SCCM Resource Library-Surviving Sepsis Campaign COVID-19 Guidelines Therapeutics Update

Video Transcription

Hello everyone, it's a great pleasure to be here today and share with you the updated surviving sepsis campaign COVID-19 guidelines. These are our disclosures.  So three of us, myself, Dr. Laura Evans and Andrew Rhodes, we all have just academic conflict of interest, no financial conflict of interest to declare.  I would like to start by thanking our fantastic panel. We had over 50 experts from around the world with different areas of expertise, complementing each other.  So it's a great privilege to be presenting the recommendations on their behalf. I would like to spend a few minutes talking about the methodology of developing these  recommendations. As we all know with any research project, the results is as good as its methodology.  We followed the GRADE approach and we followed an efficient but rigorous methodology for developing these recommendations.  For each of those recommendations, we started by formulating a question in a PICO format, population intervention control and outcomes, you're going to see in a few slides, and then  followed by frequent literature searches. So the searches were ongoing, we had a systematic review team screening the literatures on an ongoing basis.  And given the high load of literature available in the COVID era, most of the questions had pre-existing or published systematic reviews, but there are a few questions also in which  individual studies were available. So in cases where individual studies are available, we conducted our own meta-analyses, however,  if a high quality systematic review was published, there was no reason for us to reinvent the wheel, so we used the results of the systematic review and proceeded.  The next step was to assess how confident we are about the results, or in another word, assessing the quality of evidence.  And the new thing that we used in this update of the guideline is what we call the evidence to decision framework, which is a framework that allows us to move from the evidence to  the recommendation, utilizing several, or by examining several domains, like the importance  of the question, the balance between benefit and harm, the values and preferences of patients, cost and resources, feasibility, accessibility, and equity.  So it's a rigorous process that the whole panel participated in, we were able to do this electronically.  The panel debated those domains and issued preliminary recommendations in which everybody had the opportunity to review and contribute to its formulation.  And the writing process took place and submission to the journal, but also the process would include, it's a continuous process in a form of, call it living guideline that requires  frequent updates. So once new evidence emerges that requires a recommendation to change, then the panel  will convene again and review the evidence and decide whether the recommendation or strength of the evidence will change accordingly.  We also used a very strict conflict of interest to management policies, so any direct financial or industry-related conflict of interest were not permitted in this guideline.  We also tried to minimize the impact of intellectual conflict of interest. And we defined that as authors playing a major role in leading clinical trials related to  specific recommendations. Obviously in the COVID era and having the expert panel, almost everybody participated  somehow in clinical trials in order to fight this pandemic, however, so it's a balance between completely excluding experts versus including them and allowing them to participate  in the discussion. But when it comes to the recommendation, they were not allowed to vote on those recommendations.  I would like to spend a few minutes just explaining the language behind the recommendation.  So I'll take this scenario where a desirable consequences clearly outweighs the undesirable consequences.  And in that scenario, a strong recommendation for the intervention will be issued. We'll compare that to a scenario where the desirable consequences slightly outweighs the  undesirable consequences or probably outweighs the undesirable consequences of this intervention,  then we really cannot tell people you absolutely have to use this intervention, so instead we'll issue a weak recommendation.  And there are implications for the strength of the recommendation that we're going to discuss in the next few slides. So the implications for patients.  A strong recommendation means that most individuals in this situation would want the recommended course of action and only the minority would not.  As opposed to the scenario where a weak recommendation is issued, although a majority of patients would still go for the intervention, many would say no, thank you.  So the distinction between the desirable and undesirable consequences is absolutely important at the patient level.  Similarly for clinicians, a strong recommendation means you must do or must avoid and you have to think twice before not following the recommendation.  And most likely there is no need for decision aids to explain the pros and cons to patient as opposed to a weak recommendation where different choices are likely to be made by  different patients and it will be subject to families or patients' values or preferences. And at the policymaker's level, a strong recommendation means that these recommendations  can be implemented as policies, while with a weak recommendation, the policies were likely to be variable across institutions. So what has changed?  The original guideline sections focused on testing and infection control, hemodynamics, ventilation, and therapy.  In this update, we present nine recommendations that are focused on the therapy section where most of the evidence have evolved.  Three of those recommendations are new and six are updates of previous outdated recommendations.  We also used to try to harmonize the language with that of the WHO in terms of case severity definition.  