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Mount Sinai Health System Treatment Guidelines for SARS-CoV-2 Infection
Medications:
Gimsilumab:
Gimsilumab is available as part of a clinical trial for patients > 18 years old.
Consult Infectious Diseases for enrollment consideration if patient meets above criteria.
Clinical Trial Exclusions: eGFR < 30 mL/min, ANC <2000, Platelets <50,000, AST or ALT > 5 x ULN
Remdesivir4-6:
Remdesivir is currently available for compassionate use for pregnant patients and patients less than 18 years of age.
Email [email protected] for trial enrollment consideration in a clinical trial or for compassionate use.
If tocilizumab administered to patient, must wait 24 hours after tocilizumab administration to give remdesivir for inclusion in a clinical trial.
Clinical Trial Exclusions: eGFR < 50 mL/min, AST or ALT > 5 x ULN
On May 1, 2020, the FDA issued an EUA for the use of remdesivir in hospitalized patients with suspected (pending laboratory confirmation) and confirmed COVID-19
who are hypoxic (SpO2 ≤ 94% on room air).
Documentation:
Healthcare providers must document in the medical record that the patient/caregiver has been given information consistent with the “Fact Sheet for Patients and
Parents/Caregivers” and have been informed that remdesivir is not FDA-approved but its use is authorized under an EUA.
Remdesivir EUA dosing:
Patients ≥ 40 kg: 200 mg IV on day 1 then 24 hours later start 100 mg IV q 24h for 4 days (the duration can be extended for up to a total of 10 days if lack of clinical improvement)
In patients requiring mechanical ventilation or ECMO the duration can be extended for up to 5 days (i.e., up to a total of 10 days)
Caution:
Hepatic function tests should be checked prior to initiating remdesivir and daily. Elevation in transaminases have been observed in clinical trials including in both healthy
volunteers and patients with COVID-19. Hepatic function tests should be checked prior to initiating remdesivir and daily.
Remdesivir should be discontinued if AST or ALT > 5 times the upper limit of normal or if there is signs and symptoms of liver inflammation (e.g., increased
bilirubin, alkaline phosphatase, or INR)
Adverse events should be reported to FDA Medwatch.
Tocilizumab (Actmera®)
Not FDA-approved for the treatment of COVID-19-related cytokine release syndrome though case reports and case series exist1,2
ID Attending Physician approval and subsequent in-person consultation required for use in COVID-19 at all times.
A MOAB consent form will need to be completed and the discussion regarding off-label use needs to be documented in the EMR.
Use of tocilizumab and any immunomodulatory agent places patients at higher risk for infection and likely is additive to the increased risk of infection with high dose corticosteroids.
Dosing:
Patients ≥30 kg: 8 mg/kg (actual body weight) IV x single dose (maximum dose: 800 mg)
162 mg subcutaneous (SC) pre-filled syringe to be injected into left and right leg – total of TWO syringes to be injected one time
Caution:
Interaction: Tocilizumab may reduce levels of apixaban and rivaroxaban but does NOT interfere with enoxaparin or heparin
Associated with lower gastrointestinal perforations in patients on concomitant steroids (> 10 mg prednisone daily or equivalent), NSAIDS, and/or methotrexate and in
patients with diverticulitis
Avoid use in patients with platelets <50,000 and those with ANC <1,000
