Clinical Impact of New Data From Virtual ECCVID 2020 - Valean Darou
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Clinical Impact of New Data From Virtual ECCVID 2020 CCO Independent Conference Coverage* of the 2020 Virtual European Society of Clinical Microbiology and Infectious Diseases Conference on Coronavirus Disease 2020 (ECCVID 2020); September 23-25, 2020 *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
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permissions@clinicaloptions.com for detailsFaculty and Disclosure Information Barbara Rath, MD, PhD, HDR Co-founder & Chair The Vienna Vaccine Safety Initiative Research Director Université de Bourgogne Franche-Comté, France Honorary Professor Executive Board Member ESGREV (Respiratory Virus Study Group for ESCMID) Barbara Rath, MD, PhD, HDR, has no relevant conflicts of interest to report.
Outline Contact Tracing in Singapore Asymptomatic SARS-CoV-2 in Switzerland Cell-Based Culture of SARS-CoV-2 for Infectivity Determination Correlating Pathology With Viral Localization in Tissues and Cells Investigating COVID-19 Treatments Vaccine Updates Ethical Considerations for the Elderly in COVID-19 Social Determinants of Health in COVID-19
Contact Tracing in Singapore
Building Blocks of COVID-19 Management in Singapore
Prevent: “safe management measures” in place to circumvent
transmission, border control to reduce importation
Detect: case finding and comprehensive surveillance, increased testing
capacity (by > 10x) and capability
Care: strengthened healthcare capacity and resources, invested in
vaccine/treatment research and deployment
Contain: enhanced contact tracing to find cases early and probe
networks surrounding those cases, quarantine capacity and capability
Lee. ECCVID 2020. Slide credit: clinicaloptions.comContact Tracing
Mapping occurs in backward direction to discern the infection source
and in forward direction to identify contacts subsequently exposed
Lab alert of Movement and Query whether Engage Enact appropriate public
positive interactions of case linked to contacts to health measures to halt
COVID-19 test case patient known clusters confirm additional transmission events
mapped via exposure and (ie, quarantine or phone
interview assess health surveillance of contacts)
Novel technologies being used in contact tracing efforts
‒ SafeEntry app with check-in at venues, CCTV records, geospatial-temporal
mapping by IT analysts to identify clusters, TraceTogether token or app
based on Bluetooth signals shared between users
Lee. ECCVID 2020. Slide credit: clinicaloptions.comCase Identification and Contact Tracing:
Pairing Technologic and Manual Strategies
SafeEntry data
TraceTogether data
Generation of
first-cut of
contacts, ~ 3 hrs
COVID-19 Test Repository: Data fusion
Single source of truth for Quarantine
X
all COVID-19 test results order issued
Government Prefilled base activity map
admin data to interview patients
Lee. ECCVID 2020. Slide credit: clinicaloptions.comQuarantine Logistics
Electronic quarantine order (eQO) delivered via SMS, individual able to sign
declaration form remotely
‒ Homer app then prompts quarantined individual to report temperature and
health status every 3 hrs, reports GPS-based location every 5 mins
Between April 1 and September 14, 2020, 18,757 persons quarantined based
on exposure to 2325 community cases
‒ 337 individuals became subsequent cases after isolation
Outcome Aug 23-29 Aug 30 - Sept 5 Sept 6-12
Total QOs, n 641 1060 617
Total eQOs issued, n (%) 607 (95) 873 (82) 566 (92)
Homer app enrollment for monitoring, n 573 686 515
Lee. ECCVID 2020. Slide credit: clinicaloptions.comAddition of Technologic Monitoring Reduces Time
Needed to Pinpoint and Quarantine Contacts
Manual Manual Plus Manual Plus
Only VISION, SafeEntry VISION, SafeEntry, and TraceTogether
4 4
3.80
Weekly Moving Average
Raise or Issue QO (Days)