In the previous iteration of the guideline, there was no case definition available. So we stick to the ARDS definition for those with severe respiratory failure and critically  ill patients in general. So now we're more specific and we believe that by following the WHO definition, at least  people will, or readers or users of the guideline will be used to these terminology and hopefully it will facilitate implementation.  So as we all know, for severe COVID-19, it was defined as presence of clinical signs of pneumonia with one of the following, tachypnea or severe respiratory distress or hypoxia  and room air, while critical COVID represent the presence of ARDS or respiratory failure that requires ventilation, sepsis, or septic shock.  The first question that we addressed was related to awake proning. As you're familiar with, it's widely adopted in practice.  And given that this is a priority and a hot topic, especially in social media and also in published reports, the panel thought that this is an important question to address.  So that's a new question. And in this question, we looked at, as you can see, divided the PICO components in the population.  We're looking at severe COVID-19, so those who are not intubated yet, and the intervention is awake proning versus no awake proning, and we focused on certain important outcomes  for patients. When we looked up the literature and we found a systematic review that summarized what's  available, whether it's related to COVID-19 or hypoxic respiratory failure in general, and that report, there wasn't a single randomized controlled trial on this topic.  And I would say the overwhelming majority of the studies were mostly case series or single arm cohort studies. So you can imagine that the quality of evidence at best was very low.  Not only that, but the impact on patient important outcomes like intubation and need for mechanical ventilation, impact on death was unclear as there was no control arm, so  we really could not have any estimates to look at. Those studies reported adverse events. Most of them were minor, nothing major, but they included discomfort, nosebleed, some  pain, and a lot of patients were intolerant to awake proning. So again, this may add to the burden of patients.  Also, we could not find any studies on the burden to health care workers, although most patients with mild disease would be able to prone themselves.  Some might require the assistant of health care workers to go into the room and help assist frail or old patients to prone, but this is completely not looked at in the literature.  We did find that most studies reported improvement in oxygenation. Most of them were, this improvement was transient.  So after the patients in supine position, the improvement in oxygenation is gone except a few reports. And again, our confidence in these estimates were very low.  The panel debated the evidence and after extensive discussion, they thought that the current  evidence is insufficient to issue a recommendation for or against awake proning in non-intubated adults with severe COVID-19.  Also knowing that there are several randomized trials in the work, we're hoping to update this recommendation or have some recommendation for clinicians when RCTs are published.  And we believe that those statements are important and they send the message that this area is  still a gray area and we really need to follow evidence-based medicine in clinical practice. So we think that this statement is helpful to highlight that the evidence is unclear  when it comes to awake proning. Next question was addressing the corticosteroids. And again, we focused on both severe and critical COVID-19.  And the intervention was mainly systemic corticosteroids versus no corticosteroids. And the two outcomes were death and adverse events.  We're all probably familiar with the WHO meta-analysis that includes summarize the body of evidence.  And as you can see in this nice force plot that was published in JAMA, it seems that corticosteroids, particularly dexamethasone, results in closer to 36% relative risk reduction  in 28 days mortality. And you can see the point estimates for all the other corticosteroids are also in favor of corticosteroids.  A pooled estimate also suggests a 30% relative risk reduction risk of death. When we grade the evidence, we're talking about moderate to high quality evidence for  those who are basically mechanically ventilated. Again, the effect size was quite large. We're talking about 9% reduction risk of death.  For those who are critically ill in general, closer to 10% absolute reduction in death. When you look at especially for dexamethasone, the treatment effect was larger than what  has been seen in other steroids. But remember, there are no head-to-head trials comparing dexamethasone to hydrocortisone or to methylprednisone.  So the panel, after debating the evidence and going through the evidence to decision framework, which we don't have time to go through, issued a strong recommendation favoring  the use of systemic corticosteroids in patients with severe or critical COVID-19 over not using corticosteroids.  And also issued another recommendation, which is a weak, so it's worded in the form of we suggest. The panel suggested using dexamethasone over other corticosteroids.  What's unique about dexamethasone as well, that it's on the list of essential medications of the WHO. So it should be widely available.  But in situations where dexamethasone is not available and clinicians can use other steroids  and our best guess is to use equivalent doses to that that have been used in the recovery trial. So six milligrams daily for up to 10 days.  That's the best available evidence at the moment. It's unclear if higher dosing or lower dosing is more or less beneficial.  It's unclear if this is a class effect, which is most likely the case, or it's a corticosteroid specific effect.  The next question or recommendation focused on the use of hydroxychloroquine. As we all know, initial observational studies and the media focused on hydroxychloroquine  as the magic treatment for COVID-19. There was a lot of pressure to address this question in the first iteration of the guideline.  