Mayo Clinic experts discuss logistics and practicalities in treating COVID-19 patients with monoclonal antibodies, as well as monitoring the effects of treatment.
Moderator: Nita Sharma, M.B.A., associate administrator; instructor in health care systems engineering
Featured expert: Jonathan A. Leighton, M.D. , consultant, Division of Gastroenterology and Hepatology; professor of medicine
Featured expert: Marie (Jay) J. Maningo-Salinas, Ph.D., vice chair of research, Mayo Clinic in Arizona; assistant professor of nursing
Featured expert: Maria (Teresa) T. Seville, M.D. , consultant, Division of Infectious Diseases; assistant professor of medicine
Featured expert: Christopher B. Grilli, Pharm.D., R.Ph., M.B.A., manager of pharmacy
Featured expert: Penelope Heisler, R.N., O.C.N., nurse supervisor, Ambulatory Infusion Centers, Mayo Clinic in Arizona
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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 titled Monoclonal antibody therapy. Playbook, mobilizing teams, managing patients and measuring outcomes. This webinar is accredited by the AMAANCC and a away 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. Will cover a few points. The first is how to claim credit. If you'd like to claim credit after the webinar, please visit ce dot mayo dot e d u forward slash covid 0630 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 0630. 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. This 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 is also a helpful up vote button So be sure to up vote the questions that you would like to see answered. If you're experiencing any technical issues during this webinar, please use the chat feature to share so that our support team may assist. We'd like to introduce our moderator and panelists for today. Our moderator MS Anita Sharma is the Associate administrator of medical specialties at Mayo clinic in Arizona instructor and the health care systems engineering and fellow with the American College of Health Care executives. Mira has 20 years of experience in outpatient and procedural healthcare settings with the proven abilities to successfully develop physician administrative and nursing partnerships and lead teams through times of departmental and organizational change and multi practice standardization. This experience was leveraged during Covid and her role as an outpatient hospital incident command system. Lead in partnership with Dr Jonathan Layton and now for our panelists who will be formally introduced throughout today's webinar panelists. Dr Christopher, Grilli nurse, Penelope Heisler, Dr Jonathan or latin Dr J manning go Salina's and Dr Teresa Seville. Mhm Here are today's learning objectives which will be covered throughout the webinar and with that I'd like to turn things over to our moderator. MS Anita Sharma, thank you Whitney and welcome everyone again. We really are just delighted that you've taken the time to participate in this third of a three part series on mobilizing monoclonal antibodies in your hospital or healthcare institution. We have a panel of distinguished speakers today, all of whom have had a significant leadership and hands on role in the setup of monoclonal workflow for Mayo clinic in Arizona. Unfortunately as was a real time set up as monoclonal antibodies became available to us in mid december of 2020 in the midst of our covid surge to really hear about the urgency with which we put our plan together which enabled us to be agile and start out with one plan to treat patients while evolving the plan. Iterative iterative li to ensure equality and safe patient experience. I'll turn over now to Jonathan Layton for the for the introduction and overview. Dr Jonathan Layton has been my physician partner now through the pandemic here. He's a professor in medicine and gastroenterology at Mayo Clinic in Arizona. Dr Leighton was the past chair of the outpatient practice subcommittee. He has also led the hikes or the hospital incident command system outpatient branch during the pandemic. He is the current medical director for the office of Mayo Clinic patient experience. And Dr Leighton has a special interest in outpatient workflow, redesign an improvement, overall efficiency and experience for patients and their families. In addition, dr Leighton as treasurer of the board of trustees of the American College of Gastroenterology. His research interests include small bowel imaging modalities and inflammatory bowel disease. Thank you Dr Leighton. Thank you Nita. And I'd like to welcome everyone this morning as we discuss uh monoclonal antibodies On the next slide. I think it's worth reviewing uh the year 2020 and the pandemic timeline. I think Everyone should know that on January 26, the first COVID-19 case was reported in Arizona and soon afterwards. On February four we in Mayo Clinic in Arizona uh Stood up the hospital incident command system, what we call hikes and that was formally activated. On March 11 of 2020, Arizona Governor Doug Ducey declared a state public health emergency. On March 13th we at Mayo Clinic, Arizona activated the dive drive through Covid testing site at our hospital campus, which continues today. On March 22nd we received our first covid positive, impatient. Okay. And then on March 25 in December three, a portable tent was set up outside of the emergency room to take care of covid positive patients. Yeah It was then on November 20, that we began planning for monoclonal antibody infusions. Uh and we included key members from the practice. And then finally on December 2nd the first monocle in infusion was administered at Mayo Clinic Arizona. Now it's important also to understand the allocation and availability. So in the fall of 2020 the US. government purchased 300,000 doses of bam land never mob. And the FDA issued an emergency use authorization, what we call in the U. S. A. For monoclonal antibodies and this E. U. A. Required administration of treatment as soon as possible after a confirmed covid positive result and within 10 days of symptom onset. And so the weekly allocation decisions had to be proportionally based on confirmed covid 19 cases, each state or territory over the previous seven days based on data from the U. S. Data collection site. So you can see this is quite complicated overnight shipments were made to treatment sites and then there was fast testing turnaround needed to efficiently identify positive test and schedule the patient for an infusion. And so Mayo clinic in Arizona initially received 90 doses. And so this is where we required the hikes oversight because we needed to identify efficient fair equitable and safe allocation and distribution of monoclonal antibodies and other infusion related countermeasures at Mayo Clinic. And it was critical that we create processes to provide monocle antibody infusions to patients with COVID-19 consistent with the state and federal guidelines. So we set out to create processes to monitor this monoclonal antibody program. And we wanted to provide clear and reliable information about monoclonal antibody and other COVID-19 infusion therapies. And so we uh hikes coordinated the efforts and align the processes with also the Mayo enterprise monoclonal antibody stakeholder workgroup and then finally we stood up a monoclonal antibody workgroup to operationalize the process comprised of key stakeholders in Arizona and the rest was history. So we'll turn it back to Dita. Thanks thanks dr Leighton for that introduction. Next I'm going to turn to Dr Teresa Seville. Dr Civil is an assistant professor and consultant in the division of infectious diseases at Mayo Clinic in Arizona, she's the co chair of the infectious disease task force at the Mayo Clinic pharmaceutical formulary subcommittee and is a physician champion of the antimicrobial stewardship in Mayo Clinic in Arizona. She was a member of the hikes medical advisor group for the pandemic planning and is involved in formulating COVID-19 management algorithms from Mayo Clinic in Arizona. She participates in the review of patient eligibility for covid 19 monoclonal antibody infusion. And in addition she is the president of the Arizona infectious disease Society. Dr Seville will start to um we'll go through her section as our esteemed panelists on the monoclonal antibody drug overview, patient eligibility selection and outcome. Thanks dot to surveil. Thank you Nita and welcome everyone. Yeah, So many of you are familiar with this um figure and briefly just to reiterate as you know, there's viral shedding before patients start having symptoms. The viral shedding typically peaks around 1-3 days after and then starts going down within a week. Um, the neutralizing antibodies typically appear at around 7-10 days and as far as development of severe illness that usually occurs about the second week after the onset of symptoms. And that's the rationale for the timing of the monocle antibodies. Yeah, so um the SARS-COv-2 virus has several proteins and one of those is despite protein depicted here in the red spikes outside the