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PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests...

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Page 1: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 2: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 3: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 4: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 5: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 6: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.
Page 7: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

COVID-19 Response Efforts• Since March, FHCSD has tested over 24,400+ individuals! That’s

over 900 individuals a week.

• Our focus has been on the communities hit hardest; FHCSD’s test positivity rate has been double, and sometimes even triple that of the county’s average positive test rate.

• FHCSD quickly mobilized to test those experiencing homelessness sheltered at the San Diego Convention Center.

Page 8: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Testing at Logan Heights Family Health Center

Community Testing Sites

Page 9: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

COVID-19 Response Efforts• We never closed our doors: FHCSD clinics remained

open and continued to care for the community with the highest quality of care.

• FHCSD’s mental health services transitioned to telehealth, as the importance of mental health services during a mandated stay-at-home order cannot be understated.

• FHCSD test sites and labs work diligently to provide test results within 1-2 days while corporate labs take anywhere up to 8-12 business days.

Page 10: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Christian B. Ramers, MD, [email protected] - @cramersmdChief, Population HealthMedical Director, Laura Rodriguez Research InstituteDirector, Graduate Medical EducationFamily Health Centers of San Diego

Clinical Associate Professor – UC San Diego School of MedicineAdjunct Associate Professor – San Diego State Graduate School of Global Public HealthSenior Clinical Advisor – Clinton Health Access Initiative - Global Hepatitis Program

9/18/20

Page 11: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Outline

• Global/Local Epidemiology Update• FHCSD Response• Clinical Aspects• Vaccine Landscape and the path ahead • Q&A

Page 12: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Global and Local COVID-19 Epidemiology

Page 13: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 - accessed 9/14/20

India – 5,020,359 cases; 82,066 deathsBrazil – 4,419,083 cases; 134,106 deathsRussia – 1,075,485 cases; 18,853 deathsPeru – 738,020 cases; 30,927 deathsColumbia – 728,590 cases; 23,288 deathsMexico – 676,487 cases; 71,678 deathsSouth Africa – 653,444 cases; 15,705 deathsSpain – 614,360 cases; 30,243 deaths

Page 14: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 ; www.nytimes.com -accessed 8/24/20

What’s behind the resurgence?- Weak national strategy – deferring many policies to regional gov’t- Premature re-opening – welcoming tourists to bars/restaurants- Low levels of testing and contact tracing

COVID-19 Resurgence in SpainSpain Cases through 8/24/20

Spain deaths through 8/24/20

Page 15: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html- Accessed 9/16/20 -

US COVID-19 Cases – week of 9/14/20

Page 16: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

COVID-19 Trends by US State – 9/9/20

https://www.covidexitstrategy.org/- accessed 9/16/20

Page 17: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

California COVID-19 Cases & Deaths

https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/ - accessed 9/17/20https://public.tableau.com/views/COVID-19CasesDashboard_15931020425010/Cases?:embed=y&:showVizHome=no

Page 18: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

San Diego COVID-19 Dashboard

https://www.arcgis.com/apps/opsdashboard/index.html#/96feda77f12f46638b984fcb1d17bd24 – accessed 9/17/20

Hospitalizations: (N = 3,366) 7.7%ICU: (N = 791) 1.8%Death: (N = 754) 1.7%

Page 19: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

San Diego COVID-19 Testing & Diagnosis

https://www.sandiegocounty.gov/content/dam/sdc/hhsa/programs/phs/Epidemiology/COVID-19%20Percentage%20Positive.pdf – accessed 9/17/20

Page 20: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

CA REVISED Re-opening: Blueprint for a Safer Economy

• *To advance to the next tier, a county must also meet health equity measures.• **Adjusted case rate will be determined using confirmed (by PCR) cases and will not include state and federal inmate cases. Assignment of a case rate tier includes an

adjustment factor for counties that are testing above the state average.• *** Excludes state and federal inmate cases

https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/COVID19CountyMonitoringOverview.aspx

• County assigned a tier based on two metrics: – Cases/100,000 population**– Test Positivity Rate

• Data reported Tuesday based on 7d average with 7d lag• Stay in tier minimum 3 wks; move down if 2 consecutive wks

of better tier in both metrics; up if either metric worse

**

Page 21: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

CA REVISED Re-opening: Blueprint for a Safer Economy

https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/COVID19CountyMonitoringOverview.aspx