Time to Issue QO (Days)
3 2.79 2.71 3
Average Time to
2.90 2.47
2.20
2.01 2.08
2 2.31 2
1.73 1.76 1.88 1.83
1 1
0 0
Lee. ECCVID 2020. Slide credit: clinicaloptions.comAsymptomatic SARS-CoV-2 in Switzerland
Prevalence of Asymptomatic SARS-CoV-2 Infections in
Inpatient Population in Basel, Switzerland
All adult patients admitted to N = 4466 samples from 4099 patients
University Hospital Basel, Switzerland, ‒ 25 (0.6%) positive for SARS-CoV-2
April 1 - June 14, 2020, were screened
for SARS-CoV-2 within 72 hrs of ‒ Asymptomatic: 3722 (90.8%) patients
admission ‒ 6 patients positive for SARS-CoV-2
Asymptomatic vs symptomatic were asymptomatic
determination made by retrospective ‒ 27% of all positive patients
classification criteria: ‒ 0.16% of all asymptomatic patients
‒ Acute pulmonary symptoms ± Proportion of asymptomatic patients
‒ Fever ≥ 38.0°C ± among SARS-CoV-2 infected
‒ Sudden onset anosmia or ageusia ± remained similar over time even
as overall prevalence dropped:
‒ Acute confusion/deterioration in
elderly unless otherwise explained 21% in April, 33% in May
Stadler. ECCVID 2020. Abstr 155. Slide credit: clinicaloptions.comPrevalence of Asymptomatic SARS-CoV-2 Infections in
Inpatient Population in Basel, Switzerland
Systematic screening detected low but constant proportion of
asymptomatic carriers
‒ Suggests unfavorable cost–benefit ratio of universal screening
‒ Supports need for universal infection prevention and control strategies
Potential study limitations
‒ Patients classified retrospectively
‒ Unable to distinguish asymptomatic vs presymptomatic patients
‒ Restricted to inpatient population
Stadler. ECCVID 2020. Abstr 155. Slide credit: clinicaloptions.comCell-Based Culture of SARS-CoV-2 for
Infectivity DeterminationCell-Based Culture of SARS-CoV-2 as Surrogate for
Infectivity
Methods: ICU Inpatients/
Outpatients
Parameter Patients Non-ICU
‒ Culture all SARS-CoV-2 RNA+ samples (n = 5) (n = 12)
(n =178)
in Vero C1008 cells Avg age, yrs 58 43 40
‒ Inspect daily for cytopathic effect Number of samples 11 42 181
Avg days from
‒ Confirm cytopathic effect by PCR of symptom onset to 7 7 12
cell culture supernatant sample collection
Culture positive
‒ If no cytopathic effect by Day 4, and CPE, %
55 40 12
PCR of cell culture supernatant
Culture positive
27 5 3
‒ Positive culture: Ct value of cell and no CPE, %
culture reduced by ≥ 3 cycles vs Total culture
82 45 15
positive, %
original sample Ct value (determined
to be equivalent to 1 log increase in
viral quantity)
Basile. ECCVID 2020. Abstr 68. Slide credit: clinicaloptions.comCell-Based Culture of SARS-CoV-2 as Surrogate for
Infectivity: Results
SARS-CoV-2 Successfully Isolated Only From
Samples With Ct Value < 32
100 45 100
90 40 90
Ct Values (N gene)
% Culture Positive
% Culture Positive
80 35 80
70 30 70
60 60
25
50 50
20
40 40
30 15 30
20 10 20
10 5 10
0 0 0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29
18 20 22 24 26 28 30 32 34 3628 38 40
Days Since Symptom Onset Days Since Symptom Onset
Basile. ECCVID 2020. Abstr 68. Slide credit: clinicaloptions.comCorrelating Pathology With Viral Localization in Tissues and Cells
Pathology Findings in COVID-19: Background
COVID-19 spectrum in mainland China through February 11, 2020 (N = 44,415):
81% mild, 14% severe, 5% critical[1]
Clinical–therapeutic staging proposed, based on successive disease states
experienced during COVID-19: (1) early infection, (2) pulmonary phase, and
(3) hyperinflammation phase[2]
‒ Antiviral, convalescent plasma use suggested throughout; immune-targeted
therapeutics reserved for mid to late stages
Diabetes, HTN, COPD, and coronary heart disease commonly occur in COVID-19
patients with severe disease, those requiring hospitalization[3,4]
Endothelial cells hypothesized to play essential role in onset and maintenance of
severe COVID-19 via vascular leakage, coagulation, and inflammation[5]
