Answering the questions providers face daily, pediatric infectious disease specialist Ann Petru, MD, presents the evidence on how to best prevent and treat COVID-19 in children. She describes risk factors; discusses navigating home tests and return-to-school guidelines (explaining when 5 days isn’t enough); and breaks down the many new treatments, clarifying when to consider them and the pros and cons of each. Bonus: a resource for interpreting PCR and antigen tests for patients with and without symptoms.
I'm an Petra and one of the infectious disease docs in Oakland. Um and I'm the infection control officer here and kind of the buck stops here when it comes to covid related questions. So I have accumulated a bunch of questions over the last few weeks and answered them in writing and then offered Maria that I could do this for you but forgot that I needed slides. So I pulled my slides together yesterday and I borrowed some from a another colleague in our department dr processing. Um Probably gave a grand rounds on Tuesday this week on therapy for Children with covid. Um And it was an excellent excellent lecture. So if you can pick up the grand the grand rounds video tapes you'll be able to see more many of these slides. The graphic ones are from her lecture and you'll see when we get to the Q. And A. That I put together they'll be clearly labeled as questions and answers by way of a quick introduction. I just wanted to show you a little bit about the numbers of cases of Children with covid compared to the U. S. Population. You see in the graph that the predominant age group affected is the 5 to 11 year old. But you can see from the table That we they account for 6.4% of the cases of COVID But 8.7% of the population. So it's still less common in pediatrics than it is in adult medicine. And that is true for the three younger age groups and by the time you get to be teenagers, the 16 to 17 year olds account for about 2.5% of the US population and 2.8% of the cases. But if you look at deaths, the deaths in pediatrics are far far lower than the percent of the population goes across all age groups. And a reminder not that you need to hear it for the first time, but the blue is the Delta outbreak. And you see how dramatically between early december and january, they completely flipped spots with a micron so that at the present time, a micron accounts for 91% of the cases of COVID in California and 99.5% nationally. And you will have heard, I'm sure about the new um, sub species of a micron, which is referred to as stealth, stealth. Um, Akron or be a dot to more about that will come eventually, but I don't have any more on it today. Um, to give you a special perspective on the severity of illness and Children. This looks at on the left. The graph is comparing the risks for a micron versus um, uh, Delta. Um, and you're seeing what happens for edie visits. A macron is lower than Delta Hospitalization. Far lower. Icu admissions and mechanical ventilation far lower. Um, compared to Delta. If we look at treatment for Children, we have to remember that the risk of severe illness is low, that mortality from COVID and Children is less than 1%. But it doesn't mean we haven't seen Children die and the current predominant omicron variant appears to be mild in pediatrics. And we need to identify the high risk populations within the pediatric world who are at risk for progression to severe disease and to identify them as the ones who would benefit most from therapy. Looking at four major features that influence severity of disease. On the top, you see age 30 year old being the least. Um, at risk except for the kids in the first year of life who have more risk. The worst being those over 65 for comorbidities such as obesity. If you have no co comorbidities, your risk is low. But if you have more morbid obesity, the risk is huge. And I can't emphasize that enough because we see a lot of hospitalized kids with morbid obesity who have not been immunized and who are age eligible to have been given vaccines. And that's a tragedy. We look at vaccine status. The more vaccinated you are, the lower your risk and the partially vaccinated and unvaccinated are at the highest end and immuno suppression with certain drugs carries a lower risk. But other drugs carries a considerably higher risk, especially those with active him urologic malignancy and those with bone marrow transplant. So when we think about who should get meds, we need to keep those things in mind when we look at those risk factors. This is from data that was published in Jama 43,000 Children under age 18. The risk factors are listed here. Obesity being by far the worst risk factor than the others under a year. And prematurity are problematic. Congenital heart disease, complex medical conditions and kids who have anxiety and mental health issues are particularly also at risk. In this graph, you look in the top section at hospitalization and the bottom section, severe illness when hospitalized and you can see the risk of hospitalization when there's no chronic disease. The risk ratio is one, but compared to that, you're twice as likely to .9 times as likely to require hospitalization if you have non complex chronic disease. And if you have complex chronic disease, you're more like eight times more likely to require hospitalization and the severe disease in the bottom graph, similarly, the risks are considerably higher with non complex and complex diseases. So we definitely need to focus on that population. And this is looking at severe covid which is defined as icu admission, mechanical ventilation or death. For Children with chronic lung disease, there are 2-3 times higher neurologic disease about twice um cardiovascular