease progression and may benefit from early treatment with monocle antibody treatment therapies. We will also delve and evaluate the impact of racial, ethnic and socio economic disparities and this is severity and how the access of the mall therapy for mild to moderate covid detailed the logistical requirements from um the perspectives of supplies, personal training. There is initiated protocols and processes for the administration of monoclonal antibodies and finally uh logistical requirements for health care administrators who may be joining us in this webinar, the needs for infrastructure facilities management, personal training and deployment as well as safety protocols. Because we all know this is a highly infectious pathogen and we have to have safety protocols in place so that we prevent transmission to other patients as well as your personal and staff. I'd like to kind of start off by uh presenting a typical case of patients that we see uh in our clinic and in our system. So a 76 year old man diabetic hypertensive with cardiovascular disease also has a smoking history and currently has a COPD Some renal dysfunction and has a bmi of 36. He comes in uh basically calls the provider because he's been having fevers, chills, muscle aches, Headache, Sore Throat and Dry Cough for the Past two Days. There is no shortness of breath. Uh he reports an exposure history because he attended a community party about a week ago and he has been tested at a community testing center found positive for SARS. CoV in a plate acid by PcR. So this brings us to this schematic diagram of the natural history of uh covid 19 in patients, there is an approximately about a two week incubation period from the time of exposure, but the vast majority really becomes symptomatic if they develop disease within 5-7 days during this pre symptomatic phase, the patients are already having viral replication in the respiratory system uh and are considered infectious, While the vast majority, roughly, maybe about 50-60%, may remain asymptomatic. Uh there is a proportion of patients who will go on to develop symptoms just like the patient that was presented. Uh and of those that develop symptoms. The vast majority, roughly, about 80 of them will have mild to moderate disease, keep fever, muscle aches, uh cough, sore throat and then they improved. But then roughly about 20 of those who have symptoms will go on to develop severe disease as manifested by this new respiratory distress requiring admission to the hospital. Uh and then a proportion of that will require uh intensive care unit care because of progression to uh severe and critical illness. So uh the uh this is the timeline and we will use this as basically um the framework for our discussion for the next hour in terms of what treatments may be given or appropriate at various stages of the covid illness. So what are the factors associated with civil disease who are more likely to develop Uh an illness that required hospitalization and some going to the intensive care. And this is data is well known and well established during the past year. Of the pandemic older populations age over 65. Those with higher body mass index of 35 or higher those with cardiovascular disease are at increased risk for severe illness. Chronic kidney disease increases the risk of severe illness, as well as diabetes hypertension, chronic lung disease and a compromised immune system. Whether this is from uh the use of immunosuppressive therapy or an underlying immunodeficiency increases the risk for severe illness. So keep in mind this is the high risk group. And if you go back to our case, He basically fits almost every criteria with the exception of the last one because he is 76. He has a body mass index of 36 cardiovascular disease, chronic kidney disease, diabetes hypertension, as well as COPD. I'd like to ask then uh dr ganache Robbie, uh if you're presented with a patient like this, what would you recommend for this patient? Thank you remained. So for patients at this early stage of illness. Um, the therapy that's approved for this is the monoclonal anti bio therapist. Specifically, these are neutralizing anti spike monoclonal antibodies and they are proven to prevent the clinical progression of disease. So what happens to the coronavirus is it has all these little proteins on the surface called spike proteins. And these are the proteins that allow this virus to buy into the cell as you can see it internalizes and then it releases its genetic material, which is shown here, is that squiggly spaghetti line in the bottom right. This allows for replication and infection. The target of the monoclonal antibodies is this little spike protein on the outside and the monoclonal antibodies which are shown in blue attached to these green spike proteins and they prevent the virus from binding to the cell membrane and therefore it can't in fact the cell or replicate. Additionally, virus particles that have these monoclonal antibodies all over their surface are more attractive targets for the immune system to chew right up. We have some animal studies that show success in decreasing viral load and increasing resolution of symptoms, both Democratic model and the most model and later the data that Laurie Garrett is going to present in a few minutes. Um the FADA released you is for three separate monoclonal antibodies for COVID-19. The criteria of all of the ways or emergency use authorizations were mild to moderate covid 19 patients had to be within 10 days of symptom onset And they had to be at high risk of progressing to severe COVID-19 and or needing hospitalization. The first antibody to receive monotone no antibody way was bomb landed a map And I was issued in November 19 2020. and unfortunately this got revoked on April 16-2021 due to emerging resistance patterns of experience At the river map and endeavour Bob, which is the Regeneron product got an anyway on November, 21 2020 and the mob in combination with the civil map Released by Lily got an anyway on February 19 2021, which is still active. So both Combo forms are still active. Lights turned over to Lori. Aren't discussed the data behind these trials into ravindra. So the bam line of a man, the Blaze one trial, which was conducted by eli lilly and Company, was a randomized double blind placebo controlled trial, which included 452 patients. These patients were randomized to receive either 728 100 or 7000 mg of family of the math mono therapy versus placebo. The patients had to test positive for stars Kobe too Within three days and report at least one or more mild to moderate COVID-19 symptoms. In those patients, the median age was 45, the majority of which were female and caucasian. 44 of those patients were considered the high risk population, with 76 reporting mild symptoms. The average duration of symptoms was five days Medium viral load, which was reported in a threshold cycle of 24. The primary outcome in this study was the change from baseline in the stars Kobe to viral load of day 11. And the study found that in phase two, only patients who received the 2800 mg dose of family Nivea map had a greater decrease in day 11 viral load as compared to placebo and the secondary endpoints. They also looked at hospitalization or emergency room visits. And at day 29 those percentage of patients who were hospitalized with covid 19 was 1.6% in the bottom line of amount group versus 6.3% in the placebo group. Mhm. And the Phase three portion of the study, it compared family of a map to deserve a mob in high risk patients. Again, the same criteria was met mild to moderate COVID-19 symptoms within three days of testing positive. And those patients who are included were at least 12 years of age and older, with at least one risk factor for severe disease. The city outcome noted that it was able to reduce the risk of hospitalization by 70%. And these results are consistent with those seen in other data sets and other studies. In addition, it did show that the viral load reduction was also greatest in the combination therapy of family of a map. And that is a big map. Thank you so much, Laurie. I'd like to ask Richard uh to give us uh details of the other cocktail uh, of caribbean mob and in Debbie Man. Thank you. Raymond and Laurie. Um, so I'm going to be focusing on the Castle river Medvedeva mob, which was from the Regeneron