COVID-19 Antiviral and Pharmacotherapy Information

COVID-19 Management Kaleida Health Date 04/09/21, Version 23

Useful Hyperlinks

Management Considerations for Adult Patients with

Confirmed/Suspected COVID-19 at Kaleida Health

Treatment Summary

Outpatients and Inpatients NOT admitted for COVID 19 Disease Severity Treatment Recommendations

Mild to moderate symptoms; No need for new or increased (above baseline) supplemental oxygen.

Consider the Anti-SARS CoV monoclonal antibody combination on the current EUA if high risk for progression to severe disease. NIH AIIa recommendation. Inpatient-specific criteria

Patients Hospitalized for COVID 19 Category Disease Severity Treatment Recommendations

1 Not Hospitalized OR Hospitalized without need for supplemental oxygen

Corticosteroids are NOT RECOMMENDED unless there is an alternative indication

May consider remdesivir if at high risk for deterioration

2 Hospitalized requiring supplemental oxygen but not in category 3 or 4

Dexamethasone AND Remdesivir

3 Hospitalized requiring supplemental oxygen via high-flow device or non-invasive ventilation

Dexamethasone +/- Remdesivir

Consider Tocilizumab

4 Hospitalized requiring invasive mechanical ventilation or ECMO

Dexamethasone Consider Tocilizumab

What’s new in the April 9, 2021 update?

Updated Anti SARS CoV Monoclonal Antibody Guidance

Updated Investigational Therapies

Table 1: Current Recommended Therapies

Table 2: Ongoing Investigational Therapies

Table 3: Not Recommended Therapies

Table 4: Emergency Use Authorizations

Table 5: Treatment Considerations

Empiric Antibiotic Use

Influenza Vaccination

Inpatient Monoclonal Antibody Criteria

Tocilizumab Criteria

Version 23 updated 04/09/2021 – information subject to change rapidly as data becomes available, check KaleidaScope daily for updated information (http://kaleidascope.kaleidahealth.org/resources/coronavirus/ )

Please note the only FDA-approved treatments for COVID-19 is remdesivir (Veklury®) This reference tool is a collaborative effort of a multidisciplinary team. The purpose of this document is

to provide a summary of the available information regarding recommended therapies. As new information becomes available, it will be reflected in this document.

COVID-19 Antiviral and Pharmacotherapy Information

COVID-19 Management Kaleida Health Date 04/09/21, Version 23

Current Recommended Therapies (Drug-drug interaction resource: http://www.covid19-druginteractions.org/ )

Available Investigational Therapies

Agent Adult Dose Notes Main Toxicities

Remdesivir (Veklury®) FDA Approved 10/22/20 for HOSPITALIZED ADULTS and pediatric patients 12 years of age and older and weighing at least 40 kg with confirmed COVID-19 or high suspicion based on clinical symptoms. Potential Benefit: Decreased recovery time in patients with moderate disease. In patients requiring significant respiratory support (category 3 or 4) the clinical benefit is uncertain. The NIH guidelines do not recommend routine initiation for patients

on mechanical ventilation. (category 4). Individually

consider use in this population

200mg IV x 1 then 100mg IV daily x 4 Use beyond 5 days may be considered in patients who are not improved or mechanically ventilated/on ECMO The manufacturer does not recommended use if CrCl < 30 ml/min at baseline

Coadministration of remdesivir and hydroxychloroquine (or chloroquine) is not recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of remdesivir

Increase in hepatic transaminases and prothrombin time (see monitoring below) Consider discontinuing if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation. Infusion related reactions including hypotension, nausea, vomiting, diaphoresis and shivering. The patient should be monitored closely for a reaction and if mild the infusion duration may be extended to 120 minutes. Discontinue if the reaction is severe.

