Acute COVID-19, Clinical Pathway — All Settings

Remdesivir

Background

Remdesivir is an antiviral medication that has received Food and Drug Administration (FDA) approval for treatment of hospitalized COVID-19 patients ≥ 12 years of age and ≥ 40 kg. Remdesivir is additionally FDA authorized via Emergency Use Authorization (EUA) for use in hospitalized patients with COVID-19 < 12 years of age or < 40kg who weigh at least 3.5 kg.
The ACCT trial demonstrated that remdesivir may result in a modest reduction in symptom duration in adults hospitalized with COVID-19, but these findings have been inconsistent and remdesivir does not appear to reduce mortality in any study. The benefits of remdesivir appear greatest in those requiring supplemental oxygen; the benefits of remdesivir in patients requiring invasive/non-invasive mechanical ventilation or ECMO are uncertain. Further, the benefit of remdesivir is likely greatest early in the course of illness (< 10 days). See Provider Education.

Indication

Use of remdesivir is suggested for hospitalized patients requiring supplemental oxygen. Use in patients requiring non-invasive or invasive mechanical ventilation or ECMO can be considered in consultation with ID, particularly early in the course of illness (< 10 days), though benefit is unclear in these groups. Because remdesivir is most beneficial earlier in the course of illness, it should be started as soon as possible after a positive test in patients meeting these criteria.

Although the FDA has approved or authorized use of remdesivir for all hospitalized patients, we suggest against using remdesivir in children not requiring respiratory support given generally mild, self-limited illness in this group and potential for toxicity from remdesivir.

Instructions for Front Line Providers

ID consultation is recommended when use of remdesivir is being considered.

Patients < 12 years old or < 40 kg (FDA authorized):

  1. Provide the Fact Sheet for Patients and Parents/Caregivers to the patient/family.
  2. Obtain consent.
  3. Order remdesivir using COVID-19 inpatient orderset.
  4. Report all medication errors and adverse events (death, serious adverse events) considered potentially related to remdesivir within 7 days of the event to FDA MedWatch  . ID and antimicrobial stewardship will additionally monitor for serious adverse events.

Serious adverse events include any of the following occurring while receiving remdesivir: death, life-threatening event, event resulting in hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

Patients 12-17 years old and >40 kg (FDA approved)

  1. Obtain consent (consent is required in this age group given limited pediatric data)
  2. Order remdesivir using COVID-19 inpatient orderset.

Patients ≥ 18 years old and >40 kg (FDA approved)

  1. Order remdesivir using COVID-19 inpatient orderset. Written consent is not required.
Remdesivir Dosing and Administration
Category Dose/duration (see also CHOP formulary) Comments (see also CHOP formulary)
< 3.5 kg Discuss with infectious diseases/ASP
  • Baseline labs: CBC, PT/INR, CMP, pregnancy test (if applicable)
  • Follow up labs: CMP daily. CBC, PT/INR at day 5 if therapy is to be continued (sooner if concern for toxicity). Otherwise labs should be obtained as clinically indicated.
  • Renal impairment: No dose adjustment. If eGFR < 30 ml/minute, duration should be limited to 5 days and lyophilized powder should be used preferentially to minimize risk of toxicity from cyclodextrin accumulation.
  • Hepatic impairment: No dose adjustment. Do not use if ALT >10x upper limit of normal.
3.5 kg - < 40 kg
  • 5 mg/kg IV loading dose (maximum 200 mg) on day 1; followed by 2.5 mg/kg IV q24h (maximum 100 mg) on days 2-5
    • Use lyophilized powder only
≥ 40 kg
  • 200 mg IV loading dose on day 1; followed by 100 mg IV q24h on days 2-5