Kobe to trial. Um, so this is an ongoing double blind phase one through three placebo controlled trial involving non hospitalized patients with covid 19 patients were randomized in a 1 to 1 to one ratio to either receive placebo, The 2.4 g or the eight g of the Castle River map and the map combination product Patients had to have a confirmed sars-cov-2 infection with a positive test result. Um, no more than 72 hours before randomization and as well as symptoms onset no more than seven days before randomization. So the interim analysis described here involved the 1st 275 patients and this was the initial analysis during the phase 1- two portion of the trial. The medium age of the patients in these trials was 44 years, with 49 of those being male and 81 being Caucasian. At Baseline 123 patients, which is about 45%. We're serum antibody positive, while 113 patients have been 41 where serum anti body negative and 39 patients of 14 had unknown antibody status. So looking at the demographic risk factors at baseline, 42 were obese and 64 of these patients presented with at least one risk factors described previously. The medium do a number of days reported COVID-19-related symptoms before randomization was around three days. So the Castle River map and give a mob antibody cocktail reduced viral load. As illustrated in the graphic showing on your right. The greatest effect was seen in participants whose immune response had not been initiated yet or who had a very high viral load at baseline. Both the 2.4 g and the a gram dose of Castor River Vandiver map was associated with very few low grade adverse effects. And this was similar to placebo. The study also illustrated that the Castle River map individual treated patients at 2.8% had fewer um covid 19 related medical visits as compared to the placebo group at a percentage of 6.5%. Thank you so much Lori and Richard. Uh to summarize the available data to date that has been published, we have data on bamboo wannabe mob monotherapy. We have data on bamboo anime map combined with Xabi map and the data on casa, ruby mob combined with them Debbie mob. And as you can see it is consistent across the clinical trials. The trials did show as a primary endpoint declining viral load. But as clinicians, we wanted to see clinical endpoints data and the available data to date so far has been based on a small number of patients enrolled in the studies. But as you can see in the secondary endpoint towards the bottom of the slides, there appears to be a signal of reduced hospitalization in patients who receive this monoclonal antibodies compared to those who did not receive the antibodies or who had received placebo. And the adverse effect profile appears to be uh mild uh and consistent across the three trials, just like what dr garnish earlier mentioned. Uh the emergencies authorizations of Baramulla Navy mob has been revoked just because of increase uh predominance of variance in the community. And we will discuss that towards the later part of this session. With this in mind. I'd like to kind of turn over to dr Ludovic larry. Can you tell us who is eligible? Is this somebody for everybody or is this something that is only reserved for certain group of patients? All right. Thanks Ray. Um uh in review the the patients that are at high risk that are eligible for the monoclonal antibody treatment um include anyone over the age of 65 years, people who are 55 years old and older with any of the following um risk factors in cardiovascular disease, hypertension and COPD or any other chronic respiratory disease. Anyone over the age of 12 years with any of the following um risk factors B. M. I Equal to or greater than 35 chronic renal disease, diabetes, an immuno suppressive disease or condition, and those receiving immunosuppressive therapy for other diseases. And finally, individuals between the age of 12 and 17 years. His Bmi is greater than or equal to the 85th up. Individuals with sickle cell disease. Individuals with congenital or acquired heart disease, those with neuro neuro developmental disorders, medical related technological dependence such as patients with tracheostomy is guest Rostami czar on positive pressure ventilation. And finally, those individuals with asthma, broncho spasm, any reactive airway or chronic respiratory disease. Thank you so much Larry. I'd like to kind of uh move on to look and and discuss some of the logistics in setting up efficient therapy centers. Uh, so we have the products given to us through emergencies authorizations. The next hurdle in the implementation of this in the real world is that we have the facilities to infuse. So what we've done as an institution is basically developed a standalone, dedicated COVID-19 infusion therapy centers across our sites for those who are not familiar with our locations. We are located in Minnesota states of Wisconsin Arizona as well as Florida. And I I emphasize dedicated because these are outpatient therapy infusion centers that are only for covid because we don't want to mix patients that are infected with covid as well as others who are receiving therapy for other conditions. For example, And we establish about nine inefficient facilities across our sites and we started the program way back in November of 2020 and it's really important to basically respect the virus and protect our patients. Uh and doing this, we have to partner with your infection prevention and control personnel just to make sure that the procedures and the processes that you're establishing and infusing this facilities. Uh This antibodies in these facilities is within the standards to prevent spread of the virus to other patients in your center as well as to your healthcare personnel. So they are an integral component in in in administration. Um The other aspect is the personnel and the team and I'd like to turn it over to dr garnish Robbie. If you could describe how you basically developed a multidisciplinary team to facilitate infusion of this therapies. Thank you. So when we created a monoclonal antibody treatment team which had a convenient acronym of Matrix which we love. Um we tried to really get everybody on board that we thought we might need and then some. So we got clinicians together from the various departments put I'd specialists and the internal medicine and family medicine box would be the doctors on the ground. We got dogs together who had experience in managing covid patients, both adult and pediatric. We got a nursing experience from the infusion therapy center and we got nurses and pharmacists on board. We also got all the people who actually make things happen, the best corporation staff, the administrators, informatics and HR specialists. And then we got the people on the ground, compliance facilities engineering and the folks that make sure everything we do is appropriate. So we got legal and ethics involved as well. So with a really huge team and I have to commend this team because we met pretty much daily for a long time to get everything up and running. Here is a snap of one of our morning meetings. Um, this this as physicians, administrators support stuff from all across the entire midwest. You may recognize the bottom, right and second from bottom less individuals, turbo sound presenting with us. And we initially had a big challenge around patient education and confronting and when we started calling people initially or rejection rate was North of 70 and we asked people they weren't really aware of therapy. They had hesitantly because it was brand new and they weren't quite sure what an E women and they were all in that sweet part of the curve where they had minimal symptoms and a lot of people were, well, I don't feel bad right now. I don't need therapy. And we really wanted to fix that uptick. So we created an educational video and that's not the most flattering picture of me, thankfully darcy. One of our nurses did this with me and it was much more engaging and we've shared this video with our partners in the state level two, see if we can increase uptake By adding the video. We actually got our acceptance rate upwards and now we're around 60-70 of people who here about the products are willing to accept. The other issue that we had. We had to sort it rapidly was how do we provide this treatment which is potentially life saving to the wide swath of patients