and prematurity about 1.5 times interestingly enough, this graph seems to imply that feeding tube dependency is protective, but I wouldn't buy that because the next slide contradicts that and I think it might be an error. And this this Oh, maybe I skipped a slide. Yeah. Ah Here so here feeding tube dependence puts you in the highest risk category. And that's why I felt that we might be getting wrong information. But again obesity puts you on the high end of risk and diabetes mellitus one or two. Now one of the questions is how do you interpret a new diabetic with diabetic ketoacidosis would end up in the intensive care unit because of the D. K. A. If they happen to have covid they land in this group of nebulous patients who are in the hospital with covid in the ICU. But is it really the covid that put him in the ICU or is it the DK. So some of those questions are harder to answer. So we're going to now get to the Q. And A. That I started with a few weeks ago when people started sending me questions and I've modified them because things change over time any day something might change. So the first question has to do with people who have a positive test at home. And the question that came to me, is there any risk to do a pcr any sorry, any reason to do a pcr if the patient is symptomatic you should believe it. These rapid tests are remarkably um effective and useful and we should believe it if there's a positive pcr and a symptomatic patient. So you sorry a positive antigen test in a uh patient with symptoms you do not need to do a PcR in that patient, you treat the patient as if they're positive and you advise the family that everyone in that house should be considered exposed if they haven't already been infected. One thing you might suggest to them is to take a photo of the positive tests because very often later on they won't remember what day it was that they did the test and their their phone camera will have a date on it. So they'll be able to go back and look at that date. If you're in your private practice, you want to include COVID-19 infection on your problem list with the date of onset of those symptoms because the timing of discontinuation of isolation or of exposure for family members is dependent on that date. Either the date of onset of symptoms or the date of the first positive test. The standard isolation is 10 days for normal hosts. But with the CDC guidance changing relatively recently, people are allowed to return to school or work only if their symptoms abate And fever is gone for at least 24 hours and they have a negative antigen test after day five. All of those caveats need to be true. One of the questions that came to me was about a from a doctor whose patient was in a private school and all the school said is you can come back to school after five days. They didn't require testing or anything further. And I think that's dangerous and we have to be careful that families understand that it has to be with a negative test to go back to school In immuno compromised hosts. The standard isolation is 20 days and we'll come back to that later. If the patient has no symptoms and no exposure, it's possible that a test done at home could be a false positive test. And for those patients, you should encourage them to repeat the test another time and if they have a known exposure, they should be considering a positive test, indication of infection. They should isolate for five days and then retest currently with the extent of our covid pandemic. The majority of tests are true positives and most people who are infected continue to have positive tests beyond day five, we've discovered that when we carefully monitored in the employees at UCSF and found that about half of them feel well enough to think about going back to work on day five and of those who do think about going it, only half of them had a negative test on day five or six. So it's not likely that most people will be released from isolation on day five either because they don't feel well yet or they still have a positive test. That's question # one here's number two, any reason to try to report positive home test to public health. As you know, before home tests became widely available, people were getting tested at testing sites and we were all mandated to report to public health. We did it diligently even when we had 70 or 80 positives a day, we did it diligently. But the public health departments are overwhelmed and we discovered that when we found out that of the many days in a row of faxing reports to them, those reports were not even downloaded on the fax machine at the public Health Department because they were too overwhelmed. So we have to kind of think about what is the goal of reporting. And now that COVID is considered almost endemic. That is roughly 20% of the population may have had COVID already. We need to think about why are we reporting and what will happen with the reports. The public health departments indicate that they would like to hear about positive home tests. But it's not, you're the physician or clinics responsibility to report them because you didn't do the tests. So the reporting should be done by the patient or parent or family members. It's not mandatory for the clinicians to report those cases. You don't have the test in front of you. You're not the one who interpreted it. You need to let that be the family's responsibility. Question number three. Where should you sample most of the time? In our hospital based testing sites, we've been doing nasal foreign jail samples. But now that people are being encouraged and allowed to test at home collecting nasal for angel samples is not easy to do. It requires a very deep swab. So many places, most places are doing