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1.
Clin Infect Dis ; 2022 Feb 26.
Article in English | MEDLINE | ID: covidwho-1886374

ABSTRACT

BACKGROUND: Open-label platform trials and a prospective meta-analysis suggest efficacy of anti-IL-6R therapies in hospitalized patients with COVID-19 receiving corticosteroids. This study evaluated the efficacy and safety of sarilumab, an anti-IL-6R monoclonal antibody, in the treatment of hospitalized patients with COVID-19. METHODS: In this adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial, adults hospitalized with COVID-19 (ClinicalTrials.gov: NCT04315298) received intravenous sarilumab or placebo. The phase 3 primary analysis population included patients with critical COVID-19 receiving mechanical ventilation randomized to sarilumab 400 mg or placebo. The primary outcome was proportion of patients with ≥1-point improvement in clinical status from baseline to day 22. RESULTS: There were 457 and 1365 patients randomized and treated in phases 2 and 3, respectively. In phase 3, patients with critical COVID-19 receiving mechanical ventilation (n = 298; 28.2% on corticosteroids), the proportion with ≥1-point improvement in clinical status (alive, not receiving mechanical ventilation) at day 22 was 43.2% in sarilumab and 35.5% in placebo (risk difference +7.5%; 95% CI, -7.4 to 21.3; P = .3261), a relative risk improvement of 21.7%. In post-hoc analyses pooling phase 2 and 3 critical patients receiving mechanical ventilation, the hazard ratio for death in sarilumab versus placebo was 0.76 (95% CI, .51-1.13) overall and 0.49 (95% CI, .25-.94) in patients receiving corticosteroids at baseline. CONCLUSIONS: This study did not establish the efficacy of sarilumab in hospitalized patients with severe/critical COVID-19. Post-hoc analyses were consistent with other studies that found a benefit of sarilumab in patients receiving corticosteroids.

2.
Critical Care Clinics ; 38(3):i, 2022.
Article in English | ScienceDirect | ID: covidwho-1882659
3.
Am J Crit Care ; 31(4): 283-292, 2022 Jul 01.
Article in English | MEDLINE | ID: covidwho-1835010

ABSTRACT

BACKGROUND: Understanding the distribution of organ failure before and during the COVID-19 pandemic surge can provide a deeper understanding of how the pandemic strained health care systems and affected outcomes. OBJECTIVE: To assess the distribution of organ failure in 3 New York City hospitals during the COVID-19 pandemic. METHODS: A retrospective cohort study of adult admissions across hospitals from February 1, 2020, through May 31, 2020, was conducted. The cohort was stratified into those admitted before March 17, 2020 (prepandemic) and those admitted on or after that date (SARS-CoV-2-positive and non-SARS-CoV-2). Sequential Organ Failure Assessment scores were computed every 2 hours for each admission. RESULTS: A total of 1 794 975 scores were computed for 20 704 admissions. Before and during the pandemic, renal failure was the most common type of organ failure at admission and respiratory failure was the most common type of hospital-onset organ failure. The SARS-CoV-2-positive group showed a 231% increase in respiratory failure compared with the prepandemic group. More than 65% of hospital-onset organ failure in the prepandemic group and 83% of hospital-onset respiratory failure in the SARS-CoV-2-positive group occurred outside intensive care units. The SARS-CoV-2-positive group showed a 341% increase in multiorgan failure compared with the prepandemic group. Compared with the prepandemic and non-SARS-CoV-2 patients, SARS-CoV-2-positive patients had significantly higher mortality for the same admission and maximum organ failure score. CONCLUSION: Most hospital-onset organ failure began outside intensive care units, with a marked increase in multiorgan failure during pandemic surge conditions and greater hospital mortality for the severity of organ failure.


Subject(s)
COVID-19 , Respiratory Insufficiency , Adult , COVID-19/epidemiology , Humans , Pandemics , Respiratory Insufficiency/epidemiology , Retrospective Studies , SARS-CoV-2
4.
AJOB Empir Bioeth ; 13(3): 196-204, 2022.
Article in English | MEDLINE | ID: covidwho-1795422

ABSTRACT

BACKGROUND: Equitable protocols to triage life-saving resources must be specified prior to shortages in order to promote transparency, trust and consistency. How well proposed utilitarian protocols perform to maximize lives saved is unknown. We aimed to estimate the survival rates that would be associated with implementation of the New York State 2015 guidelines for ventilator triage, and to compare them to a first-come-first-served triage method. METHODS: We constructed a simulation model based on a modified version of the New York State 2015 guidelines compared to a first-come-first-served method under various hypothetical ventilator shortages. We included patients with SARs-CoV-2 infection admitted with respiratory failure requiring mechanical ventilation to three acute care hospitals in New York from 3/01/2020 and 5/27/2020. We estimated (1) survival rates, (2) number of excess deaths, (3) number of patients extubated early or not allocated a ventilator due to capacity constraints, (4) survival rates among patients not allocated a ventilator at triage or extubated early due to capacity constraints. RESULTS: 807 patients were included in the study. The simulation model based on a modified New York State policy did not decrease mortality, excess death or exclusion from ventilators compared to the first-come-first-served policy at every ventilator capacity we tested using COVID-19 surge cohort patients. Survival rates were similar at all the survival probabilities estimated. At the lowest ventilator capacity, the modified New York State policy has an estimated survival of 28.5% (CI: 28.4-28.6), compared to 28.1% (CI: 27.7-28.5) for the first-come-first-served policy. CONCLUSIONS: This simulation of a modified New York State guideline-based triage protocol revealed limitations in achieving the utilitarian goals these protocols are designed to fulfill. Quantifying these outcomes can inform a better balance among competing moral aims.