Additional Important Considerations with Remdesivir Provider informs patient/family of risks and provides a patient information sheet https://www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_patient_pi.pdf Also available on Kaleidascope: http://kaleidascope.kaleidahealth.org/resources/coronavirus/#general Additional conditions to consider: Not absolute but strongly recommended

Absence of severe hepatic dysfunction

Absence of end stage or life-limiting comorbidity

Give as early as possible in hospitalization for COVID and preference to symptom onset <= 10 days

Individually consider for patients on HFNC, NIMV, Invasive MV or ECMO due to uncertain clinical benefit Monitoring:

CMP and Prothrombin Time baseline; CMP daily and PT periodically during treatment Consider discontinuation if ALT levels increase to >10 times the ULN

Must discontinue if:

ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR

Acute anaphylactic or severe infusion reaction Renal Dysfunction: The manufacturer’s labeling does not recommend use due to the potential for accumulation of

the possibly nephrotoxic vehicle SBECD although the short duration of exposure (5 days) may minimize this risk.

A small data set in renally impaired patients demonstrated no increased risk of renal or hepatic adverse reactions. No formal efficacy, safety or pharmacokinetic data are available for patients with renal impairment or who are receiving renal replacement therapies. Individual risk benefit assessment should be used to determine if it is beneficial to consider use in patients with CrCl below 30 ml/min or who are receiving renal replacement therapy. Pregnancy: Pregnant patients were not included in the clinical trials but did receive the drug under compassionate use protocols. A report of 86 pregnant and postpartum hospitalized patients with severe disease given remdesivir demonstrated the therapy was well tolerated, with a low rate of serious adverse events. Remdesivir should not be withheld from pregnant patients if it is otherwise indicated.

COVID-19 Antiviral and Pharmacotherapy Information

COVID-19 Management Kaleida Health Date 04/09/21, Version 23

Emergency Use Authorizations

Convalescent Plasma

High-titer convalescent plasma is available on an EUA for hospitalized patients with COVID-19. Benefit is uncertain and a growing body of literature suggests it is ineffective in most cases. If considering use the patient should be early in the course of the disease. Not considered standard of care. FDA provider fact sheet:

https://www.fda.gov/media/141478/download

Contact/PI: Manoj Mammen (716.259.0589)

Baricitinib (Olumiant)

For COVID positive hospitalized patients with severe disease the Janus kinase inhibitor, baricitinib, in combination with remdesivir, may be considered if corticosteroids are not an option. It’s place in therapy continues to be delineated as it is currently being studied in comparison to dexamethasone in an NIH sponsored trial (ACTT-4)

Bamlanivimab (Eli Lilly) NOT

AVAILABLE

Due to the emergence of resistant variants only the Regeneron product will be available COVID positive patients outpatients at high risk for progressing to severe disease or hospitalization within 10 days of symptom onset with mild to moderate symptoms without a need for supplemental oxygen above baseline Referral to the infusion clinic is required. For more information see the link: https://www.kaleidahealth.org/coronavirus/support/providers/ambulatory/Monoclonal-Antibody-Treatment-for-Adults-with-COVID.pdf May be considered in COVID positive inpatients who meet specific criteria. See Below for recommendations

Casirivimab / Imdevimab

(Regeneron)

Agent Adult Dose Notes Main Toxicities

Corticosteroids NOT FDA approved The role of steroids in the management of COVID-19 continues to evolve. NIH and IDSA recommend use in patients with severe disease. Data from the RECOVERY trial indicates there is a mortality benefit in patients requiring oxygen or mechanical ventilation.

Dexamethasone 6mg (IV/PO) daily for up to 10 days is the regimen studied in that trial. Do NOT continue after discharge

Alternative corticosteroids may be used if dexamethasone is not available in a daily dose of: Methylprednisolone 32mg Prednisone 40mg Hydrocortisone 160mg

Steroids should NOT be used in patients with category 1 severity unless an alternative indication (COPD/asthma) exists due to lack of benefit and potential for harm. Monitor for adverse effects (hyperglycemia, secondary infections, psychiatric effects, avascular necrosis).