anterior nasal or mid turbinate nasal swabs, but some people have heard that oral swabs should be done either using a rapid antigen or PCR because they might have a higher positivity rate compared to nasal samples. The challenge with that is that the machines that are used to test for PcR, for example, are not all validated on oral samples. So if a sample is collected orally or a mixture of nasal and oral, those samples cannot be processed in the lab. And when samples are collected in the drive through, the vast majority of them will go to a central lab where they may be able to do both. But if somebody calls and says, hey, that kid needs to be admitted today, we can't use that sample to run. So it's a bit challenging because the rules are different in different labs. Um, but we are in the process of trying to validate a particular test on one machine that we have here that would allow us to collect oral for angel or anterior nasal mid turbinate samples. But most rapid antigen test kits that's supposed to be kits use anterior nary samples only and we don't want parents shoving swabs deep in their kids noses because you know, we'll end up with nosebleeds, Maybe perforated septum. So it's not something we want people to do on the outside. What about isolation? Many docs and schools are using the CDC guidelines And Oakland Unified School District recently updated, There's, it's hard to stay on top of all these in your private practices. You have kids attending different schools and different school districts, some public that go strictly by public health guidelines, some private that make their own rules. So what do we say is what I've been asked. Do we fly by the seat of our pants? Because not everybody is following the same rules. It's very difficult to come with one guideline that everyone would use. Um, some schools, as I said, are cutting the isolation down to five days and letting kids go back without testing. I don't think that's a wise thing to be doing. I think we don't want contagious kids and the swab testing with antigen usually correlates with positive cultures. So we don't want those kids going back to school without further testing. The other thing is that the CDC guidelines when they came out were really intended to help maintain a workforce in critical spaces such as nurses in the ICU and if a nurse had Covid And is mildly ill recovers quickly and gets tested on day five and is negative. She is deemed less likely far less likely to be contagious and could come back to work perhaps even taking care of patients with COVID who would not be at risk of getting disease from her. So that's kind of why it came out. And the problem is it's it's been interpreted in a lot of other ways. Um, and and you know, yes, we want to get our kids back in school, we want to get people back to work. But it was really, the idea was behind staffing shortages and it got quickly out of hand. Oakland Unified Schools has a new set of guidelines, which are clearer. I did not copy them here because I don't have a way of distributing them to you quickly and they change so often. But I would advise you to look at the guidelines for isolation and return to school for kids in whatever school district your patients are living are going to school. Um, and these guidelines addressed not just staff and students, but distinguishes between those who are vaccinated and those who were not and that makes a difference. But what about isolation for asymptomatic positives? five days or 10 days with or without testing? The CDC guidelines says five days retest if it's negative, they can return to school. The exceptions should be considered for kids who cannot reliably mask the kids who are less than two where it might not be safe to put a mask because of choking hazard or kids who are older who are developmentally delayed and cannot tolerating, tolerate having a mask on their face. Those kids should stay out for the full 10 days. Um, Each school will probably have someone assigned as a contact tracing team and you need to contact they, the parents need to contact that team to find out whether they're allowed to return to school on day 11. What about symptomatic patients again? The five versus 10 days and with or without testing? Most kids who are symptomatic as I just said will require 10 days of isolation because most kids are not perfectly well by day five and most kids will not have negative tests on day five. But if the patients improve substantially, you can get it. They can get a test. One of the questions for me is does it have to be done in a clinic or can it be done at home practically speaking. It doesn't make sense to do it in a clinic because it means bringing an infected kid into the clinic intentionally to test them only to find out that they are definitely infected and now you've had potential exposures in the clinic. So most of the practitioners I've spoken to are allowing the families to do that second test themselves at home but not to go back to school until it's negative. The parents and patients must be told that regardless of whether they go back to school, they are still supposed to be diligently masking until the 10 days are completed. Um, it's not practical. As I said for people to come into clinics for testing under these circumstances. Question seven And this is one of the very common miscommunications that I hear on the media all the time. The mistaken use of isolation versus quarantine. So the reminder again is that isolation refers to infected people. They are the ones who are isolated for five or 10 days depending on whether they're symptomatic and have a negative test. Quarantine refers to the exposed person, someone who is not yet infected and the