At that time, there was no randomized controlled trials on the topic. The body of evidence were based on observational studies of poor quality and subject to high risk of bias.  Therefore, we did not issue a recommendation at that time for or against the use of hydroxychloroquine in this population.  Since then, several randomized controlled trials have been published and the panel decided to readdress the question to see if there is any, if we can come up with a recommendation.  To remind folks who haven't read the previous guideline, our question also, again, addressing the same population of adults with severe or critical COVID-19, the intervention is  hydroxychloroquine at any dose for any duration. The comparator is no hydroxychloroquine or placebo. We did look at a bunch of critical outcomes.  There are several meta-analyses now published, but during the recommendation formulation, we had to do our own meta-analysis.  As you can see, most of the, in this forest plot, most of the evidence is driven by the recovery trial that showed that the point estimate, in fact, is closer to one.  Maybe the overall point estimate is actually in favor of not using hydroxychloroquine and the lower limit of confidence interval barely touches the line of no effect.  So if anything, it doesn't show a difference, but also potential harm by increasing risk of death cannot be excluded. We also looked at adverse events.  And again, in this meta-analysis, you can see at least 2.6 fold increase in risk of adverse events if hydroxychloroquine is used.  And we graded the evidence based on the available studies at that time, knowing that there are now several RCTs and several other studies confirming and with consistent messaging.  So we did not have to update the evidence table for this presentation, but it will be updated in the future publications for sure.  For the mortality outcome at 28 days, again, moderate quality of evidence, as we discussed, showing no difference in possible harm.  Even when looking at severity of illness as a subgroup, for those who are invasively mechanically ventilated, again, similar results have been observed with hydroxychloroquine.  And there was no difference in progression of illness, although the confidence interval was extremely wide, and there was at least low quality evidence  suggesting increase in risk of adverse events. When the panel debated the evidence, they looked at other factors, including equity, the feasibility, the cost and resources,  and they came up with a recommendation, a strong recommendation, in fact, against using hydroxychloroquine in patient with severe or critical COVID-19.  Thanks so much, Waleed. Really appreciate that. Hi, everyone. My name is Laura Evans. I'm one of the co-chairs of the Surviving Sepsis Campaign COVID-19 Guideline,  and I have the privilege of presenting kind of the next batch or next section of recommendations that we issued for this updated version of the guidelines.  I do wanna acknowledge, of course, the contributions of Andy Rhodes in this process. Unfortunately, the pandemic situation in London is such that Andy wasn't able to join us  for the recording of this session, and so we miss you, Andy. Wish you were here and able to present this with us, but thanks for everything that you're doing.  So I'm gonna move right into the next piece, which is about a question about convalescent plasma. So a PICO question that we developed for this  was for adults with severe or critical COVID-19, should we recommend using convalescent plasma versus not using convalescent plasma? And we looked predominantly at two outcomes  in this question, which is mortality and adverse events.  So when we looked at this, there were four randomized trials that we looked at for this. Two of them were published at the time of this guideline,  and two of them were available as preprints only, but with full data available for us to analyze.  And you can see from here, looking at the mortality at hospital discharge or 28-day mortality, that the point estimate was a relative risk of 0.77,  but it had very wide confidence intervals, which spanned one from 0.48 to 1.24. So low quality of evidence, lots of uncertainty as to the effect of convalescent plasma  in adults with severe or critical COVID-19.  So after a lot of discussion, the panel issued a recommendation that says, for adults with severe or critical COVID-19, we suggest against the use of convalescent plasma  outside of clinical trials. That's a weak recommendation, so a suggestion based on low quality of evidence. The overwhelming majority of the panel agreed with this recommendation.  However, a significant minority thought that we should issue no recommendation due to insufficient evidence.  So with that, I'm gonna bring into some of the recommendations that perhaps are slightly more controversial around this update. And I just wanna refresh everybody's memory.  Waleed went over this in the first part of the session, but a refresher in terms of the guideline scope and definition. So when we're talking about severe COVID-19,  we're using a definition very similar to the WHO definition of severe COVID-19 is clinical signs of pneumonia, so fever, cough, dyspnea, breathing fast, and one of the following,  a respiratory rate greater than 30, severe respiratory distress, or an oxygenate, poltox less than 90% on room air. And critical COVID-19, and it was defined as the presence of ARDS  or respiratory failure requiring ventilation, sepsis or septic shock. And this is pertinent because for the remdesivir recommendation that's coming up,  as you'll see, we split this into two different populations with different recommendations for based on severity of illness.  So the first piece we'll tackle here is about the use of remdesivir in severe COVID-19. And that's about should we use it or versus not using it,  again, looking predominantly at mortality and adverse events.  