membrane. The S one subunit has the receptor binding domain or R. B. D. That then interacts with the ace two receptor in the host cells. And this interaction is the first event before the virus can get into the host cells and the monocle antibiotics work by binding to the receptor binding domain, therefore interfering with this interaction. And so the virus could not enter the host cells. Um there are several monocle antibodies are now available for Covid 19. Uh The ones that have published clinical trials are listed on this table. Eli lilly initially came out with someone of a mob and then the combination of online Ivana and at the seven map and for east and brevity, I will refer to them as the eli lilly monaco knows after this and then Regeneron has cast a river map and indeed the mob. And again I'm going to refer to them as story Regeneron antibodies. And these were tested in placebo controlled trials in adult patients enrolled within three days of diagnosis. And there were several doses that were tried for these different antibodies. The primary endpoint being decrease in viral load and with all three of these products there was a significant decrease in viral load with the drug compared to placebo. The secondary endpoints were outcomes of hospitalization or visit to the emergency department. And similarly, these were decreased in the drug compared to placebo around one To 2% compared to 6% um in the untreated placebo patients. Side effects um and serious adverse events were no different and were generally mild. Um This is the timeline bam landed Ahmad was approved by the FDA for emergency use on november 9 2020 which was revoked on april 16th because of lack of action against variants will show in the next slide. Uh The Regeneron antibodies were approved shortly thereafter on november 21st And then the combination Eli Lilly product was approved by the FDA in February nine And most recently on May 26. Petrova Knob was approved by the FADA for emergency use. Yeah, so this is a table looking at the activity of the different monocle antibody products against the main um Covid 19 variants alpha being the previously term U K beta or the South africa variant gamma or the brazil variant delta variant or the one that came from India. Um And as you can see here, Bamyan Ivana really doesn't work very well for the variance. Um Similarly, the combo product, eli lilly combo product has really not much activity against the South africa or beta gamma variance. There is no report of its activity and a delta variant. But because it has this mutation e for 84 K. Similar um to the gamma and the beta variants, um it is anticipated that it won't work very well for that. And actually the Department of Health and Human Services has now um discontinued is used in the United States because of the prevalence of these variants going up in comparison the Regeneron monoclonal antibody and the Petrova map has had no change for susceptibility against these variants and they are available for use and effective participated to be effective for these parents. Yeah, so the F. D. A. S. Criteria for use of these agents are identical. So they are for mild to moderate covid 19 infections in adult and paediatric patients at least 12 years old and at least weighing 40 kg. And they have to have a positive result of direct SARS-COv-2 viral testing. Either PcR or Auntie gin. Um and there's a high risk for progression will go over those. The infusion should be administered as soon as possible after the positive viral test and within 10 days of symptom onset. They are not approved for anybody who is hospitalized due to COVID-19 Or record oxygen therapy due to COVID 19. Or if they are on baseline chronic oxygen therapy and they require an increase in that baseline oxygen flow rate, they do not qualify. These are the only real exclusions for monoclonal antibodies. So in november 2020 when the first FDA US were granted, these were the criteria for high risk patients eligible for infusion. So anybody uh 65 or older, Anybody 55 or older with cardiovascular disease, hypertension, or COPD or other chronic respiratory disease, anybody 12 or over who has A. B. M. I. At least 35 chronic kidney disease, diabetes, immunosuppressive disease or condition, or currently receiving immunosuppressive treatment. And for those who are 12 to 17 years old, If they have any of these, they would qualify A B. M. I. At least 85th percentile um of their group, sickle cell disease. Can general are required heart disease, new event neurodevelopmental disorders such as cerebral policy, any medical related technological dependence, like having a tracheostomy, restaurants, Tamir positive pressure ventilation, or asthma, or reactive airway, or other chronic respiratory disease. Now the FDA has updated that last month. Um and um now it's um there are a lot more conditions that would qualify patients for this. One of the changes is the B. M. I. Has gone down from 35 to 25 pregnancy has been included. Um And other conditions are including here and anything that can first medical complexity like the presence of genetic or metabolic syndromes um and other neuro development disorders and other lung diseases. In addition, the CDC stated that health care providers should consider the benefit risk for an individual patient. So those who may not have had the conditions that have already mentioned but are in um minority or racial or ethnic minority groups that have long standing systemic health and social inequities could be considered for monocle antibody infusion. Um As you may know, patients who are african, american or latino have had higher morbidity and mortality for a variety of reasons. And they could be considered for monocle antibody infusions. Similarly, people with disabilities are more likely than those without have chronic health conditions living congregate settings and face more barriers to healthcare and could be candidates for Monica antibiotic infusion and there are additional conditions here and the C. D. C. Does update this and it's available at this website. So how do we do this? Um As part of that planning there was a report that was made that would pull in um to a daily report. Everybody at Mayo Clinic that has a laboratory confirmed SARS Kobe to infection. Patients who are tested outside the Mayo clinic system would have their results put into the electronic health records so they could be pulled into this daily report. And then after that we determine their clinical eligibility and drug allocation. And um as part of planning we anticipated that we would not have enough of the monocle antibody supply. And so we thought we would um come up with some sort of prioritization um for giving the infusion to those that are highest risk. Uh So we came up with a monocle antibody screening score, which I'll show you. Um And this was based on our internal outcomes and also the eligibility criteria set by the F. D. A. E. U. A. As well as state guidance. So this is what we call the mass score. Um And anybody who is 65 or older gets two points. Um Somebody who has cardiovascular disease A. B. M. I. Of 35 or over diabetes also get two points. Just hypertension and age of 55 gets one point. And those who have COPD or other chronic respiratory disease, chronic kidney disease or immuno suppression get three points and we add those up to their total mass score. Um And then we get that in the report and I'll show you a screenshot and we review that then to see first of all if they reside in our respective regions. Because as you know, mayo clinic has many different sites across the US. And we verify the comorbidities by manual review of the electronic health record. So for example, um somebody maybe on the cancer registry but that was 10 years ago. They're not on active chemotherapy, they're not immuno suppressed. Um So they would not be prioritized. Um And we would also look at the onset of symptoms which is actually pulled into the report, the severity of illness and the date of testing. So this is a screenshot a part of the spreadsheet that we look at every day to review uh monocle antibody eligibility. We have the patient's age gender. When the first positive test was if they actually the infection where they reside, this is the mass score and it gives us the total based on that scoring system um that I showed you. Um It gives us their B. M. I. Um do they have chronic kidney disease COPD diabetes? Are they on the cancer registry? Have they had a transplant? And it goes on further to the right And we review these and then review there a medical record to see if they do qualify based on the EU A criteria. So then patients who do qualify or contacted for education about the monoclonal antibodies and obtain and consent is obtained then. Um and they're scheduled for infusion as soon as possible. And those who are undecided or initially consent can call us back within 24 hours to reconsider their decision. So the workflow is we meet at five p.m. To review all those SARS-COv-2 pcR positive patients and rank them based on priority Because as