and our relative areas? So we have to think about people with health disparities, the underserved populations and folks who are exceptionally high risk and non mobile in the long term care facilities. So we partnered with our community organizations and we tried our best to get this going. One of our major achievements in my mind, what I'm most proud of getting to the skilled nursing facilities Because if these facilities do have an outbreak, it can spread like wildfire, reported mortality is over 50%. And we put together a mobile team and we work closely with our local nursing facilities to identify patients at high risk and send or mobile infusion team out to the facility. And in doing so we're able to infuse Anywhere from 2 to 20 patients in the facility at one time. And I think we greatly reduce the spread of illness. Here is a picture of or mayo infusion van along with two of our nurses speaking to a resident of a nursing facility with her permission of course. And this was one of the best things we did. Thank you Robbie. So as both Raymond and Robbie have pointed out, we have the therapy, we have the infusion centers, we know which patients are at high risk. Now it's actually identifying those patients. And so here at Mayo Clinic in our health systems, those patients who tested at our locations were automatically screened for eligibility to receive the monoclonal antibody therapy based on a positive stars Kobe to test patients who were non male clinic patients or those who had tested outside of male clinic and the health system could also be eligible. And they were reviewed by our covid frontline care team through any consultation and those referrals were reviewed and any pertinent information was added to the electronic medical record including a copy of their positive test result patients um were determined for their clinical eligibility and drug allocation based on something called the monoclonal antibody screening score. This was essentially um a score that was developed based on internal outcomes data and eligibility criteria set forth in the A. F. D. Emergency use authorization as well as the state guidance. This was a weighted score. And as you can see here you've seen this diagram previously. Um those patients were given a weighted number based on specific criteria. And so those patients who are 55 with, let's say hypertension would have a lower score, one versus those individuals who may be 65 older with an immunosuppressive disease or chronic kidney disease would have a much higher score with at least three. And this was certainly important because we knew that being able to risk stratify was important as these patients um with higher rates of hospitalization, we're more or had higher rates of hospitalization based on their risk factors. And so it was essential really to be able to uh wait. Uh they're comorbidities score based on this mass score. Yes. And finally we would have to manually review these patients for their eligibility. Um They were screened to ensure that they reside within their respective regions. We would verify their comorbidities by manually reviewing their electronic medical record. We would verify the eligibility based on onset of symptoms, severity of illness and the data testing. And finally, once that would be done, uh nurses would contact patients for education of monoclonal antibodies and obtained consent for infusion. And the consenting patients would be scheduled as soon as possible, typically with same day or within 24 hours. And those patients who are undecided or non consenting patients were provided 48 hours of time to reconsider their decision. I'd like to kind of turn uh take it over and basically discussed some of the factors we've learned uh since the start of the program, we have observed that there is a group of patients that are more likely to accept the offer and there are those that are more likely to decline therapy. And as you can see here, patients are more likely to accept our offer for monoclonal antibodies if they are non hispanic white caucasian, if they have english as a primary language, if they have a stronger social support system as indicated by having a spouse or a life partner or being a member of a religious organization or affiliation. This on the contrary, uh, patients who are considered underrepresented are more likely to decline the offer. Uh There are potentially multiple reasons behind that and as a result, there should be bigger efforts to reach out to those communities uh particularly if they are considered high risk. And another factor that basically was associated with the decision to accept monocle antibody therapy is a so called monoclonal antibody screening score. The higher the score a patient has, the more likely that they will accept the offer for treatment, potentially because they're aware of their high risk conditions and their higher propensity to uh develop severe disease and get hospitalized With our program. We have a time to infusion of about 2.8 days from the time of testing. With the vast majority patients will get their infusion during the first three days after they have been tested positive for COVID-19. Let's turn it over to larry Larry. So in summary, the milestones related to the Matrix program november 9th was the day that then Matrix program at May have a Mayor was organized and started 10 days later, the first monoclonal antibody infusion was given By the end of two of 2020, it's about six weeks. Um the program had infused 1700 patients um by the end, by into the first week of January of 2021, the the milestone of 2000 patients was reached and by the middle of January, almost 3000 patients were infused. And by 22 April Um an estimated 50 200 patients were infused. This slide gives you an idea of the timeline of infusions in each of the states that we have our matrix system running. And the top saw the line being the total number of infusions given over the 10 weeks, the 1st 10 weeks of the program. Thank you so much. Larry. I'd like to ask uh Richard to comment. One of the questions that patients have as well as providers asked us is how safe is monoclonal antibody therapy and what have we been observing in our program in terms of adverse reactions and how do we manage them? Well, thank you. Um Raymond. Yes, that that is a question that pops up pretty frequently and uh we thankfully have had a lot of experience around these infusions with like dr liquid had mentioned, 5200 patients have been infused um to date. So when we look at the number of adverse events, we see that in about 19 patients, only about one of our patients. Some of the most common ones are similar to infusion reactions are fevers and chills. Um So six patients there Um some experience some noisy environment in um those are only five patients. Uh lightheadedness was seen in about three and then in in the following um rash, chest pain, confusion and weakness was seen in to each and then diarrhea, headache, facial swelling, one each in those respective categories. Um We are really happy to to have seen that no one had a an infusion anaphylactic reactions and really all adverse events were mild and did not require hospitalization. And this was across the board with our infusions that were over one hour. Um As well as the infusions that we had cut down when the eu a change to the shorter infusion times. So, thank you so much. Uh Richard just to kinda highlight while the adverse reactions are mild and the vast majority are basically, you know, systemic symptoms of fevers and chills. There's the potential for anaphylaxis. We have not observed that. But uh if you have an efficient center, just make sure that you have the capacity to address those. Uh huh in case it happens. Uh The other uh big question is clinical outcomes. Uh if you recall back several slides ago when we're looking at the randomized controlled trials, there's a signal. But the numbers of patients in those clinical trials are not large enough to develop or to perform statistical analysis in the real world. What are we seeing? And I'd like to turn over to dr gonna Sharad if you could describe the outcomes of the Mayo Clinic program on the use of this medical antibodies. Yeah. So When we start to analyze our data and we did this initially back home we had our 1st 1600 feminism and patients Currently we have over 5000 patients