Coronavirus disease: from origin to outbreak adnan i. qureshi - The ebook version is available in PD

Page 1


https://ebookmass.com/product/coronavirus-disease-from-

Instant digital products (PDF, ePub, MOBI) ready for you

Download now and discover formats that fit your needs...

The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak Hussin A. Rothan

https://ebookmass.com/product/the-epidemiology-and-pathogenesis-ofcoronavirus-disease-covid-19-outbreak-hussin-a-rothan/

ebookmass.com

2019 novel coronavirus (2019-nCoV) outbreak: A new challenge Tommaso Lupia

https://ebookmass.com/product/2019-novel-coronavirus-2019-ncovoutbreak-a-new-challenge-tommaso-lupia/

ebookmass.com

COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses Muhammad Adnan Shereen

https://ebookmass.com/product/covid-19-infection-origin-transmissionand-characteristics-of-human-coronaviruses-muhammad-adnan-shereen/

ebookmass.com

Greek Gods Box Set: Books 1 - 4 Holly Rayner

https://ebookmass.com/product/greek-gods-box-set-books-1-4-hollyrayner/

ebookmass.com

Set Lighting Technicianu2019s Handbook: Film Lighting Equipment, Practice, and Electrical Distribution 4th Edition, (Ebook PDF)

https://ebookmass.com/product/set-lighting-technicians-handbook-filmlighting-equipment-practice-and-electrical-distribution-4th-editionebook-pdf/

ebookmass.com

John Locke and the Grounds for Toleration 1st Edition Flavio Fontenelle Loque

https://ebookmass.com/product/john-locke-and-the-grounds-fortoleration-1st-edition-flavio-fontenelle-loque/

ebookmass.com

Butler, Vermont Series: Boxed Set, Books 1-8 Force

https://ebookmass.com/product/butler-vermont-series-boxed-setbooks-1-8-force/

ebookmass.com

Economics of Social Issues, 21e 21st Edition Charles A. Register

https://ebookmass.com/product/economics-of-social-issues-21e-21stedition-charles-a-register/

ebookmass.com

Sustainable Horticulture: Microbial Inoculants and Stress Interaction Seymen

https://ebookmass.com/product/sustainable-horticulture-microbialinoculants-and-stress-interaction-seymen/

ebookmass.com

Biology. Concepts & Applications 10th Edition Cecie Starr

https://ebookmass.com/product/biology-concepts-applications-10thedition-cecie-starr/

ebookmass.com

CoronavirusDisease

Thispageintentionallyleftblank

CoronavirusDisease FromOrigintoOutbreak

ZeenatQureshiInstitutesandDepartmentofNeurology, UniversityofMissouri,Columbia,MO,UnitedStates

OmarSaeed

DepartmentofNeurology,UniversityofTennesseeHealthScienceCenter, Memphis,TN,UnitedStates

UzmaSyed

SouthShoreInfectiousDiseases,Bayshore;TravelMedicineConsultants andAntibioticInfusionCenter,Syosset,NY,UnitedStates

AcademicPressisanimprintofElsevier

125LondonWall,LondonEC2Y5AS,UnitedKingdom 525BStreet,Suite1650,SanDiego,CA92101,UnitedStates 50HampshireStreet,5thFloor,Cambridge,MA02139,UnitedStates TheBoulevard,LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom

Copyright 2022ElsevierInc.Allrightsreserved.

Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans, electronicormechanical,includingphotocopying,recording,oranyinformationstorage andretrievalsystem,withoutpermissioninwritingfromthepublisher.Detailsonhowto seekpermission,furtherinformationaboutthePublisher’spermissionspoliciesandour arrangementswithorganizationssuchastheCopyrightClearanceCenterandtheCopyright LicensingAgency,canbefoundatourwebsite: www.elsevier.com/permissions .

Thisbookandtheindividualcontributionscontainedinitareprotectedundercopyrightby thePublisher(otherthanasmaybenotedherein).

Notices

Knowledgeandbestpracticeinthis fieldareconstantlychanging.Asnewresearchand experiencebroadenourunderstanding,changesinresearchmethods,professionalpractices,ormedicaltreatmentmaybecomenecessary.

Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgein evaluatingandusinganyinformation,methods,compounds,orexperimentsdescribed herein.Inusingsuchinformationormethodstheyshouldbemindfuloftheirownsafety andthesafetyofothers,includingpartiesforwhomtheyhaveaprofessionalresponsibility.

Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,or editors,assumeanyliabilityforanyinjuryand/ordamagetopersonsorpropertyasamatter ofproductsliability,negligenceorotherwise,orfromanyuseoroperationofanymethods, products,instructions,orideascontainedinthematerialherein.

LibraryofCongressCataloging-in-PublicationData

AcatalogrecordforthisbookisavailablefromtheLibraryofCongress

BritishLibraryCataloguing-in-PublicationData

AcataloguerecordforthisbookisavailablefromtheBritishLibrary

ISBN:978-0-12-824409-8

ForinformationonallAcademicPresspublicationsvisitour websiteat https://www.elsevier.com/books-and-journals

Publisher: StacyMasucci

AcquisitionsEditor: KattieWashington

EditorialProjectManager: PatGonzalez

ProductionProjectManager: MariaBernard

CoverDesigner: MatthewLimbert

TypesetbyTNQTechnologies

Timescaleoftransmission75

Susceptiblegroups76

Clinicalmanifestations 77

Initialphase78

Pulmonaryphase78

Inflammatoryphase80

Extrapulmonarymanifestations80

Clinicalclassificationofsymptomaticpatients85

Riskfactorsforseveredisease85

Diseasecourseinspecialgroups87

Diagnosis 89

Specificdiagnostictests89 Laboratoryfindings92

Radiologicalfindings94

Casedefinitions97

PrecautionaryguidelinessetupbytheCentersfor DiseaseControlandPreventionregardingthetesting processofCOVID-19andlaboratorybiosafety 101

