DOCSLIB.ORG

Policy Brief 002 Update 04.2021.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Policy Brief 002 Update 04.2021.Pdf .................................................................................................................................................................. 3 1 Background: policy question and methods ................................................................................................. 7 1.1 Policy Question ............................................................................................................................................. 7 1.2 Methodology ................................................................................................................................................. 7 1.3 Selection of Products for “Vignettes” ........................................................................................................ 10 2 Results: Vaccines ......................................................................................................................................... 13 2.1 Moderna Therapeutics—US National Institute of Allergy ..................................................................... 22 2.2 University of Oxford/ Astra Zeneca .......................................................................................................... 23 2.3 BioNTech/Fosun Pharma/Pfizer .............................................................................................................. 25 2.4 Janssen Pharmaceutical/ Johnson & Johnson .......................................................................................... 27 2.5 Novavax ....................................................................................................................................................... 27 2.6 CureVac ....................................................................................................................................................... 29 2.7 Sanofi and GSK .......................................................................................................................................... 30 2.8 Valneva ........................................................................................................................................................ 31 3 Results: Therapeutics ................................................................................................................................. 33 3.1 Remdesivir (Veklury®) .............................................................................................................................. 40 3.2 Lopinavir + Ritonavir (Kaletra®) ............................................................................................................ 49 3.3 Favipiravir (Avigan®) ................................................................................................................................ 49 3.4 Darunavir .................................................................................................................................................... 58 3.5 Chloroquine (Resochin®) and .................................................................................................................. 60 3.6 Hydroxychloroquine (Plaquenil®) ........................................................................................................... 60 3.7 Camostat Mesilate (Foipan®) ................................................................................................................... 60 3.8 APN01/ Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) ...................................... 61 3.9 Tocilizumab (Roactemra®) ....................................................................................................................... 61 3.10 Sarilumab (Kevzara®) ............................................................................................................................... 68 3.11 Interferon beta 1a (SNG001) (Rebif®, Avonex®) and Interferon beta 1b (Betaferon®, Extavia®) .................................................................................................................................................... 71 3.12 Convalescent plasma transfusion .............................................................................................................. 75 3.13 Plasma derived medicinal products .......................................................................................................... 81 3.13.1 REGN-COV2 - combination of two monoclonal antibodies (REGN10933 and REGN10987) ........................................................................................................................................... 81 3.13.2 LY-CoV555 - neutralizing IgG1 monoclonal antibody (bamlanivimab) and LY-CoV016 - recombinant fully human monoclonal neutralizing antibody (etesevimab) ................................... 85 3.13.3 AZD7442 - combination of two monoclonal antibodies (AZD8895 + AZD1061) .......................... 96 3.13.4 VIR-7831 monoclonal antibody ............................................................................................................. 96 3.13.5 Regdanvimab (CT-P59) .......................................................................................................................... 98 3.14 Combination therapy – triple combination of interferon beta-1b, lopinavir–ritonavir and ribavirin vs. lopinavir–ritonavir or other triple combination of interferons ......................................... 98 3.15 Solnatide .................................................................................................................................................... 104 3.16 Umifenovir (Arbidol®) ............................................................................................................................ 105 3.17 Dexamethasone and other corticosteroids .............................................................................................. 109 3.17.1 Inhaled corticosteroids: Budesonide ................................................................................................... 115 3.18 Anakinra (Kineret®) ................................................................................................................................ 116 3.19 Colchicine ................................................................................................................................................. 119 3.20 Nafamostat (Futhan©) ............................................................................................................................. 122 3.21 Gimsilumab ............................................................................................................................................... 122 3.22 Canakinumab ............................................................................................................................................ 123 3.23 Lenzilumab ............................................................................................................................................... 123 3.24 Vitamin D .................................................................................................................................................. 124 3.25 Baricitinib ................................................................................................................................................. 128 3.26 Molnupiravir ............................................................................................................................................. 131 3.27 Ivermectin ................................................................................................................................................. 132 3.28 Aspirin (acetylsalicylic acid).................................................................................................................... 137 3.29 Aviptadil (RLF-100) ................................................................................................................................. 138 References ........................................................................................................................................................ 140 Figure 1.2-1: A living mapping of ongoing randomized trials, living systematic reviews with pairwise meta-analyses and network meta-analyses ..................................................................................... 9 Figure 1.2-2: Global Coronavirus COVID-19 Clinical Trial Tracker - a real-time dashboard of clinical trials for COVID-19 ......................................................................................................................... 10 Table 1.2-1: International Sources ..................................................................................................................... 8 Table 2-1: Vaccines in the R&D pipeline (Phase 1 - Phase 3 clinical trials, not preclinical stages), April 9, 2021 ............................................................................................................................ 18 Table 2-2: SARS-CoV-2 variants and vaccines contracted or exploratory talks have concluded for EU, and some vaccines not contracted nor exploratory talks have concluded for EU: clinical effectiveness and in-vitro neutralisation ...................................................................................................... 19 Table 2-3: COVID-19 Vaccines in development in children .................................................................................. 20 Table 2-4: Intranasal vaccine in development ........................................................................................................