So when we break this down in severe COVID-19, we looked at mortality at 28 days, looking at three randomized trials,  and found a risk estimate of death for those who received remdesivir versus those who did not of relative risk of 0.8 with a confidence interval that spans 0.63 to 1.01.  So very close to one, just slightly across one for mortality benefit in severe disease with the use of remdesivir. There was also signal of improvement  in time to clinical improvement and time to clinical recovery for studies that measure that. So two of the three studies looked at time to clinical improvement,  one looked at time to clinical recovery. And there was signal of benefit in severe disease with remdesivir in that.  So we issued a suggestion of conditional recommendation for adults with severe COVID-19 who do not require mechanical ventilation. We suggest using remdesivir over not using it.  That's a weak recommendation based on moderate quality of evidence. And we add an important remark here at the bottom, which is that remdesivir should ideally be started  within 72 hours of a positive PCR or antigen testing for SARS-CoV-2.  There were a lot of considerations that went into this  recommendation, and I'll just summarize them by saying that the panel's opinion was that remdesivir in severe COVID-19 seems to have moderate benefit,  again, evidenced by some suggestion of mortality benefit, although the confidence interval in our meta-analysis did span one. There's no clear evidence of harm.  There's low to moderate quality of evidence overall. The costs were judged to be large. There was an unclear effect on equity in terms of access to this medication.  And there was variability regarding availability of the drug, particularly  within different countries of the world.  When we looked at the population with remdesivir with critical COVID-19, so same PICO question just changed the population from severe COVID-19 to critical COVID-19,  looking at mortality and adverse events. Same evidence profile you'll see here, the same three clinical trials, but again, with a different population here.  So when we looked at mortality at 28 days, we saw relative risk for those who received remdesivir of 1.16 compared to those who did not receive remdesivir.  Again, they had broad confidence intervals that do span one from 0.85 to 1.60.  There was some signal of potential time to clinical improvement within that, and no significant adverse effects to report from this. So after a lot of discussion,  we issued a recommendation that for adults undergoing mechanical ventilation for critical COVID-19, we suggest against starting intravenous remdesivir. That's a weak recommendation  based on low quality of evidence.  Again, it's worth noting that the vast majority of the panel agreed with this recommendation. However, one member preferred to issue a neutral recommendation to say,  we could use to, neutral recommendation would be, we make no recommendation for or against the use of remdesivir in this population.  The considerations that went into this recommendation were that our judgments were that there was no clear benefit of remdesivir in critically ill patients with COVID-19.  There was, however, important to note, no clear harm. We judged the quality of evidence around that to be low to moderate. Again, the cost to be large, unclear effects on equity,  and there was variability regarding the availability of the drug.  I do think it's worth noting  that there are other clinical practice guidelines out there obviously about COVID-19 management and the remdesivir recommendations in the Surviving Sepsis Campaign recommendations,  the WHO recommendations and the NIH guideline recommendations all read slightly differently. And I think it's just worth talking about the nuances around them.  And I tried to be very clear in the previous slides about the judgments that our panel made in arriving at the recommendations that we issued.  So on the left-hand part of the screen here is the infographic from the WHO Rapid Update Guideline. From that, again, you can see the reference at the bottom.  It was published in the BMJ. And they make a recommendation, a weak recommendation or a conditional recommendation against the use of remdesivir  in all categories of disease severity, whether that be not severe, severe, or critical COVID.  In contrast to that, the NIH guidelines  defined these disease severities slightly differently from that. And so when you look at the population of hospitalized patients who require supplemental oxygen,  but who are not on high flow, not on non-invasive ventilation, not invasively mechanically ventilated and not on ECMO,  then the NIH recommendation is a moderate strength recommendation to use remdesivir.  And then a moderate strength recommendation  based on expert opinion to use a combination of dexamethasone plus remdesivir potentially.  The NIH goes on to say that in hospitalized patients who require high flow oxygen or non-invasive ventilation, that dexamethasone is highly recommended,  an A1 recommendation by the NIH grading scale, and the combination dexamethasone plus remdesivir is a moderate recommendation based on expert opinion.  So those three guidelines do have slightly different recommendations. And it probably, the basis beyond that is probably a slightly different judgments by the different panels  as to some of the considerations that go into behind us. And again, I tried to explain the considerations that went into the surviving sepsis recommendations around this.  That leads me to the next section, which is about venous thromboembolic disease prophylaxis. So we had a PICO question. I think the topic of anticoagulation in COVID  has obviously been a very provocative one with a lot of clinical uncertainty around it. So we developed a PICO question around should we be using VTE prophylaxis  versus not using prophylaxis? And I think most of you will probably not be surprised to know that we issued a recommendation around the use of venous thromboembolic prophylaxis.  