Useofpersonalprotectiveequipment101

Collecting,handling,andtestingclinicalspecimensfor COVID-19103 COVID-19laboratorybiosafety105 References 107

8.Treatmentandtherapeuticagents

IqraNaveedAkhtar

EmergencyuseauthorizationsduringtheSARS-CoV-2 pandemic 123

Whatisanemergencyuseauthorization?123

EUAforvaccinedevelopment124

PartI:Antiviraldrugtherapy 126

DrugsthatinhibitSARS-CoV-2cellentry,endocytosis,and membranefusion126

DrugsthatinhibitproteolysisofSARS-CoV-2134

DrugsthatinhibittheRNA-dependentRNA-polymerase (RdRp)ofSARS-CoV-2136

Drugswithunspecifiedantiviralactivity142

PartII:Immunomodulatoryagents 144

Corticosteroids144

PartIII:Convalescentplasma,Intravenousimmunoglobulin, andCell-basedtherapies 155

ClinicalResearch 156

Wuhan,China156

TheNetherlands(CONCOVID)156

Contributors

IqraNaveedAkhtar,ZeenatQureshiStrokeInstitute,Columbia,MO,UnitedStates

YaseminAkinci,ZeenatQureshiStrokeInstitute,UniversityofMissouri,Columbia, MO,UnitedStates;IstanbulUniversity-Cerrahpasa,CerrahpasaSchoolof Medicine,DepartmentofNeurology,Istanbul,Turkey

ImaanBashir,AlbirrMedicalResearchConsultants,Gainesville,FL,UnitedStates

MohammadRaufA.Chaudhry,DepartmentofNeurology,TexasTechUniversity HealthScienceCenter,ElPaso,TX,UnitedStates;ZeenatQureshiStrokeInstitute, St.Cloud,MN,UnitedStates

IrynaLobanova,ZeenatQureshiStrokeInstituteandDepartmentofNeurology, UniversityofMissouri,Columbia,MO,UnitedStates

AhmedA.Malik,DepartmentofInternalMedicine,UCF-COM/HCAGME Consortium,NorthFloridaRegionalMedicalCenter,Gainesville,FL,United States;ZeenatQureshiStrokeInstitutes,Columbia,MO,UnitedStates

AbhiPandhi,UniversityofTennesseeHealthScienceCenter,Memphis,TN,United States

AdnanI.Qureshi,ZeenatQureshiStrokeInstituteandDepartmentofNeurology, UniversityofMissouri,Columbia,MO,UnitedStates

IhteshamQureshi,FellowshipPhysician,Epilepsy,DepartmentofNeurology, UniversityofTexasHealthScienceCenteratHouston,Houston,TX,UnitedStates

UsmanSaeed,IndependentAdvisoronInternationalsPoliticalEconomy

IshitaVasudev,SirGangaRamHospital,NewDelhi,Delhi,India

GhaidaZaid,DepartmentofNeurology,UniversityofTennesseHealthScience Center,Memphis,TN,UnitedStates

Thispageintentionallyleftblank

Chapter1 Introduction

ZeenatQureshiStrokeInstituteandDepartmentofNeurology,UniversityofMissouri,Columbia, MO,UnitedStates

Thegoalofthisbookistoprovideadetaileddescriptionwitheasy-to-understandaccountsofoneofthefastestgrowinginfectionsintheworld.An outbreakofrespiratorydiseasewascausedbyanovelcoronavirusthatwas firstdetectedinChinaandwhichhasnowbeendetectedinalmostevery locationinternationally.Therespiratorydiseasecausedbyvirushasbeen named“coronavirusdisease2019”(COVID-19).AnoutbreakofCOVID-19 beganinWuhan,HubeiProvince,China,inDecember2019.OnJanuary30, 2020,theWorldHealthOrganizationdeclaredtheChineseoutbreakof COVID-19tobeaPublicHealthEmergencyofInternationalConcernposinga highrisktocountrieswithvulnerablehealthsystems.ByFebruary23,2020, therewere76,936reportedcasesinmainlandChinaand1875casesinlocationsoutsidemainlandChina.ByMarch5th, 2020,360casesofCOVID-19 werereportedintheUnitedStates.AsofApril2021,136millionpersonshad beeninfectedbythenovelcoronaviruswith2.94millionpersonsdyingfrom theinfectionworldwide.Severalweb-basedresourceshavebeencreatedto providereal-timeupdatesontheoccurrenceofCOVID-19.Oneofthemost widelyusedisdevelopedatJohnsHopkinsUniversityavailableat COVID-19 Map-JohnsHopkinsCoronavirusResourceCenter(jhu.edu).Theinterfaceis shownin Fig.1.1.

TheprogressionofCOVID-19overtimeisshownin Fig.1.2 adaptedfrom Wikipedia.