9/8/20

9/14/20

Page 22: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Outbreak at San Diego State

• 750 cases reported in 92115 zip code • SD County on site conducting investigations/mass testing • Test positivity initially 20%, now decreasing significantly

Page 23: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Why can some things stay open and others must close?

https://covid19.ca.gov/safer-economy/

Page 24: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Why restaurants, bars, gyms?

https://www.cdc.gov/mmwr/volumes/69/wr/mm6938e1.htm?s_cid=mm6938e1_w

• 11 outpatient clinics (MA, CO, MN, UT, OH, NC, TN, MD, CA, WA)• N = 154 cases (RT-PCR confirmed COVID-19), compared with N = 160 controls• 42% of cases and 14% of controls had a known COVID-19 contact• Analyzed overall, and among those without known contact• Activities associated w/ COVID: restaurant (aOR 2.8), bar/coffee shop (aOR 3.9)

*

*

*

*

Page 25: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

CDC indicators/thresholds for risk of introduction and transmission of COVID-19 in schools

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/indicators.html

Page 26: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

CDC indicators/thresholds for risk of introduction and transmission of COVID-19 in schools

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/indicators.html

Page 27: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/ - accessed 9/17/20

California COVID-19 Racial Disparities

Page 28: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

San Diego Racial/Ethnic Disparities

https://www.sandiegocounty.gov/content/dam/sdc/hhsa/programs/phs/Epidemiology/COVID-19%20Race%20and%20Ethnicity%20Summary.pdf

• San Diego County = 33% Latino by population

Page 29: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

FHCSD Response: testing, testing, testing

Page 30: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

SARS-CoV-2 Testing Basics• Virologic (a.k.a. ‘Diagnostic’) Testing: Nasal, Oral swab, sputum/saliva

– Currently all RT-PCR, future may be Antigen or CRISPR-based– Only positive during small window of infection -2 to +7-10 days in relation to symptoms– Sensitivity ~70-95%

• Serologic (a.k.a. Antibody) Testing: Capillary or Venous blood– Antibody or ‘Immunoglobulin’ tests (IgM or IgG)– Become positive 10-14 days (mean 11.8 days) after onset of symptoms– Sensitivity/Specificity: HIGHLY VARIABLE!!

https://thenativeantigencompany.com/why-we-need-antigen-and-antibody-tests-for-covid-19/

Sym

ptom

ons

et

Virologic Testing Window-2 0 +7

Serologic Testing Window+10 +14

Page 31: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

In-house FHCSD testing– Validated 4/6/20 on Abbott m2000

• ~80 tests per run; 6-hour prep/run time• Close to 200 tests/day• Turnaround time approx. 24 hrs

– Testing offered in all 23 clinics– Open Access testing at Logan Urgent Care– Massive testing effort of unsheltered

at SD Convention Center• Self-collected nasal swabs of all individuals

– New testing protocol for OB patients– Testing later offered for pediatric patients– Antibody testing introduced on Abbott

Architect platform (100% sens/99.9% spec)

FHCSD COVID-19 Testing Experience

https://www.copanusa.com/sample-collection-transport-processing/utm-viral-transport/ (3:00 – 4:45)

Page 32: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6917e1-H.pdf

Mass testing at Convention Center

Page 33: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Marquez H, Ramers C, Norris J, Godino J et al Emerg Infect Dis 2020 (in Preparation)

Asymptomatic Screening in SD Conv Center/Congregant Settings• Collaboration with Father Joe’s Village, Alpha Project, Veteran’s Village SD, City

of San Diego, County of San Diego• Expanded to include PATH/Downtown Connections, SD Rescue Misson,

Salvation Army, MacAllister, House of Metamorphosis• Mass testing campaigns of asymptomatic residents of congregate settings to

identify and isolate COVID-19 cases• Results: 4/16/20-8/5/20 1,937 homeless individuals tested in convention center;