quarantine is different if they're unvaccinated or if their booster eligible and haven't gotten the booster, they are also considered unvaccinated or insufficiently vaccinated or under vaccinated. And the question then is about what about the quarantine period? Again, quarantine applies for those who are exposed and it's regardless of immune status. So the only consideration is that a normal kid who can mask properly can exit quarantine. If they have a negative pcr test or a rapid test on or after day five. So this shortens the quarantine period substantially because it used to be 14 days. We've moved it to 10 and now we're saying if you're negative on day five you can come out and again it won't apply to many, but it will to some. Um The other, the next point here is that if kids cannot mask, they should stay in quarantine for that 10 days. And again, everybody must be told about the masking diligent masking, especially indoors any of these people in quarantine known exposure who develops symptoms have to be presumed to have covid and they should stay home, they should test and they should isolate. We have had shocking numbers of people who just don't bother to test and they don't say anything to anybody. Oh yeah, I have a sore throat. But if they don't test their presuming they're okay and they keep going to school. Not okay. So the screening at school needs to be optimal and I don't know that it is. So how do we define fully vaccinated? I implied what under vaccinated means and the definition of fully vaccinated is changing. It's a moving target. Previously it meant that they got their primary vaccine series. Either two doses of fighter or moderna or one dose of the Johnson, Johnson and Johnson and Johnson vaccine. Now the additional dose of Fizer, what we're calling a booster. But is there an extra doses given five months after dose number two. And from Moderna, The extra doses given six months after dose, number two for the J. And J. Either of the M. RNA vaccines is recommended after the single earlier dose of a J and J vaccine. Because the effectiveness of the J and J vaccine is not as good as the other two and either of the other two will boost to a better degree. How do we define fully vaccinated? Again, one has to think about why are we being asked this question. If you're a healthcare worker Boosted dose is required. It was supposed to be on by Monday next week January 31 but it just got extended a couple of days ago to March one. So by March one any health care worker who's had the primary tudo series Needs to have the booster by March one part of the reason for this delay is that this a micron surge has created such a staff shortage that if we keep people out of the hospital because they're infected and we keep people out of the hospital because they're exposed. Then we have added problems with staffing here and people are leery about getting the booster because a number of people felt really lousy for a couple of days after they got the booster. And what that meant was that they also didn't work post booster dose because they're feeling unwell And that added to the shortage. So that's why there's a one month extension of this booster requirement. We're changing the label from fully vaccinated to use the word up to date. And the definition of up to date depends on what the date is. As of today up to date means two doses of the Moderna or fighter plus a booster for fighter. It means one dose of five. Sorry for J. And J. It means one dose of J. And J. Plus either of the M. RNA vaccines as a booster. So be careful when the school district uses the words fully vaccinated because sometimes they only refer to that primary two dose series. There'll also be some further clarification for boosters for kids 12 and up forthcoming. And in the future up to date may actually be a 4th dose. So we have to come back to visit that depending on where the pandemic goes. Question nine. What about quarantine if the patients are fully vaccinated fully vaccinated? As I just said, now is two doses plus a booster. If they're eligible for the booster, they do not need to be quarantined if they're fully vaccinated. So you have a kid who's been exposed to a sibling at home who has covid, The older child has had their vaccine series. They do not need to quarantine at home. That means they can go right back to school. Um They may get covid but there are 2 to 4 times less likely to get covid and they're far less likely to require hospitalization or die because they've been immunized. They should get tested on day five after the most recent exposure. They should always be wearing a well fitting mask for those 10 days, especially indoors. And the same thing applies if they develop symptoms, stay home test or isolate for 10 days. I've had questions from practitioners about clinic and about office. Can the patient who has recovered from covid come back into the clinic and how many days must go by before they can come in for a routine appointment. The recovery that we, how we label recovery referring to a diminishment diminution in viral shedding is generally 10 days. A normal host after 10 days can come back into the office if it's for other routine stuff, An immunocompromised host, the shedding can be more prolonged and so the recommendation is 20 days. But if a patient is sick and needs acute care, you have to figure out how to take care of that patient. We don't want to neglect them and let them sit at home and get worse and worse. So they either have to have a way to safely come into the office or they should be referred to the emergency room for evaluation if they're still in that 10-20 day period, depending on whether they're normal or immunocompromised. Otherwise you can defer