Court filing
Exhibit 9 (Sentara COVID-19 Treatment Guidelines) — Apter v. HHS
Filed June 2, 2022 in Apter v. Department of Health and Human Services; one of 66 filings from this case.
Record facts
| Court | U.S. District Court for the Southern District of Texas (Galveston Division) |
|---|---|
| Filed | 2022-06-02 |
U.S. District Court for the Southern District of Texas (Galveston Division) · No. 3:22-cv-00184 · Doc. 1-9 · 2022-06-02 · Docket on CourtListener
Full text
Exhibit 9
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 1 of 9
E-Mail Joel Bundy 10/6/2021
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 2 of 9
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 3 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 1
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
Mechanical Ventilation - Mortality increases after initiation of mechanical vent support; consider decreasing SaO2 target to greater than or equal to 85%.
Proning
Recommend proning for 16 hours per day while on ventilatory support with P/F ratio <150 (can consider earlier)
Consider setting up proning team at facilities that don’t currently have it
Encourage awake proning for those not on mechanical ventilation
Respiratory/Ventilation
Use static compliance, physiology, and radiographic evidence to guide selection of high peep vs. low peep strategy
Avoid volume overload; do not provide Surviving Sepsis 30 cc/kg IV fluid bolus to avoid worsening oxygenation
If intubation is required, should be performed by most experienced intubator available, with video laryngoscopy
Early discussion of goals of care and potential involvement of palliative medicine is recommended
If unable to wean off ventilator, consider tracheostomy
ENDORSED PHARMACOLOGIC THERAPIES
DVT Prophylaxis
All COVID (+) patients should receive enoxaparin as prophylaxis for deep venous thrombosis, unless contraindicated.
Pharmacy may automatically interchange orders for heparin SC to enoxaparin for the COVID population when clinically
appropriate.
Anticoagulation
Treatment
COVID-19 positive patients appear to have a process consistent with hypercoagulable disseminated intravascular coagulation
(DIC). Society recommendations differ for anticoagulation based on the severity and trajectory of disease.
Enoxaparin is the preferred agent
Consider monitoring anti-Xa levels for patients who are obese, critically ill, or CrCL < 50 (check 4 hours after 3rd dose)
ICU or critically-ill patients: should NOT be empirically anticoagulated based on d-dimer alone
Anticoagulation should be utilized for all clinically indicated disease states, including VTE, atrial fibrillation, and others
but not based on d-dimer alone in this population
Recommend standard VTE prophylaxis with enoxaparin as the preferred agent – enoxaparin 40mg SC q24h
Non-ICU Patients: MAY benefit from being empirically anticoagulated for 14 days or until discharge based on elevated d-dimer
of at least 2x the ULN in conjunction with additional risk factors
Weigh risk vs benefit for each patient, especially those on dual antiplatelet therapy or at high risk of bleeding
Enoxaparin is the preferred agent at 1mg/kg SC q12h or 1.5mg/kg SC q24h
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 4 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 2
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
Remdesivir
*Course may be
continued if patient’s
oxygen status worsens
but should be held or
stopped for renal or liver
dysfunction.
Initiation Use Criteria – Inpatients Only. Discharge should NOT delayed to complete the 5-day course of Remdesivir.
Lab confirmed diagnosis of COVID-19
Symptom onset within the last 10 days
Oxygen requirements due to COVID: any supplemental nasal cannula or device up to 15 L/min
(This criteria is derived from patients who saw benefit in the ACTT-1 Trial)
o Not candidates if on CPAP, BiPAP, high flow device > 15L/min, or mechanical ventilatory support
o Consider patient’s baseline oxygen requirements when reviewing inclusion/exclusion criteria
CrCl > 30 ml/min
LFTs < 10x ULN
Systemic Corticosteroids
Systemic corticosteroids show mortality benefit in patients on mechanical ventilation or oxygen support. Caution is advised
with previously immunosuppressed patients and/or increased risk of fungal infection. Increase steroid dose based on response.
Dexamethasone 6mg IV or PO daily x 10 days (Or methylprednisolone 32mg daily or prednisone 40mg daily)
Expert opinion/not supported yet in literature: Consider increasing methylprednisolone up to 80mg IV BID x 10 days as
needed
Higher dosing of steroids is beneficial in ARDS.
Methylprednisolone 1 mg per kg IV then 0.5 mg per kg every 12 hours for 7 days - consider BMI for dosing.
Follow with a slow taper of oral prednisone as dictated by clinical course. Optimal duration of taper is unknown.
Patients receiving steroids who did not require oxygen support showed a trend towards patient harm. (RECOVERY trial)
Tocilizumab (Actemra)
*EUA Approval for COVID*
Black Box Warning: for a
risk of serious infections
that may lead to
hospitalization or death,
including tuberculosis (TB),
bacterial, invasive fungal,
viral, and other
opportunistic infections.