1. Wu. JAMA. 2020;323:1239. 2. Siddiqi. J Heart Lung Transplant. 2020;39:405. 3. Guan. NEJM. 2020;382:1708.
4. Richardson. JAMA. 2020;323:2052. 5. Teuwen. Nat Rev Immunol. 2020;20:389. Slide credit: clinicaloptions.comSigns of Endothelial Cell Disruption During COVID-19
Endotheliitis in the lung, small intestine, kidney, myocardium, and liver
Small thrombi in the lung and small intestine with mesenteric ischemia
Apoptosis of endothelial cells (measurable via caspase 3 staining) also
prominent in the lung and small intestine
Varga. ECCVID 2020. Varga. Lancet. 2020;395:1417. Slide credit: clinicaloptions.comMethodology for Detecting SARS-CoV-2 in Tissue
Method Sensitivity Turnaround Advantages Disadvantages
“Classical” smear Good, depends on Short Postmortem tissue
Not cell type specific
(swabs) disease stage (up to 24 hrs) Triage autopsy
Short Testing organ
RT-PCR in FFPE High Not cell type specific
(1-2 days) involvement
Short Lab techniques demanding
FISH and CISH in FFPE Low to medium Cell type specific
(1-2 days) Fixation time dependent
Short Background stain
Immunohistochemistry Low to medium Cell type specific
(1 day) Unequivocal signals
Cell type specific (exact Lab techniques demanding
Fluorescence-labeled Short
Low to medium anatomical localization IF microscope
immunohistochemistry (1 day)
of signals) IF >>> IHC
Lab techniques demanding
Exact anatomical
Long Time-consuming analysis
Electron microscopy Low localization of virus-like
(days to wks) Requires confirmation with
particles
immunoelectron microscopy
Varga. ECCVID 2020. Slide credit: clinicaloptions.comBroad Organotropism of SARS-CoV-2
SARS-CoV-2 detected by RT-PCR, in situ hybridization, and IHC/IF across
organs in postmortem FFPE tissue samples[1-3]
‒ Localizes virus predominantly to the lung with lower concentrations
observed in the heart, kidney, liver, spleen, brain, and blood
‒ EM also a valuable tool for visualizing viral infection[4]