the visits until after day 10 or day 20 and they'll be safe to come into the office without putting people at risk. But the caution with all of this is that even if the kid is the one who was tested and you know, is recovered, you don't know whether the parents have had it and those parents maybe in their quarantine period after an exposure and you don't want them to be coming in either infectious or wild quarantined if they don't need to. So that's one of the other caveats to ask the questions of the people who accompany Children as well Question 11, what can we do for very complicated patients who require? A lot of other subspecialty services, especially kids who have chronic lung disease or oxygen or obese diabetics, kids on chemotherapy. What can we do with regard to preventive and therapeutic monoclonal antibody infusions or injections And these patients may be eligible but it's hard to access the medications because the supply is very short. The whole state of California. Got 6000 doses for a population of what is it? 30 million. So it's not very much drug made available. The CDC advisory. And I put in the if you type in C. D. C. H A. N. And double double zero for 61 you'll get the details about how we decide which patients might benefit from these meds. I also strongly suggest that you look at the grand rounds from two days ago because this is exactly what probably spent an hour talking about and I'm given maybe two minutes to talk about it with this question. I did include some of her slides in a minute and I'll show you some of those. And what can we do with regard to kids and these preventive therapies. There are some treatments that were available for ambulatory patients in the past. The earliest monoclonal that was released is called Regeneron but it doesn't work against a microphone So we can't use Regeneron when we have 91% of California cases due to a microphone and 99% nationwide. The alternative is another monoclonal antibody called So troma bob Bob and it's effective but it's also in short supply and it's only approved for kids over 12 years old and over 40 kg. So there is nothing for the younger kids among these. There's also a medication called Abu Shelled, which is the only drug that's approved for prophylaxis for those high risk patients who cannot get vaccine because of their own health problems or who aren't expected to make antibody in response to vaccines. And every shelled also is low supply. It's an injected drug will come back to that in a minute and we at the hospital are trying to set up an infusion clinic that dr Singh will oversee in such a way that every patient who might benefit would have to be referred through DR Singh to get approval. And part of that is that everybody thinks their patient is special, but some are more special than others, meaning higher risk and greatest risk. And so we needed to set up a tier system just as they did initially about vaccines, who should be the first ones to get vaccines. It's the frontline workers. Similarly for patients, there's a tier system to decide which ones are at highest risk and would benefit the most. The added challenge is that if we infuse medications in the hospital setting and we bring in patients who are at high risk or especially when it comes to treatment, ones who've been exposed or are in early a stage of treatment. We need to have a safe place to put them and we don't have such a safe place that's ready to go. We have an infusion center But it's a big open room with 15 beds with no barriers between the patients. And we can't bring covid infected patients into that space to get monoclonal antibodies. And we I don't want to bring the highest risk patients into those shared spaces. So what we're working on is using to intensive care unit rooms as you saw on the um artwork at the beginning that we are very proud to have a new intensive care unit in Oakland. And right now we have more rooms available than we need to fill. So we're setting aside a few of those as an infusion center for outpatient infusions. Just need to work on getting a nurse to fill that role. What about antiviral medications? Not the monoclonal antibodies but others. There are two drugs that are approved under emergency use authorization. Again, this is an FDA category that says you're not free to use these in whatever way you want. You can only use these if you meet these very specific criteria. One of them is called packs loaded. It's a mixture of two drugs. None of us can pronounce the first one, the N. I. R. One, but right on a beer is a drug I've been using for years in my HIV infected population for 25 years. It's an these are oral drugs. The newer matt trail veer is two pills twice a day. The retina. Beer is one pill twice a day and they're taken for five days. A nice idea. But and available for outpatients with mild to moderate covid, they're much more effective than the mall new pair of ear, which is the alternative. And that's an intravenous medication because they're much more effective there Um higher level of indication to use them. But like everything else, they're not approved for under 12 or under 40 kg. And because of the rotunda beer, there are many, many drug interactions that make it exceedingly difficult to give to kids who have chronic medical problems and are on a variety of meds. Um So there's a pharmacy supply issue. These drugs are released by the federal government, to the states, by the states, to the counties and by the counties to a few limited number of pharmacies um for the patients who can't tolerate packs loaded because of those drug drug interactions. Multiplier if there is an alternative And again nothing approved for kids under 12. So this is referring to the