Frequently asked questions

Last updated: October 27, 2020

US COVID Plasma EAP FAQ

How long do I need to retain signed consent forms for patients enrolled in the EAP?

Signed consent forms and other materials related to patient enrollment in the EAP should be kept securely at the participating site for three years after discontinuation of the EAP. These records must be complete, accurate, traceable and retrievable in a timely and efficient manner in case there is a need for subsequent review by a regulatory entity.

What must I do after my patient(s) receive the plasma product?

After you administer the plasma product, you will need to complete several, short additional forms: Transfusion Form, Medical History Form (if not already completed), SAE Report Form, capturing the essential data on serious adverse events (SAE) that are required by the Sponsor and US Government, SAE Resolution Form, the Weekly Rapid Patient Update, and End of Study Form.

Why is the study using a central IRB?

The US Food and Drug Administration asked Mayo Clinic to be the Central IRB for the US Expanded Access Program protocol. This request was intended to reduce the administrative burden on other institutions and the FDA by essentially allowing the use of the same product in the same manner in an already established and reviewed EAP that would otherwise have been available from multiple eIND submissions. In this way it would potentially reduce the time to initiation of treatment.

What is an Expanded Access Program?

The Mayo Clinic IRB is serving as the IRB of record for this Expanded Access Program (EAP), sometimes colloquially referred to as 'compassionate use' at the request of the U.S. Government. An EAP is the mechanism by which access to certain investigational new drugs (IND) are made available outside of clinical trials. The focus of an EAP is to provide treatment whereas a clinical trial is focused on research. An EAP is sometimes necessary when the presence of a disease is classified as life threatening or severe and there is no current or readily available off-label intervention. In these instances, an EAP can be combined with an Investigational New Drug (IND) application to quickly make available a desired therapy to qualifying medical centers throughout the United States. Learn more here

What do we do for reliance on the Mayo Clinic IRB?

The U.S. Food and Drug Administration asked Mayo Clinic to serve as the Central IRB for the U.S. Expanded Access Program. The FDA and Mayo legal counsel discussed at length how to streamline the typical reliance agreement process to match the urgency of the situation. We settled on the mechanisms that are on the website (USCOVIDplasma.org), which requires hospitals/medical centers to check a box on the patient enrollment form indicating their agreement to rely upon the Mayo Clinic IRB, agree to follow all applicable regulations, follow the protocol and adhere to the principles of the Belmont Report.

What are you expecting from us to be able to participate?

We ask institutions wanting to participate as sites to agree to (1) rely upon the Mayo Clinic IRB by checking the box on the site and physician/PI enrollment form, (2) abide by all US and state regulations and the Principles in the Belmont report, (3) use our approved consent form and (4) not ask for any other written agreements. The FDA has waived certain requirements for us to allow the EAP to proceed as quickly as possible as exceptions to policy. The use of REDCap is one example. The use of typical written reliance agreements are another.

Is the data that I submit through REDCap secure?

The Mayo Clinic REDCap database resides behind multiple layers of physical security. Additionally, when a user submits a form, it is transmitted with a secure HTTPS-encrypted connection. All inbound network traffic is monitored 24 hours per day; and any web traffic without the proper, secure token is immediately blocked. This has been approved by the FDA.

Why are the mandates to use the protocol and consent form without modification so strict?

This is a situation where we are asking medical centers to take the protocol and consent form as is or they are not eligible to participate. This was a joint decision by officials at US FDA and the Mayo Clinic IRB. We apologize if it seems brusque. It is not intended in that manner, but rather to ensure safety and efficacy.

Do hospital blood banks need certificates in order to obtain convalescent plasma?

No, the Expanded Access Program (EAP) does not require a certificate in order for hospital blood banks to obtain convalescent plasma, which may be required for other programs such as eINDs.

How many units of convalescent plasma can be transfused and at what rate? What reporting is required?

If the plasma isn’t ordered or transfusion of plasma does not occur, please complete the Discharge/No Transfusion Form, citing the reason(s) the transfusion did not occur.

If a patient has multiple transfusions within 12 hours, only one Transfusion Form needs to be completed. If transfusing one unit of plasma: The Transfusion Form should start with the beginning of the transfusion period and include the 4-hour window following the transfusion. Thus, if the transfusion requires 1.5 hours for completion, the Transfusion Form represents a 5.5-hour period.