it turns out we did not have a shortage of the monocle antibody product but we actually have limited space. So we had limited infusion slots every day. And so we had to prioritize who gets it first um and go about that way. And then the infectious disease nurse calls the patient reads the FDA EU a script to the patient and obtain some documents, patient consent. Um And then the orders are placed in the chart. And then the nurse calls the infusion center to schedule the patient and then calls back the patient to provide instructions about the employment and answer any additional questions. So what are our outcomes? Um This is available as a pre print. This is the proportion of hospitalization rate and this is just the Regeneron um uh product compared to propensity match and treated control this affected here in the blue. And as you can see the hospitalization right here is different and lower than those who were untreated and this was statistically significant. Yeah. With regards that mass score, I stated that was based on internal outcomes. This is the mask or here on the X axis and we're going from 0 to 1 to 5 to 11 as a total score. As we go to the right this is the percent of hospitalization on the Y axis. And as you can see as the mass score goes up the hospitalization rate and those who declined the treatment and the light gray goes up and particularly so in those who have a score of four higher and those who accepted and got the monocle antibiotic treatment had lower hospitalization rights compared to the untreated ones with regards our adverse reactions. There were few and generally mild. This is the minimum over 2000 patients infused and almost 700 with the Regeneron product. And you can see there are very few patients who complain a fever, nausea, lightheadedness, rash, chest pain, confusion, weakness, diarrhea, headache, cough, facial swelling, Disney a are flushing. All adverse events were mild and did not require hospitalization and there were no cases of anaphylaxis. So the ideal treatment timeline is to initiate the infusion as soon as possible after the confirmed positive test results and within 10 days of symptom onset. As for the F. D. A. E. U. A. Criteria to do that and get the right treatment of the right patients at the right time requires a strong partnership and communication between patients testing center, the prescribing provider in the infusion center in sight. Fast testing turnaround is obviously needed to efficiently identify positive tests and scheduled for treatment. So ideally, you know, within three days of onset of symptoms, we can test. The patient confirmed that within two days and then try and get that within three days of that first positive test result to get within that 10 day window except to Seville. So with that we're in a really for the next 15 minutes or so. Um learn from Dr. Meninga Selena's um the effort it takes to mobilize teams, space and supplies in the way that dr civil just spoke about. So Dr J. Meaning of Selena's is my colleague and I'm excited to be able to introduce her today. She is a vice chair of research in Arizona and partners with the Dean of Research to oversee all aspects of strategy and operations for research in the southwest. She's been a member of the Mayo Clinic staff since 2000 and five, brings a deep understanding of Mayo clinic having served on several committees and brings a leadership roles supporting both the practice research and education. She holds academic rank of assistant professor of nursing and the Mayo Clinic College of Medicine and Science. And in her role as nurse administrator. She led and coordinated the opening of the monoclonal antibody infusion site at Mayo Clinic in Arizona on this campus. Thank you, Duchess Lena's data. And so this is a good follow up to Dr Seville's introduction about the medication, it's side effects and the outcomes. So I'd like to discuss with our participants today a checklist, a plan of action checklist regarding how to implement monoclonal antibody infusions within their own facilities. The first thing is to review the need for monoclonal antibody treatments in the outpatient setting and ensure that your facility is prepared to meet the needs for the treatment. It's also very important to confirm that you have the support of your hospital facility and leadership. Um including also that pharmacy would be able to secure monoclonal antibodies for the facility. That's quite important. Probably one of the first things that you want to make sure. Secondly you want to make sure that you're also able to secure the supplies and the equipment needed for the infusion and then um work with key stakeholders to outline the process for scheduling patients um identifying the patient referral process that Doctors Seville um have outlined down to the how patients are admitted or referred, admitted and then discharged from the facility. It's also very important to develop a communication plan to the referring providers. These are the providers who are who may have had patients walking into the facility tested positive for covid and how will they find you the infusion setting? So that's an important communication pipeline as well. Penelope Heisler, one of our nurses will talk about the staffing plan and the mix of nurses and allied health staff that you'll need in order to successfully stand up the monoclonal antibody infusion center. I'll talk a little bit also about the dedicated space that you will need um in order to run an infusion center. You'll be very surprised how small of a space you actually need in order to successfully treat patients. And with the surge of the pandemic. Many hospitals and facilities here in Arizona and throughout the United States. Actually got very creative with the permission of the government. So I'll discuss that a little bit later. It's also important to talk about and loop in the infection prevention teams within your facility to ensure that you have a plan to keep staff and patients also protected. Um And then most importantly although dr civil um review the infusion reactions were very minimal. It is still very important to identify what your process will be in the event of an adverse reaction. Whether that's an immediate response, who would be on call that your team would call to come in and put um lay their eyes on the patients and review and assess the patient's on symptoms. And then um given that you might not have consistent nurses because nurses were floated in and out at the infusion center. Um you might, it's going to be very important that you have somebody that can do just in time education to the nursing staff And like I said earlier, a workflow for at first reporting. So where can monoclonal antibodies be infused? Again, it's important to identify a dedicated COVID-19 patient area. Um when we first started opening up our infusion center, we put in our in our mind a medical mission mentality. So this was really looking at the ability and uh mobile parts supply vince a medication cabinet with a lock. We knew that we had to repurpose space and none of these spaces would be ideal. But with the use of card supply bins and locking them up at the end of the night uh and then putting them out available in the morning, we were able to successfully again implement the infusion center. Um some sites like I mentioned used different areas for for the infusion as well as monitoring patients observation after the infusion. Um the Centers for Medicare and Medicaid Services implemented the Hospital Without Walls initiative, which gave permission for many facilities hospitals and organization to be creative and repurpose different open spaces that they had available um to convert that into an infusion site. Again, the only thing that really not the only thing, but one of the most important items that you need to consider when you are repurposing a space is that what is your answering the question of what will be your workflow in activating the emergency medical system in the event of an emergency or an adverse reactions such as anaphylaxis. So the Hospital Without Walls initiative, as I mentioned, that was initiated by the Centers for Medicare and Medicaid services allowed hospitals to use urgent care clinic doctors, offices, even waiting rooms. Um, el pasO in texas converted or convention center. You'll see photos of that. Later on, hotels became repurposed to be infusion sites. Um several facilities in um installed or stood up tense trailers, community centres, common community centres, Jim asians, open spaces were also converted into infusion sites. Church halls, nursing homes, open areas in nursing homes became also an infusion center. Again, very important when you're doing this to identify how you would address in the event of an emergency um what your activation will be for the emergency medical system during the infusion. During the higher the height of the surge. Mayo clinic also continued to experience very limited space for us to be able to um implement a monoclonal antibody infusion site. But we were very creative