6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-308534

ABSTRACT

Background: Equitable protocols to triage scarce life-saving resources must be specified prior to disasters in order to promote transparency, trust and consistency. The degree to which proposed utilitarian protocols may maximize lives saved is unknown.Methods: We constructed a simulation model based on New York State 2015 guidelines for ventilator triage (NYS) compared to a first-come-first-served (FCFS) method for ventilator allocation under various hypothetical ventilator shortages. We included patients with laboratory confirmed SARs-CoV-2 infection admitted with respiratory failure requiring mechanical ventilation to three acute care hospitals in New York from 3/01/2020 and 5/27/2020. We estimated (1) survival rates, (2) number of excess deaths, (3) number of patients extubated early due to capacity constraints, (4) survival rates among patients not allocated a ventilator at triage or extubated early due to capacity constraints.Findings: 807 patients were included in the study. Survival rates were similar between the NYS and FCFS policies at all the survival probabilities estimated for those triaged to removal of the ventilator. At the lowest ventilator capacity, the NYS policy has an estimated survival of 28.5% (CI: 28.4-28.6), compared to 28.1% (CI: 27.7-28.5) for the FCFS policy. The two policies had similar estimated excess deaths above historical observed deaths.Interpretation: This simulation of a SOFA-based triage protocol for distributing ventilators during the COVID-19 pandemic revealed limitations in achieving the utilitarian goals these protocols are designed to fulfill. Quantifying these outcomes can inform a better balance competing moral aims.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: This study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center IRB (IRB # 2020-12128) and the Columbia University IRB (IRB # AAAT4062).

7.
Disaster Med Public Health Prep ; : 1-11, 2022 Feb 14.
Article in English | MEDLINE | ID: covidwho-1683844

ABSTRACT

OBJECTIVE: To model performance of sequential organ failure assessment (SOFA) score-based ventilator allocation guidelines during the COVID-19 pandemic. METHODS: A retrospective cohort study design was used. Study sites included three New York City hospitals in a single academic medical center. We included a random sample (205) of adult patients intubated (1002) from 3/25/20-4/29/20. Protocol criteria adapted from New York State's 2015 guidelines were applied to determine which patients would have had mechanical ventilation withheld or withdrawn. RESULTS: 117 (57%) patients would have been identified for ventilator withdrawal or withholding, based on the triage guidelines. Of those 117 patients, 28 (24%) survived hospitalization. Overall, 65 (32%) patients survived to discharge. CONCLUSIONS: Triage protocols aim to maximize survival by redirecting ventilators to those most likely to survive. Over half of this sample would have been identified as candidates for ventilator exclusion. Clinical judgment would therefore still be needed in ventilator reallocation, re-introducing bias and moral distress. These data suggest limited utility for SOFA score-based ventilator rationing. This raises the question of whether there is sufficient ethical justification to impose a life-ending decision based on a SOFA scoring method on some patients to offer potential benefit to a modest number of others.

9.
10.
Ann Am Thorac Soc ; 18(4): 623-631, 2021 04.
Article in English | MEDLINE | ID: covidwho-858614

ABSTRACT

Rationale: How to provide advanced respiratory support for coronavirus disease (COVID-19) to maximize population-level survival while optimizing mechanical ventilator access is unknown.Objectives: To evaluate the use of high-flow nasal cannula for COVID-19 on population-level mortality and ventilator availability.Methods: We constructed dynamical (deterministic) simulation models of high-flow nasal cannula and mechanical ventilation use for COVID-19 in the United States. Model parameters were estimated through consensus based on published literature, local data, and experience. We had the following two outcomes: 1) cumulative number of deaths and 2) days without any available ventilators. We assessed the impact of various policies for the use of high-flow nasal cannula (with or without "early intubation") versus a scenario in which high-flow nasal cannula was unavailable.Results: The policy associated with the fewest deaths and the least time without available ventilators combined the use of high-flow nasal cannula for patients not urgently needing ventilators with the use of early mechanical ventilation for these patients when at least 10% of ventilator supply was not in use. At the national level, this strategy resulted in 10,000-40,000 fewer deaths than if high-flow nasal cannula were not available. In addition, with moderate national ventilator capacity (30,000-45,000 ventilators), this strategy led to up to 25 (11.8%) fewer days without available ventilators. For a 250-bed hospital with 100 mechanical ventilators, the availability of 13, 20, or 33 high-flow nasal cannulas prevented 81, 102, and 130 deaths, respectively.Conclusions: The use of high-flow nasal cannula coupled with early mechanical ventilation when supply is sufficient results in fewer deaths and greater ventilator availability.