ThetopfivecountrieswiththehighestratesofCOVID-19areshownin Table1.1 (adaptedfromWikipedia):

Paradoxically,thereisadisproportionatelyhighburdenfacedbysomeof themostdevelopedcountriesintermsofbothhealthcareandeconomic infrastructureintheCOVID-19pandemic.Thisisverydifferentfromprevious pandemicssuchasthosecausedbyEbolavirusorDenguevirus.Also,there appearstobedifferencesinCOVID-19-relatedmortalitybetweencountries. ThedifferencesinratesofCOVID-19-relateddeathsbetweencountriesarea functionofthetotalnumberofcases,theproportionofthepopulationwhoare athighriskforsevereCOVID-19,theimplementationofprecautionary

CoronavirusDisease. https://doi.org/10.1016/B978-0-12-824409-8.00010-2 Copyright © 2022ElsevierInc.Allrightsreserved. 1

FIGURE1.1 InterfaceofJohnsHopkinsCoronavirusResourceCenter.

measuresbyrespectivegovernmentsandpopulations,andeffectivenessof medicaltreatment.Countriescanbedividedbasedonratioofbetween observedmortalityandvulnerabilityindextoquantifyhoweffectivethepreventivemeasuresandmedicaltreatmentwereinreducingmortality(measure ofperformance)[1].Thethreegroupsofcountriesarepresentedontheworld map(see Fig.1.3)withcountriesdepictedingreenasthosewithhighperformanceinreducingmortality,inyellowasmoderateperformance,andredas lowperformance.Countriesforwhichnostatisticsordatawasavailableon COVID-19-relateddeathsormortalityper1,000,000personshavebeen markedingrayonthemap.Countriesinthehigh-performancegroupincluded severalAfricanandsouth-eastAsiannationsthataretypicallyresourcedeprivedandarethoughttofacetheworstbruntofanyinfectiousdisease.

FIGURE1.2 GlobalprogressionofCOVID-19overtime.
FIGURE1.3 PerformanceofvariouscountriesinreducingCOVID-19-relatedmortality.

TABLE1.1 FivecountrieswiththehighestratesofcasesofCOVID-19and associateddeaths.

AnotherinterestingfindingwasthatTaiwanwasinthehigh-performance groupdespitetheislandcomprising23millioninhabitantsislocatedjust81 milesfrommainlandChina.FrequenttravelbackandforthbetweenChinaand TaiwanoccursonadailybasisandthousandsofTaiwanesenationalsliveand workinChina.Despitethechallenges,theCOVID-19-relatedmortalitywas lowinTaiwanafteradjustingforvulnerabilitytosevereCOVID-19infection. Amongcountriesinthelow-performancetierwerethewealthyandresourceful countriesofwesternEuropeandNorthAmerica,supportingtheargumentthat merehealthcareresourcesandfinancesarenotenoughwhenitcomesto effectivelydealingwiththecurrentpandemic.Thesecountrieshavehigh proportionofpersonsatriskforsevereCOVID-19andpoorperformancewas stillidentifieddespiteadjustmentforvulnerabilityindex.

CoronavirusesarealargefamilyofvirusesthatareresponsibleforMiddle EastRespiratorySyndromeCoronavirus(MERS-CoV)andSevereAcute RespiratorySyndromeCoronavirus(SARS-CoV).Thecausativeagentwas identifiedfromthroatswabsamplesconductedbytheChineseCenterfor

DiseaseControlandPreventiononJanuary7,2020andwassubsequently namedSevereAcuteRespiratorySyndromeCoronavirus2(SARS-CoV-2). TheSARS-CoV-2virusisabetacoronavirus,likeMERS-CoVandSARS-CoV. Allthreeoftheseviruseshavetheiroriginsinbats.TheSARS-CoVwas transmittedfromcivetcatstohumansandMERS-CoVfromdromedary camelstohumans.

Commonsignsofinfectionincluderespiratorysymptoms,fever,cough, andshortnessofbreath.Inmoreseverecases,infectioncancausepneumonia, severeacuterespiratorysyndrome,andevenrespiratoryfailureleadingto death.COVID-19isnotlimitedtopulmonarysystembutresultsinmultiorgan dysfunctioninvolvinggastrointestinal,cardiac,hepatic,neurologic,andrenal systems.Anotherfeaturethatgainedprominencewasinflammatorythrombosis,whichresultedinischemicstroke,pulmonaryembolisms,cardiac ischemia,andperipheralvenousthromboembolism.Therewasasecondary component2 4weeksafterprimaryinfectionattributedtoexcessiveimmunologicalresponse(cytokinestorm)resultinginmultisysteminflammatory syndromeconsistingofshock,cardiacinvolvement,andgastrointestinal symptoms.Anecdotaldatasuggeststhataproportionofpersonsaftercontact withCOVID-19-infectedindividualsdevelopsymptomsofCOVID-19butdo nothavethedisease,anentitywetermasCOVID-19mimic.Thepooled prevalenceofCOVID-19mimicwas16per100personsundersurveillance (95%confidenceinterval11 23per100persons)[2].Intheanalysisofa priorisubgroups,byregionofthestudies,prevalenceofCOVID-19mimicwas 16(95%CI11 23)inNorthAmerica,15(95%CI4 40)inEurope,and15 (95%CI7 32)per100personsinAsia.

TheCOVID-19pandemicresultedinwidespreadandunprecedented institutionofmandatedsocietallockdown.Mandatedsocialdistancing comprisingacombinationoftravelrestrictions,closureofnonessentialgroup meetingvenues(restaurants,schools,shops),andstepstoavoidclosecontact atessentialmeetingvenues(hospitals,foodsupply,pharmacies).Using publiclyavailabledata,wehadexaminedtheeffectoftimingofmandated socialdistancingontherateofCOVID-19in119geographicregionsderived from41stateswithintheUnitedStatesand78countries[3].Theprimary outcomewasthehighestnumberofnewCOVID-19casesperdayrecorded withineachgeographicunit.WefoundthathighestnumberofnewCOVID-19 casesperdaypermillionpersonswassignificantlyassociatedwithtotal numberofCOVID-19casespermillionpersonsonthedaybeforemandated socialdistancing(b ¼ 0.66, P < .0001).Ourfindingssuggestedthatthe initiationofmandatedsocialdistancingafterdoublinginnumberofexisting COVID-19caseswouldresultineventualpeakwith58%highernumberof COVID-19casesperday.Initiatingmandatedsocialdistancingwithsmaller numberofCOVID-19caseswithinaregionsignificantlyreducesthenumber ofdailynewCOVID-19casesandperhapsalsoreducesthetotalnumberof casesintheregion.