5/720-7/10/20 an additional 523 tested at 9 additional congregant settings

April May June July August Total

# Tested 593 369 728 230 536 2456

# COVID + 2 4 7 2 7 22

% COVID + 0.3% 1.1% 1.0% 0.9% 1.3% 0.9%

Page 34: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

E-HR/Power BI – Dashboard – FHCSD COVID-19 testing experience

FHCSD COVID-19 Testing Experience 6/17/20• 11.2% positive (Stable! 11.0%, 11.1%, 9.9%, 7.7%) • Testing rate 89.5% (88.3% last week, 79.4% 2 wk ago, 76% 3 wks ago)• 826 COVID-19 cases (up from 639, 479, 358, 247, 137, 86)

– Averaging 175 tests/day (stable: 180/d, 207/d, 160/d)– Multiple ‘open access’ locations: Diamond, CH, LH, NC, CV, EC, LH, NP, GSV)

Page 35: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

E-HR/Power BI – Dashboard – FHCSD COVID-19 testing experience

FHCSD COVID-19 Testing Experience – 7/29/20• Last two weeks: 15.8% positive (Increased from prior 2-week

intervals: 13% 11.9% 11.2%, 11.0%, 11.1%, 9.9%, 7.7%) • 2,255 COVID-19 cases (up from 1707,1160, 826, 639, 479, 358, 247, 137, 86)

– Averaging 370 tests/day (increase from: 240/d, 175/d, 180/d, 207/d, 160/d)– Multiple ‘open access’ locations: Logan Heights, GSV, Diamond, Chula Vista– Overall FHCSD positive: 13.6%; Overall County positive 5%– FHCSD has contributed 2.8% of county’s testing but 8.0% of cases

7/14/20: 65/380 (17.1%) positive7/20/20: 72/344 (20.9%) positive

Page 36: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

E-HR/Power BI – Dashboard – FHCSD COVID-19 testing experience

FHCSD COVID-19 Testing Experience 9/9/20• 11.9% positive (13.8%, 13%,11.9% 11.2%, 11.0%, 11.1%, 9.9%, 7.7%) • 3,039 COVID-19 cases (2,850, 2,548, 1,707, 1160, 826, 639, 479, 358, 247, 137, 86)

– Averaging 170+ tests/day (decrease from: 211/d, 282/d, 240/d, 175/d, 180/d, 207/d, 160/d)

– Multiple ‘open access’ locations: Logan, GSV, Diamond, Chula Vista– Overall FHCSD positive: 13.9%; Overall County positive 4.6%– FHCSD has contributed 2.5% of county’s testing but 7.4% of cases

Page 37: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

FHCSD COVID-19 Testing Experience• FHCSD Testing population younger

than SD County

Tent Testing Site Positive Rate last 2 weeks Prior 2 weeks

CVFHC 12.4% 14.1%

DNFHC 13.0% 16.3%

GSVFHC 12.3% 8.9%

LHFHC 10.3% 13.3%

• Asymptomatic cases 15.8% of total since we started open access testing

• Pre-symptomatic cases 4.8% of total• Thus 20.6% presenting for testing w/o symptoms• Known COVID contact is 52.7% of cases

Page 38: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

• Multiple simultaneous ‘shots on goal’ from public, private entities• Testing and production in parallel• Multiple disparate platforms:

https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines

Page 39: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Abbott Architect SARS-CoV-2 IgG Ab Tests

• Useful in correct clinical situation and with a reliable test (high sensitivity/specificity)

• 527 total• 321 positive, 206 negative

(Note: when investigating these, a number are ‘hearsay’ positives never confirmed. Others are truly antibody negative. Sometimes this is due to blood draw happening too soon)

Estimated Pretest Probability OutcomesVery low (2%) 6/79 Positive (7.6%)Low (10%) 12/93 Positive (12.9%)Medium (50%) 17/47 Positive (36.2%)High (100%) 286/306 Positive (93.5%)

Page 40: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

FHCSD Outcomes

• Hospitalization rate is 2.5%• ICU rate is 0.5% • Ventilation rate is 0.3% • 3 currently hospitalized• Successful extubation rate is 50% (4/8)• One additional death (88 yo F, dementia, exposure through daughter)• Overall 5 (CFR 0.2%)• 184 active cases (last week’s 168 was lowest since May 4th when we were at 158 active cases)