and we had much to our luck. An RV. That was our mobile research unit that had been in storage for quite a while. We were able to get the RV out of storage and inside it had to base to treatment infusion sites to improve infusion chairs in order to maximize our number of patients that we could treat. We actually put up two tents um Outside of it. One was for a staff changing tent and the other was our post infusion observation tent. We put chairs in there. So essentially patients would have their infusion inside the RV And then they would be discharged after the 60 minute infusion. And we would discharge them into the tent into a common waiting area tent where they're monitored by the nurse for another 60 minutes prior to being discharged to home. Keep in mind that it sounds like this is quite a long process at that time. During the search There wasn't much information yet about maps. So we were actually infusing it 60 minutes and observe observing the patients 60 minutes as as I'll show you now in a in another slide, you can see that as more maps have been infused. We have seen greater if Safety of of the medication so that we are now able to infuse it within 20 minutes and observe the patient for 30 minutes. So that's quite an advance um in the in the in the delivery of the medication. We also had a portable toilet um That was that was placed adjacent to the RV. Um initially the RV being that it was parked in the parking lot of the hospital was only open between 7-5 p. m. so it was for 10 hours. And within that 10 hours we were able to take care of of about 7-8 patients per day. Um Our main source of the medication was the hospital pharmacy. So we had a runner or a golf cart that moved medication back and forth. So communication is really key in here. Um And then on Saturdays and Sundays we were open from seven am to noon. We considered a lot of alternatives, as are a number of patients increased, including increasing our number of hours. But we also have to balance that with making sure that the staff and the patients were saved in the dark of the night. So we really considered going late into evening. But then we decided that if we were going to treat a patient late into the evening we would probably just take care of the patient either in the E. D. Or in one of our exam room treatments rooms inside the hospital that was vacant by that time late in the evening the R. V. Or our site was staffed with two nurses or we had one nurse and one patient care assistance to be able to to again be our runner to obtain the medications for us. This is a picture of our RV that we put into commission as you can see. Um It's the regular trailer and in on the right side of the photo here is what the inside looks like. This is bay number one. We had another chair and the up side of the trailer towards the drivers Side of the RV. And that was Vain # two. Keep in mind that even with two base we were able to actually treat about 400 patients within a month and a half two months of the search. So very quite impressive work by the nursing staff um pharmacy staff to be able to continue and meet the mission and the needs of the patient. Like I said we treat the patients and the chair, we discharge them into the tent. This is what the tent looks like outside. This is the tent. Um The first picture here is the 10th of the changing room of the nurses um where they have all of their PPE equipment there, capper equipment Um stored and then next to this, which I didn't have a photo of. On the right side is the other tent um that we also used as observation for for our patients. And you can see the nurse treating a patient there up the steps inside. Like I said, there's been a number one that you can see on the far side of the photo, there's a work area of um a nurse were a tech in the middle there that computers. So again very important to engage I. T. To make sure that you have a connection to the hospital system. And um again, this is how we were able to meet the needs of the patients initially. Um With permission I was able to obtain these photos as far as what other organizations did in order to stand up there. Monoclonal antibody infusion centers, You can see here on the top left is a photo of a fancy tent that was actually put up and stood up to again be an infusion center. On the upper right, there is again, another tent that was in this was in Nevada. And again, we don't really worry about the matching chairs or the matching. Uh, what were therefore, is to be able to deliver the medication on the bottom left. You can see this is a convention center that was repurposed into um, into an infusion site and then on the bottom right is also another one that is a photo of another site where they converted. Um, one of the halls of a convention center. I also want to point out and noticed that, you know, again, very creatively, curtains and PVC piping were used to serve as dividers. And you can also see that the convention center laid down plywood to protect the carpet, um, of of the big room in order to again be able to quickly clean up any spills that may occur. This is also another, another slide. Just to point out further that, you know, you can be creative in the space that you have available um, regarding again, you can see a waiting room here that's been converted. And again, another tent. We also several facilities in um, obtained the support of the National Guard and the military to assist in the in the infusion. There were several facilities that were short on nursing staff to be able to staff the outpatient infusion sites. And you could see here on the right side that military was engaged. And this was a hospital in Nevada that actually had uh, the support of the military. This is the supplies checklist that you will need um, in your infusion site. It's not exhaustive, but it gives you a clear idea of what you may need to consider to secure before you. Uh, when you're opening up your site again from the PPS and won't read every single one of these. But you have the PPE you have the infusion supplies that you need in the general supplies that you need. I do want to point out that um eli lilly and Regeneron created or manufactured their medications. They're monoclonal antibodies so that it can be delivered as a by gravity or through a pump. Our organization mayo clinic delivered the medication via the pump. We had it available, we had pumps available. However, we had nurse educators that we're ready to train and orient the nurses to doing the medications by gravity should um, if in the event that we wouldn't have pumps available for us anymore. Um this is just a quick guide for everybody that tells you about the rate of medications on the, when you're infusing them. Pretty much Regeneron and eli lilly are the same. So if you're looking at the total volume to be infused, for example, now we're heading towards, you know, mixing the medication with a 50 ml bag of normal saline. You're looking at being able to infuse that within 20 minutes at a rate of 35 drops per minute. If you're doing this by gravity and or you can do the spike pump as well. It really all depends on what's available for you in your organization. Uh All right, well, that ends my section and Penny will take it over from here. Thank you jay so much. That was a very practical guide. Um an important guide of how to set up in any space that you have small large um a monoclonal antibody infusions space. So thank you again jay. You spoke about the importance of nursing support for the successful throughput of patients. So this Penelope Heisler um is our nurse supervisor and it has been um a key edition in this work. She is the ambulatory infusion center nurse supervisor here at Mayo Clinic in Arizona. Um Miss Hessler has over 20 years of experience in he monk and blood and marrow transplant. She was instrumental in the planning and implementation of the monocle antibody for COVID-19 and fusion centers. And so she is now going to walk you through the staffing and operational workflow of setting up the monoclonal antibody infusion. Thanks Penelope. Thank you and good morning to everybody. Um I wanted to talk to you about how we set up the staffing and operational workflow and really this was how we were going to meet the needs of our patients after the patient selection meeting that you had heard from our team. They would contact our schedule er and they would go ahead and set up the appointments for the following day you see. Then our pharmacists were there to present or to prepare the medication and then our nurses or a health care provider. But in our instance it was all of our ambulatory infusion nurses. They would see the patient, they would start the I. V. They would administer the medication. There was the monitoring throughout the treatment the infusion. And then as J mentioned there was the post infusion observation after the patient was deemed ready to be discharged they would go home and uh and then our nurses or R. P. C. A. Um They were trained in how to clean the area in between patient to prep for the next