Load more

Recommended publications
  • Assessment Report COVID-19 Vaccine Astrazeneca EMA/94907/2021
    29 January 2021 EMA/94907/2021 Committee for Medicinal Products for Human Use (CHMP) Assessment report COVID-19 Vaccine AstraZeneca Common name: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Procedure No. EMEA/H/C/005675/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ..................................................................................... 7 1.2. Steps taken for the assessment of the product ........................................................ 9 2. Scientific discussion .............................................................................. 12 2.1. Problem statement ............................................................................................. 12 2.1.1. Disease or condition ........................................................................................ 12 2.1.2. Epidemiology and risk factors ........................................................................... 12 2.1.3. Aetiology and pathogenesis .............................................................................
    [Show full text]
  • Physiology-2021-Abstract-Book.Pdf (Physoc.Org)
    Physiology 2021 Our Annual Conference 12 – 16 July 2021 Online | Worldwide #Physiology2021 Contents Prize Lectures 1 Symposia 7 Oral Communications 63 Poster Communications 195 Abstracts Experiments on animals and animal tissues It is a requirement of The Society that all vertebrates (and Octopus vulgaris) used in experiments are humanely treated and, where relevant, humanely killed. To this end authors must tick the appropriate box to confirm that: For work conducted in the UK, all procedures accorded with current UK legislation. For work conducted elsewhere, all procedures accorded with current national legislation/guidelines or, in their absence, with current local guidelines. Experiments on humans or human tissue Authors must tick the appropriate box to confirm that: All procedures accorded with the ethical standards of the relevant national, institutional or other body responsible for human research and experimentation, and with the principles of the World Medical Association’s Declaration of Helsinki. Guidelines on the Submission and Presentation of Abstracts Please note, to constitute an acceptable abstract, The Society requires the following ethical criteria to be met. To be acceptable for publication, experiments on living vertebrates and Octopus vulgaris must conform with the ethical requirements of The Society regarding relevant authorisation, as indicated in Step 2 of submission. Abstracts of Communications or Demonstrations must state the type of animal used (common name or genus, including man. Where applicable, abstracts must specify the anaesthetics used, and their doses and route of administration, for all experimental procedures (including preparative surgery, e.g. ovariectomy, decerebration, etc.). For experiments involving neuromuscular blockade, the abstract must give the type and dose, plus the methods used to monitor the adequacy of anaesthesia during blockade (or refer to a paper with these details).
    [Show full text]
  • Réponse Rapide
    2021-05-17 13:58 17 mai 2021 Réponse en continu COVID-19 et biothérapies dirigées contre l’interleukine 6 ou son récepteur Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) 2021-05-17 13:58 Cette réponse a été préparée par les professionnels scientifiques de la Direction de l’évaluation et de la pertinence des modes d’intervention en santé et la Direction et de la Direction de l’évaluation des médicaments et des technologies à des fins de remboursement de l’Institut national d’excellence en santé et en services sociaux (INESSS). RESPONSABILITÉ L’INESSS assume l’entière responsabilité de la forme et du contenu définitif de ce document au moment de sa publication. Les positions qu’il contient ne reflètent pas forcément les opinions des personnes consultées aux fins de son élaboration. MISE À JOUR Suivant l’évolution de la situation, les conclusions de cette réponse mise à jour pourraient être appelées à changer. Dépôt légal Bibliothèque et Archives nationales du Québec, 2021 Bibliothèque et Archives Canada, 2021 ISBN 978-2-550-86479-0 (PDF) © Gouvernement du Québec, 2021 La reproduction totale ou partielle de ce document est autorisée à condition que la source soit mentionnée. Pour citer ce document : Institut national d’excellence en santé et en services sociaux (INESSS). COVID-19 et biothérapies dirigées contre l’interleukine 6 ou son récepteur. Québec, Qc : INESSS; 2021. 123 p. L’Institut remercie les membres de son personnel qui ont contribué à l’élaboration du présent document. 2 2021-05-17 13:58 COVID-19 et biothérapies dirigées contre l’interleukine 6 ou son récepteur Le présent document ainsi que les constats qu’il énonce ont été rédigés en réponse à une interpellation du ministère de la Santé et des Services sociaux dans le contexte de la crise sanitaire liée à la maladie à coronavirus (COVID-19) au Québec.