Interleukin- 6 Inhibitor NOT FDA approved NIH guidance recommends use early in the course of rapidly deteriorating severe disease. IDSA suggests use with evidence of systemic inflammation (CRP > 75 mg/dl)

Tocilizumab 8mg/kg up to 800mg max with dexamethasone

See treatment criteria checklist to determine appropriateness. Do NOT use if possibility of concurrent bacterial infection

Potential to increase infection risk although clinical trials have not demonstrated a major safety signal. Infusion reaction potential requires close monitoring during administration

Therapies that are NOT RECOMMENDED

Hydroxychloroquine Emergency Use Authorization revoked by the FDA. Determined that known risk of severe adverse effects outweigh any proposed benefit for use in the treatment of COVID-19. FDA Statement on HCQ

Multiple additional therapies are postulated to be beneficial for COVID-19 but no convincing evidence exists to support their use. As information becomes available to support additional treatments this guidance will be updated

to reflect that evidence.

COVID-19 Antiviral and Pharmacotherapy Information

COVID-19 Management Kaleida Health Date 04/09/21, Version 23

Ongoing Investigational Therapies

ACTIV 1 BGMC and MFS

Adaptive-design, RCT evaluating three different immunomodulators (Inflimximab, abatacept, or cenicriviroc) on a background of remdesivir in hospitalized patients with COVID-19. STATUS: Pre-enrollment

Contact/PI: Manoj Mammen (716.259.0589)

ACTIV 5: BET 1 and BET 2

BGMC

Adaptive-design, RCT evaluating two different immunomodulators, lenzilumab and risanlizumab on a background of remdesivir in hospitalized patients with COVID-19. STATUS: Enrolling

Contact/PI: Carla Frederick (716.259.0589)

ACTIV 4: VTE Prophylaxis

BGMC

Placebo controlled RCT of VTE prophylaxis with apixaban for 30 days post discharge. STATUS: Enrolling

Contact/PI: Alberto Monegro CORTEXT

Treatment Considerations

Viral Screening Should be obtained on presentation to aid in ruling out other causes of symptoms ED: Rapid influenza swab when influenza is prevalent Inpatient PUI: Rapid SarsCoV2/Influenza/RSV (Cepheid) (unnecessary to confirm with PCR) Abbott ID NOT recommended for PUIs: https://www.kaleidahealth.org/coronavirus/support/providers/testing/Abbott-IDNow-Logistics-and-Appropriate-Use-10212020.pdf

ACEi/ARB If a patient is already maintained on therapy, do not hold in the absence of alternative indication(s) to hold (i.e. hypotension, AKI). Current evidence does not support stopping these medications.

DVT Prophylaxis / Anticoagulation

Emerging evidence indicates increased risk of clotting in COVID-19 patients. Enoxaparin is the preferred agent unless the patient is ESRD. Routine use of therapeutic anticoagulation is not recommended outside of treatment for a known/suspected thrombosis or the presence of a chronic indication. Please refer to the “Anticoagulation Guidance for Patients with COVID-19” on Kaleidascope for more detailed information.

NSAIDs No clear evidence exists to define the role of NSAIDs in COVID-19. Concerns for increased risk of severe adverse effects in hospitalized patients with COVID-19. Reasonable to avoid in management of these patients. NSAIDs should not be withheld if patient has a clear alternative indication for use.

Nebulized treatment Avoid in non-intubated patients. Aerosol-generating procedure, medium to high risk of exposure to health care personnel in the surrounding area without respirators. Inhalers should be used when nebulized treatments are indicated.

Beta-agonist (albuterol)

Beta-agonist breathing treatments have not been studied to show any additional benefit in shortness of breath associated with COVID-19. In the absence of clear indication (history of asthma, COPD) there is no clear benefit to use.

Empiric Antibiotic Use

Routine Empiric antibiotics are not recommended.