risk stratification. The highest risk are the ones listed on the top Orange section, obesity, greater than 95th%ile medical complexity, severe immuno compromised patients in the middle group are chronic respiratory congenital heart, mild to moderate immuno compromised and sickle cell and in the lower group diabetes mellitus and chronic kidney disease. So this stratification is going to be used to help select the patients who would most benefit from these aggressive treatments. And again there's a reminder at the top of what an EU A. Is. Um There are inclusion criteria and the patients have to meet all three inclusion criteria and neither of the exclusion criteria to qualify for getting the meds that are available under Eu A. You can read them, I won't read them aloud. This has to do with the federal allocation and this one medication to the Petrova Mob is a monoclonal antibody given intravenously the entire state 6000 doses every shell the prophylactic Uh intra muscular agent. Again only 8000 doses for the whole state packs loaded 9000 in the in the week. That is in this week. Multiplier Ville 38,000 but again not as good as packs loaded except for patients who have too many drug interactions and won't tolerate it. I don't expect you to remember all of that. But um these are challenges because the drugs keep changing and the approvals keep changing. There is a website that you can see here protect dash public dot health and human services HHS dot gov And you can put in an area code and it will tell you where those meds are available in this geographic area at Children's. We have different workflows on the two sides of the bay. The resource allocation is different. We are in Alameda County. The main campus in Mission Bay is in SAn Francisco city and County. There are different supplies and there's different licenses on the two sides of the bay. We're using the same risk stratification. Um and we can get patients from either side of the bay into the other side's infusion clinic. Once we get it up and running and I refer you again to the monoclonal antibody guides. There are a lot of ways that we can share this information. So of these treatments that have been available for treating covid since the beginning of the pandemic. On the top left are the three vaccines. That's the best for the uninfected people get them immunized. The bottom left is the tick Sagdiyev, a mob, blah blah blah blah. That's every shelled. That's the preventive medication. Um And again that's an intra muscular injection. For those who can't take or tolerate vaccines with the big red. Uh no signs are Regeneron and something that was referred to as bam EDI. The first monoclonal antibody combo. Neither of those are to be used now because neither of them works for all Macron only the ones at the top and the Petrova mob at the bottom. And on the far right side are the immuno modulators that can be used once. People are sick enough to be in the hospital and are more than five or seven days into their illness. They do not get the other drugs but they can benefit because of the severe inflammatory response from immune modulators like decks and methadone. Parasitic nib and and tussle is a mob. I didn't mention remdesivir yet. It's one that is used as an in the outpatient setting for people with mild to moderate disease for three days and in the hospital for five days for patients who were admitted early in the course of their illness with severe enough disease to require hospitalization. So this is sort of the layout of what treatments we're dealing with right now. Just a couple of diagrams that show you that the monoclonal antibodies like Sinatra, the mob worked to prevent the virus from entering the cells. Protease inhibitors um like the packs loaded worked to prevent the long chains of protein from being cut into short chains and there are viral RNA dependent RNA inhibitors and that's where mullen appear beer and remdesivir fit. These are mouthful of drugs. I wish somebody would find an easier way to name them. Most importantly with regard to treatment time is of the essence and as you see in the on the right passive immunity and antivirals are beneficial only if used early but because that's when viral replication is happening once the virus has replicated and the host response starts kicking in. That's when immuno modulators become more effective and you can see that the number of SARS cov um copies is highest between the by the second to third day. Um, and in Children there in red. So second to third day is the highest amount of virus. And by the time you get to day six or seven you're down below the million mark which is the cut off that they were using here and beyond that time, you're not likely to detect it by antigen testing. So we're really concerned about the 1st 5-7 days after um onset. Um Just a reminder that we are dependent on clinical trials to give us the guidelines about what we should be doing and why we should be using these drugs on the left. You see that for these drugs were used in outpatients With symptoms less than five days. Remdesivir with less than seven days who have high risk comorbidities have not been vaccinated. And all these studies were done before um Akram became available and the injectable trials were even done before Delta started which was in october so september october So once enrolled patients are randomized to either active treatment or placebo. The primary outcomes or hospitalization and death and the secondary our death symptoms and viral load. So this this is a comparison of the drugs that are available now that we've been talking about. Um N. N. T. Is the number needed to treat and in pediatrics. This is data from adults in pediatrics, we know