    [Show full text]
  • Ventilation Recommendations Table
    SURVIVING SEPSIS CAMPAIGN INTERNATIONAL GUIDELINES FOR THE MANAGEMENT OF SEPTIC SHOCK AND SEPSIS-ASSOCIATED ORGAN DYSFUNCTION IN CHILDREN VENTILATION RECOMMENDATIONS TABLE RECOMMENDATION #34 STRENGTH & QUALITY OF EVIDENCE We were unable to issue a recommendation about whether to Insufficient intubate children with fluid-refractory, catecholamine-resistant septic shock. However, in our practice, we commonly intubate children with fluid-refractory, catecholamine-resistant septic shock without respiratory failure. RECOMMENDATION #35 STRENGTH & QUALITY OF EVIDENCE We suggest not to use etomidate when intubating children • Weak with septic shock or other sepsis-associated organ dysfunction. • Low-Quality of Evidence RECOMMENDATION #36 STRENGTH & QUALITY OF EVIDENCE We suggest a trial of noninvasive mechanical ventilation (over • Weak invasive mechanical ventilation) in children with sepsis-induced • Very Low-Quality of pediatric ARDS (PARDS) without a clear indication for intubation Evidence and who are responding to initial resuscitation. © 2020 Society of Critical Care Medicine and European Society of Intensive Care Medicine Care Medicine. RECOMMENDATION #37 STRENGTH & QUALITY OF EVIDENCE We suggest using high positive end-expiratory pressure (PEEP) • Weak in children with sepsis-induced PARDS. Remarks: The exact level • Very Low-Quality of of high PEEP has not been tested or determined in PARDS Evidence patients. Some RCTs and observational studies in PARDS have used and advocated for use of the ARDS-network PEEP to Fio2 grid though adverse hemodynamic effects of high PEEP may be more prominent in children with septic shock. RECOMMENDATION #38 STRENGTH & QUALITY OF EVIDENCE We cannot suggest for or against the use of recruitment Insufficient maneuvers in children with sepsis-induced PARDS and refractory hypoxemia.
    [Show full text]
  • Progress in the Development of Potential Therapeutics and Vaccines Against COVID-19 Pandemic
    Acta Scientific Pharmaceutical Sciences (ISSN: 2581-5423) Volume 5 Issue 7 July 2021 Review Article Progress in the Development of Potential Therapeutics and Vaccines against COVID-19 Pandemic Abhishek Kumar Yadav, Shubham Kumar and Vikramdeep Monga* Received: May 02, 2021 Department of Pharmaceutical Chemistry, ISF College of Pharmacy, Moga, Punjab, Published: June 09, 2021 India © All rights are reserved by Vikramdeep *Corresponding Author: Vikramdeep Monga, Department of Pharmaceutical Monga., et al. Chemistry, ISF College of Pharmacy, Moga, Punjab, India. Abstract Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19 or coronavirus disease 2019 and the same has been declared as a global pandemic by WHO which marked the third introduction of a virulent coronavirus into human society. This a threat to human life worldwide. Considerable efforts have been made for developing effective and safe drugs and vaccines against is a highly pathogenic human coronavirus in which pneumonia of unknown origin was identified in China in December 2019 and is SARS-CoV-2. The current situation and progress in the development of various therapeutic candidates including vaccines in preclini- cal and clinical studies have been described in the manuscript. Until now, many people have been infected with this lethal virus, and a lot of people have died from this COVID-19. This viral disease spreads by coming in contact with an infected person. Understand- ing of SARS-CoV-2 is growing in relation to its epidemiology, virology, and clinical management strategies. Till date, very few drugs or vaccines have been developed or approved for the treatment of this deadly disease of COVID-19 and many candidates are under the clinical development pipeline.
