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PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGED INFORMATION CREATED AS PART OF LPSES – LEE HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM COVID-19 Meeting # 8 Medical Staff Updates and Discussion May 6, 2020 “Failing to prepare is preparing to fail” Benjamin Franklin

COVID-19 Meeting # 8 Medical Staff Updates and Discussion

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Page 1: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGEDINFORMATION CREATED AS PART OF LPSES – LEE HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM

COVID-19 Meeting # 8Medical Staff Updates and Discussion

May 6, 2020

“Failing to prepare is preparing to fail”

Benjamin Franklin

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Lee Health Continuing Medical Education

Thank you for participating in the COVID Guidelines Update

• To receive CME credits for todays event:- Go to www.eeds.com- Enter code: 10joey

• All attendees will be muted on entry

• Questions to the speaker:

-Use the chat option in WebEx.

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Guiding Premise

“The one thing we know- We have no idea what the ideal management of these patients really is.”

We will continue to learn, modify and adapt our guidelines as more information and literature becomes known.

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Thanks to Covid-19 Anticoagulation Team

Tim Dougherty Parmeet Saini Mallory Fiorenza

Marilyn Kole Javaad Khan Sunil Pammi

Dolan Abu Aouf Shyam Kapadia Keith Lafferty

Razak Dosani Ragai Meena Lily Bustamante

Lisa Markgraf Jordan Taillon Justin Burkholder

Ken Tolep Ashley Cubillos Dr KatzJulie Katz

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AGENDA

Radiology Updates in COVID 19

Medical Informatics Update

Anticoagulation guideline review

Toxicology Updates

Mayo Convalescent Serum update

Medication updates

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Thank You

Radiology Updates in COVID 19Dr T. Presbrey

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So What Happened to Radiology?

• Overall imaging volumes down up to 70%

• Inpatient and ER down 40%

• No more “routine elective studies”

• No more screening mammography

• Protection of essential staff to maintain

imaging capabilities - techs healthy

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Benjamin Strong, MD vRad Medical Director

The Chinese managed to obtain a chest CT approximately every 6 minutes.

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Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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HPMC 3/22 The patient is a 94 y.o. male presenting with generalized malaise, weakness and a fever. CXR 3/22 at 2035 and 3/23 1612. CT below on 3/22 at 2158. Collected 3/22 Reported COVID + 3/25. Stage 1 findings. GGO. No effusion.

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CCH 3/27 71 y/o Male complains of L sided abdominal pain x 1 week. Denies nausea, vomiting or diarrhea. ”Loss of smell and taste" x 10 days. Seen at Millennium Physicians Group and sent to ED for evaluation. CT A/P ordered. Specimen 3/27 COVID + 3/31

Page 16: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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Benjamin Strong, MD vRad Medical Director

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The Role of Chest Imaging in Patient Management during the COVID-19 Pandemic:

A Multinational Consensus Statement from the Fleischner Societyhttps://doi.org/10.1148/radiol.2020201365 4/7/2020

Imaging Logistics a Pandemic

• Droplet transmission followed by contaminated surfaces are believed to be the main

modes of spread for SARS-CoV2 in radiology suites

• All patients undergoing imaging should be masked and imaged using dedicated

equipment that is cleaned and disinfected after each patient encounter.

• CDC guidelines recommend radiology staff wear a mask, goggles or face shield,

gloves, and an isolation gown.

Three Clinical Scenarios Considered

• Imaging needs to provide clinically actionable information.

• Common Clinical Presentations

• Varying Risk Factors

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Essential Points

• Imaging is not indicated in patients with suspected COVID-19 and mild clinical features

unless they are at risk for disease progression.

• Imaging is indicated in a patient with COVID-19 and worsening respiratory status.

• In a resource-constrained environment, imaging is indicated for medical triage of patients

with suspected COVID-19 who present with moderate-severe clinical features and a high

pre-test probability of disease.

• Chest x-rays are insensitive in mild or early COVID infection with baseline sensitivity 69%.

In another study in NY/NJ urgent cares almost 60% of initial CXR in symptomatic patients

were interpreted as normal.

• CDC does not currently recommend CXR or CT to diagnose COVID-19.

• A normal chest CT does not mean a person does not have COVID-19 infection - and

an abnormal CT is not specific for COVID-19 diagnosis.

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CT

• A normal chest CT does not mean a person does not have COVID-19 infection -

and an abnormal CT is not specific for COVID-19 diagnosis.

• CT has been stated to be a much as 98% sensitive for the detection of findings but is

non-specific and should not be used for screening for COVID-19.