If transfusing two units of plasma: The Transfusion Form should encompass the time between the beginning of the transfusion of the first unit and 4-hours following the completion of the transfusion of the second unit. Thus, if the first transfusion requires 1.5 hours for completion, the second transfusion requires 1 hour, and there is a 4 hour break, the Transfusion Form will represent a 10.5-hour period.

If a patient has multiple transfusions more than 12 hours apart, one Transfusion Form should be completed for each plasma transfusion.

Who can complete and submit the EAP report forms?

While the EAP program prefers that the attending physician/PI complete the forms, any required form can be completed by the delegate the physician/PI chooses. It is a regulatory requirement that all forms be completed and submitted at the appropriate time.

However, the physician/PI is required to complete the physician/PI registration (which includes the Form FDA 1572).

When do Serious Adverse Events need to be reported, and using what forms?

Each serious adverse event (SAE) within 7 days of any convalescent plasma transfusion needs to be individually reported on the SAE Report Form and include the time of SAE onset, regardless of relatedness to the transfusion. This is a regulatory requirement. The physician must report:

  • Death
  • Transfusion related acute lung injury (TRALI)
  • Transfusion related circulatory overload (TACO)
  • Transfusion related infection
  • Severe allergic transfusion reaction (requiring medical intervention other than antihistamines)
  • Severe hemolytic transfusion reaction (requiring medical intervention)
  • Severe anaphylactic reaction
  • VF ventricular arrhythmia requiring treatment
  • VT ventricular arrhythmia requiring treatment
  • Atrial arrhythmia requiring treatment
  • Atrial fibrillation requiring treatment
  • Cardiac arrest
  • Need for ECMO or ventricular assistance
  • Thromboembolic or thrombotic complication
  • Need for ICU transfer (since transfusion)
  • Need for increased oxygen support (since transfusion)
  • Need for mechanical ventilation (since transfusion)
  • Development of sustained low blood pressure (SBP < 80 or need for IV pressure support in estimation of treating physicians)
  • Additionally other SAEs determined by the local physician/PI can be reported

How can I reach the Mayo Clinic IRB with questions?

What is the change for ABO compatible convalescent plasma?

ABO-compatible convalescent plasma will be transfused preferentially. If ABO-compatible convalescent plasma is not available, investigators may follow their institution’s guidelines for administration of incompatible plasma with respect to ABO mismatch, titer and volume limits.

What are the reporting requirements for the Expanded Access Program?

All reporting requirements are available through the Unique Patient Status Dashboard. After patient enrollment, please fill out the Medical History Form to provide additional pre-transfusion information. Within 24 hours of each convalescent plasma transfusion, please complete the Plasma Transfusion Form. If two transfusions are completed within 12 hours of each other, you may report them both on one form.

It is a regulatory requirement to report any Serious Adverse Events (SAEs) that occur within 7 days of ANY transfusion on a SAE Report Form. When the SAEs resolve, complete the linked SAE Resolution Form as well. If no SAEs occur, the SAE Report Form will still appear in your Dashboard, but the form does not need to be completed.

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:

  • Physician decided no plasma transfusion was required
  • Patient was in hospital for ≥ 30 days after latest transfusion in the EAP
  • Patient was discharged
  • Patient passed away

If the patient passes away, which forms are required to be completed?

If the death occurs within seven days of any convalescent plasma transfusion, it is classified as a Serious Adverse Event and must be reported on a SAE Report Form in addition to the Weekly Rapid Patient Update and End of Study Form. If the death occurs outside of the seven-day window, only denote this on the Weekly Rapid Patient Update and End of Study Form.

What is the Unique Patient Dashboard?

The Unique Patient Dashboard is a centralized location (Survey Queue) that provides a list of forms for each patient. You are automatically directed to the dashboard after Patient Enrollment and provided a unique link for each patient. At the dashboard, you can complete, edit and review all forms for the patient.

The link to each Unique Patient Dashboard is patient specific and accesses their Protected Health Information (PHI). Do NOT distribute the link, use the link for other patients, or share the link with unauthorized personnel. This link should be treated as PHI.

What is the Survey Queue?

The survey queue is the list of available and completed forms in the Unique Patient Dashboard providing information about whether the forms have been completed.

The link to each Unique Patient Dashboard is patient specific and accesses their Protected Health Information (PHI). Do NOT distribute the link, use the link for other patients, or share the link with unauthorized personnel. This link should be treated as PHI.

Are all forms viewable on the homepage of the patient dashboard or will certain forms only populate based on other forms’ responses?