patient. As you saw we had our mobile research unit and it was in our parking lot in the north of our facility. And we had this workflow established that our patients would call when they were leaving their home. So that notified our nurses that there would be a patient coming in. Uh huh. The patients then when they arrived to the parking lot there was a number that they would call and the nurse then would go outside two meet the patient at their vehicle. They would perform an assessment. And as you noticed they did require to have their oxygen saturation At 90% or greater. If it was not 90% or greater, they would call the provider for further direction because that would mean that patient may not qualify for the infusion. They would then supply mask to the patient because it would be clean and that would be helpful for the patient to have us to start the clean mask and then they would room them immediately. At this point the pharmacy would be aware of the patient was good to go. They would prepare the medication and then our nurse or PC. A. Would pick up the medication and the supplies. And as jay mentioned also we had a golf cart that we used to go back and forth between the. Uh huh. Yeah. Um Are you in the hospital now? We also had patients come into the infusion center as at times. And because they were coming into the facility we had a different uh flow set up. And what we did here you can see we would have our nurses put on their PPE, they would meet the patient at the front door and really the patient would pull up in their car the R. N. Would go out to see them do their assessment and then they would escort them into the treatment area. The R. N. Would give the treatment. They would monitor them for the 60 minutes post infusion. And then uh once they were ready to go home it was the same as before. Now if there was any adverse events they would contact the covid infectious disease. RN um If they were good to go the patients would be escorted back out by the R. N. And then again the nurses would clean the area and the surface after treatment and prepped for the next patient. This was the nursing education and really it was just in time education and it was to focus on patient safety and how to keep the staff safe also. So we had an a I see covid 19 resource web page on our Mayo clinic internet. It showed proper PPE donning and doffing. It also showed proper use for our camper which is the controlled air purifying respirator. We also discussed how to manage an emergency and we had a mock code. So we had the emergency room team come out in their golf cart to see how long would it take for them to leave the facility come out to our um are you take care of the patient and then return the patient? The nursing education also was for the monoclonal antibodies. We had fact sheets from eli lilly. We also had the fact sheets from Regeneron manufacturer. We also had up to date which is on our Mayo clinic internet and all of that was to provide education to the staff that would be infusing these medications. We had a learning module. It was interactive learning and it described the treatments and the workflows for the Covid ambulatory infusion center. And the RNS would go in and do this learning module. And you would work through like the background indicated um like when Covid first started, the monaco knows which you're aware of are the Regeneron and the eli lilly. It also showed pictures of the new unit. We were standing up on the Scottsdale campus and then references for um information we also had within the learning module. If you see the pictures on the left, it showed proper PPE E. The one on the left is the face shield that covered the N 95. That is what was used for direct patient care. The second picture, that one was Uh not direct patient care. It was it shows goggles and an N- 95. And the reason that would not be for direct patient care is you would not want the droplets to go onto your N- 95 masks. And the picture on the right that one shows goggles and a surgical mask that could be worn for non patient care areas, like if you were in the hallway or at the desk. So we tried to be very clear with the staff what was proper PPE for direct patient care and non direct patient care. On the other side, it talked about the baseline assessment and you've heard this several times. Um The treatment orders were in therapy plan. That's how the doctors entered the orders. That's where pharmacies saw the which medication they were receiving. Also the vital signs, parameters. It was key that if the oxygen saturation was less than 90% that the patient may not qualify for the medication and then the RNS could click through each of these administration monitoring stability and required documentation. Finally, we had our charting in our patient record, which is epic that we currently use. The nurses would chart the infusion date and time they would chart the vital signs throughout the infusion. Their observation period prior to discharge. This was taken care of If there was any other um findings anything unusual, they would be able to chart their assessment and at the final piece if there were other medications administered, this is where that would be also seen. There was several occasions that if somebody had a lot of allergies, for example, they would have pre meds prior to the infusion. Um, that wasn't a routine, but it did happen on occasion. So this is where that would be documented. And then if they had any reactions during the infusion and were directed to receive medications such as Benadryl or a steroid, it would be documented there. So all in all, I think the standup was very quick. It was very prompt, it was safely done. Our nursing staff felt supported throughout by our team and we really did take care of a lot of patients. And that goal was to prevent hospitalization or even a prevent an emergency room visit if possible. And I think our team did a great job. Thank you. Penelope. That was terrific information. So I hope you're getting a real theme now between our clinicians or operational leaders are nursing and now we'll turn to pharmacy. So dr Christopher Grilli doctor really is a member of Mayo Clinic Covid. That's our Covid operations workgroup committee which has been responsible for the safe distribution of covid vaccine across all of Mayo Clinic. He's also Mayo Clinic's primary vaccine coordinator. And part of a collaborative team that has represented Mayo Clinic at various states and county Covid planning and strategy meetings. DR really oversees the pharmacy operations support of covid specific ambulatory infusion center here at Mayo Clinic in Arizona. As the assistant secretary to the pharmacy and therapeutics committee doctor really has had an instrumental role in reviewing and reporting of formulary covid compounds including emergency use authorizations. So with that really turned it over to you to talk about dozing preparation and administration of the infusion. Thanks. Thank you. Nita mm. Mhm. So I'm gonna take a fairly practical approach in describing this. I think one of the things that as we were learning how to administer these medications, um it was a little bit more complex because there are multiple vials, there's multiple options for putting them, putting them in different pre filled um sodium chloride bags. And so uh one of the biggest lessons learned that we discovered at Mayo Clinic was just how to manage some of the logistics of this. And so one of the things I can't stress enough is um you know you get the option when things are normal and supply chains are normal to pick what you want and and um that was something that was not afforded to us early on as as we started to prepare these doses um for the great work that my colleagues before me have kind of outlined, so we had to have multiple plans, multiple contingencies, multiple redundancies. And so um what I've tried to do is kind of outlined for for those attending today. Kind of all the different considerations that that we were we were we had to take into account as we started to prepare these doses. So this is the lily product um and so one of the nice things about this product is it has the flexibility so it can be mixed in various pre filled um infusion bags, sodium chloride. So 50 100 152 50 we currently are using the 50 ml because we were able to maintain our supply but we did have contingency plans for all the other bags as well um in the event that there wouldn't there would be a disruption in that. And um kind of our experience really, when we were seeing a global surge early on in the pandemic things like plastic and fluids all became very difficult to get right as each country was kind of focusing on its own public health initiatives. We we had very, very big concerns and so what you get is what you get and you need to be prepared for that. One of the other things is um it's a little a little um a bit of a logistical challenge as you start to prepare doses, keeping the number of vials um um straight right, so if you are running both the Regeneron and the lily