that the risk of getting really sick or hospitalized or dying is far lower than adults. So the number needed to treat to get a benefit from any of these drugs is going to be far higher than the numbers that are in bold black hospitalization or death. As you see, pardon me, is dramatically improved. And Um with packs loaded from .8 Percent to 6.3% of patients needing hospitalization or death with the placebo Similarly, so Trofimov 1% hospitalization or death versus 7% with placebo. And across the board. Um there are some pros for each drug. There wasn't much more mortality in the studies that were done. So that's harder to assess. But the pros of packs a lot of it is that it's oral. Petrova mob is a single infusion of remdesivir is available. It's one of the few that we can get relatively readily and more. All new pair of ear um is an oral agent which is a nice huh? I don't think it's oral. That's a mistake. That's a typo I think it's a typo. And the cons with Paxil of it are the drug drug interactions. The ones that require infusions are more of a challenge because you have to find a way a place and staffing to do the infusions. Um Again, going back to the oral one packs loaded. It shows you where it's working. Again, it's a pretty ace inhibitor. So I'm gonna just stop with that because otherwise the diagram is beautiful but not that helpful. Um this was a double blind study. They were randomized 12 drugs for everyone on placebo. They looked um they enrolled everyone within five days. They had to have some risk factor and they reduced hospitalization and death by 88% compared to placebo. That's a very strong um ah advocacy of the use of this drug. Um We think it will be active against omicron as far as we know it is. But look at the drug drug interactions, every possible category of drugs you could imagine pax love it is a troublemaker. So it's very difficult to find the patients for whom this would be a good choice especially given that they will have high risk conditions that usually are associated with treatment. Um Anybody can prescribe it so you don't need to call us to prescribe it, you can contact your local pharmacy that has it. Um The medications are the two tablets of the end drug with one of ritonavir twice a day for five days. There's a drug interaction guideline. You can plug in the name of the drug the kid is getting and it'll tell you whether or not packs loaded will interfere with the drug levels of that drug or whether those drugs will interfere with the levels of pax Slovin Remdesivir. The study was called Pine Tree and when they're looking at it and little kids they're calling it baby Pine Tree. But the pine trees study was also placebo controlled 87% reduction in risk, No difference in the viral loads. Um and just this week they expanded the EU. For outpatients that allows for kids under 12 and anybody from 3.5 kg and up. So Remdesivir will be more used in pediatrics just because it's one of the few available for Children and so trove. A mob. Um It's an injectable drug 85%. Relative risk reduction can be should be given within the first week. Very few infusion reactions and no drug drug interactions. So relatively safe. Small new pair of ear is the not so good one that only has a risk reduction of 30%. And we're really not advocating for its use also not approved in any pediatric age group and in pregnancy. Multiplier. Beer in particular shouldn't be used. Um Leave it at that. The rest is shared decision making. When you look at overview of these drugs. Um You know, I think I already included this. I'm gonna skip it renal adjustment for some of them required but for most no adjustment necessary. So how does it all come together? Sex. Love. It works well it's convenient because it's oral but the drug drug interactions are a big downer and there are possibly some fertility issues but not as bad as with multiple review. So trophy mab efficacy good. Not so convenient because you have to do an injection drug drug interactions not so much and fertility concerns similarly. Remdesivir good efficacy but not convenient because it has to be given as three daily infusions for the less severe cases and five daily infusions for the more severe. There are some drug interactions and multiply revere again, not as efficacious. So not very help. So there's one therapeutic which has an adequate supply, has no risk stratification and is effective against covid 19. Covid 19. What is that vaccine vaccine vaccine? Well, look at what's happened in California In the 5 to 11 year age group. Each bar reflects the total pediatric population, 68% have not yet been vaccinated. And yet the vaccine is approved in ages five and up In the 12-17, 64% have been. But the flip side right? 36% have not been immunized. So that's what we should be focusing on. Get this patient population vaccinated similarly for the young adults, we still have 15% of young adults who have not yet been immunized. There's a racial discrepancy with some of these, but it's not as bad as one might have thought. for example, Latinos. 