Patients should be progressing despite high-dose steroids before considering tocilizumab. Trend IL-6 and CRP to ensure
inflammation is not due to other causes, especially active or suspected infections. Serious risk of secondary infection
following receipt of tocilizumab. Many patients may improve on increased steroid doses and not require tocilizumab.
Weight-based dosing x 1 dose 40- 65kg = 400mg; 66 – 90 kg = 600mg; > 90 kg = 800mg
*Medication is limited to pulmonary/critical care and must meet criteria below: Exclusions:
IL-6 ≥ 2x ULN (> 14 pg/mL) 1. Immunosuppression
CRP > 7.5mg/dL or 75 mg/L 2. ALT/AST > 5x ULN
Hospitalized < 3 days (all patients), and ICU admission < 24 hours (if applicable) 3. Platelets < 50
Rapidly increasing oxygen needs beyond nasal cannula 4. Not accepting all treatments
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 5 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 3
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
THERAPIES THAT ARE NOT SUPPORTED OR ENDORSED
Ivermectin
Concentrations needed to inhibit SARS-COV-2 would be difficult to achieve in humans and are extremely toxic. There is no
available data on outcomes or efficacy in humans from a RCT.
This medication is not recommended until further studies evaluating appropriate dosing regimens are found to be safe and
effective. Several organizations, including AMA, ASHP, CDC, FDA and Merck, have issued statements recommending against
the use of ivermectin for prevention or treatment of COVID-19.
There is a Call for Immediate End to Prescribing, Dispensing, and Use of Ivermectin to Prevent or Treat COVID-19 Outside
Clinical Trials.
Ascorbic Acid (Vitamin C)
Ascorbic acid IV is not endorsed for treatment or prevention of COVID-19 or sepsis/septic shock.
Bicalutamide (CASODEX)
Etoposide (TOPOSAR)
Fluvoxamine (LUVOX)
Dutasteride (AVODART)
Finasteride (PROSCAR)
These medications are NOT endorsed for use in COVID-19. Many do not have published peer-reviewed, RCT available to
assess both efficacy and safety in COVID-19.
Use is limited to patients enrolled in a clinical trial for treatment of COVID-19.
There are other medications currently being studied for use in COVID-19 prevention and treatment. Until published literature is available to evaluate both
safety and efficacy these medications will not be endorsed or recommended in Sentara’s COVID-19 treatment guidelines. Literature will be evaluated on a
continual basis and the guidelines updated as needed to reflect the on-going changes.
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 6 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 1
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
Mechanical Ventilation - Mortality increases after initiation of mechanical vent support; consider decreasing SaO2 target to greater than or equal to 85%.
Proning
Recommend proning for 16 hours per day while on ventilatory support with P/F ratio <150 (can consider earlier)
Consider setting up proning team at facilities that don’t currently have it
Encourage awake proning for those not on mechanical ventilation
Respiratory/Ventilation
Use static compliance, physiology, and radiographic evidence to guide selection of high peep vs. low peep strategy
Avoid volume overload; do not provide Surviving Sepsis 30 cc/kg IV fluid bolus to avoid worsening oxygenation
If intubation is required, should be performed by most experienced intubator available, with video laryngoscopy
Early discussion of goals of care and potential involvement of palliative medicine is recommended
If unable to wean off ventilator, consider tracheostomy
ENDORSED PHARMACOLOGIC THERAPIES
DVT Prophylaxis
All COVID (+) patients should receive enoxaparin as prophylaxis for deep venous thrombosis, unless contraindicated.
Pharmacy may automatically interchange orders for heparin SC to enoxaparin for the COVID population when clinically
appropriate.
Anticoagulation
Treatment
COVID-19 positive patients appear to have a process consistent with hypercoagulable disseminated intravascular coagulation
(DIC). Society recommendations differ for anticoagulation based on the severity and trajectory of disease.
Enoxaparin is the preferred agent
Consider monitoring anti-Xa levels for patients who are obese, critically ill, or CrCL < 50 (check 4 hours after 3rd dose)
ICU or critically-ill patients: should NOT be empirically anticoagulated based on d-dimer alone
Anticoagulation should be utilized for all clinically indicated disease states, including VTE, atrial fibrillation, and others
but not based on d-dimer alone in this population
Recommend standard VTE prophylaxis with enoxaparin as the preferred agent – enoxaparin 40mg SC q24h
Non-ICU Patients: MAY benefit from being empirically anticoagulated for 14 days or until discharge based on elevated d-dimer
of at least 2x the ULN in conjunction with additional risk factors
Weigh risk vs benefit for each patient, especially those on dual antiplatelet therapy or at high risk of bleeding
Enoxaparin is the preferred agent at 1mg/kg SC q12h or 1.5mg/kg SC q24h
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 7 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 2
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
Remdesivir
*Course may be
continued if patient’s
oxygen status worsens
but should be held or
stopped for renal or liver
dysfunction.