product, right, so lily requires one vial of bangla, maybe mob and two vials um of the S S tv mob um and so I kind of put the total volumes here for those folks that will be preparing the doses and this is really important because it's a 33 vials versus four vials uh and so as we kind of were doing our tracking um and trace mechanisms um this was something that we had to be very diligent on and you know for a normal drug rollout we have several months for this particular uh initiative. We had weeks, two days and so uh it really is important that your detailed in this uh so each vial is single dose um and and that was something that we had many internal conversations on how do we squeeze as much of this as we can. Uh It is imperative that you guys recognize that these files are not meant for multi dose use as tempting as that may seem. Um There is serious infection prevention considerations with this. These are not um designed to be entered into multiple times or even under sterile conditions. Um We had the conversations vetted it out and it was just too high of a risk um to do that. We do get to use one infusion bag, which was really good. So that helped kind of control supply and extend when we were in those those hard times. Um The nice thing too is it's it's room temp after reconstitution. So that was a very nice um A very nice feature that you don't normally get under you. A uh The other big thing is these are very fragile compounds that that's something I can't emphasize enough. So you have to be really careful shaking or exposing it to heat. Uh And so the lily product is very fragile. And so you don't shape, you invert gently, right 10 times with that. And you may say, well what's the reason for that? And you will inactivate the medication. It will be less effective if you vigorously shake exposed to heat or light. And so just be very very mindful of that. Um Once again, there are no preservatives in this. So shelf life is limited um and it has to be stored uh in under certain conditions. You cannot go beyond that, right under an emergency use authorization, there's little to no data outside of the narrow parameters for this. And so a lot of planning went into um you know we kind of say we just picked it up from pharmacy and moved it from Point A. To point B. And that that isn't always the case. A lot of planning went into kind of the cold chain um and maintaining stability across that spectrum. And so we we really um you know we tested it, we had models that went into it, i for the lily product, you can store it between two degrees Celsius and eight degrees Celsius for up to 24 hours. You can store it at 20°C in 25°C for seven hours. And all of these will impact your workflows or impact how far the drug can get away from say your pharmacy or how far your drug can get away from your med prep area. Um And depending upon what your infrastructure is. Right. Do you have fridge aeration? Do you not have fridge aeration? If you don't have Federation, there's absolutely a workflow that that's available to you, you just have to be um um um You know aware of what the parameters and limitations of that are. The other thing is is um you know obviously before infusion for this product you want to allow it to to warm to room temperature. So here's the Regeneron product um You know one of the big things with this is um you know I uh you know we we started out with one dose right? Um um a 24 100 mg dose that's now been amended and reduced to a 1200 mg combined dose between the two products. 600 for each of the individual products. So that's something I want to kind of emphasize and point out. Um One of the things with, especially with the USA or emergency use authorization medications is constantly evolving, right? So things like shelf stability, things like expiration date, things like dozing. Um These are all the things that the folks that are preparing these doses that are responsible for the storage and stability of the product need to be continuously monitoring, right? Because if if you aren't um you may be giving an old dose or you may be storing it under conditions that um you know, have are no longer applicable because of the new information. And so um this is a great example of that. So this particular one also has the same flexibility as the lily product Multiple bags. Once again we use the 50 ML bag. Um It's really important though, that, you know, I'm gonna emphasize it again, you have a contingency plan um for all of them so that you're not surprised if something goes on shortage or you surge and supply becomes difficult to maintain. So for this particular one, um it's it's too, so what we use our two step, the so the vials, so the actual individual drug into two separate vials. So we'll use two vials um um for each of them for a total of five mls for for each individual component and then 10 ml um combined and then here's some of the same um kind of considerations. The other big thing is visual inspection. Um You really want to make sure that you're visually inspecting the product after reconstitution. One of the things that is important about each product is uh it's not necessarily colorless. There can be a slight or pale yellow tint to it. There should be no particulates and then um once again there are no preservatives. So all the remainders, all the remaining remaining drugs should be discarded if it isn't used, it cannot be reused or or um extend used to extend supply. And then very quickly just wanted to show you guys um the kind of our facilities. So on the bottom we have our anti room. Um And then on the top two pictures are actual clean compounding areas. So we are using a laminar flow hood. So for those of you who are familiar with sterile compounding that is an eye. So five environment within an ISO seven um clean room. So both the anteroom and the clean room um are are under the under those conditions. And so so it is standard for most hospitals to use that. Um But uh we we use that to support kind of the covid a. I see. So with that I'm going to pause. Thank you chris So now we enter into our Q. And a portion of this panel discussion. You know, there are several questions in the chat, so I will begin to go through them. So first question from Mark martins are the monoclonal antibody small enough to cross a cross the placenta. And if so, would that be helpful in pregnant patients? Dr Seville. Let's start with you on that question. Um I actually do not know the answer to that question. I mean in general though, um that's why we immunize pregnant women to try and protect their um fetus um from other things while they're still pregnant and the baby for the first few months, as long as the antibodies last. So it is possible. I am not aware of information regarding that um pregnancy as I had stated as one of those high risk conditions for which patients could qualify for it. We do not think it will be harmful. Um So there may be potential benefit to the baby but we do not know that. I don't know if chris knows some information about it. Yes. So I actually saw this question come through. I don't know any Kind of direct um data uh that I'm aware of but just kind of general rule of thumb. Um if the molecule has a molecular mass of less than 500 daltons, we generally assume it crosses the placenta and these are fairly large molecules. So there's a theoretical suggestion that it may not. Um but once again I think it would have to be studied um to confirm because that isn't always the case. Um There are situations where um you know, we think it should behave one way and it behaves another. Um So so I'm unaware of any um studies and that's that's a little bit outside my my expertise. Thanks doctor Civil. Thanks doctor really. So another question and and chris me will stay with you on this one. I think this will vary by the site and quite honestly the countries. But what was the average cost for the drug alone for the entire course of not going to be able to pronounce this. But so excuse me um Carisa mab or in the end of a mob Regeneron or if you do not have total cost including nursing nursing infusion. So I think the kind of cost of the the the drug um and then the cost of the program. So um in our particular case drug was provided um um bye bye, kind of state and county officials and so we really didn't keep track of kind of the financial impact. Um You know, when we were kind of at the height of of everything, I don't think um that was something that that we really focused on with that. So I don't know if I can give you an exact cost of what the actual drug is at wholesale price with that. Um as far as kind of the time um You know, that went into it. Uh It was a little bit more intensive because it was such a short timeframe. But once again, I don't know if we really um tracked, you know, kind of what are our costs were um at that particular during this time period that that were disgusting. Yeah, and I'm happy to take that on a little bit more. So while not specifically on the cost of the drug to dr gillies point, we were receiving those. Um The our