COVID-19 Convalescent Plasma Program

C3PO Facilities

A world-renowned leader in infectious disease and transfusion medicine research, Vitalant Research Institute (VRI)—a division of Vitalant—is helping direct collection of blood plasma donations from recovered COVID-19 patients and developing technologies to detect and quantify virus-fighting antibodies. Recovered COVID-19 patients may have immune-boosting antibodies in their plasma; that plasma—called “convalescent plasma”—could be used to treat critically ill COVID-19 patients.

For customers who have a current agreement with Vitalant to receive CCP units:

CCP Product Label Examples

For customers recruiting potential CCP donors for qualification:

Donor Recruitment Flyer (English)
Donor Recruitment Flyer (Spanish)
Click to download a PDF flyer to help recruit potential CCP donors.

Donor Recruitment Email/Letter Template
Click to download a Word document with suggested email/letter copy to help recruit potential CCP donors.

Donor Recruitment Social Media Copy
Click to download a Word document with suggested social media copy to help recruit potential CCP donors.

Social media graphics
Click to download graphics you can post on social media with the suggested copy.
 

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Frequently Asked Questions about Vitalant's Convalescent Plasma Program

How does a current, contracted hospital customer obtain convalescent plasma from Vitalant?
Once a contracted customer has worked with their local contact(s) and taken the necessary steps to be part of Vitalant’s convalescent plasma program, they can take the following steps to order CCP.
 

1. Please consent your patient to receive CCP as per your institutional policy. You may call Vitalant prior to the consent of the patient to obtain an estimated time of arrival of CCP to your facility. The consent is not needed prior to distribution of CCP to your facility but is needed prior to transfusion.
2. Please provide the blood type of your patient to Vitalant if ABO-compatible plasma is requested.
3. Please have your blood bank staff order CCP units through their online portal.
4. Please inform Vitalant Hospital Services of the blood type of CCP needed, or if you can accept a non-compatible CCP unit for your patient. A Vitalant Transfusion Medicine MD is available for consultation regarding transfusing incompatible plasma.
5. If an additional unit is needed for your patient, please have your blood bank staff order online or call Vitalant Hospital Services to order the additional unit.
6. Please obtain the emergency IND prior to transfusion of the unit if your facility is not under a traditional IND or the expanded access program through Mayo Clinic. This is not needed prior to distribution of the unit from Vitalant to your hospital.

How does a non-contracted hospital obtain convalescent plasma from Vitalant?
Non-contracted customers can reach out to Vitalant’s Inventory Management team at ProductManagement@vitalant.org  or to discuss potential convalescent plasma ordering.

What can your organization do now to prepare to accept convalescent plasma?
To prepare for program expansion and accepting convalescent plasma at your organization, please enter the following ISBT codes into your system as soon as possible.

Highest Priority

Product Description	Product Codes
Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|COVID-19	E9747V00
Apheresis CONVALESCENT PLASMA|ACD-A/XX/<= -18C|Irradiated|COVID-19	E9753V00
Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|COVID-19	E9752V00

Secondary Priority

Product Description	Product Codes
Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|Psoralen-treated|COVID-19	E9771V00

We will communicate additional action items for organizations who wish to accept convalescent plasma as they are identified.

Where can your organization get the most up-to-date information about convalescent plasma?
This website is where we will maintain up-to-date information about the convalescent plasma program. We will continue to send email communications with major updates and required actions but please use this webpage as a frequently-checked resource at your organization.

If your organization is interested in the emergency use of investigational COVID-19 convalescent plasma, we strongly recommend you visit the FDA’s webpage regarding “Recommendations for Investigational COVID-19 Convalescent Plasma” for more information about how your facility should work directly with the FDA to prepare.

Who should I contact at Vitalant about its convalescent plasma program?
If you represent a facility that has interest/need to transfuse active COVID-19 patients please reach out to your area’s Regional Account Manager and Medical Director with questions/inquiries.
 
What types of investigational new drug (INDs) applications will Vitalant support?
Vitalant supports any IND your hospital uses to transfuse CCP: emergency INDs, in-house INDs, or the Mayo expanded access IND (Mayo EA IND). The FDA has determined that CCP is essentially a unique version of normal frozen plasma and thus the IND requirement falls on the treating hospital.
 
The FDA's website contains excellent information for hospitals on how to get started with convalescent plasma, including how to establish a single patient eIND. All relevant forms and FDA contact information can be found on their website. 

What is the Mayo process/expanded access IND (Mayo EA IND)?
The Mayo process/expanded access IND provides an alternative for hospitals to obtain FDA permission to transfuse convalescent plasma. All hospitals can be a part of the Mayo process – and must follow Mayo protocols.
More information can be found at: www.uscovidplasma.org

Can my institution set up its own process for transfusing convalescent plasma and not go through the Mayo process?
Yes. Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product. As such, administration of COVID-19 convalescent plasma by a health care provider must be under an IND (a traditional institutional IND, the Mayo EA IND, or a single-patient emergency IND application).

Vitalant recommends contracted customers enroll in the Mayo program AND have a signed addendum in place with Vitalant to increase likelihood of getting critically needed products.

What is the Red Cross process for sourcing donors?
There are many avenues to identify and qualify potential donors including Vitalant’s website, the Red Cross and other providers’ websites, public health programs, and direct physician or hospital referrals. Donors who register with the Mayo program at www.uscovidplasma.org may be referred to Red Cross’ website. If there is no local ARC center, the Red Cross will refer donors to their local blood center.

For questions regarding reimbursement for CCP products under various INDs/programs, please reach out to your Vitalant contact.