30 account for 30 of the Well, let's see, did I do this. Right? Mm hmm. The the blue bar is the percent of population. And the the, sorry, the blue vertical line Is the percent of of population that is Latino. So you can see that 30% of Latinos uh, vaccine has been administered To a population that includes 30% Latino and they account for about 40, or 40% of the population Similarly whites 33.6% of population and maybe 36% or 37% of California's population. In contrast to african americans, um, are 16% of the population and a higher percent vaccinated. Which isn't, sorry, I'm looking at the asian american african americans. The proportion of the population is roughly proportionate to those who are vaccinated. So, um, you know, it varies, it's not as bad as we thought it might be. What about which vaccine on the left? You see Fizer vaccine two doses and you see what happens over a six month period. The vaccine responds as measured by effectiveness against delta, which is the dark box is about 60% after after 25 weeks With a micron, it's more like 10%. So it's much, much less efficacious six months later. But if you give a booster which is the middle section, you'll see, I don't know if you can see with my arrow, but I'll put here, you can see that you do get a significant bump. If you've given a booster for the fighter vaccine with a fighter vaccine, but that also drops over the subsequent 10 weeks. Um, for Delta, you get a better response and you have more protection. But the problem is we're dealing with a micron, not with Delta. And if you give this same population, the fighter population who got two doses here a Moderna booster, you actually push it way up there. So it may be that there's an argument for flipping from one to the other. But the biggest argument is get a booster regardless of what you do. Just don't sit at home without a booster. So summary Children have less risk for progression to severe covid. We have this risk stratification for patients at risk for severe disease and we have scarce resources. So we need to think carefully about how to use them and the vaccines are safe and effective to prevent severe covid. I have a few more questions. Um, and I have only about 10 minutes. So I'm gonna just tell you that the american Academy of Pediatrics when you just google help me interpret PcR versus antigen tests. They have three really nice little tables that look like this. The first one walks you through symptomatic patients, You've done a pcR test, it's positive, they're infected. It's negative. But you have a known exposure. They're not infected if if it's negative and there's a known exposure. Yes. Then they have no current evidence of Covid but there's still people who you might have to worry about because they aren't infected yet. So they may need further testing antigen tests. Similarly, it breaks it down based on test positivity whether you've done a PcR to confirm and whether there's a known exposure. And as I said, there are three slides like this. This is the symptomatic person, this is someone who's had a close contact. And again with all of these a positive tests should make you highly suspicious if there's a known contact especially and if they're symptomatic. Absolutely. And the 3rd group is an asymptomatic group. If they're pcR positive, they're infected. If their antigen positive but they're not symptomatic then you have to sort of think about whether you want to do a pcR because it may pick up those whose antigen is already a bit negative. Question 14, simple answer with the at home kits. Can you test kids under age two or should they come in for pcr? I found the answer on the CDC website. The guidance applies to all Um consumer uses of antigen tests includes all age groups. So the home kits are not restricted under age two question 15. Once you're positive, how soon can you get a vaccine? Once you're out of isolation you can get the vaccine. Do not delay. It's not different for kids or adults. Um and finally, um there are some studies validating the accuracy of home tests mostly on been X. But there's no reason I could find that tells you that one home antigen test is better than another. All of the data that I find including this one which was on the CDC website. They all just combine them all as antigen. It's not it doesn't matter which one and then this was the phone question that we got. Um you've had a phone visit with the family there, you know that the kid has tested positive but you're hearing the engine start and you know the families driving somewhere, How do you handle a family like that? To tell them to stop traveling and stay at home. So I came up with some, you know, not anything different than you would. I need to remind you that families with Covid should stay at home in isolation. You shouldn't be traveling anywhere until your child's isolation is over and others in the family are out of quarantine and you need to protect your family, friends and our community, help us get through this pandemic without making it worse question. There were so many questions that came at the end of the day yesterday, worried about vaccines for little ones. I'll just tell you that we are going to have a vaccine study open here. We're in the process of negotiating with Fizer. It'll be for kids six months to five years. Uh and it will be run through our primary care clinic but it might physically be in the infectious disease clinic in the rooms behind me and we will be looking for kids from our clinics as well as referred from the community. Um it's a blinded placebo controlled study. So two kids will get vaccine for everyone who gets placebo requires a few blood draws, requires careful monitoring. We'll tell you more As soon as we have approval to move forward, Dr Singh came up with these seven or eight more unanswered questions. Not because she didn't have time to answer them, but because we don't have answers yet. So stay tuned. There will have to be more of these talks in the future, I added on the bottom of this helpful link. If you look up Children's Hospital of philadelphia vaccine, Q. And A. They came up with a new one just recently. It's in english and spanish. It's excellent. It's a little bit more sophisticated than many of our patients will be able to read. But it's got great answers for you. The providers. Um and with that, I'll stop and open it up for a few questions. Mm hmm.