    [Show full text]
  • The Solidarity Trial ‘Solidarity’ Is an International Clinical Trial to Help Find an Effective Treatment for COVID-19, Launched by the WHO and Partners
    CORONAVIRUS (COVID-19) UPDATE NO. 22 / LAST UPDATED: 16 APRIL 2020 CURRENT SITUATION | COVID-19 RESPONSE | SCIENCE | FAITH COMMUNITY | RESOURCES CORONAVIRUS UPDATE 22 The Solidarity Trial ‘Solidarity’ is an international clinical trial to help find an effective treatment for COVID-19, launched by the WHO and partners. Find out which therapies are included in the trial. MORE Transmission Measures to reduce Guidance for the faith scenarios transmission community EPI WiN CORONAVIRUS (COVID-19) UPDATE NO. 22 / LAST UPDATED: 16 APRIL 2020 CURRENT SITUATION | COVID-19 RESPONSE | SCIENCE | FAITH COMMUNITY | RESOURCES Current global situation • Nearly 2 million confirmed cases • More than 123 000 deaths USA has more than 575 000 confirmed cases – • the most in the world Top ten countries with the highest number of new cases COUNTRY NEW REPORTED CASES IN LAST 24HRS United States of America 24 446 For the latest data, please access: France 5 483 è WHO situation dashboard United Kingdom 5 252 è WHO situation reports Turkey 4 062 è UNWFP world travel restrictions Russian Federation 3 388 Spain 3 045 Italy 2 972 Germany 2 486 Islamic Republic of Iran 1 574 Canada 1 360 Data as of 15.04.20 EPI WiN CORONAVIRUS (COVID-19) UPDATE NO. 22 / LAST UPDATED: 16 APRIL 2020 CURRENT SITUATION | COVID-19 RESPONSE | SCIENCE | FAITH COMMUNITY | RESOURCES Number of new cases of COVID-19 per day, by WHO Region 100 000 90 000 80 000 70 000 60 000 50 000 New daily cases New 40 000 30 000 20 000 10 000 0 * 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 March April AFRO AMRO EMRO EURO SEARO WPRO * There is no data from 22 March due to a change in the WHO situation reporting period EPI WiN CORONAVIRUS (COVID-19) UPDATE NO.
    [Show full text]
  • Accelerated Development of COVID-19 Vaccines: Technology Platforms, Benefits, and Associated Risks
    Perspective Accelerated Development of COVID-19 Vaccines: Technology Platforms, Benefits, and Associated Risks Ralf Wagner, Eberhard Hildt , Elena Grabski, Yuansheng Sun, Heidi Meyer, Annette Lommel, Brigitte Keller-Stanislawski, Jan Müller-Berghaus and Klaus Cichutek * Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, 63225 Langen, Germany; [email protected] (R.W.); [email protected] (E.H.); [email protected] (E.G.); [email protected] (Y.S.); [email protected] (H.M.); [email protected] (A.L.); [email protected] (B.K.-S.); [email protected] (J.M.-B.) * Correspondence: [email protected] Abstract: Multiple preventive COVID-19 vaccines have been developed during the ongoing SARS coronavirus (CoV) 2 pandemic, utilizing a variety of technology platforms, which have different properties, advantages, and disadvantages. The acceleration in vaccine development required to combat the current pandemic is not at the expense of the necessary regulatory requirements, including robust and comprehensive data collection along with clinical product safety and efficacy evaluation. Due to the previous development of vaccine candidates against the related highly pathogenic coronaviruses SARS-CoV and MERS-CoV, the antigen that elicits immune protection is known: the surface spike protein of SARS-CoV-2 or specific domains encoded in that protein, e.g., the receptor binding domain. From a scientific point of view and in accordance with legal Citation: Wagner, R.; Hildt, E.; frameworks and regulatory practices, for the approval of a clinic trial, the Paul-Ehrlich-Institut Grabski, E.; Sun, Y.; Meyer, H.; requires preclinical testing of vaccine candidates, including general pharmacology and toxicology as Lommel, A.; Keller-Stanislawski, B.; well as immunogenicity.