Wearingfacemasktocovermouthsandnoseswithfilteringmaterialshas beenwidelyusedtopreventinhalationofparticulatescontainingSARS-CoV-2 virus.ByFebruary2020,CentersforDiseaseControlandPreventionhad recommendedthatpersonswithsuspectedSARS-CoV-2infectionshouldwear facemasks[4].ByJuly2020,CentersforDiseaseControlandPreventionhad recommendedfacemaskuseduringallpublicencountersforallpersons.A studyfromalargehealthcaresysteminMassachusettswithmorethan75,000 employeesevaluatedtheeffectofmandatorypolicyofuniversalmaskingforall healthcareworkersandforallpatients[5].Aftertheuniversalmaskingpolicy wasinplace,theproportionofsymptomatichealthcareworkerswithpositive testresultssteadilydeclined,from14.7%to11.5%(ameandecreaseof0.49% perday).Anotherstudythatlookedattransmissionamong139clientsexposed totwohairstylistwithCOVID-19foundnocaseofSARS-CoV-2transmission whenbothhairstylistsandclientswerewearingfacemasks[6].

Oneoftheuniqueaspectsofdevelopingdiagnostictests,vaccines,and medicationsforpreventionandtreatmentofSARS-CoV-2infectionwasthe useofEmergencyUseAuthorization(EUA)byFoodandDrugAdministration (FDA).OnFebruary4,2020,pursuanttosection564(b)(1)(C)oftheFD&C Act(21U.S.C.360bbb3(b)(1)(C)),theSecretaryofHealthandHumanServicesdeterminedthatthereisapublichealthemergencythathasasignificant potentialtoaffectnationalsecurityorthehealthandsecurityofUScitizens livingabroad,andthatinvolvesthevirusthatcausesCOVID-19.Onthebasis ofsuchdetermination,onMarch27,2020,theSecretarythendeclaredthat circumstancesexistjustifyingtheauthorizationofemergencyuseofdrugsand biologicalproductsduringtheCOVID-19pandemic,pursuanttosection 564(b)(1)oftheFD&CAct(21U.S.C.360bbb-3(b)(1)).Acopyofthenotice isprovidedin Fig.1.4.

Severalinvitrodiagnostic(IVD)deviceswereapprovedunderEUAfor performingtestsonsamplessuchasswabsofmucusfrominsidethenoseor backofthethroatorbloodtakenfromaveinorfingerstick.TheFDAclassifies theseIVDsasfollows:

DiagnosticTests: Moleculartestsandantigenteststhatdetectcomponents oftheSARS-CoV-2todiagnoseinfectionwiththeSARS-CoV-2.

Serology/AntibodyandOtherAdaptiveImmuneResponseTests: Tests thatdetectIgMandIgGantibodiestotheSARS-CoV-2virusorthatmeasurea differentadaptiveimmuneresponse(suchasTcellimmuneresponse)tothe SARS-CoV-2virus.Thesetypesoftestsarebestsuitedforidentifying previousinfection.

TestsforManagementofCOVID-19Patients: Teststhatareauthorized foruseinthemanagementofpatientswithCOVID-19,suchastodetect biomarkersrelatedtoinflammationandguidepatientmanagementdecisions.

SeveralmedicationswereapprovedforuseinpatientswithCOVID-19 underEUA.Alistisprovidedin Table1.2 asadaptedfrom https://www.fda. gov/medical-devices/coronavirus-di sease-2019-covid-19-emergency-useauthorizations-medical-devices/ .

FIGURE1.4 Emergencyuseauthorizationdeclaration[7].

TABLE1.2 MedicationswereapprovedforuseinpatientswithCOVID-19 underEUA.

Dateoffirst EUA issuance Mostrecentletterof authorization(PDF)Authorizeduse 04/30/2020FreseniusMedical, multiFiltratePROSystem andmultiBic/multiPlus Solutions(171KB) [also listedunderMedical DeviceEUAs]

January05, 2020 RemdesivirforCertain HospitalizedCOVID-19 Patients(423KB) (ReissuedAugust28, 2020,October1,2020, andOctober22,2020)

Toprovidecontinuousrenalreplacement therapy(CRRT)totreatpatientsinan acutecareenvironmentduringthe COVID-19pandemic

Foremergencyusebylicensedhealthcare providersforthetreatmentofsuspected orlaboratory-confirmedCOVID-19in hospitalizedpediatricpatientsweighing 3.5kgtolessthan40kgorhospitalized pediatricpatientslessthan12yearsof ageweighingatleast3.5kg. OnOctober22,2020,FDAapproved

TABLE1.2 MedicationswereapprovedforuseinpatientswithCOVID-19 underEUA. cont’d

Dateoffirst

EUA issuance

Mostrecentletterof authorization(PDF)Authorizeduse

Veklury(remdesivir)foruseinadultsand pediatricpatients(12yearsofageand olderandweighingatleast40kg)forthe treatmentofCOVID-19requiring hospitalization.Vekluryshouldonlybe administeredinahospitalorina healthcaresettingcapableofproviding acutecarecomparabletoinpatient hospitalcare.Thisapprovaldoesnot includetheentirepopulationthathad beenauthorizedtouseVekluryunderan emergencyuseauthorization(EUA) originallyissuedonMay1,2020.Inorder toensurecontinuedaccesstothe pediatricpopulationpreviouslycovered undertheEUA,theEUAforVeklury continuestoauthorizeVekluryfor emergencyusebylicensedhealthcare providersforthetreatmentofsuspected orlaboratory-confirmedCOVID-19in hospitalizedpediatricpatientsweighing 3.5kgtolessthan40kgorhospitalized pediatricpatientslessthan12yearsof ageweighingatleast3.5kg.