who have refused. So the first analysis that we did was looking at families, my patients who are in the blue here. Um and we compare them 1-5 control match last an age comorbidities, gender, everything that would make them as close to these patients that were treated as possible. And we can see here that the families map treated group has less hospitalization, especially earlier in the disease In the 1st 2025 days. And this is unpublished data which we're trying to get out there sounds good arrive if I may ask. Can you comment on the orange line which appears to also show not much of hospitalization uh compared to the reported 10 to 15% from randomized controlled trials. Yes. So looking at the orange line, I mean, our hospitalization rate in our system for Patients who were not treated was about 4%. And this is, As Raymond said, Drastic, a less than 10- 15 as reported. And that may be a factor of our system because we did we did reach out to people early and we didn't monitor them with these specialist telehealth teams to try and identify who was going south and getting them into the hospital early. And we proposed that early treatment and very dedicated in pavement covid treatment team who went through and trying to get people therapies as early as possible may have contributed to better outcomes. Or Islam group sounds good. Thank you. And and despite the low baseline hospitalization rate for the cohort or propensity match and treated cohort, there was still a significant decline based on this graph. Uh The association between monoclonal antibody this case bombed enemy monotherapy uh and all cause hospitalization. Uh Do you mind to comment about, you know, severity of illness as well as maybe uh admission to the intensive care unit and mortality? Doctor Garnish? Yeah. So when we analyzed that data, we also found that people who were admitted were less likely to get admitted to the ICU are to require mechanical ventilation when compared to people who are not treated. And in our national analysis of that 1600 patients, only one had died at 28 days Compared to seven in the untreated group. So our initial take away from this study was that people who are treated early have lower admission rates and if they do get admitted are less likely to progress the severe disease and death a virtue of treatment with them deliver man sounds good. And of course the next question now is there's three products now to products out there during the town. The study there were bombed, a navy mob monotherapy and there's the other one, casa reforma, mdb mob cocktail is their outcomes difference between the two and this is what this side is. So we start to analyze the different outcomes between our patients treated with vandalism at monotherapy and the Castle Castle government in government coffee along the curbs do separate a little here. It does not reach statistical significance and this is an adjusted curve. Um, that looks at home abilities. So both groups of patients treated here are equally sick and equally at risk of being admitted. And it does seem that tends to rhythm have may do a little better, but it doesn't reach significance. And we need bigger numbers to confirm this data may change as we continue to get variants with emerging resistance patterns and we will have to keep updating this as we go. As of right now, we have no data to recommend one product over another. Okay. And and just to kind of emphasize this comparison here is comparison of kasserine in Debenham Campo and the bombs and maybe monotherapy. Who's uh emergencies authorizations has just been revoked because of the emergence of variance. This did not transmit. Did not do not comment as well as we would have hoped. So what we're looking at here was hospitalization rates for the people who had accepted versus those who had declined monoclonal antibody therapy and we will fix the slide and send it out with the cmI materials. But what we found is that as the Corbett discord fans, one people were being admitted to the hospital the higher rate. But to the monoclonal antibodies did show a decrease across all To their two scores. Poor hospital admission, especially when compared head to head. And this difference did get larger as we increased in. Um, and one of the antibiotic severity score, which is our mobility predictor. Thank, thank you so much for having just to kind of highlight and summarize what is supposed to be in this slide. It shows basically the the higher the comparability, the higher is the risk for hospitalization, but that is reduced with the use of monoclonal antibody three. And this is uh grasp just kind of showing the relationship between um patients money, client was very discord and their likelihood of admission. And you know, the traditional risk factors get highlighted here with older age, male gender, chronic kidney disease, chronic respiratory disease, kind of vascular disease given a suppression hypertension does not seem to be an independent risk factor. But when you add it to other diseases, it does seem to really wrap that rate of admission up. And when you score them all together, it turns out that as you accumulate um, system dysfunction, your likelihood of being admitted increases. So one more ability is not nearly as bad as two comorbidities. Sounds good. And the graph Uh on the right is really something that is really uh informative. If I may say uh you know, uh the patients that are going to be admitted, uh there's about four of them at least in this chord of 3600, almost 3600 patients, about four is still ended up getting admitted despite monocle antibody infusions. And the significant risk factor for that is the number of medical capabilities just like shown in the purple bar on this graph. But the key here though is even if they get admitted, there's severity of illness appears to be not as bad, just like what dr Dennis had said, there's really low risk of mortality uh in these patients. Okay. All right. Richard, can you tell us something about variants? This is something that's spreading in the community. How does multiple antibodies uh impact uh the variance in the community. Thank you Raymond. Yes, this is definitely the I think one of the hot topics currently is is how do we manage these variants that are circular circulating around the global community? Um And this table really illustrates um some of the identified variants um and the reduction in susceptibility um that has come from the C. D. C. Data as well as other um other organizations to um to these variants. Um as you can see on the right hand side, the Castle River Medvedeva mab product is the one that has been shown to be susceptible um to the various variants from the u k, the south africa won, the California new york and brazil. Um The family never map and a test a map product um as well as the straight down the river map is um has no show and reduced um susceptibility to the UK variant. Um However, um the family never map and a test map also shows just a slight reduction in susceptibility to the California virus. What is not detected detected on on here? We're showing on this table here are the two other variants that have recently popped up and that was the one down in texas, the the B b one um variant as well as the the variant from India, which is the B 1.617 variant. Um So we do not have susceptibility uh information on those two variants currently that are are circulating. So thank you so much richard. And just to kind of emphasize these are basically uh testing done on pseudo viruses. Uh It's it's on the particular hepatitis virus. The virus experiment the this uh so these are experimental data uh and we will need to know uh clinical outcomes as as we learn more about this. But because of this uh this is the reason why van monotherapy as a the U. S. A. By itself has has been revoked. So going back to our case. So you remember we presented a 76 year old man diabetic hypertensive with cardiovascular disease, COPD CKD and B. M. I. Of 36 based on the data that we have this patient despite monoclonal antibody therapy may still get hospitalized. What if he gets hospitalized? How is the management of this patient? I'll turn it over to uh Laurie. Uh This is a city is kind of this patient who subsequently developed severe covid pneumonia. Uh and uh going back to the uh timeline of infection has been basically