    [Show full text]
  • WHO COVID-19 Database Search Strategy (Updated 26 May 2021)
    Search purpose: Systematic search of the COVID-19 literature performed Monday through Friday for the WHO Database. Search strategy as of 26 May 2021. Searches performed by Tomas Allen, Kavita Kothari, and Martha Knuth. Use following commands to pull daily new entries: Entry_date:( [20210101 TO 20210120]) Entry_date:( 20210105) Duplicates: Duplicates are found in EndNote and Distillr using the Wichor method. Further screening is done by expert reviewers but some duplicates may still be in the database. Daily Search Strategy: Database Daily Search Strategy Medline (coronavir* OR corona virus* OR corona pandemic* OR betacoronavir* OR covid19 OR covid OR (Ovid) nCoV OR novel CoV OR CoV 2 OR CoV2 OR sarscov2 OR sars2 OR 2019nCoV OR wuhan virus* OR 1946- NCOV19 OR solidarity trial OR operation warp speed OR COVAX OR "ACT-Accelerator" OR BNT162b2 OR comirnaty OR "mRNA-1273" OR CoviShield OR AZD1222 OR Sputnik V OR CoronaVac OR "BBIBP-CorV" OR "Ad26.CoV2.S" OR "JNJ-78436735" OR Ad26COVS1 OR VAC31518 OR EpiVacCorona OR Convidicea OR "Ad5-nCoV" OR Covaxin OR CoviVac OR ZF2001 OR "NVX-CoV2373" OR "ZyCoV-D" OR CIGB 66 OR CVnCoV OR "INO-4800" OR "VIR-7831" OR "UB-612" OR BNT162 OR Soberana 1 OR Soberana 2 OR "B.1.1.7" OR "VOC 202012/01" OR "VOC202012/01" OR "VUI 202012/01" OR "VUI202012/01" OR "501Y.V1" OR UK Variant OR Kent Variant OR "VOC 202102/02" OR "VOC202102/02" OR "B.1.351" OR "VOC 202012/02" OR "VOC202012/02" OR "20H/501.V2" OR "20H/501Y.V2" OR "501Y.V2" OR "501.V2" OR South African Variant OR "B.1.1.28.1" OR "B.1.1.28" OR "B.1.1.248" OR
    [Show full text]
  • Antivirals Against SARS-Cov-2 by Autumn?
    EDITORIALS BMJ: first published as 10.1136/bmj.n1215 on 17 May 2021. Downloaded from 1 St George’s, University of London, Antivirals against SARS-CoV-2 by autumn? London, UK An over ambitious target that risks forced errors 2 St George’s University Hospitals NHS Foundation Trust, London, UK David Smith, 1 , 2 Dipender Gill1 , 2 Correspondence to: D Gill 5 [email protected] The UK government has launched a covid-19 drugs. In the 1980s, trials showed that Cite this as: BMJ 2021;373:n1215 antivirals taskforce with the aim of deploying drugs azidothymidine improved survival in people with 1 http://dx.doi.org/10.1136/bmj.n1215 for home treatment by autumn this year. The HIV infection, and the drug was initially viewed as a Published: 17 May 2021 description suggests that the government wants direct success before viral resistance emerged.9 It became acting orally administered drugs that reduce clear that patients required a combination of three replication and help eliminate SARS-CoV-2 from the drugs in order to avoid resistance.10 More recently, body. Taken after a positive swab test result or the pandemic influenza strain H1N1 has developed prophylactically after exposure, these drugs could resistance to oseltamivir.11 If SARS-CoV-2 shares this reduce viral transmission, morbidity, and mortality. capacity to generate escape mutations, then multiple antiviral drugs may be required in combination for And they may well be needed. Vaccine efficacy effective treatment or prophylaxis. against symptomatic disease is 67-95%, with unknown durability and effectiveness against new The targets variants.2 Peak viral loads seem to determine the SARS-CoV-2 does present a few potential targets for duration and severity of symptoms,3 but current antiviral therapy.