our intent, I think Penelope, you talked a little bit about this, our intent at the height of the surgeon at that continues was to ensure that our patients were receiving the care that they needed. And so um and then secondarily, um to ensure that the patients who are being admitted to the hospital with those that should be admitted while we had very limited capacity in our bed situation that we got as many patients through at the point that they needed to be put through um our patients. So there was an absolute cost um for nursing um for um pharmacy, for building out infrastructure to house all of this. Um And that really was the cost of providing care at the height of our search. So great question. Um I think you know as the months go by will start to tally up the cost of this pandemic. But at the at the time it was the immediate needs of the patients and we were doing this um as as a state. So the state of Arizona came together with the five hospital systems here in Maricopa um coming together to facilitate and ensure that patients were spread through the different hospital systems. Ada I'm happy to add on to this conversation. Perfect. Well, um so as dr Leighton shared in his initial slides um eli lilly made available right away um Family the mob to the different states because they know that it can prevent people from getting admitted. The government then secured these medications to be made available for free to the public. Um And that's why they were fully supporting endorsing the creation of standup infusion sites. Having said that the medications were free to the organizations as soon as long as you can prove that you've got a valid workflow um as I've shared in my logistics presentation. Um so they were free to us. Um the organization however, um charged about $310 so for infusion to the patient. So the patients that we took care of In our infusion, we charged $310 That was fully covered 100% by the patient's insurance company. I do want to share though that that is not a limiting factor if patients do not have insurance or in their public aid, they still were able to avail themselves of the medication in addition to that um towards the downward trend of the surge. When we were realizing that monoclonal antibodies were beginning beginning to be more available, We started partnering and seeking out clinics from underserved populations to see how we may be able to assist them. Um And since we now have the facility, we had the workflow, we had the medications available so that then we can open up the pipeline to assist those underserved populations and be able to take care of the patients. So we started exploring ways that we may be able to support them. But I do again uh it was free to Mayo Clinic and we then covered most of the cost with insurance payments. Thank you. J so I think again, really important to be working with your county and state or other government officials as you embark on this work, maybe I'll stay with you for just another question around resourcing. So did Mayo Clinic in Arizona have to pay nurses over time to staff for the monoclonal antibody infusions suite or when nurses repurposed um for that effort. Yeah, great question. As I shared and Penny shared as well, this was really all hands on deck effort on the part of all mayo clinic staff. So we did have in the initial search we had a staffing plan where we ramped down our ambulatory care practices, those who could and including our surgical practices. And so we were able to repurpose staff from ambulatory setting, including surgery and identify which of them which of the staff um could be up skilled and re skilled to support the infusion clinic. So we did have several nurses from other areas that weren't historically infusion nurses. Penny led that charge with getting them oriented and be comfortable being in front of the patients in this manner. So for the most part, we did repurpose there were a few times when we did have to uh maybe pay overtime. But again for the most part I'd say that it was really using nurses from other areas to support this infusion infusion centers. Right Thank you J Penney anything to add to that? No I agree. Um We were like the rest of the facility truly we used the overtime nurses as needed but being able to use the redeployed staff um worked out extremely well and they did a great job with the upscaling and learning how to do this infusion. So it truly was an excellent team. Great very resilient team too. So I opened this question up to the panelists. Can someone rely on monocle antibody without vaccinating dr Seville? No the answer is no. So the monocle antibody gives a person passive immunity. So you're giving them you know antibodies against the virus. Um There is I saw a question further down saying how long do they last? And I actually am not aware of how long they are present in what would be deemed to be protective amount. And so they are not a substitute for vaccination. Anybody who has received the monoclonal antibody infusions should still be vaccinated to provide that active immunization active immunity. And and I would just add there is a period of time if you have received the monoclonal Um and about the infusion I think believe it's 90 days before you can vaccinate. So so be mindful that there are clinical considerations um when uh when the two are therapeutically appropriate for one patient Just to follow up on that. The reason for that timing interval is there is a theoretical um uh concern that having had the monocle antibody could interfere with the formation of the active immunity. If you give it within you know the 90 day period. And I'll add to the conversation as well. Need to we have a scientist here at Mayo Clinic who's actually um now has close to more than 1000 patients participants in his study um He is following the participants on a weekly basis and doing um antibody uh testing draws on participants to see where they started after they got their vaccination and then how and then um uh what their levels are as as the weeks go by. So we do have for vaccination. We have a a scientist doing that examination but it would be interesting to see for monoclonal antibodies. Um a parallel study. That would be interesting. And doctor uh dr Seville. Um can you just explain once again why the why it was important to give the monoclonal antibody within 10 days. So most of the viral shedding happens within the first week. And the idea of the monocle antibody is to actually block all those viruses from infecting the whole cells and making more of themselves. Usually within a week. There's not much viral shedding anymore. After about a week you start making neutralizing antibodies and also the people who will develop severe disease that will require hospitalization. Um Typically that happens after the first week of symptoms. And so it's really important to give it early on after the infection and onset of symptoms. Thank you. Thanks everyone chris I'm gonna look to you. So Georgia pharmacy technician from Uganda Is asking the question which group of people are limited to the use of monoclonal antibodies in this period of COVID-19. So great question George. I think Dr civil kind of address that. So I refer back to her slides about what the inclusion criteria are for patients. Um There are limitations so um I would familiarize yourself with that. I don't know Doctor Seville if you want to maybe speak to that. Um So we go by whatever the F. D. A. Um approves but as I had showed the list has gone considerably longer and actually allowed more leeway in terms of whom you can give it to. Really. The only exclusions like I stated is somebody who is hospitalized for Covid um or they're needing more oxygen than their baseline. Um And you know it's also there if they need oxygen for Covid but usually for those patients we would admit those patients anyway. So those are the only real um uh criteria that would make somebody ineligible for the monocle antibody. Um I will add if you know if somebody is wondering if somebody has gotten the vaccine before and then they develop covid they would still be candidates for it if they're in between two doses of the vaccine, they are still candidates for it. If they had covid six months ago and they got a reinfection, they would still be a candidate for the monocle antibody. So they're very very few exclusions for the infusion and and uh dr Seville um in addition to decreasing um hospitalization um in the clinical trials, can you tell us a little more about the benefits of uh this therapy? So um so the main outcome that the companies were looking for is a viral reduction and and they all did that compared to placebo. Um There was a decrease in the hospitalization and mortality um with the patients who received the monocle antibody. And it also appears not in those trials that I um put in that table. But for example, Regeneron has a study on household context to see if it protected the household contacts from covid from a household member who has covid. And in that um I think it's just a press report, it appears