• 104 patients off the Diamond Princess were scanned who were PCR confirmed

positive. 39% had no lung opacities, including 21% of symptomatic patients. CT had

only a 61% sensitivity for detecting any lung abnormalities in COVID-19, and a 20%

false-negative rate in symptomatic patients. https://doi.org/10.1148/ryct.202 0200110

• Two recent studies have shown 23-30% of patients with severe symptoms have CTA

showing pulmonary emboli. CT performed to evaluate secondary processes in

COVID patients should be performed with IV contrast if possible. https://doi.org/10.1148/radiol.2020201544 https://doi.org/10.1148/radiol.2020201561

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Current Situation at LMHS Radiology 5/6/20

• Imaging Staff has adequate appropriate PPE to interact with all

patients.

• Patients undergoing imaging are masked.

• Patients in airborne and contact isolation for COVID status (PUI) wear

a mask and staff wear PPE with N95. As long as no AGP is

performed in the room, the room DOES NOT require a 70 minute

downtime.

• We have just discontinued asking for consultation between radiologist

and ordering provider prior to imaging PUI or COVID + patients.

• All inpatient procedures are being performed.

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Current Situation at LMHS Radiology Outpatient 5/6/20

• Outpatient imaging is open and elective outpatient invasive procedures have resumed.

• Screening mammography has resumed.

• Patients who are having a potentially AGP are going to be imaged at the hospitals and Coconut Point to

avoid service disruptions at the other outpatient centers. Procedures include upper GI, esophagram,

aspiration studies, and enemas.

• Patients are being asked the following questions. An affirmative to any gets scheduled at the hospitals or

Coconut Point.

• Have you traveled outside Florida in the last 14 days?

• Within the last 3 days, has anyone in your house been diagnosed with or tested for Covid-19?

• Within the last 3 days, or today, do you have any: diarrhea, headache, SOB, chest pain, cough, sore

throat, fever, chills/shivering, muscle pain, or loss of taste or smell?

• Have you been diagnosed with COVID-19 in the last 10 days?

• These procedures are an attempt to keep the outpatient centers as “COVID free” as possible, maintain

patient and worker safety, and maintain PPE.

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Resource Sites

• https://www.rsna.org/covid-19

• https://www.acr.org/Coronavirus-Covid-19-Resources

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Thank You

Epic Risk Scores for the Inpatient Provider

Tom Walsh, RN, BSN

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Scoring System vs Predictive Model

Scoring Systems

- Simple calculated tools based on objective data found in the electronic medical record

- Often uses weighted scoring and then adds up for a total score

- Accuracy is as stated through literature

Predictive Models

- Advanced algorithmic models designed to work within our EMR data set

- Trained on well over 100,000 patient encounters at 3 or more Epic sites

- Validated within our system on our patient population - known accuracy

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Risk Scores at a Glance

Tool Best Use Compare to Data Store Frequency

Type of model/system

SOFA In ICU patients for projecting outcome q 4 hr Scoring system

DeteriorationIndex

In non-ICU adult patients for predicting adverse event within 12 hours or mortality within 38 hours

Improves upon NEWS, MEWS, and Rothman index

q 15 min Predictive model

ICU Readmission / Mortality

In ICU patients for predicting likelihood a patient in current state would return to ICU or expire

Improves upon APACEII and APACE iV

q 4 hr Predictive model

NEWS In ED patients or direct admits within first 1-2 hours where data might not be available for predictive models

Q 1 hr Scoring system

Padua In all admitted patients for risk stratifying need for VTE prophylaxis

Caprini Q 4 hr Scoring system

Sepsis Risk Detects the likelihood of a patient developing sepsis within the current encounter

Improves upon SIRS, qSOFA, and other 3rd

party scores

Q 15 min Predictive model

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SOFA Score

• Calculated Scoring System

• https://jamanetwork.com/journals/jama/fullarticle/194262

• Installed with Sepsis 2.0 Project

• Takes into account both the number and severity of failed organs

• For identification of ICU patients at risk for in-hospital mortality

Score Outcome data based on literature

11 or more at ICU admission or mean scores of > 5

Associated with mortality of more than 80%

A decreasing score within first 48 hours Associated with mortality rate of less than 6% when initial score was less than 11

An increasing score within first 48 hours Associated with mortality rate of 37% when initial score was 2 to 7 and 60% when initial score was 8 to 11