FHCSD COVID-19 registry

Page 41: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Policy, public information, other responses• FHCSD COVID Response team• Policy development: PPE, testing, OB, Peds• Bi-weekly system-wide clinical COVID updates• Participants on HHSA Community FQHC/Tribal call• SD County Laboratory Testing Task Force

– COVID-19 Serology sub-committee

• Equitable COVID-19 Recovery Task Force– Data Subcommittee– Health Equity Subcommittee

• UCSD-SDCMS-FHCSD Tijuana volunteer group• CDPH Dept of Epidemiology Sentinel Surveillance Site• CDC/IDSA COVID-19 Clinical Call volunteer team• Public Awareness Campaigns, English/Spanish

informational website, community-based testing, vaccine awareness

https://www.sandiegouniontribune.com/opinion/commentary/story/2020-08-13/latino-latina-latinx-covid-19-coronavirus-testing ; https://www.sandiegouniontribune.com/opinion/story/2020-05-26/covid-19-cases-south-bay-san-diego-commentary

Page 42: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Clinical Aspects: Transmission, Pathophysiology, Treatment Landscape

Page 43: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Huang, S – Institute for Systems Biology (www.medium.com/@Cancerwarrior/covid-19-why-we-should-all-wear-masks-there-is-new-scientific-rationale-280e08ceee71)

Conventional Wisdom – start with SYMPTOMATIC patientsSARS-CoV-2 in moderate-sized respiratory droplets expelled from symptomatic person at range of ~2 m

SARS-CoV-2 attaches to ACE2 receptor (rich in nasopharynx)

Evidence of rare transmission through aerosol route (>2 m); unclear how significant

Page 44: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

• Outbreak investigation in Seattle area SNF (26% mortality)• Two separate point-prevalence surveys with RT-PCR, Viral Culture• 57 of 89 SNF residents (64%) tested positive for SARS-CoV-2• 27 of 48 (56%) asymptomatic at time of testing; 24 of 27 (88%)

later developed symptoms in mean 4 days (pre-symptomatic)

Pre-symptomatic Transmission is Likely

Arons M et al NEJM - https://www.nejm.org/doi/pdf/10.1056/NEJMoa2008457?articleTools=true

Page 45: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Zhang R et al – PNAS 2020 https://www.pnas.org/content/117/26/14857 Wang et al – JAMA 2020 https://jamanetwork.com/journals/jama/fullarticle/2768533https://science.sciencemag.org/content/early/2020/05/27/science.abc6197?utm campaign=SciMag&utm source=JHubbard&utm medium=Twitter

COVID-19 Transmission

Page 46: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

FHCSD Policy on Mask & Eye Protection Usage

I. Non-clinical staff Face coveringsII. Pt-facing clinical staff extended mask +

eye protectionIII. HCW’s evaluating COVID-19 suspects

PPE (single use) with droplet precautions

Page 47: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Acute to Subacute time course

EXPOSURE DEATHSxs

~ 5 d (range 2-14 d)

3-4 d?

Dx DECOMPENSATION

7-10 d 10-14 d

Siddiqi HK et al – 2020 https://doi.org/10.1016/j.healun.2020.03.012

Incubation Period

Page 48: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

https://special.croi.capitalreach.com – Dr. John Brooks – US CDC

COVID-19: Age Distribution and Case Fatality Rate (N = 44,672)

80% mild/moderate, 15% severe, 5% criticalDisease course strongly influenced by age, underlying conditions

Page 49: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Confirmed US COVID-19 Cases/Deaths

https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6912e2-H.pdf

• N = 4,226; first cases reported to CDC• No data on underlying conditions• 80% of cases < age 65• 80% of deaths > age 65• 20% of hospitalizations, and 12% of ICU admissions in age 20-44• ZERO ICU admissions or death in age < 19• (Separate analysis from Lancet: 61% of deaths occurred in persons with obesity)

Page 50: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

• Random telephone survey of patients w/ positive SARS-CoV-2 RT-PCR 4/15-6/25/20; 14 Academic health Systems in 13 states

• Interviews conducted 14-21 d after testing (median 16 d)

• N = 292 respondents: • N = 274 (94%) symptomatic at the

time of testing with median 3 d symptoms (IQR 2-7 d)