Based on the available literature, Procalcitonin (PCT)

levels remain low in the early phase of disease (7-10

days) and can rise in the later phase of disease, even

without superinfection

If starting empiric antibiotics, utilize the “Adult

Infection Pneumonia” order set

Recommended duration of therapy for community

acquired pneumonia is ~5 days

Does not favor empiric antibiotics

COVID positive (or high clinical

suspicion)

CXR: peripherial / bilateral infiltratesBaseline PCT < 0.2Non-ICU admission

Favors empiric antibiotics COVID-19 diagnosis

not yet made

CXR: lobar infiltrate

Baseline PCT ≥ 0.2

ICU admission

COVID-19 Antiviral and Pharmacotherapy Information

COVID-19 Management Kaleida Health Date 04/09/21, Version 23

Inpatient monoclonal antibody utilization criteria for use in adult inpatients

Patient is admitted to the hospital for an indication other than COVID

Patient has a positive molecular test for COVID and a NEGATIVE SARS CoV antibody test

Meets EUA criteria as below

EUA Criteria for administration MUST be met Patients must have at least one of the following criteria:

• Body mass index (BMI) ≥35 • Chronic kidney disease • Diabetes • Immunosuppressive disease • Currently receiving immunosuppressive treatment • Age ≥65 years • Age ≥55 years AND have one of the following:

cardiovascular disease, or hypertension, or COPD/other chronic respiratory disease.

PATIENT DOES NOT QUALIFY IF:

Require O2 therapy due to COVID

Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Symptom duration is greater than 10 days

SARSCoV Antibody Test is POSITIVE

Additional Conditions

The antimicrobial stewardship service should be contacted for final approval: BGMC: 859-4392 MFSH: 568-3850

May ONLY be administered by an RN trained in the administration of monoclonal antibodies per Kaleida policy TX IVs & Meds 26

Provider must complete the EUA of Monoclonal Antibody Therapy in COVID qualification checklist

(KH24919) and document the following in the EMR:

Patient meets the criteria outlined in the Emergency Use Authorization (EUA)

Patient and/or the caregiver have reviewed the EUA information sheet and are aware of the following:

o Any alternatives to receiving the monoclonal antibody o The medication is an unapproved drug that is authorized for use under the EUA

Patient and/or the caregiver is aware that SARSCoV vaccine administration should be deferred for at least 90 days post monoclonal antibody administration

Obtain consent for biologic treatment (KH00049-035)

Influenza Vaccination The following points should be considered with regard to influenza vaccination:

There are no data to inform optimal timing of influenza vaccination in persons with or those

recovering from COVID-19 with regards to influenza vaccine effectiveness.

For patients with COVID-19 treated with medications that can suppress the immune system

(e.g. high dose steroids). o Immune response to influenza vaccination may be diminished and the ideal time to vaccinate

after discontinuation of these medications is not known.

o These persons might also be at increased risk for severe illness due to influenza as a result of

immunosuppression

o Timing of vaccination for these individuals should be guided by considerations of the individual’s

underlying risk of medical complications due to influenza, and the degree of influenza circulation

in the local community

COVID-19 Antiviral and Pharmacotherapy Information

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TX_IVs_and_MEDS_26

Criteria Yes No

1. PCR-confirmed COVID pneumonia

2. Rapidly progressing oxygen requirements o Ie nasal cannula → high flow and/or NIPPV (FiO2 > 70%)

3. Early disease course o < 10 days from symptom onset o < 7 days from PCR positive test o Within 48 hours of hospital admission

4. Comorbid conditions present with higher likelihood of poor outcome o Morbid obesity, diabetes, significant pulmonary disease

5. C-reactive protein >75 mg/dL o Without alternative explanation (ie cardiovascular disease,

bacterial infection, rheumatologic disease, malignancy, etc) o Insufficient without above consideration as evidence for use

6. Known or suspected active bacterial or fungal infection o Black box warning for serious and fatal infections

7. Known active or latent tuberculosis or high risk population

8. Alternative explanation(s) for hypoxemia evident o Pulmonary edema, pulmonary embolism, pneumothorax,

interstitial lung disease, etc

9. Absolute neutrophil count < 1,000/mm3 or platelets <50,000/mm3

10. AST or ALT >5x ULN

11. Mechanical ventilation >24 hours at time of initiation

12. Dexamethasone doses exceeding 6mg

13. Patient condition(s) unlikely to achieve functional recovery with meaningful quality of life

14. Death imminent

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