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SOFA Score Breakdown

Respiratory

PO2 to FiO2 ratio

Both values must be charted/resulted within the last 24 hours

Score

• <= 100 is 4

• <= 200 is 3

• <= 300 is 2

• <= 400 is 1

• > 400 or no value is 0

Coagulation

PLT result

Value must be within the last 24 hours

Score

• <= 20 is 4

• <= 50 is 3

• <= 100 is 2

• <= 150 is 1

• > 150 or no value is 0

Liver

Total Bilirubin result

Value must be within the last 48 hours

Score

• >= 12 is 4

• <= 11.9 is 3

• <= 5.9 is 2

• <= 1.9 is 1

• < 1.2 or no value is 0

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SOFA Score Breakdown

Cardiovascular

Evaluates administered vasopressor therapy or if none uses MAP

All documentation within last 24 hours

Medications (max 60 minute dosing period)

• Dopamine score

• > 900 = 4

• > 300 = 3

• > 0 = 2

• Epinephrine score

• > 7.955 = 4

• > 0 = 3

• Norepinephrine score

• > 7.955 = 4

• > 0 = 3

• Dobutamine score

• > 0 = 2

• MAP BP score

• < 70 = 1

• >= 70 or no value is 0

Central Nervous System

Glasgow Coma Scale Score

Minimum value within last 24 hours

Score

• < 6 is 4

• 6 to 9 is 3

• 10 to 12 is 2

• 13 to 14 is 1

• 15 or no value is 0

Renal

Evaluates renal creatinine and urine output

Maximum creatinine within last 24 hours is used

Score

• >= 5 is 4

• <= 4.9 is 3

• <= 3.4 is 2

• <= 1.9 is 1

• < 1.2 or no value is 0

Urine Output score

• output < 200 within last 24 hours is 4

• output < 500 within last 24 hours is 3

• output >=500 within last 24 hours or no output charted is 0 (true zero output should be entered with a 0 value to count as < 200)

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Deterioration Index

• Epic Predictive Model

• Installed with 2018 Upgrade

• Validated 12/12/2018 (n=12,966)

• Trained on non-ICU patients

• Uses up to 125 variables

• Takes into account prior data and can show trend

• Predicts mortality within 38 hours or adverse event within 12 hours

Score Outcome based on internal validation data

0 - 30 Patients unlikely to need escalation of care (less than 12% have adverse event)

30 – 60 Undetermined need – patients with rapid changes in this category (10 or morewithin 2 hours) should be evaluated

60 or more Very likely to need escalated care (73% will have adverse event)

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Deterioration Index with COVID

• Validated specifically in COVID patients at Lee Health

• C-statistic for combined mortality and adverse event: 86.39%

• 226 COVID-19 patients, 34 had an adverse event (transfer to ICU/code within 12 hours) or suffered mortality (within 38 hours).

Confirmed COVID case for a non-ICU patient with deterioration index score:

60 = 78.57% went on to have an adverse/mortality event

45 = 51.52% went on to have an adverse/mortality event

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ICU Mortality / Readmission

• Epic Predictive Model

• Installed March 2020

• Pending Validation

• Uses up to 49 variables

• Predicts likelihood that a patient currently admitted to the ICU would expire or be readmitted to the ICU within 5 days if they were transferred to a lower acuity unit in their current condition

Score Potential outcome based on future internal validation

0 – X % Good candidates for successful ICU discharge

X – 100 % Patients that likely warrant continued ICU services

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NEWS Score

• Custom Built per Royal College of Physician Specifications

• Installed with Sepsis 2.0 Project

• Validation Completed 12/2016

• Calculated Scoring System

• Uses 7 objective measures

• In the absence of stored data maturity (~1-2 hours LOS) can be used to identify patient deterioration and those at risk for sepsis

Score Outcome based on literature and internal workgroup decision

0 - 4 Patients unlikely to have sepsis

5 + Patients who should be screened further by clinicians

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NEWS score with COVID

• Validated specifically in COVID patients at Lee Health

• C-statistic for combined mortality and adverse event: 94.64%

• 421 COVID-19 patients, 58 had an adverse event (transfer to ICU/code within 12 hours) and 7 of those suffered mortality (within 38 hours).

