Investigational Drug Service

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Remdesivir Expanded Access

**GILEAD HAS SUSPENDED ENROLLMENT IN THIS PROGRAM FOR ALL PATIENTS EXCEPT THOSE WHO ARE PREGNANT AND CHILDREN UNDER 18 YEARS OLD WITH SEVERE COVID-19 MANIFESTATIONS.  INFORMATION ABOUT A NEW PROCESS WILL BE MADE AVAILABLE WHEN IT IS RELEASED.  CURRENTLY, THE PROCESS REMAINS THE SAME FOR THE PATIENT POPULATIONS PREVIOUSLY MENTIONED**

In response to the COVID-19 pandemic, Gilead Sciences, a research-based biopharmaceutical company, has set up a portal to allow for expanded access to remdesivir, an experimental treatment. Below are the steps for obtaining Gilead, FDA and IRB approval for this treatment.

Contact the Investigational Drug Service at one of the contacts below as soon as possible when beginning this process.

Step 1: Gilead approval

Visit Gilead Compassionate Use Portal. You will need pharmacy shipping and contact information when completing this process.

Shipping information

  • Department of Pharmacy Services
    Investigational Drug Service
    University of Mississippi Medical Center
    2500 N. State St.
    Jackson, MS 39216

Contacts

  • C. Scott McKenzie, PharmD
    Supervisor, investigational Drug Service
    Department of Pharmacy Services
    2500 N. State St.
    Jackson, MS 39216
    (601) 984-2060 (office)
    (318) 450-0276 (cell)
  • Trey Warnock, PharmD
    Investigational Pharmacists Specialist
    Investigational Drug Service
    Department of Pharmacy Services
    2500 N. State St.
    Jackson, MS 39216
    (601) 984-2060 (office)

Confirm patient eligibility

  • Inclusion criteria
    • Hospitalization
    • Confirmed SARS-CoV-2 by PCR
    • Mechanical ventilation
  • Exclusion criteria
    • Evidence of multi-organ failure
    • Vasopressor requirement to maintain blood pressure
    • ALT levels > 5x ULM
    • Creatinine clearance < 30 mL/min, dialysis or continuous veno-venous hemofiltration
    • Remdesivir cannot be used in conjunction with other experimental antiviral agents for COVID-19
  • Additional information required
    • Patient initials
    • Date of birth
    • Brief clinical course
    • Patient sex
    • Current clinical status
    • Imaging results
    • Pertinent physical exam findings/vital signs (must include current supplemental oxygen requirement)
    • Labs (BUN, creatinine, creatinine clearance, ALT, AST, Alkaline Phosphatase, Total Bilirubin) – all of the must include units of measure
    • Pregnancy status

Step 2: FDA Approval

Step 3: Procurement

  • Forward FDA authorization to Gilead at USRegulatoryCOVIDCU@gilead.com
  • Obtain Informed Consent – a template will be provided by Gilead
  • Dosing instructions for adult and pediatric patients will be provided by Gilead
  • Order remdesivir in Epic

Step 4: IRB Notification

  • Within 5 days of beginning treatment, an IRB protocol must be submitted
  • For any questions in reference to follow-up forms or regarding the eINC process, contact the FDA - website
  • For questions regarding UMMC processes, contact the IRB or Investigational Drug Service.