    [Show full text]
  • An Examination of COVID-19 Medications' Effectiveness
    healthcare Review An Examination of COVID-19 Medications’ Effectiveness in Managing and Treating COVID-19 Patients: A Comparative Review Mahmoud Al-Masaeed 1,* , Mohammad Alghawanmeh 2, Ashraf Al-Singlawi 3 , Rawan Alsababha 4 and Muhammad Alqudah 1 1 Faculty of Health and Medicine, University of Newcastle, Callaghan 2308, Australia; [email protected] 2 Faculty of Pharmacy, Philadelphia University, Amman 19392, Jordan; [email protected] 3 Independent Scholar, Amman 11731, Jordan; [email protected] 4 School of nursing and Midwifery, Western Sydney University, Sydney 2560, Australia; [email protected] * Correspondence: [email protected] Abstract: Background: The review seeks to shed light on the administered and recommended COVID- 19 treatment medications through an evaluation of their efficacy. Methods: Data were collected from key databases, including Scopus, Medline, Google Scholar, and CINAHL. Other platforms included WHO and FDA publications. The review’s literature search was guided by the WHO Citation: Al-Masaeed, M.; solidarity clinical trials for COVID-19 scope and trial-assessment parameters. Results: The findings Alghawanmeh, M.; Al-Singlawi, A.; indicate that the use of antiretroviral drugs as an early treatment for COVID-19 patients has been Alsababha, R.; Alqudah, M. An useful. It has reduced hospital time, hastened the clinical cure period, delayed and reduced the Examination of COVID-19 need for mechanical and invasive ventilation, and reduced mortality rates. The use of vitamins, Medications’ Effectiveness in minerals, and supplements has been linked to increased immunity and thus offering the body a Managing and Treating COVID-19 fighting chance. Nevertheless, antibiotics do not correlate with improving patients’ wellbeing and Patients: A Comparative Review.
    [Show full text]
  • Mechanical Ventilation Bronchodilators
    A Neurosurgeon’s Guide to Pulmonary Critical Care for COVID-19 Alan Hoffer, M.D. Chair, Critical Care Committee AANS/CNS Joint Section on Neurotrauma and Critical Care Co-Director, Neurocritical Care Center Associate Professor of Neurosurgery and Neurology Rana Hejal, M.D. Medical Director, Medical Intensive Care Unit Associate Professor of Medicine University Hospitals of Cleveland Case Western Reserve University To learn more, visit our website at: www.neurotraumasection.org Introduction As the number of people infected with the novel coronavirus rapidly increases, some neurosurgeons are being asked to participate in the care of critically ill patients, even those without neurological involvement. This presentation is meant to be a basic guide to help neurosurgeons achieve this mission. Disclaimer • The protocols discussed in this presentation are from the Mission: Possible program at University Hospitals of Cleveland, based on guidelines and recommendations from several medical societies and the Centers for Disease Control (CDC). • Please check with your own hospital or institution to see if there is any variation from these protocols before implementing them in your own practice. Disclaimer The content provided on the AANS, CNS website, including any affiliated AANS/CNS section website (collectively, the “AANS/CNS Sites”), regarding or in any way related to COVID-19 is offered as an educational service. Any educational content published on the AANS/CNS Sites regarding COVID-19 does not constitute or imply its approval, endorsement, sponsorship or recommendation by the AANS/CNS. The content should not be considered inclusive of all proper treatments, methods of care, or as statements of the standard of care and is not continually updated and may not reflect the most current evidence.
    [Show full text]
  • Tracheotomy in Ventilated Patients with COVID19
    Tracheotomy in ventilated patients with COVID-19 Guidelines from the COVID-19 Tracheotomy Task Force, a Working Group of the Airway Safety Committee of the University of Pennsylvania Health System Tiffany N. Chao, MD1; Benjamin M. Braslow, MD2; Niels D. Martin, MD2; Ara A. Chalian, MD1; Joshua H. Atkins, MD PhD3; Andrew R. Haas, MD PhD4; Christopher H. Rassekh, MD1 1. Department of Otorhinolaryngology – Head and Neck Surgery, University of Pennsylvania, Philadelphia 2. Department of Surgery, University of Pennsylvania, Philadelphia 3. Department of Anesthesiology, University of Pennsylvania, Philadelphia 4. Division of Pulmonary, Allergy, and Critical Care, University of Pennsylvania, Philadelphia Background The novel coronavirus (COVID-19) global pandemic is characterized by rapid respiratory decompensation and subsequent need for endotracheal intubation and mechanical ventilation in severe cases1,2. Approximately 3-17% of hospitalized patients require invasive mechanical ventilation3-6. Current recommendations advocate for early intubation, with many also advocating the avoidance of non-invasive positive pressure ventilation such as high-flow nasal cannula, BiPAP, and bag-masking as they increase the risk of transmission through generation of aerosols7-9. Purpose Here we seek to determine whether there is a subset of ventilated COVID-19 patients for which tracheotomy may be indicated, while considering patient prognosis and the risks of transmission. Recommendations may not be appropriate for every institution and may change as the current situation evolves. The goal of these guidelines is to highlight specific considerations for patients with COVID-19 on an individual and population level. Any airway procedure increases the risk of exposure and transmission from patient to provider.
    [Show full text]