Pairing viral tropism data with morphologic findings may yield a better
understanding of SARS-CoV-2 pathophysiology
1. Puelles. NEJM. 2020;383:590. 2. Liu. JCI Insight. 2020;5:e139042.
3. Sekulic. Am J Clin Pathol. 2020;154:190. 4. Park. J Korean Med Sci. 2020;35:e84. Slide credit: clinicaloptions.comPulmonary Pathology: Progression During COVID-19
Pulmonary observations for 4 fatal COVID-19 cases in Tübingen, Germany[1]
‒ Early disease: neutrophilic, exudative capillaritis with microthrombosis, copious
IL-1β and IL-6
‒ Subsequently: diffuse alveolar damage, intravascular thrombosis in
small/medium vessels, occasional infarction, lab features of DIC
‒ Late stages: organizing pneumonia with intraalveolar fibroblast proliferation,
marked metaplasia of alveolar epithelium, mutiorgan failure
Viral RNA present in the lung (eg, endothelial cells and pneumocytes)[1-3]
Organ involvement coincident with clinical involvement/organ damage[1-3]
1. Bösmüller. Virchows Arch. 2020;477:349. 2. Schaller. JAMA. 2020;323:2518. 3. Skok. Virchows Arch. 2020;[Epub]. Slide credit: clinicaloptions.comSporadic Discordance Between Swab Positivity, Organ
Damage in Autopsy Data From COVID-19 Patients (Graz, AT)
Patient
Characteristic
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Swab result
Throat: first am Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos
Throat: last am Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Neg Pos Pos Pos Pos Neg Pos
Throat: first pm Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Neg Pos Pos Neg Neg Neg Pos
Right lung Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Neg Pos Pos Pos Neg Pos Pos
Left lung Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Pos Neg Pos Pos Neg Neg Pos Pos
Colon - - - - - - - Pos Pos Neg Neg Neg Neg Pos Pos Pos Neg - Neg
Lung damage
Edema Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Hyaline membranes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Proliferation Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Thrombosis Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
Infarction Yes Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes
Bronchopneumonia No Yes Yes No Yes No Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes
Fibrosis No Yes Yes No Yes No Yes Yes No Yes Yes Yes Yes No Yes Yes Yes Yes Yes
Degree of damage Sev Sev Mod Mod Mod Sev Sev Sev Sev Sev Sev Sev Sev Mod Mod Mod Sev Mod Sev
Ischemic bowel
No No No No No No No Yes No No No Yes Yes Yes No No Yes Yes No
changes
Skok. Virchows Arch. 2020;[Epub]. Slide credit: clinicaloptions.comInvestigating COVID-19 Treatments:
UmifenovirUmifenovir in Hospitalized COVID-19 Patients in Iran
Umifenovir: broad-spectrum antiviral (fusion inhibitor) used for influenza
and other ARI in Russia and China; shown to inhibit SARS-CoV-2 in vitro[1]
Study evaluated efficacy of umifenovir against COVID-19 in hospitalized,
symptomatic patients in Iran[2]
Control Regimen: Lopinavir/Ritonavir 400/100 mg BID for 10-14 days +
Hydroxychloroquine 400 mg +
Hospitalized adults with symptoms*
Interferon-b1a 44 mg SC on Days 1,3,5
≤ 14 days and peripheral capillary
(n = 50)
SpO2 ≤ 93% on pulse oximetry,
respiratory frequency ≥ 24/min on
ambient air Umifenovir 200 mg 3x/day for 10 days +
(N = 101) Control regimen
(n = 51)
*At least one of: body temperature ≥ 37.5∘C, cough, shortness of breath, nasal congestion/discharge, myalgia/arthralgia, diarrhea/vomiting,
headache, fatigue
1. Wang. Cell Discov. 2020;6:28. 2. Darazam. ECCVID 2020. Abstr. Slide credit: clinicaloptions.comUmifenovir in Hospitalized COVID-19 Patients in Iran
Umifenovir did not significantly improve time to clinical improvement,
mortality, time on ventilation, or length of hospitalization
20 Control
18 Umifenovir + control
16
14
12
10