uh divided into different faces. Uh We saw this patient when he presented with during the early part where it's predominantly still viral response with constitutional symptoms, cough, sore throat and headache. Got monocle antibody therapy. He's high risk but he seems to have progress to develop shortness of breath. What is the treatment for this case? Laurie? Thank you Raymond. Yeah. So transitioning and looking at patients who are now seeking hospital admission or emergency room presentation. Um The National Institute of Allergy and infectious disease funded the adaptive covid 19 treatment trial or the Ac one trial. This was a double blind randomized placebo controlled trial of hospitalized patients Or hospitalized adults with COVID-19 infection with evidence of lower respiratory tract infection. The primary outcome in this study was time to recovery And Remdesivir did show that it hastened time to clinical recovery by 4-5 days. However, based on the Kaplan Meier estimates there was no mortality benefit. Additionally, it did show that there was a benefit of Remdesivir most apparent in those who were on low flow oxygen. So not in those on rainier or high flow or non invasive mechanical ventilation. Hence based on these and other observed findings that led to the guidelines from the NIH as well as the I. D. S. A. So, the N. I. H. Has stated that patients requiring supplemental oxygen or invasive mechanical ventilation or ECMO received Remdesivir plus texoma zone. the I. D. S. Day came to the conclusion that those patients with severe covid 19 on supplemental oxygen but not on invasive mechanical ventilation or ECMO. They recommended treatment with five days of remdesivir And they recommended against remdesivir for those patients who were on room air that is greater than 94%. And uh the immune modulator therapies is also something that has gained attention during the past year of the pandemic. And uh if I could ask dr Ludwig Larry if you could just describe some of the findings on the use of the medicine. And then later on this Elizabeth Thanks Ray. Um Clearly the anti direct antiviral effects of Remdesivir have are somewhat useful. But as the disease goes on it appears to be a hyperactive immune response. Seems relevant in causing substantial morbidity and mortality. And one of the agents that's found that was found early on in the especially reported in the recovery collaborative study um in the New England Journal last year was dexamethasone. And this slide shows you graphically um broke down with regards to the kind of patients, how what kind of fact dexamethasone had in the upper left, showing all participants? Um There was a decrease in mortality um for for dexter methods own versus usual care uh in the lower left in oxygen. Only, in other words, people um that we're receiving oxygen and not mechanical ventilation. There was also some effect of dexamethasone in decreasing mortality. Um But the most prominent effect, which is in the upper right, is in those patients that required an invasive mechanical ventilation where where the decrease in mortality was much more prominent with dexamethasone versus invasive mechanical ventilation and the lower right. Um In those individuals who did not require receive oxygen, there was no positive effects of death. dexamethasone in the in overall mortality. The next side um shows the same data in a somewhat graphic form with regards to rate ratio demonstrating clearly um The dexamethasone was most prominently useful in those individuals who required mechanical ventilation. Um but was also useful in those people getting supplemental oxygen and not useful at all. In fact, some slightly detrimental in those individuals who were not requiring oxygen and when you um combine them all together, there was a somewhat there was a useful effect and dig using mortality of of decks and multi zone versus usual care. And that was from the same the day, from the same study. Um uh This side is the current NIH Covid 19 treatment guidelines are received for treatment and those individuals who are hospitalized in requiring supplemental oxygen. Ah NIH currently um recommends using Remdesivir, especially in those requiring minimal supplemental oxygen. The combination of dexamethasone remdesivir. Remember you need to follow liver function tests and people on Remdesivir viral infection itself can cause elevated amino transformations. Or Remdesivir can increase the the you know transfer races sometimes limiting its usefulness in giving the five days and um dexamethasone alone when when Remdesivir can't be used or is not available. And those individuals who are hospitalized in requiring um high flow oxygen or non invasive ventilation um decks or decks and Remdesivir are recommended and for those who are recently hospitalized were deteriorating um with evidence of systemic inflammation with regard to the inflammatory markers Crp and the light. Um NIH currently recommends using Tosa losing my lab um to one of the options above and for those who are hospitalized and on ventilation um it dexamethasone and those who are recently admitted tex and Tosi next side now finally toast Saluzzi might Is a humanized monoclonal antibody which is directed against anti Luke interleukin six receptor. And it is when added to dexamethasone is found to improve survival among the group that are exhibiting rapid respiratory decompensation Due to COVID 19. Um And the though these two lines here are basically the same two lines that were on the side before saying those who are rapidly deteriorating or recently requiring hospitalization, um invasive mechanical ventilation that the anti IO six receptor model monoclonal should be added to dexamethasone. Thank thank you so much Larry. You know dr Elizabeth has has had uh I guess of course during the pandemic. It was really very popular early on and then it lost its uh I guess it's following once we had the randomized controlled trials sometimes uh performed middle of last year and now it's regaining back because of emerging data that it may add benefit to dixie medicine just like what Larry had mentioned and then uh the other uh immune modulator that is also given authorization is very sensitive. Richard. Can you comment on this? Thank you Raymond yet. Um So barrister and have received its FDA EU approval based on the act to trial, which was a face three adaptive randomized double blind trial, which compared the regimen of remdesivir alone versus a regimen um of remdesivir with paracetamol in hospitalized patients. And the results from there, I'm sure to reduce medium time to recovery of seven days versus eight days. Um There was a 30% higher odds of improvement in clinical status at at day 15 And the incidence of progression to death or invasive ventilation was 31 lower uh in that group, as was the 28 day mortality rate of 5.1 vs 7.8%. Now when we look at the NIH Covid 19 treatment guideline panels um there there is insufficient data ready to recommend either for or against the use of paris cinema in combination with Remdesivir uh for the treatment of our Covid 19 patients who are hospitalized especially when corticosteroids can be utilized in its um in its place. This is this is some recommendation by the I. D. S. A. As well um stating that among hospitalized patients with severe Covid 19 who cannot receive steroids because of a contra indication. Um The I. D. S. A then guideline panel really suggests the use of paracetamol with Remdesivir rather than remdesivir alone in those patients. So really the recommendations is to to use the corticosteroids first. And if there are contraindications to those two to incorporate the barest minimum into the treatment with Remdesivir. Thank you so much. And of course the big question is now there's a push towards having the vaccines to almost everybody that's eligible uh depending of course on the supply of the vaccination. One of the common questions that come to mind as well as being asked of the Matrix team is what is the relation between monocle antibody infusions and vaccines and uh dr garnish. If you could give us uh answers to two specific questions, can I get vaccinated after monoclonal? And if I get monopoly, You know, and I developed Covid uh you know uh am I still eligible or if I get vaccinated and I developed Covid, am I eligible for monocle antibody therapy? All