The outcomes of interest were in VTE, pulmonary embolism, bleeding, and mortality.  Permanently, there are no, all of this is indirect evidence from other studies of critically ill patients. There was no direct evidence in COVID-19 around use of VTE prophylaxis  compared to not using VTE prophylaxis. Nonetheless, the data is pretty interesting. And I think many of you will already be familiar with this that shows that VTE prophylaxis  in other critically ill populations reduces the risk of DVT. It reduces the risk of pulmonary embolism.  So we issued a strong recommendation about using pharmacologic venous thromboembolic prophylaxis over not using prophylaxis. And that's a strong recommendation  based on moderate quality of evidence, again, with the caveats that it was based on indirect evidence from other critically ill populations.  There has been an enormous level of interest in terms of coagulation disorders associated with COVID-19 and what, if any, role the use of  therapeutic anticoagulation or even intermediate dose anticoagulation may have in the management of patients with COVID-19 who are critically ill, who do not have evidence of VTE.  So we developed a PICO question around that again.  So we're looking at adults with severe or critical COVID-19 who are in the ICU and do not have evidence of active VTE. And the intervention we looked at was empiric anticoagulation.  The comparator was VTE prophylaxis. And the outcomes we were interested in were VTE, PE, bleeding, and mortality.  So at the time of this update, there were three observational studies that we looked at in terms of mortality in mechanically ventilated patients from this.  The effect reported in these observational studies was a significantly lower odds ratio of death with the use of anticoagulation in these patients.  However, the quality of the evidence was deemed to be very low for multiple reasons. And all of this data is available in terms of the evidence ratings  and the evidence to decision is all available in the supplemental materials to this guideline.  As we were going to publication of this guideline, this press release was issued, which I think many of you will already be familiar with,  that the combination of three clinical platform trials that we're using to share protocol together to test anticoagulation in COVID-19 patients without clinical evidence of VTE,  the DSMB decided to stop enrollment  of critically ill COVID-19 patients in these trials.  And so this is just the press release about this DSMB announcement. With paused enrollment for one group of patients among critically ill COVID-19 patients requiring ICU support,  therapeutic anticoagulation drugs did not reduce the need for organ support. Enrollment continues for moderately ill hospitalized COVID-19 patients in trials.  Now, it's important to realize that we haven't seen the data from this yet.  We, along with many others, are eagerly awaiting publication of this data and may issue an updated recommendation based upon that once we have the data.  But incorporating the elements of this press release, incorporating the observational data that we have, we issued a recommendation that says,  for adults with severe or critical COVID-19 and no evidence of VTE, we suggest a weak recommendation against the routine use of therapeutic anticoagulation  outside of clinical trials.  And it's a weak recommendation based on very low quality of evidence.  So I will wrap up here by just showing you two of infographics that summarize many of the critical recommendations from the both first initial publication  of the SSC COVID-19 guidelines, as well as this update. It doesn't incorporate every recommendation, but I think it's a useful tool and image  potentially to use as you're teaching others or even with your own practice at the bedside. So the green checkboxes that say do it reflect strong recommendations.  The red stop sign or do not enter signs reflect strong recommendations against an intervention. And the kind of yellow or amber caution sign reflects a weak recommendation  or conditional recommendation in this phrasing a consideration.  So this is the suggested algorithm based on their summary of recommendations for the initial management of hypoxic COVID-19 patients.  And then we have a similar summary of recommendations on the management of patients with COVID-19 and ARDS with the same kind of color schematic  of a green being a strong recommendation for an intervention, a do not enter being a strong recommendation against an intervention, and the amber caution signs being considerations  or weak recommendations around a intervention. So in the future, this has been a great, I think, effort of SCCM and ESICM and the Surviving Sepsis Campaign  to produce guidelines that are a living guideline. And so we are going to have future updates to these guidelines as other data emerges. The two areas where we anticipate  having recommendations probably in the fairly near future will be around anticoagulation. Again, as some of those critical studies become published,  we're eagerly looking forward to that. And around the use of IL-6 antagonists or IL-6 inhibitors in the population of critically ill patients with COVID-19.  So with that, I want to say stop. I want to thank you. I want to stop and really recognize, as Waleed already did, the guidelines panelists for doing a terrific job  and really, we've actually never met in person. This has all occurred virtually, and it's been a terrific effort, I think, by a huge international group  to generate these recommendations.  The methodology support, of course, I think we have a really rigorous methodology for that. I do want to particularly recognize SCCM and ESICM for their support for this effort.  And none of this is possible, of course, without our colleagues at Clinical Care who are taking care of patients in this global pandemic, as well as all of our colleagues  who are engaged in research and investigation, which allows us to produce high-quality guidelines. So thank you again for that. ♪♪