Initiation Use Criteria – Inpatients Only. Discharge should NOT delayed to complete the 5-day course of Remdesivir.
Lab confirmed diagnosis of COVID-19
Symptom onset within the last 10 days
Oxygen requirements due to COVID: any supplemental nasal cannula or device up to 15 L/min
(This criteria is derived from patients who saw benefit in the ACTT-1 Trial)
o Not candidates if on CPAP, BiPAP, high flow device > 15L/min, or mechanical ventilatory support
o Consider patient’s baseline oxygen requirements when reviewing inclusion/exclusion criteria
CrCl > 30 ml/min
LFTs < 10x ULN
Systemic Corticosteroids
Systemic corticosteroids show mortality benefit in patients on mechanical ventilation or oxygen support. Caution is advised
with previously immunosuppressed patients and/or increased risk of fungal infection. Increase steroid dose based on response.
Dexamethasone 6mg IV or PO daily x 10 days (Or methylprednisolone 32mg daily or prednisone 40mg daily)
Expert opinion/not supported yet in literature: Consider increasing methylprednisolone up to 80mg IV BID x 10 days as
needed
Higher dosing of steroids is beneficial in ARDS.
Methylprednisolone 1 mg per kg IV then 0.5 mg per kg every 12 hours for 7 days - consider BMI for dosing.
Follow with a slow taper of oral prednisone as dictated by clinical course. Optimal duration of taper is unknown.
Patients receiving steroids who did not require oxygen support showed a trend towards patient harm. (RECOVERY trial)
Tocilizumab (Actemra)
*EUA Approval for COVID*
Black Box Warning: for a
risk of serious infections
that may lead to
hospitalization or death,
including tuberculosis (TB),
bacterial, invasive fungal,
viral, and other
opportunistic infections.
Patients should be progressing despite high-dose steroids before considering tocilizumab. Trend IL-6 and CRP to ensure
inflammation is not due to other causes, especially active or suspected infections. Serious risk of secondary infection
following receipt of tocilizumab. Many patients may improve on increased steroid doses and not require tocilizumab.
Weight-based dosing x 1 dose 40- 65kg = 400mg; 66 – 90 kg = 600mg; > 90 kg = 800mg
*Medication is limited to pulmonary/critical care and must meet criteria below: Exclusions:
IL-6 ≥ 2x ULN (> 14 pg/mL) 1. Immunosuppression
CRP > 7.5mg/dL or 75 mg/L 2. ALT/AST > 5x ULN
Hospitalized < 3 days (all patients), and ICU admission < 24 hours (if applicable) 3. Platelets < 50
Rapidly increasing oxygen needs beyond nasal cannula 4. Not accepting all treatments
Case 3:22-cv-00184 Document 1-9 Filed on 06/02/22 in TXSD Page 8 of 9
Sentara Comprehensive COVID-19 treatment guidelines – VERSION 26
Endorsed by COVID taskforce, Pharmacy, CC, HM, and ID
This document will be updated as public health priorities and clinical evidence evolve. Please refer to
P a g e | 3
the Sentara COVID-19 website or MD Office for the most up to date information. This documented is intended
Updated: 9/27/2021
to help clarify decision points and allow clinicians to gain a better understanding of system endorsed recommendations.
THERAPIES THAT ARE NOT SUPPORTED OR ENDORSED
Ivermectin
Concentrations needed to inhibit SARS-COV-2 would be difficult to achieve in humans and are extremely toxic. There is no
available data on outcomes or efficacy in humans from a RCT.
This medication is not recommended until further studies evaluating appropriate dosing regimens are found to be safe and
effective. Several organizations, including AMA, ASHP, CDC, FDA and Merck, have issued statements recommending against
the use of ivermectin for prevention or treatment of COVID-19.
There is a Call for Immediate End to Prescribing, Dispensing, and Use of Ivermectin to Prevent or Treat COVID-19 Outside
Clinical Trials.
Ascorbic Acid (Vitamin C)
Ascorbic acid IV is not endorsed for treatment or prevention of COVID-19 or sepsis/septic shock.
Bicalutamide (CASODEX)
Etoposide (TOPOSAR)
Fluvoxamine (LUVOX)
Dutasteride (AVODART)
Finasteride (PROSCAR)
These medications are NOT endorsed for use in COVID-19. Many do not have published peer-reviewed, RCT available to
assess both efficacy and safety in COVID-19.
Use is limited to patients enrolled in a clinical trial for treatment of COVID-19.
There are other medications currently being studied for use in COVID-19 prevention and treatment. Until published literature is available to evaluate both
safety and efficacy these medications will not be endorsed or recommended in Sentara’s COVID-19 treatment guidelines. Literature will be evaluated on a
continual basis and the guidelines updated as needed to reflect the on-going changes.
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