• Median age 42.5 yrs (IQR 31-54 yrs); 141 (53%) reported > 1 underlying health condition• N = 19 (7%) hospitalized; mean 3.5 days after testing positive • 35% reported not having returned to baseline state of health at time of survey (26% age 18-34;

32% age 35-49; 47% age > 50)Tenforde et al - https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6930e1-H.pdf

Persistent Symptoms Post-COVID-19

Page 51: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

Time/Severity-dependent Effect of Therapeutics

Siddiqi HK et al – 2020 https://doi.org/10.1016/j.healun.2020.03.012

RemdesivirDexamethasoneOxygen/Pronation

Convalescent Plasma

Page 52: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

• Remdesivir – FDA EUA, IV only, 32% decrease in time to recovery• Dexamethasone – Mortality reduction 20-35% in sicker pts• Convalescent plasma – FDA EUA approval, mixed evidence• Tocilizumab – marginally effective in ICU• Baricitinib – JAK 1/2 inhibitor, studies ongoing • LY-CoV555 - phase II showing 72% reduction in hospitalization

• What not to use: – Interferon– HCQ/Chloroquine– Interferon + / - Ribavirin– Oleandrin– Ivermectin– Lopinavir/Ritonavir

Potential Therapeutic Agents

UW site - https://covid.idea.medicine.uw.edu/IDSA Guidelines - https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/NIAID Guidelines - https://www.nih.gov/news-events/news-releases/expert-us-panel-develops-nih-treatment-guidelines-covid-19?referringSource=articleShare https://covid19treatmentguidelines.nih.gov/introduction/

Page 53: PowerPoint Presentation...In-house FHCSD testing – Validated 4/6/20 on Abbott m2000 • ~80 tests per run; 6-hour prep/run time • Close to 200 tests/day • Turnaround time approx.

SARS-CoV-2/COVID-19 Immunity

- Stephens and McElrath JAMA 2020 - https://jamanetwork.com/journals/jama/fullarticle/2770758

• Most who are infected develop strong IgG (antibody) and T-cell responses that should be able to protect from future infection

• Unclear how long immunity will last and whether it will prevent infection/disease• Re-infection has been described extremely rarely• Vaccine development aims to provoke same response with durable immunity

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Vaccine Landscape, Operation Warp Speed, and the path ahead

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San Diego County Hospitalizations and NPI

https://www.sandiegocounty.gov/content/dam/sdc/hhsa/programs/phs/Epidemiology/covid19/MediaBriefingSlides/mediaBriefingSlides.pdf accessed 8/24/20

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Serologic Survey from CDC• Three rounds of serosurvey.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768834?guestAccessKey=7a5c32e6-3c27-41b3-b46c-43c4a38bbe00&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=072120

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COVID-19 Vaccine landscapeMultiple simultaneous ‘shots on goal’ from public, private entitiesTesting and production in parallelMultiple disparate platformsAssurance from FDA, industry that safety standards won’t be compromised

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

https://www.modernatx.com/cove-study

Current US Phase III Vaccine trials• Moderna/NIH• Pfizer/BioNTech/Fosun• Oxford/Astra Zeneca

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FHCSD Vaccine Outreach/Recruitment coordinators

• Moderna vaccine study: enrolling – only open 2-3 weeks (N=26,296 enrolled)• Oxford/AZ vaccine study: ON PAUSE• Janssen vaccine study: TBD in mid-September• Any interested participant can be referred to: [email protected]

• Elizabeth Flores & Carolina Carrillo – COVID Outreach/Recruitment coordinators

https://www.covidvaccinesd.com/

• SD CoVPN registry: – >1,000 enrolled– 21% non-white

• 12% Latino• 9% Asian/Pacific

Islander

https://www.coronaviruspreventionnetwork.org/ ; https://www.covidvaccinesd.com/

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How must vaccines be tested?