Confirmed COVID case for a non-ICU patient with NEWS score:

7 or higher = 62.8% went on to have an adverse/mortality event

5 or higher = 43.3% went on to have an adverse/mortality event

And

10 or higher = 44.4% rate of mortality

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Padua Score

• Scoring System for VTE risk

• Installed with VTE program

• Uses 10 objective measures

Score Outcome based on literature and internal workgroup decision

0 - 3 Patients at low risk for VTE, no prophylaxis, encourage early ambulation

4 + Patients at high risk for VTE, chemoprophylaxis preferred

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Padua Score Breakdown

Active cancer 3 pts Age > 70 years 1 pt

Previous VTE 3 pts Heart and/or respiratory failure 1 pt

Reduced mobility 3 pts AMI and/or ischemic stroke 1 pt

Thrombophilic condition 3 pts Acute infection and/or rheumatologic

disorder

1 pt

Recent trauma/surgery (30 days) 2 pts Obesity BMI >= 30 1 pt

Age > 70 years 1 pt Ongoing hormonal treatment 1 pt

Total score 0-3 is low risk; 4 or more is high risk

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Padua and COVID patients

All COVID Confirmed patients will score a minimum of 4 points

• 3+ for thrombophilic condition

• (known potential for)

• 1+ for acute infection

COVID Confirmed = High Risk

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PATIENT SAFETY WORK PRODUCT: CONFIDENTIAL AND PRIVILEGEDINFORMATION CREATED AS PART OF LPSES – LEE HEALTH SYSTEM’S PATIENT SAFETY EVALUATION SYSTEM

Anticoagulation GuideRecommendation

May 4, 2020

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COVID-19 is a disease that thus far has been demonstrated to induce a hypercoagulable state Higher VTE than normally seen on admitted patients with non COVID-ARDS Elevations in D-dimer have been associated with higher VTE risk and worse prognosis. We created the following recommendations We relied heavily on the UNC protocol We have chosen the cut off D-dimer value of 2.5 which is 5 times ULN of D-dimer These recommendations were based on a task force put together and evaluating the available case

reports, podcast information, and reviewing other centers guidelines Clinical judgement should always supersede all clinical management and decision making

PRINCIPLES

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Inpatient Recommendations

Criteria

Inclusion: Covid-19 PCR test positive, clinically highly suspected Covid-19 patient in the absence of an

alternative diagnosis, Adults over 18 years of age

Exclusion: Thrombocytopenia (less than 25,000), pregnancy, any active signs of bleeding, any recent

bleeding -including but not limited to GI, GU, ICH and any risk of bleeding due to recent surgery or other

risk factors.

Recommended testing:

-Initial CBC, ferritin, LDH, D-dimer, Fibrinogen, LDH, CMP, PT and PTT.

-Daily CBC, D-dimer and Fibrinogen.

If there are any concerns: Consult pulmonary or hematology for collaboration.

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Patients admitted with illness related to Covid-19: Apixaban 2.5 mg bid or Rivaroxiban 10 mg daily for 30 days

or until ambulatory.

Patients admitted with Non -Covid illness: Use clinical discretion on discharging on anticoagulation

Lee HealthCOVID 19AnticoagulationGuidelines

Clinical Judgement supersedes this guideline

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Page 49: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Thank You

Toxicology UpdateDr T. Dougherty

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The Cure maybe worse than the Cause

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False Claims

Source:BBC

Page 52: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Haiti

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Colloidal Silver

Page 54: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

The price alone will give you heart burn

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Methanol Deaths

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Methanol Deaths

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President Trump 4/23/20

“And then I see the disinfectant, where it knocks it out in a minute. One minute. And is there a way we can do something like that, by injection inside or almost a cleaning?” Trump said. “Because you see it gets in the lungs, and it does a tremendous number on the lungs. So it would be interesting to check that. So you’re going to have to use medical doctors with — but it sounds interesting to me.”

Page 58: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

In the ensuing hours

New York Poison Center (in 18 hours)30 exposure calls:9 specifically about Lysol

10 about bleach 11 about other household cleaners.

Maryland Poison CenterOver 100 calls about Lysol and disinfectants

Similar increases in other states including Florida

Page 59: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

From a local physician's office….

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MMWR / April 24, 2020 / Vol. 69 / No. 16

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CDC Case Studies

Case 1

Adult female heard on news to clean all food before consumption

Filled sink with 10% bleach/vinegar/hot water

Bronchospasm – called 911

Case 2

Preschooler found unresponsive

64 oz hand sanitizer empty

ETOH 273 mg/dl

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Case Rate Comparison 2020- 2019/2018

Number of daily exposures to cleaners and disinfectants reported to U.S. poison centers — United States, January–March 2018, 2019, and 2020*,†

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Ingestion of Caustic Substances (Hoffman et al)

Source: NEJM 4/30/20

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Review of Initial Management

Early Intubation: change of voice/drooling/stridor

Endoscopic placement of NGT (not blindly)