August05, 2020

FreseniusKabiPropoven 2%(209KB)

08/13/2020REGIOCITreplacement solutionthatcontains citrateforregional citrateanticoagulation (RCA)ofthe extracorporealcircuit (92KB)

08/23/2020COVID-19convalescent plasma(284KB) (ReissuedFebruary23, 2021andMarch9, 2021)

Tomaintainsedationviacontinuous infusioninpatientsolderthanage16 withsuspectedorconfirmedCOVID-19 whorequiremechanicalventilationinan intensivecareunit(ICU)setting

Tobeusedasareplacementsolutiononly inadultpatientstreatedwithcontinuous renalreplacementtherapy(CRRT),and forwhomregionalcitrateanticoagulation isappropriate,inacriticalcaresetting

Forthetreatmentofhospitalizedpatients withcoronavirusdisease2019 (COVID-19) Continued

TABLE1.2 MedicationswereapprovedforuseinpatientswithCOVID-19 underEUA. cont’d

Dateoffirst

EUA issuance

September 11,2020

Mostrecentletterof authorization(PDF)Authorizeduse

Bamlanivimab(339KB) (reissuedFebruary9, 2021andMarch2, 2021)

11/19/2020Baricitinib(Olumiant)in combinationwith remdesivir(Veklury) (322KB)

Forthetreatmentofmild-to-moderate COVID-19inadultandpediatricpatients withpositiveresultsofdirectSARS-CoV-2 viraltestingwhoare12yearsofageand olderweighingatleast40kg(about88 pounds),andwhoareathighriskfor progressingtosevereCOVID-19and/or hospitalization.

Foremergencyusebyhealthcare providersforthetreatmentofsuspected orlaboratory-confirmedCOVID-19in hospitalizedadultsandpediatricpatients 2yearsofageorolderrequiring supplementaloxygen,invasive mechanicalventilation,orextracorporeal membraneoxygenation(ECMO).

11/21/2020REGEN-COV (Casirivimaband Imdevimab)(232KB) (ReissuedFebruary3, 2021andFebruary25, 2021)

September 02,2021

Bamlanivimaband Etesevimab(344KB) (ReissuedFebruary25, 2021)

Casirivimabandimdevimabtobe administeredtogetherforthetreatmentof mildtomoderatecoronavirusdisease 2019(COVID-19)inadultsandpediatric patients(12yearsofageandolder weighingatleast40kg)withpositive resultsofdirectSARS-CoV-2viraltesting, andwhoareathighriskforprogressingto severeCOVID-19and/orhospitalization.

Forthetreatmentofmild-to-moderate COVID-19inadultandpediatricpatients withpositiveresultsofdirectSARS-CoV-2 viraltestingwhoare12yearsofageand olderweighingatleast40kg(about88 pounds),andwhoareathighriskfor progressingtosevereCOVID-19and/or hospitalization.

December 03,2021

Propofol-Lipuro 1%(344KB)

Tomaintainsedationviacontinuous infusioninpatientsgreaterthanage16 withsuspectedorconfirmedCOVID-19 whorequiremechanicalventilationinan ICUsetting.

DevelopmentofvaccineforpreventionofSARS-CoV-2infectionwasa healthcareprioritywiththefirstclinicaltrialofavaccinecandidateforSARSCoV-2beginninginMarch2020[8].TheFDAprespecifiedsomeoftherequirementsforapprovalunder“DevelopmentandLicensureofVaccinesto PreventCOVID-19”guidance,whichincludedapointestimateforaplacebocontrolledefficacytrialofatleast50%,withalowerboundoftheappropriatelyalpha-adjustedconfidenceintervalaroundtheprimaryefficacyendpoint pointestimateof >30%withadditionalsafetyandeffectivenessdata. Messengerribonucleicacid(mRNA)-basedvaccinesassumedamajorrolein vaccinecandidatesforSARS-CoV-2.Thegeneticinformationfortheantigen isdeliveredbymRNA(withmodifications)oraself-replicatingRNA.The antigenisthenexpressedinthecellsofthevaccinatedindividualinvokingan immuneresponse.

SeveralvaccineswereapprovedforuseunderEUA.Alistisprovidedin Table1.3 asadaptedfrom https://www.fda.gov/medical-devices/coronavirusdisease-2019-covid-19-emergency-use-authorizations-medical-devices/.

TABLE1.3 VaccinesapprovedforuseforpreventionofSARS-CoV-2 infectionunderEUA.