• Must be proven to be safe and effective (Ve > 50%)

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https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccines

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CDC letter to Local Health Jurisdictions

https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html?auth=login-google

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Pushback from IDSA & Industry

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccines https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccines

https://www.wsj.com/articles/covid-19-vaccine-developers-prepare-joint-pledge-on-safety-standards-11599257729?mod=hp_lead_pos2

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Moderna mRNA Vaccine – COVE study• Run through CoVPN – Coronavirus Prevention Network, PI Stephen Spector• Started enrolling last week. Notified that will be open only for 2-3 weeks• 1:1 Placebo controlled• Recruitment arms:

– > 65 yrs– < 65 yrs with underlying

medical condition (e.g. DM II, HTN, HIV)

– <65, no underlying medical condition

Jackson et al – NEJM - https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true

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Oxford/Astra Zeneca phase III trial ‘pause’

• Single female participant in ‘active’ arm of AZD1222 Oxford/Astra Zeneca trial admitted with transverse myelitis

• DSMB recommended ‘clinical hold’ on global phase III trial

• UK phase II/III trials restarted 9/15/20• US phase III trials still on hold,

awaiting more data from potential adverse event

https://www.statnews.com/2020/09/09/astrazeneca-covid19-vaccine-trial-hold-patient-report/

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NASEM Framework for Equitable Vaccine Allocation• 9/2/20 5-hour online discussion • Comments from broadly representative stakeholders

https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus

https://www.nap.edu/catalog/25914/discussion-draft-of-the-preliminary-framework-for-equitable-allocation-of-covid-19-vaccine

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The Road Ahead

• Vaccines alone will be insufficient to completely end the pandemic; will need COMBINATION PREVENTION: (frequent) testing/tracing, better treatments, masks, social distancing for foreseeable future

• Still, vaccine development and widespread implementation is the best way out of the COVID-19 pandemic on a population scale

• Process is intense, politically charged, depends on massive clinical trials, regulatory approval (FDA) and implementation (CDC), with community trust and overcoming vaccine hesitancy essential to achieving herd immunity

• COVID-19 pandemic has revealed disturbing disparities among communities of color, which already have higher levels of suspicion and mistrust of biomedical research.

• Our challenge is to engage in excellent science communication, sensitivity to past abuses, engagement of affected communities, while holding decision-makers accountable to a transparent, fact-based, careful process that ensures the highest standards of safety and promotes public trust, and ultimately results in equitable vaccine allocation

https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus

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Questions/Discussion

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Questions

• How does FHC test (throat or nasal?), do you offer drive up testing?

• How often would you suggest we get tested for covid-19? we (health care workers who are in the community)

• Is there any evidence that the virus remains in hiding after initial clearance and could become reactivated as with varicella, herpes, and other viral illnesses?

• Are you more or less at risk if already been exposed to COVID-19?

• Could you go deeper into the recent news regarding the CDC and the statistic listed on their website that states only 6% of US CoVid19 deaths list CoVid19 as the only cause of death where 94% include other causes?

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Questions

• I'm a Covid survivor, and luckily due to a good immune system. What can everyone be doing now health wise to build up their immunity? There's an emphasis on wearing masks and social distancing but we rarely hear about getting healthy and building immunity as a deterrent to Covid.

• Are survivors of a COVID-19 infection immune from a second infection?

• How could community clinics be preparing to support the growing number of patients who will be struggling with “long COVID” enduring symptoms

• Are you, or any of your colleagues working closely with local schools to advise for in-person/reopening plans?

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Questions• How will COVID-19 affect the way patients are treated in

clinic? What efforts are being done to address the disproportionate impact of the disease in communities of color and those with comorbidities like Alzheimer's disease/dementia?

• Do you see a scenario PRIOR to the release of a vaccine where it will be safe enough for kids to return back to the classroom?

• Hello, I have observed that there is an overwhelming sentiment to not get the vaccine when it becomes available. I know that this is usual with vaccines and public opinion. But this sentiment is particularly worrisome with a pandemic. I know that it also stems from a distrust of our establishments. This is true for conservative and liberal. What is the strategy for informing the public of the vaccine?

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Questions• Once the vaccine is fully available and distributed and

most people have gotten it, how do you foresee society moving forward? Do you think it will go back to pre-pandemic ways or is the way we socialize going to be different (kind of like how it is today?)

• What are your thoughts on the COVID-19 vaccine? Do you think that the existence of vaccine will allow us to return to a normal life?

• What can we do to help other than social distance and wear masks?

• What is covid?• Would you explain why AstraZeneca paused their study

and is this typical in Phased trials? Will this "pause" delay the rollout of a vaccine? – From Fran

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