right, thanks very much. So, this is kind of a hot topic as shown by the fact that four or more of the questions in the Q. And a referring to vaccines. The first question, can somebody get vaccinated after treatment with the anti static monoclonal antibodies? The answer is yes. And right now we have a 90 day um photos from after receiving the multiple antibody to when people can receive their vaccination series. And that's been determined by the american College of immunization physicians. And the thought is that people will have passive immunity was the anti aspect monoclonal antibodies during this program during this period of 90 days and when if you try to immunize them before that you may not get a robust enough immune response. The second question is what if I am vaccinated and I do wind up with corporate symptoms? Well if you have covid and symptoms after being vaccinated, it would mean that you I mean that's so to speak. And we know that most people who are in this group, we tend to have a milder course of covid, but in people who are at high risk of being hospitalized, it would be reasonable to go ahead and give them monoclonal antibody. One of the specific questions asked him the Q. And A. Was what about the people who have been immunized but have immune suppression. And I think that group is a prime group that if they did have symptoms of covid, I would go ahead and give them medical event by even if they were vaccinated. Perfect. Thank you so much. Doctor organization. That's really what's happening also. Because as you know, there is emerging data that vaccination may not be as effective in patients who are immuno suppressed for some reason. And there's a data from the transplant community showing that uh so uh they may not have developed uh immune response of the vaccination and if that's the case and if they developed covid then they are definitely eligible for the anti spike monoclonal antibodies. So that brings us to the concluding section of this webinar. Before we take the Q. And a section uh the presented to you uh the data on monoclonal antibodies, how it neutralizes the Spike protein. We've shown clinical data that came from randomized clinical trial. Also have shared with you the emerging data coming from our real world practice here at the Mayo Clinic uh to emphasize this treatment is only for mild to moderate covid in the outpatient setting for patients who are hospitalized for covid. That means they have severe or critical illness. Then there's data to suggest that monoclonal antibodies will not work in that situation. There's a high risk group that has been defined as defined by age over 65 B. M. I. Over 35 certain medical comorbidities including chronic kidney, cardiac lung diseases, diabetes hypertension as well as compromised immune system. Uh the country indications to therapy includes if they don't belong to the high risk category, then they are not yet eligible for emergency use authorization of these products. And just like what I said, if they are hospitalized for covid, then this treatment is probably not going to be effective patients who are on oxygen therapy because their hypoglycemic, that means that they have severe disease. So this treatment will also not be available for uh for them because data suggests that it will not work if the patient has progressed to severe illness. We monitor for infusion reactions and complications. We discussed about the mild nature of this uh adverse reactions at least in our experience as well as reported in clinical trials. But there is a potential for uh anaphylaxis. So you should have a resuscitation card available to you. Um We describe the process and how we do this at our institution with a proactive approach of notifying and engaging uh as soon as we know of a positive results and there's also a more positive, a more passive approach. We're in, patients are being referred to us from other facilities. We all screen them based on the manipulable allocation screening score to determine eligibility. These are still investigational, which means that patients should be aware that they are not yet if they approve at least in the U. S. Uh And this be documented and consent beside we discuss about how we procure them. Uh We discuss about are inefficient center as well as our mobile unit. Uh huh. And the infrastructures and facilities that are needed and supported by administration uh dedicated intuition centers, uh ethics and all those uh things needs to be addressed as well as the heart of the program, which is really uh the multidisciplinary team that basically made it an effort to reach as many patients that are eligible for monocle antibody treatment as well as education. And then of course uh this has to be done safely uh in the context of the fact that this is a highly infectious pathogen. So we have to prevent transmission to our staff as well as to other patients that we care for. With. That. I'd like to uh uh to end with with the other therapies that are available. We discuss about the remdesivir and that's a medicine as well as indications for the use of the immuno modulators to sell is a mob and bar sitting. There are many other therapists out there that are being proposed. Those are not yet either approved or authorized and we can answer them in the Q. And A questions. But since they are not yet authorized for use for covid, we did not prepare a slight presentation for them. Uh And on behalf of the other speakers, I'd like to thank you for your attention. We will turn it over now to the Q. And A. Uh dr. Gosh, if you could take take it over. Yeah. Thank you. Dr reasonable. One question is coming up repeatedly which you touched. But people who like to know about the role of convalescent plasma and what is the what is the role of convalescent class far in in the new realm of Monaco antibody use? Yeah. So I could take that on convalescent plasma. Also has some data behind that. Uh ah The the it's also under emergencies authorization. But it's only given a hospitalized patient, we cannot give that in the outpatient setting for example. So that's one difference. Uh And the other difference is uh convalescent plasma. It has, you know, a combination of multiple antibodies present compared to the monoclonal elsewhere in it's only a specific one antibody in that bias. So those are the two difference. Uh So I don't know if I was able to answer the question, but that's that's the difference between the two convalescent plasma hospitalist, but it has to be given early as well. Uh And that's where the data is as well as the fact that we should have a high tighter for the plasma if we use it, I'd like to just add onto that. We shouldn't think of these as separate products necessarily because all the monoclonal is got derived from Congress in plasma. They were all identified the Congress implants, maybe just been purified. So one of the questions which have come up is the logistics part of the monoclonal. Who can give it to talk about nursing teams and what should be the qualification of these nurses? And the second question which came out, you did show the band going out. Is there any scope for delivering it at home the monoclonal treatment? There are some programs that do that. Like for example, some of the home infusion facilities, uh, that maybe that you may partner with. I know some, at least in some areas of the country we're in. They partnered with, uh, the home efficient therapy programs that go out and infuse two patients at home. Yeah, there's there's that, uh, option as well. One of the question which is coming up to the top is do you expect to roll out subcutaneous injection based on restaurant announcement earlier this month? We are dependent on what the FDA will decide if they're going to give that uh emergencies authorizations for that. Then that's going to be another option. Yes, I know we did uh cover it. Richard did mention about it but there's repeated question on, do the panelists feel that monocle antibody cocktails are likely to work just as well for SARS cov two variants as with the wild type virus in the pre hospitalized patients. I think Richard did mention that you want to kind of take that on Richard. Yeah. Um, Yeah. So yes. I mean the the castle river map and the map is definitely showing some um, is showing the best um, data with regards to, to those those