that those who got the monocle antibody did not develop symptomatic covid, even though some of them developed a symptomatic covid. Um and then another um report. It appears that those who did develop a symptomatic covid and got the monoclonal and had a shorter course of symptoms compared to those who didn't get the monocle antibody. So it appears, you know, we don't have the full information regarding those, but it appears that even for for for context there is some benefit to that. Now the FDA has not granted approval for giving it as a preventive measure. It is for treatment for those who have mild to moderate um infection at this point. Thank you. Sorry I'll take myself off. So a question that I know is is on a lot of people's minds around the delta variant and is map being developed for other variants such as um the current delta variant. That's um so much in the news right now. So there are a variety of monaco antibodies that are in development. Um you know details of those of course are not available to us. Um and some of these like I said are just available in press reports but for example uh Petrova mob which is the newest one that was approved appears to be um bound to the spike protein at a spot that is actually highly concerned. So it actually has activity against the First Stars Kobe virus, the one that caused an epidemic back in 2000 to 2000 and three. So it's actually active against that and it's active against the SARS COv two. So it is very possible that it will be active even in subsequent variants of concern. Um And then you know there are those that are still in earlier um clinical faces of trials. So we'll see. And up to surveil or chris j would you add anything else is another question again related to to tax Ilham mab? I said that correctly and how it compares to the other monoclonal antibodies that you included in your presentation. Anything else that you'd want to add in response to that question? From? Well I will take a shot at that. So none of them have been compared head to head. So none of the monocle antibodies have been compared with each other. None of them have been compared with convalescent plasma. So we don't know which one works better than the other. Now, I think the key, the key point here and somebody posted this in the chat is that it's really very this is a very fluid situation still, even though um here in the United States where at least in the in Arizona we're seeing, you know, kind of a downward uh in our numbers. But it's very important, as one of the participants stated, it's important to really look at the most recent evidence and it's that's really kudos to our infectious disease team and pharmacy to constantly just have um conversations regarding recent publications and what's out there. They're constantly just monitoring what new monoclonal antibodies are coming out in the pipeline and what does it work? Um, you know, what does it work again? So, um, I think if there's anything that I continue to encourage participants is just to continue to look at the evidence. Um, and what's out there, let me follow up because I just looked at the question. So the question is about socialism app Now that is not a monoclonal antibodies against the virus. Um, it is actually a drug that has been approved for the side of kind of release syndrome. So it works very differently from the COVID-19 monoclonal antibodies. And again, there is no comparison between the, you know, how patients do with that. But I would say though, that we do not use those Eliza mob in patients who are outpatients. So those are patients who are in the hospital and usually quite ill. So, um, so I guess in one way you can look at it, the Monaco antibodies do not work for hospitalized patients. So you can, you know, make the inference that, you know, they would not perform the same but they work very differently and are used for very different sets of patients. Thank you. Yeah. Question coming in from Dr Redwood comrade neurologists. So his question is has mayo clinic used or considered use of antiviral agents including but not limited to the older non specific agent such as X ciclovia which prevent viral replication is compared to use of monoclonal antibodies. Again this compare comparing efficacy, cost and other relevant clinical variables. No um there's a group of us at Mayo Clinic all over the enterprise that look at what's available out there. Um and we were one of those that got into the hydroxychloroquine bandwagon initially on. But um but no we are not using any antivirals really for outpatients. Um And yeah, no. Mhm. Dr Seville. Um There's a question, also a very good question about long term side effects uh Covid 19 infections. Are the do we have any data on the use of the monoclonal antibodies and their impact on any long term sick quella? Yeah, not that I know of the only one that I know of is what I mentioned earlier for the household contact study. Where those who got it seemed to be to have symptoms for a short period time, one week versus three weeks. How is going to affect, will it prevent long covid or post covid syndrome? We don't know that at this point. Thanks. And I I just want to comment. My apologies. So, Dr Edwards Conrad is a lady. So my error there, We just have a few more minutes. So um prioritize our questions. Um one of the questions that's come in, hypothetical patient who received mab treatment followed by recovery and re infection, I'm greater than 90 days ago. What's the group's opinion on providing another course of mab? Um So like I stated earlier somebody who's gotten a reinfection regardless of how we treated them before they would again be reconsidered and could qualify if they have those criteria that put them at higher risk for severe illness and and just to preempt this. I think there was a question about this being an I. V. Infusion and you have to have facilities to do this. I didn't have time earlier. So I'm just going to mention now that the Regeneron monocle antibody um is actually also approved for subcutaneous administration. So for um sites that absolutely have no capacity resources or what not to provide ivy infusions there is that available to you as well? And I would just add if if that is a route that you do decide to use uh make sure that you increase your monitoring of the patients. So there tends to be a little bit more side effects local injection type reactions. If you do the subcutaneous route versus the intravenous route jane. Maybe that's just something for the last few minutes that you'd want to take on. So one of the things that we did was evolve over and very quickly evolved from the area that we were infusing patients in which is a recreational vehicle, the research vehicle into our facilities. Do you want to just spend a minute speaking on that topic? Yeah. So thanks. Nida says I shared earlier, you know, in the height of the search got creative. We used our recreational vehicle, the RV to stand up our sights as we were doing that. We really did not have a clear picture of how long the How long the search was going to take. And so we intend them. Were already planning for Phase two, a bigger space and we were able to repurpose another space that could accommodate um 10 chairs. And and so that would really enable us to take care of 2 75 infusions that day at maximum. And compared to the 14 that we could do in the RV per day. So we were we were again working with key stakeholders, pharmacy uh supply chain, our facility staff to make sure that we had a new workflow for this new space that we were creating. So I think that you know, again, some parting words with our participants is to um even when you're in the height and then you're in the middle of the search. Start thinking ahead as to what might this look like for you? And have a like chris doctor Gurley said have a contingency plan um for if this goes, you know, still will go much higher surge. Where do we continue to take care of patients? And it may be that you might be standing up to different infusion centers in your facility just because that's the space that's available to you. Um um and that's just what you have to deal with. What would be best is one big space. Again, it was more efficient for staffing for supply chain, for pharmacy, but you know, no matter what the best interests of the patient is, what you have to keep in mind. And you know, clinical staff are very agile and flexible and it clearly shows that we all rose to the occasion and taking care of the patient and the needs of the patients and their families during this difficult time. So um again, just continue to continue to plant for what may happen next. And, you know, we all wish that we all hope that we will never put that plan into place. But we're ready. Yeah. And on that closing note, thank you all to all of our esteemed panelists on behalf of Mayo Clinic School of continuous Development. Thank you for joining and for your time and participation. We hope that you will continue to join us for these and many other sessions um, around Covid. Thank you everyone.