Video Summary

The Surviving Sepsis Campaign has released updated guidelines for the management of COVID-19. The guidelines were developed by a panel of over 50 experts from around the world and provide recommendations for the treatment of severe and critical cases of COVID-19. The guidelines use the GRADE approach and a rigorous methodology for developing recommendations. The panel formulated questions in a PICO format, conducted literature searches, assessed the quality of evidence, and utilized an evidence-to-decision framework to guide their recommendations. The panel addressed several key questions including the use of awake proning, corticosteroids, hydroxychloroquine, remdesivir, and venous thromboembolic prophylaxis. For awake proning, the panel found insufficient evidence to issue a recommendation for or against its use in non-intubated adults with severe COVID-19. For corticosteroids, the panel issued a strong recommendation favoring the use of systemic corticosteroids in severe or critical COVID-19. For hydroxychloroquine, the panel issued a strong recommendation against its use in severe or critical COVID-19. For remdesivir, the panel issued a weak recommendation for its use in severe COVID-19, and a weak recommendation against its use in critical COVID-19. For venous thromboembolic prophylaxis, the panel issued a strong recommendation for its use in severe and critical COVID-19. The guidelines will be updated as new evidence emerges.

Asset Subtitle

Sepsis, Crisis Management, 2021

Asset Caption

The Society of Critical Care Medicine's Critical Care Congress features internationally renowned faculty and content sessions highlighting the most up-to-date, evidence-based developments in critical care medicine. This is a presentation from the 2021 Critical Care Congress held virtually from January 31-February 12, 2021.

Learning Objectives

Describe rapid clinical guidelines methodology and its application to public health emergencies
Apply evolving medical literature to the care of patients with COVID-19
Identify knowledge gaps in the critical care management of patients with COVID-19

Surviving Sepsis Campaign COVID-19 Guidelines Therapeutics Update

Laura E. Evans

Waleed Alhazzani

Meta Tag

Content Type Presentation

Knowledge Area Sepsis

Knowledge Area Crisis Management

Knowledge Level Foundational

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Tag Guidelines

Tag COVID-19

Year 2021

Keywords

Surviving Sepsis Campaign

COVID-19 guidelines

awake proning

corticosteroids

hydroxychloroquine

remdesivir

venous thromboembolic prophylaxis

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