variants. Um, you know, leaping back onto the to the Texas one. It's, we don't have the information around the the the taxes information yet. Um But you know but some of the other variants of the same genetic markers as BB one. Um But like I said we don't have authority on that one as well. The India one has a mutation that um has kind of two I think 12 mutations. Um And two of those are are similar to the to the California one um As well as um the south african and the Brazilian one. So Um potentially the casserole moment of a man will be able to be effective against against that that Indian one. But unfortunately this point in time we can't we don't have the data to support that. Um that recommendation. Okay. Other question which came out was the cost and I mean we do hear about all the other kinds of therapy but monoclonal, what's the cost of this therapy? Is it covered by insurance? I'll take I can take that on. So the drug is free uh in the U. S. Because it's under emergencies authorizations that the federal government has basically bought supplies and drugs that are distributed to facilities that can infuse. So product is free. Uh There is a cost to the administration of course and insurance usually pays for that but that should not be a deterrent for somebody who is uninsured or underinsured because there is a federal pathway that will cover the cost of those administration fees. Uh and could be free for patients who are uh under or uninsured. Question of path of physiology, do the monoclonal antibodies contain antibody to the spike protein or the nuclear captured protein or just the spike protein? About Yes to despite. Yeah. Uh couple of questions came out about the use of governmental, What what is the role there? I know the studies it's still used in several countries. Um could you mention about what the current standing is about the use of connected. Yeah. So there's really no strong data to support or for or against the use of Ivor Mactan. Uh the I. D. S. A. And the N. I. H. As well as mayo discourages the use of that on routine use. If there is a desire to use ivermectin for covid. It has to be done under the auspices of clinical trials. So I know there's some that are ongoing at this time, but it should not be given routinely. one question came out about how should you monitor these patients and should Measurement of aisle six be a gold standard in covid management. Um Any any ideas on that or how uh Monica loans would affect L six and whether that should be monitored routinely in mild to moderate on moderate cases or it should be monitored only in hospitalized cases. Uh Nice. You kind of setting? Okay. Um I can take that on as well. So for patients in the outpatient setting we do not do blood work just because you know these are multi moderate patients. There is no blood work that is required of their care. Uh But if they get admitted to the hospital, usually we get the usual C. B. C. Differential count crp as uh different function test creating a space line I. L. Six. Yes or no depending on your availability. The turnaround time for getting I. 06 is also variable depending on the center. There are uh many labs that do not even uh perform those testings. So it's yes or no depending on availability but it should not really be the one guiding uh management uh you know, a baseline cRP is the, you know, easiest measure for inflammation. Could you comment about dexamethasone studies? Well known? And there are other studies on bureau tonight and hydrocortisone. How effective are there? Uh Because beauty is number it can be given as an inhaler. Um What would your recommendations? We are? The study is still not conclusive. It's still not conclusive. There's data that are reassuring out there, but they are not yet part of standard of care if if I may say that, but it's it's reassuring. But the data, the data indexing medicine just like what Larry had mentioned is uh you know, it's not for everybody either. Uh It has to be for patients who are already requiring oxygen. And if you look at, if you remember that graph towards the bottom, right on that slide, if you give it actually in patients who are not on oxygen or not requiring oxygen, it's worse. It leads to worse outcome. Um There's a lot of rush to sort out which medications to give and that has led to all these combination therapies, cultures and somebody has put it which almost every medicine from vitamins, two cultures and two others have been tried out. What would be your recommendation be if you were to give outpatient therapy versus inpatient therapy evidence based um For out patient, what would you say really works? And for in patient if you have become if you have to take the remnants aware um and and dexamethasone which is all the other biologicals which you mentioned, what would be the ones which we know definitely has changed mortality or definitely has shortened the length of stay in the hospitals. Just as a summary summary. Yeah. So for the outpatient setting, the one that uh at least has some data are monoclonal antibodies. Uh you know, we are just grasping the impact of this on clinical care. Uh if you recall most of the data that's published are on small trials. Uh but the outcomes are uh in those trials are basically uh viral load data. Which you know, what does that really mean? Uh In in real world, what's the impact of that on mortality? What's the impact on that on hospitalization? We are just learning them as those trials are expanding and as the use of these products are also expanding in the real world. With the with the authorization DR Garnish uh described the data of reduced hospitalization for the products that we've been using. There's also a signal of uh you know, mortality or I should say survival benefit uh in those patients as well. But those are still uh if I make qualified my statement, those are investigational. They have not yet been FDA approved for you. So you cannot just go to a pharmacy and buy them. It's it's still under emergency use authorization for the impatient setting. What has been shown to really improve survival is Dixon medicine. And, you know, the old cheap medicine that we've had for decades and decades and decades, but only in a select patient population. They have to have been requiring oxygen supplementation from the severe uh There's mixed data out there in terms of survival. Uh trials have not really shown that it improves survival or it reduces mortality. But uh there's an argument that, you know, mortality is just one of the outcomes. Another outcome that you look into is they get better. Right? So, uh Laurie had mentioned about the 40 difference in time to recovery uh, in in patients like this. So, really mortality from Covid has been reduced or has improved survival has improved over because we learn how to care for them. Uh So for us to look at a mortality benefit in patients whose mortality rate has been reduced with improved standard of care, You really need thousands and thousands and thousands of patients to see those outcomes. So, this question is for dr garnish. Doctor Garnish your leading the the Long Covid Clinic here. Thank you for doing it. What is the take on patients who have received some kind of therapy, Whether it's monoclonal or whether they are hospitalized with all this course that you have got the renders were Dexia and others with the possibility of developing into a post covid long hauler syndrome worse is if I have mild to moderate symptoms, I stay home, I keep myself safe. I don't take any of these medications. My 02 sacks is fine. What is my chance of getting a post Covid long hollow syndrome? And do these medications make any difference or they're separate issues? That's a fantastic question. And one that we're trying to figure out the answer to um, thinking about it from a scientific perspective, we have data that says that people even with mild symptoms do wind up developing disposed Covid syndrome. And um, we have data that suggests that people get hospitalized, have a higher rate of developing post Covid syndrome with 60 70% of people in some reports having persistent symptoms that six weeks plus no mechanistic lee. It would make sense that if we treated people early and decreased the amount of inflammation, we would hopefully prevent post covid syndrome. Now we don't have the data to back that yet. Um we're