Dateoffirst EUA issuance

Mostrecentletterof authorization(PDF)Authorizeduse November 12,2020 Pfizer-BioNTech COVID-19Vaccine (455KB)(Reissued February25,2021)

LetterGrantingEUA Amendment(January6, 2021)(164KB)

LetterGrantingEUA Amendment(January22, 2021)(190KB)

LetterGrantingEUA Amendment(April6, 2021)(166KB)

12/18/2020ModernaCOVID-19

Vaccine(392KB) (ReissuedFebruary25, 2021)

LetterGrantingEUA Amendment(April1, 2021)(193KB)

02/27/2021JanssenCOVID-19

Vaccine(183KB)

LetterGrantingEUA Amendment(March29, 2021)(152KB)

Forthepreventionof2019coronavirus disease(COVID-19)forindividuals16 yearsofageandolder

Forthepreventionofcoronavirusdisease 2019(COVID-19)forindividuals18years ofageandolder

Forthepreventionofcoronavirusdisease 2019(COVID-19)forindividuals18years ofageandolder

Anotherissuethatisgainingimportanceisreinfection.AbetterunderstandingofreinfectionbecameoneoftheprioritiesforCentersforDisease ControlandPreventiontoinformpublichealthaction[9].andtheEuropean CentreforDiseasePreventionandControl[10]duetoimplicationsfor durationofacquiredimmunity.TheEuropeanCentreforDiseasePrevention andControl[10]andCentersforDiseaseControlandPrevention[11] emphasizethatindividualsthathavebeeninfectedoncewithSARS-CoV-2are notalwaysimmuneandinfectionprevention/controlandcontactprinciples shouldbefollowedevenaftertheinfection.ByOctober2020,fivecasesof reinfectionwithSARS-CoV-2hadbeenreportedfromHongKong,Belgium, theNetherlands,Ecuador,andtheUnitedStates[12 16]whenover37million SARS-CoV-2-infectedpersonshadbeenreportedworldwide[17].Reinfection wasidentifiedin0.7%(n ¼ 63,95%confidenceinterval0.5% 0.9%)during follow-upof9119patientswithSARS-CoV-2infectionamong62healthcare facilitiesintheUnitedStatesbetweenDecember1,2019andNovember13, 2020[18].Themeanperiod( standarddeviation[SD])betweentwopositive testswas116 21days.SimilarresultswerereportedbySARS-CoV-2 ImmunityandReinfectionEvaluation(SIREN)[19]Thestudyidentified44 reinfections(twoprobable,42possible)inthebaselinepositivecohortof6614 healthcareworkers.Theseobservationsstronglysuggestthatsurvivorsfrom SARS-CoV-2infectionmustnotrelaxcompliancewithproveninterventionsin preventionofSARS-CoV-2transmissionsuchassocialdistancing[3]and universalfacemaskuse[20].Duetoconcernsforreinfection,theCentersfor DiseaseControlandPrevention[11]currentlyrecommendsvaccinationfor patientswhohadSARS-CoV-2infectionafter90daysbutacknowledgesthe limiteddataisavailabletosupporttherecommendation.

References

[1]QureshiAI,JilaniT,HuangW,etal.PerformanceofvariouscountriesinreducingCOVID19mortalityafteradjustmentforvulnerability.HealthCareResJ2020;1(1):9 10.

[2]QureshiAI,JaniV,AkhtarI,etal.OccurrenceofCOVID-19mimicinpersonsunder surveillanceafterCOVID-19exposure:asystematicreview.HealthCareResJ 2020;1(1):2 8.

[3]QureshiAI,SuriMFK,ChuH,SuriHK,SuriAK.Earlymandatedsocialdistancingisa strongpredictorofreductioninpeakdailynewCOVID-19cases.PublicHealth 2021;190:160 7.

[4]PatelA,JerniganDB,nCoVCDCResponseTeam.Initialpublichealthresponseand interimclinicalguidanceforthe2019novelcoronavirusoutbreak-UnitedStates, December31,2019 February4,2020.MMWRMorbMortalWklyRep 2020;69(5):140 6.

[5]WangX,FerroEG,ZhouG,HashimotoD,BhattDL.Associationbetweenuniversal maskinginahealthcaresystemandSARS-CoV-2positivityamonghealthcareworkers. JAmMedAssoc2020;324(7):703 4.

[6]HendrixMJ,WaldeC,FindleyK,RTrotman.Absenceofapparenttransmissionof SARS-CoV-2fromtwostylistsafterexpos ureatahairsalonwithauniversalface coveringpolicy Springfield,Missouri,May2020.MMWR(MorbMortalWklyRep). 2020;69(28):930-932.

[7]DepartmentofHealthandHumanServices.Emergencyuseauthorizationdeclaration.2020. UpdatedApril1,2020.[Accessed13April2021], https://www.federalregister.gov/ documents/2020/04/01/2020-06905/emergency-use-authorization-declaration

[8]KrammerF.SARS-CoV-2vaccinesindevelopment.Nature2020;586(7830):516 27.

[9]ReinfectionwithCOVID-19.2020.UpdatedOctober27,2020.[Accessed7Febaruary 2021], https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfection.html

[10]EuropeanCenterforDiseasePreventionandControl.ReinfectionwithSARS-CoV-2: considerationsforpublichealthresponse.2020.AccessedApril4,2021, https://www.ecdc. europa.eu/sites/default/files/documents/Re-infection-and-viral-shedding-threat-assessmentbrief.pdf.

[11]FrequentlyaskedquestionsaboutCOVID-19vaccination.2021.AccessedFebaruary10, 2021, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html#:w:text¼Yes.,already %20had%20COVID%2D19%20infection.

[12]Firstcaseofcovid-19reinfectiondetectedintheus;n.d. https://www.ajmc.com/view/firstcase-of-covid-19-reinfection-detected-in-the-us.[Accessed7February2021].

[13]TillettRL,SevinskyJR,HartleyPD,etal.GenomicevidenceforreinfectionwithSARSCoV-2:acasestudy.LancetInfectDis2021;21(1):52 8.

[14]Prado-VivarB,Becerra-WongM,GuadalupeJJ,etal.COVID-19re-infectionbya phylogeneticallydistinctSARS-CoV-2variant,firstconfirmedeventinSouthAmerica. September3,2020.