8
6
4
2
0
Mortality Median Time on Median Hospital Stay, Time to Clinical
Ventilation Median No. Improvement, Median
Darazam. ECCVID 2020. Abstr. Slide credit: clinicaloptions.comVaccine Updates
Development of Vaccines Against SARS-CoV-2
36 candidate vaccines in clinical Oxford vaccine: SARS-CoV-2 spike
development, 146 in preclinical protein in nonreplicating chimpanzee
stages[1] adenovirus (ChAdOx1)[3]
Neutralizing antibody
Anti–SARS-CoV-2 spike protein
neutralizing antibody correlates with
protection in macaques[2] 256
MNA IC80
Approaches under evaluation include 64
spike protein nanoparticles with
Matrix M, spike protein mRNA in lipid
16
nanoparticles, spike protein DNA,
Ch: N = 45 45 9
adenovirus vectors (Ad5, Ad26) Mn: N = 2 2 0
0 28 42
Day
1. https://www.eccvid.org/media-790-news-regarding-covid-19-vaccines. 2. Yu. Science 2020;369:806. 3. Pollard. ECCVID 2020. Slide credit: clinicaloptions.comSARS-CoV-2 Vaccine Clinical Trials
International trial of Oxford vaccine: Development Timeline 6-12 Mos
United Kingdom (19 sites), Brazil (6 Vaccine Animal
sites), South Africa (6 sites) Design Studies
Phase
‒ Phase II/III studies started at end of
I/II GMP
June: South Africa (6 sites, planned
enrollment 2000); Brazil (3 sites, Phase I 1000 adults 18-55 yrs of age
planned enrollment 10,000)
Phase II 56 yrs+
Nonlinear trial progression with
highly compressed time scale; first Phase III 10,000 > 18 yrs
Phase III of age
safety and immunogenicity data GMP
coming in from several vaccines Upscale
Licensure
GMP
Pollard. ECCVID 2020. Slide credit: clinicaloptions.comNormal Vaccine Development in Comparison
Development Timeline 5-10 Yrs
Vaccine Animal Phase I/II Upscale
Design Studies GMP Phase I Phase II Phase III GMP
Phase III
GMP Licensure
Pollard. ECCVID 2020. Slide credit: clinicaloptions.comEthical Considerations for the
Elderly in COVID-19Considerations on Aging and COVID-19
Aging is heterogeneous with variable effects of genetic, socioeconomic, and
behavioral factors[1]
‒ In 2018, 88% of persons ≥ 75 yrs of age in US had no limitation in activities of
daily living[2]
Potential for single trigger to cause disproportionate complications[3]
‒ Iatrogenic events, healthcare-associated infection, falls, malnutrition,
immobilization or pressure sores, delirium or behavioral disorders, exacerbation
of chronic disease
Atypical COVID-19 presentation in older patients with sizeable rates of
hospitalization and death; many infections arising in nursing homes[4,5]
‒ In context of stressed healthcare system, pushes clinicians to determine if age
should be a primary criterion in medical care decision-making
1. Lowsky. J Gerontol A Biol Sci Med Sci. 2014;69:640. 2. https://www.cdc.gov/nchs/nhis/shs/tables.htm.
3. Clegg. Lancet. 2013;381:752. 4. Annweiler. Clin Infect Dis. 2020;[Epub]. 5. Zerah. J Gerontol A Biol Sci Med Sci. 2020;[Epub]. Slide credit: clinicaloptions.comCOVID-19 in Nursing Homes or LTCFs in France
Case fatality rate: 39% (14,214 resident deaths among 36,857 cases)
Outcome* Among Residents Among Staff
Confirmed cases 36,857 17,975
Hospital deaths 3771 NR
Establishment deaths 10,443 NR
*Among 6267 reports for EHPA.
Gavazzi. ECCVID 2020. Slide credit: clinicaloptions.comAdapting Logistics of Medical Care During COVID-19
During COVID-19 pandemic, potential for ICUs to become overwhelmed
despite surge strategies in place[1]
May be necessary to develop triage policy to prioritize patients (eg, by age
for ICU admission) and ration resources[1]
Key unknowns[1]
‒ Effect of long-term hospitalization or ICU stay on older populations
‒ Age limit for full recovery or benefit from hospitalization
In single French LTCF, at least 24 COVID-19–related deaths over 5 days[2]
‒ Most attributed to hypovolemic shock, no ARDS observed; providers lacked
