The Workflow U.S. COVID-19 Expanded Access Program

Before starting the process, please review the protocol document to fully understand the requirements of this program.

Quick reference guides

If you need assistance completing any of the required forms, see our quick reference guides.

Detailed workflow

Patients enrolled in the EAP prior to the conversion to a EUA (patient consented before 11:59 p.m. EDT on 08/28/2020) must complete all forms. This is required as part of the agreement to participate in the program and in compliance with federal regulations.

Data collection forms are required for all patients enrolled in the Mayo Clinic EAP (use the following guidelines for completion of these required forms.)

Note: Data collection forms are not required for COVID-19 convalescent plasma administered as part of the Emergency Use Authorization (EUA).

  1. The Medical History Form must be completed prior to the first SAE Report Form submission. The Medical History Form can be edited and updated.
  2. Complete the Transfusion Form with (1) unit number and (2) patient medical record number utilizing the unique link to the patient dashboard. This report must be completed for every patient enrolled in the EAP that receives a transfusion. The Transfusion Form should encompass the transfusion period(s) and the 4-hour window following transfusion. For additional information, see the FAQs.

    This form must be filled out separately for each unit of plasma administered (two units given within a 12-hour window can be submitted on a single Transfusion Report Form. See FAQ for a more detailed explanation).

  3. Report any expected or unexpected Serious Adverse Events (SAEs) that occur within 7 days of each convalescent plasma transfusion administered through the EAP. If you have a SAE, you must complete this form. This is a regulatory requirement.

    Each SAE reported must have an accompanying SAE Resolution Form to document whether the SAE did or did not resolve and when resolution occurred.

  4. Beginning seven days after the date of enrollment and then every seven days thereafter, complete the Weekly Rapid Patient Update and End of Study Form for each patient until one of the following occurs:
    1. Physician decides no plasma transfusion was required
    2. Patient remains alive but still in hospital for ≥ 30 days after most recent transfusion in the EAP
    3. Patient was discharged
    4. Patient passed away
  5. Once the end of study requirements are met (above), you will be able to complete the end of study information, which is found in the Weekly Rapid Patient Update and End of Study Form to close out the study for each patient.