[15]ToKK,HungIF,IpJD,etal.COVID-19re-infectionbyaphylogeneticallydistinctSARScoronavirus-2strainconfirmedbywholegenomesequencing.ClinInfectDis 2020:ciaa1275.

[16]VanElslandeJ,VermeerschP,VandervoortK,etal.SymptomaticSARS-CoV-2reinfection byaphylogeneticallydistinctstrain.ClinInfectDis2020;73(2):354 6.

[17]Coronavirusdisease(COVID-19).2020.UpdatedOctober11,2020.AccessedFebaruary7, 2021, https://www.who.int/docs/default-source/coronaviruse/situation-reports/20201012weekly-epi-update-9.pdf

[18]QureshiAI,BaskettWI,HaungW,etal.Re-infectionwithSARS-CoV-2inpatientsundergoingseriallaboratorytesting.ClinInfectDis2021:ciab345.

[19]HallV,FoulkesS,CharlettA,etal.Doantibodypositivehealthcareworkershavelower SARS-CoV-2infectionratesthanantibodynegativehealthcareworkers?Largemulti-centre prospectivecohortstudy(theSIRENstudy),England:JunetoNovember2020.medRxiv 2021;01.13.21249642. https://doi.org/10.1101/2021.01.13.21249642.

[20]BrooksJT,ButlerJC,RedfieldRR.UniversalmaskingtopreventSARS-CoV-2 transmission-thetimeisnow.JAmMedAssoc2020;324(7):635 7.

HistoryofSARS-CoV-2

IrynaLobanova

ZeenatQureshiStrokeInstituteandDepartmentofNeurology,UniversityofMissouri,Columbia, MO,UnitedStates

OnDecember31,2019,theWorldHealthOrganization(WHO)wasformally notifiedaboutaclusterofcasesofpneumoniainWuhanCity,hometo11 millionpeopleandtheculturaland economichubofcentralChina[1 ].By January5th,59caseswereidentifiedandnonehadbeenfatal[ 1 ,2 ].Tendays later,WHOwasawareof282confirmedcases,ofwhichfourwereinJapan, SouthKorea,andThailand[ 1, 3].TherehadbeensixdeathsinWuhan,51 peoplewereseverelyill,and12wereinacriticalcondition.Thevirus responsiblewasisolatedonJanuary7thanditsgenomesharedonJanuary 12th[1 ,4 ].Thecauseofthesevereacuterespiratorysyndromethatbecame knownascoronavirusdisease2019(COVID-19)wasanovelcoronavirus, severeacuterespiratorysyndromeco ronavirus2(SARS-CoV-2).PhylogeneticanalysissuggeststhatSARS-CoV-2originatedinanimals,probably bats,andwastransmittedtootheranimalsbeforecrossingintohumansatthe HuananwetmarketinWuhanCity[ 1, 5 7 ].AsofFebruary22,2021,more than111millioncaseshavebeenconfirmed,withmorethan2.46million deathsattributedtoCOVID-19[8 ].

Thehistoryofhumancoronavirusesbeganin1965afterTyrrellandBynoe [9,10]identifiedavirusnamedB814.Theviruswasfoundinhumanembryonictrachealorganculturesobtainedfromtherespiratorytractofanadultwith acommoncold.Ataboutthesametime,HamreandProcknow[9,11]were abletogrowaviruswithunusualpropertiesintissueculturefromsamples obtainedfrommedicalstudentswithcolds.BothB814andHamre’svirus, whichshecalled229E,wereether-sensitiveandthereforepresumablyrequired alipid-containingcoatforinfectivity.Whileworkinginthelaboratoryof RobertChanockattheNationalInstitutesofHealth,McIntoshetal.[9,12] reportedtherecoveryofmultiplestrainsofether-sensitiveagentsfromthe humanrespiratorytractbyusingatechniquesimilartothatofTyrrelland Bynoe[9,12].Thesevirusesweretermed“OC”todesignatethattheywere growninorgancultures.Withinthesametimeframe,AlmeidaandTyrrell [9,13]performedelectronmicroscopyonfluidsfromorganculturesinfected

CoronavirusDisease. https://doi.org/10.1016/B978-0-12-824409-8.00007-2

withB814andfoundparticlesthatresembledtheinfectiousbronchitisvirusof chickens.Inthelate1960s,Tyrrellwasleadingagroupofvirologistsworking withthehumanstrainsandanumberofanimalviruses.Thisnewgroup ofviruseswasnamedcoronavirus(corona denotingthecrown-likeappearance ofthesurfaceprojections)andwaslaterofficiallyacceptedasanewgenusof viruses[9,14].

Epidemiologicandvolunteerinoculationstudiesfoundthatrespiratory coronaviruseswereassociatedwithavarietyofrespiratoryillnesses;however, theirpathogenicitywasconsideredtobelow[9,11,15 17].Thepredominant illnessassociatedwithinfectionswasanupperrespiratoryinfectionwithoccasionalcasesofpneumoniaininfantsandyoungadults[9,18,19].These viruseswerealsoshowntobeabletoproduceasthmaexacerbationsinchildrenaswellaschronicbronchitisinadultsandtheelderly[20 22].