Subject(s)
COVID-19/mortality , COVID-19/therapy , Cannula , Oxygen Inhalation Therapy/instrumentation , Respiration, Artificial/instrumentation , Adolescent , Adult , Aged , COVID-19/complications , Computer Simulation , Critical Care , Female , Hospital Mortality , Hospitalization , Humans , Male , Middle Aged , Oxygen Inhalation Therapy/statistics & numerical data , Procedures and Techniques Utilization , Respiration, Artificial/statistics & numerical data , Survival Rate , Treatment Outcome , United States , Ventilators, Mechanical , Young Adult
11.
Crit Care Med ; 48(6): e440-e469, 2020 06.
Article in English | MEDLINE | ID: covidwho-685042

ABSTRACT

BACKGROUND: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. METHODS: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. RESULTS: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. CONCLUSION: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.


Subject(s)
Coronavirus Infections/therapy , Intensive Care Units/organization & administration , Pneumonia, Viral/therapy , Practice Guidelines as Topic/standards , Betacoronavirus , COVID-19 , Critical Illness , Diagnostic Techniques and Procedures/standards , Humans , Infection Control/methods , Infection Control/standards , Intensive Care Units/standards , Pandemics , Respiration, Artificial/methods , Respiration, Artificial/standards , SARS-CoV-2 , Shock/therapy
12.
AJOB Empir Bioeth ; 11(3): 148-159, 2020.
Article in English | MEDLINE | ID: covidwho-176144

ABSTRACT

Background: The COVID-19 pandemic has highlighted health care systems' vulnerabilities. Hospitals face increasing risk of periods of scarcity of life-sustaining resources such as ventilators for mechanical respiratory support, as has been the case in Italy as of March, 2020. The National Academy of Medicine has provided guidance on crisis standards of care, which call for the reallocation of scarce medical resources to those who will benefit most during extreme situations. Given that this will require a departure from the usual fiduciary duty of the bedside clinician, we determined and mapped potential barriers to the implementation of the guidelines from stakeholders using an implementation science framework. Methods: A protocol was created to operationalize national and state guidelines for triaging ventilators during crisis conditions. Focus groups and key informant interviews were conducted from July-September 2018 with clinicians at three acute care hospitals of an urban academic medical center. Respiratory therapists, intensivists, nursing leadership and the palliative care interdisciplinary team participated in focus groups. Key informant interviews were conducted with emergency management, respiratory therapy and emergency medicine. Subjects were presented the protocol and their reflections were elicited using a semi-structured interview guide. Data from transcripts and notes were categorized using a coding strategy based on the Theoretical Domains Framework. Results: Participants anticipated that implementing this protocol would challenge their roles and identities as clinicians including both their fiduciary duty to the patient and their decision-making autonomy. Despite this, many participants acknowledged the need for such a protocol to standardize care and minimize bias as well as to mitigate potential consequences for individual clinicians. Participants identified the question of considering patient quality of life in triage decisions as an important and unresolved ethical issue in disaster triage. Conclusion: Clinicians' discomfort with shifting roles and obligations could pose implementation barriers for crisis standards of care.


Subject(s)
Attitude of Health Personnel , Betacoronavirus , Coronavirus Infections/therapy , Critical Care/standards , Pneumonia, Viral/therapy , Standard of Care , Withholding Treatment/ethics , Academic Medical Centers , COVID-19 , Coronavirus Infections/epidemiology , Critical Care/ethics , Emergency Medicine/standards , Focus Groups , Humans , Interviews as Topic , Pandemics , Pneumonia, Viral/epidemiology , Practice Guidelines as Topic , Quality of Life , Respiration, Artificial/standards , Respiratory Therapy/standards , SARS-CoV-2 , Standard of Care/ethics , Triage/methods , Triage/standards
13.
Intensive Care Med ; 46(5): 854-887, 2020 05.
Article in English | MEDLINE | ID: covidwho-17690

ABSTRACT

BACKGROUND: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. METHODS: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. RESULTS: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which 4 are best practice statements, 9 are strong recommendations, and 35 are weak recommendations. No recommendation was provided for 6 questions. The topics were: (1) infection control, (2) laboratory diagnosis and specimens, (3) hemodynamic support, (4) ventilatory support, and (5) COVID-19 therapy. CONCLUSION: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new recommendations in further releases of these guidelines.


Subject(s)
Coronavirus Infections/therapy , Critical Care/standards , Intensive Care Units/standards , Pneumonia, Viral/therapy , Sepsis/therapy , COVID-19 , Coronavirus Infections/prevention & control , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Sepsis/diagnosis , Sepsis/etiology , Survivors
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