After completion of the Patient Enrollment Form, the following forms will appear: Medical History, Plasma Transfusion Form, Serious Adverse Event Form, Weekly Rapid Patient Update and End of Study Form, and Additional Contacts Form.

The Serious Adverse Event Resolution Form populates after each SAE Report Form is completed. Proceed immediately to the SAE Resolution Form regardless of whether the SAE has been resolved, as you may indicate the SAE is unresolved and return later to edit your response and provide resolution data. You must complete the SAE resolution forms in the order that you complete the SAE Report Forms as these forms are linked by the instance number in the Unique Patient Dashboard.

Will providers receive confirmation emails and reminders?

Yes. Confirmation emails, reminders and alerts will be sent to all contacts on record for each patient. This includes the physician and optional coordinator that you provided on the Patient Enrollment Form, as well as the optional additional five contacts you provided on the Additional Contacts Form at the bottom of the Unique Patient Dashboard.

Where are Serious Adverse Events (SAEs) reported?

All Serious Adverse Events are reported using the SAE Report Form available on the Unique Patient Dashboard that may be completed multiple times for each patient. One SAE is reported per SAE Report Form.

Does the physician have to complete the Serious Adverse Event Form?

While the SAE Report may be filled out by support personnel, the SAE Report must be reviewed, signed and dated electronically by the physician.

What is the time frame for reporting Serious Adverse Events (SAEs)?

All Serious Adverse Events that occur within seven days of any convalescent plasma transfusion must be reported within 24 hours of occurrence.

What should providers do if they see incorrect data displayed on their forms?

Providers may edit forms as necessary, if possible. If something is seen on a form that cannot be edited such as the Serious Adverse Event Form, email uscovidplasma@mayo.edu to notify the data team of the error.

What if I submit a form unintentionally or want to delete a reported form?

If you would like the form entirely deleted, that must be done by the US COVID plasma data team. Please contact us at uscovidplasma@mayo.edu with this request.

Can providers delete forms from the unique patient dashboard?

No, deletion of forms must be completed by the US COVID plasma data team at uscovidplasma@mayo.edu. Please contact us with your request.

How are Serious Adverse Events (SAEs) reported?

All SAEs are reported using one SAE Report Form for each event per form. This is the only non-editable form in the Unique Patient Dashboard. Multiple SAEs can be reported by submitting this form multiple times.

After submitting the SAE Report Form, you will have the option to download a PDF of your responses in the Unique Patient Dashboard. Afterwards, proceed immediately to the linked SAE Resolution Form (linked by the instance number that is displayed after the form, e.g., Serious Adverse Event Report - #1 which is linked to Serious Adverse Event Resolution - #1). On this SAE Resolution Form, you will see the SAE data provided on the linked SAE Report Form and have the opportunity to either provide resolution data or state that the SAE has not yet been resolved. This SAE Resolution Form is editable, so you may return to the form later to provide resolution data.

Information on reported SAEs will be viewable in the Unique Patient Dashboard under both the SAE Report Forms and SAE Resolution Forms.

What should providers do if they do not receive Unique Patient Dashboard Links for patients?

If you do not receive the Unique Patient Dashboard Link for a previously enrolled patient, contact uscovidplasma@mayo.edu to request that a Unique Patient Dashboard link be sent to you. However, only the contacts on record for a patient may request these links since they contain patient PHI. If you are not a contact on record, you may ask for the contacts on record for a patient and have them send an email requesting we add you to the record and distribute the Unique Patient Dashboard link.

How many contacts are permitted in the system? How are they added?

Seven total contacts can be added for each patient. This includes the physician and optional coordinator provided on the Patient Enrollment Form, as well as the optional additional five contacts provided via the Additional Contacts Form located at the bottom of the Unique Patient Dashboard.

If a form appears in my Unique Patient Dashboard, do I have to complete it?

No. Many of the forms that appear in the Unique Patient Dashboard are provided for your opportunity to report if necessary. The appearance of the forms does not necessarily indicate a requirement that you fill the form out (e.g., only fill out the SAE Form if an SAE occurs).

Can multiple units of plasma be transfused to the same patient under the Expanded Access Program? How is this recorded?

Yes. If a patient receives multiple transfusions within 12 hours using blood from the same blood bank, providers can fill out one Plasma Transfusion Form for the transfusions. If a patient receives multiple transfusions within 12 hours from different blood banks, or if the transfusions are more than 12 hours apart, separate Plasma Transfusion Forms must be completed.