In2004,vanderHoeketal.[9 ,23]reportedthediscoveryofanewhuman coronavirus,NL63,isolatedfroma7-month-oldgirlwithcoryza,conjunctivitis,fever,andbronchiolitis.Usinganovelgenomicamplificationtechnique,theseinvestigatorswereablet osequencetheentireviralgenome. PhylogeneticanalysisdemonstratedthatthisviruswasagroupIcoronavirus relatedto229Eandtransmissiblegastroenteritisvirus,avirusofpigs. Screeningof614respiratoryspecimenscollectedbetweenDecember2002 andApril2003identifie dsevenadditionalindividualswithupperorlower respiratorytractdiseaseorboth.Shortlyafter,Fouchieretal.[ 9 ,24 ]reported theidentificationofacoronavirus,namedNL,isolatedfroman8-month-old boywithpneumoniaandgrownfromaclinicalspecimenthatwasobtainedin April1988.FullgenomicsequenceanalysisofNLshowedthatthisviruswas alsoagroupIcoronavirusandclosely relatedtoNL63.Thediscoveryofboth NL63andNLdependedonthepropagationofthevirusesincellculture. Withtheuseofmolecularprobesthattargetedconservedregionsofthe coronavirusgenome,monthslater,Esperetal.[ 9].foundevidenceofahumanrespiratorycoronavirusinrespira toryspecimensobtainedfromchildren youngerthan5yearsofage,whichwasdesignatedtheNewHavencoronavirus(HCoV NH).Graf[25 ]detectedthepresenceofapeptidecorrespondingtothespikeglycoproteinofNL63,thecloselyrelatedvirus identifiedintheNetherlands,intissu efromindividualswithKawasakidisease.ThesummationofthesefindingssuggeststhatHCoV-NHmayplaya roleinthepathogenesisofKawasakidisease.

Twononendemiccoronaviruseshave causedseriousdisease.Averynew coronavirus,severeacuterespiratorysyndrome,calledsevereacuterespiratorysyndrome(SARS),emergedin2002 03asacoronavirusfromsouthern Chinaandspreadthroughouttheworldwithquantifiablespeed[9 ,26, 27]. Duringthe2002 03outbreak,SARS-CoVinfectionwasreportedin29 countriesinNorthAmerica,SouthAme rica,Europe,andAsia.Thisvirus wasresponsibleforSARS,aflu-likeilln ess,thoughdiarrheawascommon.It couldprogresstopneumoniaandrespiratoryfailurein2weeks,and25%of peopleinfectedrequiredintensivecare[ 1].SARS-CoVwastransmittedvia

HistoryofSARS-CoV-2 Chapter|2 15

dropletsinrespiratoryaerosol,con tactwithsurfaces,andpossiblyvia fecal oralcontact[ 28 ].Within1monthof55indexcasesbeingrecognized inHongKong,Hanoi,andSingapore,atotalof3000caseshadbeen confirmedgloballywithapeakreportingrateof200newcasesperday[29].

Overall,8098infectedindividualswereidentified,with774SARS-related fatalities[30 ].ItisstillunclearhowthevirusenteredthehumanpopulationandwhethertheHimalayanpalmcivetswerethenaturalreservoirforthe virus.SequenceanalysisofthevirusisolatedfromtheHimalayanpalmcivets revealedthatthisviruscontaineda29-nucleotidesequencenotfoundinmost humanisolates,inparticularthoseinvolvedintheworldwidespreadofthe epidemic[31 ].TheSARSepidemicgavetheworldofcoronavirusesresearch anenormousinfusionofenergyandactivitythatcontributedtothelarge amountalreadyknownaboutthevirologyandpathogenesisofcoronavirus infectionsfromtheexpandingareaofveterinaryvirology[ 32 ].

ThesecondseriousinfectionduetoacoronaviruswasMiddleEastern respiratorysyndrome(MERS).TheMERS-CoVviruswasfirstidentifiedas thecauseofafatalinfectioninSaudiArabiain2012[9 ,33 ].Itspreadto27 countries.UnlikeSARS,MERSisstillprevalent,andasofNovember2019, 2494infectionshadbeennotified,ofwhich858provedfatal[ 9 ,34].Like SARS,MERScausesaflu-likeillnes swithsymptomsrangingfrommild (withaboutone-quarterofpeoplealsohavingdiarrhea)toseverepneumonia, acuterespiratorydistresssyndrome ,septicshock,andmultiorganfailure. MERS-CoVisbelievedtohavereachedhumansviadromedarycamels, whichappeartobeareservoirinseveralMiddleEaststates.Theoriginal sourcespeciesisnotknown,butbatsarethemostlikely.SARS-CoV-2more closelyresemblesthebatwildvirusthanitdoeseitherSARS-CoVorMERSCoV,stronglysuggestingthatitisanovelcoronavirusinhumans[6 , 9]. OutbreaksofMERS-CoVinfectionnow occurmostlyduetoanimal-to-humantransmission(probablyduringthecamelcalvingseason)[9 , 35 ].Personto-personspreadseemstodependonclosecontact,suchasprovidingcareto aninfectedpersonorwithinahospitalsetting.Inall,40%ofconfirmedcases havebeenacquirednosocomially on1dayinMay2015,anindividualwith MERSvisitedseveralhospitalsinKoreaandinfected186people[ 9, 33].No vaccinesareyetavailablethatcanprotectagainstMERS-CoVinfection[33].

Astudyofthefirst41casesofconfirmedCOVID-19,publishedinJanuary 2020in TheLancet,reportedtheearliestdateofonsetofsymptomsas December1,2019[36].OfficialpublicationsfromtheWHOreportedthe earliestonsetofsymptomsasDecember8,2019[37].Human-to-human transmissionwasconfirmedbytheWHOandChineseauthoritiesbyJanuary 20,2020[38].

Duringtheearlystagesoftheoutbreak,thenumberofcasesdoubled approximatelyeverysevenandahalfdays[39].Inearlyandmid-January 2020,thevirusspreadtootherChineseprovinces,helpedbytheChinese NewYearmigrationandWuhanbeingatransporthubandmajorrail

Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.