Ingestion of Water only for particulate/powdered caustics on the mucosa

No role for AC

No vomiting

Page 65: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Pharmacological Management

Glucocorticoid Tx

Usta et al (Pediatrics 2014)

3 days methylprednisolone for Grade 2B Alkaline Esophageal injuries

(1 Week Ceftriaxone and ranitidine)

Sucralfate

Gumurdulu et al (Turk J Gastroentrol 2010)

(Glucocorticoids, PPI, antibiotics) +/- sucralfate

Sucralfate + (0/8 symptomatic strictures) v Sucralfate – (6/7 strictures)

Mitomycin C

Topically Administered endoscopically

Induces fibroblast apoptosis- reducing scarring

Decreased need for esophageal dilatation

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Don’t try this at home

Page 67: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Old Lysol Medicinal Ads

Netflix: The Crown

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Paracelsus

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H202 as a Preventative & Treatment for Covid 19

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Hydrogen Peroxide

Household 3 % hydrogen peroxide.

Hair bleach is about 6 to 10% hydrogen peroxide.

"Food grade" hydrogen peroxide is 35%. Despite its name, "food grade" hydrogen peroxide should never be taken internally, unless it is extremely dilute.

Industrial up to 90%

www.undark.org

Page 71: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

IV Hydrogen Peroxide

Touted to treat MS, Lyme disease, “adjunct” for heart disease…and infections

The National MS Society: Intravenous hydrogen peroxide "unproven" and "potentially dangerous."

The American Cancer Society: ”There is no evidence that it has value as a treatment for cancer or other diseases." NYCIM.org

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Hydrogen Peroxide Mechanisms of Toxicity

Corrosive damageOxygen Gas Formation

35% can result in substantial volumes of Oxygen

- Venous/Arterial Emboli

Bowel perforation Lipid Peroxidation

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Lancet 1920…

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Thank You

Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

Douglas Brust, MD, PhD and the Lee Health Research Team

"For internal Lee Health Use Only. Do Not Forward or Distribute"

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Disclosures

Gilead Sciences

• Consultant and Speaker’s Bureau for HIV division.

• Applied as principal investigator to make Lee Health a site for remdesivir expanded access protocol. To date, no action on application.

• No other relationship with COVID-19 division.

• Not stock shareholder.

• No other financial interests.

"For internal Lee Health Use Only. Do Not Forward or Distribute"

Page 76: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

"For internal Lee Health Use Only. Do Not Forward or Distribute"

• Early disease

• Patient in ED being admitted

• T&S

• Positive SARS-CoV-2 NAA test

• Consult placed in EPCI by ER, pulmonary, ID, and ICU docs on patients in the ED

• Consults are placed in the ED, but the patient may be on the floor/unit when enrolled and transfused with

plasma

• Because a consult was placed DOES NOT MEAN the patient will be transfused with plasma

• Only a member of the clinical trials team will be discussing the study with the patient or the LAR

In most cases, this will be performed as a telehealth consult.

Expanded Access to Convalescent Plasma for the

Treatment of Patients with COVID-19

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"For internal Lee Health Use Only. Do Not Forward or Distribute"

• The Research Team is a skeleton crew: Until we can increase staffing, consults can be placed at any hour, but the study team will only be available to enroll participants (and thus give plasma):

Mon - Fri, 9 AM - 5 PMNo availability holidays, Saturdays and Sundays

• Consults that come in off hours will be performed the upcoming business day.

Expanded Access to Convalescent Plasma for the

Treatment of Patients with COVID-19

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"For internal Lee Health Use Only. Do Not Forward or Distribute"

Inclusion Criteria:

• Age at least 18 years• Laboratory confirmed diagnosis of infection with SARS-CoV-2• Admitted to an acute care facility for the treatment of COVID-19 complications• Severe or life threatening COVID-19, or judged by the treating provider to be at high

risk of progression to severe or life-threatening disease• Informed consent provided by the patient or healthcare proxy

Exclusion Criteria:

• None

Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

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"For internal Lee Health Use Only. Do Not Forward or Distribute"

Severe COVID-19 is defined by one or more of the following:• dyspnea• respiratory frequency ≥ 30/min• blood oxygen saturation ≤ 93%• partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300• lung infiltrates > 50% within 24 to 48 hours

Life-threatening COVID-19 is defined as one or more of the following:• respiratory failure• septic shock• multiple organ dysfunction or failure

Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19

Page 80: COVID-19 Meeting # 8 Medical Staff Updates and Discussion

Thank You