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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

• Obtain a letter of authorization (LOA) from Gilead to submit to the FDA and submit with FDA Form 3926
• After approval by Gilead, contact the FDA to request FDA Emergency Use Authorization - website
• During normal business hours (7 a.m.-e:30 p.m. CT weekdays), call (301) 796-3400 or email druginfo@fda.hhs.gov
• After 3:30 p.m. CT on weekdays or any weekend day, contact the FDA’s Emergency Call Center at (866) 300-4374
• Fill out FDA form 3926 - Individual Patient Expanded Access to Investigational New Drug (IND)
  • Instructions for Filling Out Form FDA 3926 - Individual Patient Expanded Access to Investigational New Drug (IND) 
  • FDA 3926 - Individual Patient Expanded Access to Investigational New Drug (IND)

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.