trying to study this and NIH is graciously trying to fund a research on post Covid syndrome, but the answers won't be available for a while. The next question. Either. Lori can take a doctor can it can take MS lorient. This is about how we select patients to get their monoclonal antibody. Do they really need to see a physician are based on the criteria, they get the test and they get the criteria. They can be referred for the monoclonal antibody infusions. Sure, I'm happy to take that question. So essentially any patient who test positive, they end up going into a report system here at Male Clinic. And again, those patients who test positive outside of Mayor are also eligible and their primary care provider or whoever may have ordered their test or ask that they go get tested, can submit an e consult and those patients are also then reviewed by our team for eligibility. If they in fact do test positive. And so once they test positive, we actually filter them out and we decipher based on their medical record, their past medical history, medications that they're on their eligibility, which again goes back to the mass board. And that's the weighted score for their comorbidities. And as long as they have one or more those patients who are symptomatic Who have tested positive within that 10 day window because there is the way that says, you know, we can only give this medication within 10 days um are then eligible. And somewhere nurses then call them and give consent, explain to them what the risks are. And they ask a variety of questions. And if the patient does have further questions and they want to speak to their provider, the nurse will then get their provider involved or one of us from the Matrix team to answer any additional questions. And from there the patient then get scheduled if they consent and usually they are scheduled same day or the next day for their infusion um which can take approximately an hour. We ask patients to come in and give us an hour so that we can infuse and then monitor them for a period of time afterwards. So this next question is what richard despite protein, a small RNA virus it's called a nightmare for all of us. And we realize teamwork is essential. Can you summarize your role of taking being at the charge of a major male health system? What is the pharmacist's role in monitoring what's going on? We got medication supply chain. What kind of questions do you get at the tertiary center? Yep. Thank you for that question. Um Yeah supply chain. Global supply chain is always a hot topic in in health care and especially for us in the pharmacy world. Um The when the amount of colonials initially came to through the F. D. A. E. U. A. Process, it was done by um uh federal and then state allocation. Um And within the within our state it was allocated based on regions that had the higher positivity rate. Um So we were we were thankfully um able to to maintain the supply um of monoclonal is to meet the needs of our patients that uh that like Gloria and and um ravindra we're discussing um uh in order to infuse those patients. Um Now we we did have some flux um when um when the Regeneron product had to get relabeled um that that supply was on hold for a bit. We could still get hold of the bamboo liver map. Uh The test um ab aspect was not yet FDA approved. And when that came on later the initial decision there was that it would be supplied as a combination both Obama liver map and the test a map together. However it was soon realized that most sites had had a may have an excess supply of the bamboo never maps that we're able to to shift their test a map on on its own. Um We've kept a really good eye on the variants that have popped up around around the nation and also travel history of patients. And that's one of the screening questions that we do as well um is when we're consenting is determining the patients travel history. So um if the patient is local, has not traveled, we have mostly the U. K. Variant that is um circulating in our area. So the babbling of a map and a testament is it can be a good choice. However, if we have any concerns around travel um we will do the cast member map endeavor map combination products. So we have therapy plan uh sorry therapy plans built within our electronic health record. Um And the providers are able to to select the nurses when they are placed in those therapy plans, which one of the bomb notice a mob or the the Castle River management plan to utilize. We also did a lot of work around those patients that had heart failure or chronic kidney disease with end stage renal disease in order to reduce the volume overload. And we reduced we did the reduced volume products. Um So in order to um to go down from about 302 150 to 310 mls down to about 70 ml for infusion volume. Um And we and that's that's kind of how we we have settled so far. So we had a very good handle on being able to ensure that our supply chain uh electronic health record um and as well as meeting the exact specific needs of the patient are all kind of encompassed into one action plan. And that's kind of how pharmacies role has been involved in working closely with the with this Matrix team. Thank you. Thank you Richard. That has been amazing. The coordination dr clinician dr reasonable. You've been actually the key stakeholders here in male clinic. What is your I know you've got maybe three minutes before I give it to miss pregnant. What have you learned the lessons of taking care of these patients? What can I infrastructure or what kind of coordination to information do you need to have to get something going in abandonment? Abby? Um, I think we both learned the same lesson. I mean it takes a team, it takes a huge team of committed people. And the reason that we have been successful is that everybody who came onto our team and it's about 80 people, um, all wanted to be there, all wanted to help and they all turned up every day to work, to identify problems as they occurred and to help us troubleshoot going forward. So I think that the common shared value and goals really helped us moving forward. Can you last word dr ray? Oh no, that is correct. And also trying to kind of, you know, appreciate the role of everybody and uh, you know, everyone contributes to the whole objective of giving these therapies potentially life saving therapies to patients and you know, everybody has a role and that those have to be recognized and appreciated and just like what ravi had said, everybody who is a member of the team really wants to be there. Ah and uh basically also uh giving feedback to everyone. Uh another thing that we learned as we assess our outcomes like almost every week, almost every day, uh just to kind of see whether this is something that's working so that you can kind of pivot or change course in case there's some there's some concerns, but uh feeding back to the team that the outcomes are good actually makes people want to come more and and and contribute more to the to the cost initiatives. So and then sharing our experiences to you all as well as to our state and the federal government to see how we can help uh in having this program Uh you know, uh as as uh as as a model or as an example of uh providing treatment to COVID-19. Thank you to our distinguished panel of speakers and from the male school of CPD. We thank you all over to written me for your closing comments. Yes, thank you. I'd like to thank our speakers as well as our audience for joining us today to discuss updates on recently authorized therapies for COVID-19. If you enjoyed today's discussion, please be sure to check out and register for our upcoming webinars in the series. If you'd like to claim credit after this webinar, please visit ce dot neo dot e d u forward slash covid 04 to eight. You'll need to log into the site. If this is your first time visiting, you will need to create an account After you've done this and loved in. You'll see an access code box, you'll want to type in today's code, which is COVID 04-8. This will allow you to access the course, complete a short evaluation and then you'll have access to your certificate. Please claim credit within 72 hours. Once again, thank you for joining us today. We hope you can join us for our next webinar as part of the Mayo Clinic, monoclonal antibodies and other novel therapeutics and Covid 19 treatment series.