protective masks, were overworked due to 40% staff absenteeism rate leading
to patient neglect
1. Gavazzi. ECCVID 2020. 2. Diamantis. J Am Med Dir Assoc. 2020;21:989. Slide credit: clinicaloptions.comExcess Winter Death in France: Younger Populations
600 15-44 Yrs of Age
Excess Deaths (n)
400
Cumulative
2014/15 2015/16 2016/17
2017/18 2018/19 2019/20 200
0
-200
Younger Than 15 Yrs of Age 40 44 48 52 4 8 12 16 20 24 28 32 36 38
300 Wk
Excess Deaths (n)
200 45-64 Yrs of Age
3,300
Cumulative
100
Excess Deaths (n)
2,800
0
Cumulative
2,300
-100 1,800
-200 1,300
-300 800
40 43 46 49 52 3 6 9 12 15 18 21 24 27 30 33 36 39 300
Wk
-200
40 43 46 49 52 3 6 9 12 15 18 21 24 27 30 33 36 39
Wk
Gavazzi. ECCVID 2020. Slide credit: clinicaloptions.comExcess Winter Death in France: Older Populations
2014/15 2015/16 2016/17
2017/18 2018/19 2019/20
Cumulative Excess Deaths (n)
Cumulative Excess Deaths (n)
15,000 65-84 Yrs of Age 20,000 ≥ 85 Yrs of Age
15,000
10,000
10,000
5000
5000
0
0
-5000 -5000
2
4
6
8
38
40
42
44
46
48
50
52
10
12
14
16
18
20
22
24
26
28
30
32
34
36
2
4
6
8
52
40
42
44
46
48
50
10
12
14
16
18
20
22
24
26
28
30
32
34
36
38
Wk Wk
Gavazzi. ECCVID 2020. Slide credit: clinicaloptions.comMeta-analysis Regarding Effect of Age on Mortality
Among Patients With COVID-19
Prioritize older populations for infection control and prevention;
adapt the healthcare system as needed
OR (95% CI)
Mortality by Country Patients, n
70-79 Yrs vs 60-69 Yrs > 80 Yrs vs 70-79 Yrs
China 44,672 2.32 (1.97-2.72) 2.00 (1.66-2.42)
USA 2634 2.53 (1.87-3.44) 2.45 (1.87-3.22)
UK 129,799 2.17 (2.06-2.28) 1.30 (1.26-1.35)
Spain 220,375 3.24 (3.05-3.44) 1.66 (1.60-1.73)
Italy 214,103 2.91 (2.78-3.05) 1.22 (1.19-1.26)
Overall 611,583 2.62 (2.18-3.15) 1.60 (1.36-1.88)
Bonanad. J Am Med Dir Assoc. 2020;21:915. Slide credit: clinicaloptions.comFactoring Ethics, Reason Into Decisions on Rationing
Severity, Acute Disease Physiologic Reserves, Geriatric Criteria
Benefit Autonomy
Risks for death Hospitalization Nonmaleficence
Risks for other ICU Beneficence
outcomes Nursing home Equity
Other Justice
Personalized Medicine
Gavazzi. ECCVID 2020. Slide credit: clinicaloptions.comEmerging ICU Guidance in Paris
1. ANTICIPATE
the use of critical care for COVID+ patients on oxygen
In the nursing home and long stay care units, emergency units,
standard hospital care units – before clinical severity + traceability
2. COLLECT
ADAPT the elements for decision-making
Local organizations CLINICAL SINGULARITY PATIENT’S SINGULARITY
Sanitary situation PATIENT’S WILL
Respiratory Frailty + CFS
Expressed
COORDINATE Hemodynamics Comorbidities
Advance directives
Care pathways Neurology Age
Trusted/close person
Expertise (multiple) SOFA Score Neurocognitive
INFORM-SUPPORT-COMMUNICATE 3. DECIDE
Patients under the responsibility of a physician after a collegial process
Relatives and friends ADMISSION NOT REQUIRED
Caregivers IMMEDIATE ADMISSION ADMISSION DENIED
Hospitalization (wards)
The lay public Unrestricted/restricted Hospitalization (wards)
Monitoring
Re-evaluation Supportive/palliative care
Reassessment
Azoulay. Crit Care. 2020;24:293. Slide credit: clinicaloptions.comSocial Determinants of Health in COVID-19
COVID-19 in São Paulo Slums
Slums defined by: high population density, low per capita income,
absence of basic urban infrastructure (garbage collection, basic
sanitation)
In Brazil, > 11 million people live in slums
Higher social vulnerability co-maps with more COVID-19 deaths in
São Paulo slums
‒ Underscores need to direct more effective public policies for disease
mitigation toward vulnerable groups
Oliveira. ECCVID 2020. Abstr. Slide credit: clinicaloptions.comGo Online for More CCO
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