COVID-19 Convalescent Plasma For Clinicians

The Expanded Access Protocol (EAP) is administered by Mayo Clinic. New patient enrollment in this program has discontinued in light of the EUA.

Registration: Registration has been discontinued.

Ordering Convalescent Plasma: Hospitals should contact their regular blood supplier for requests for COVID-19 Convalescent Plasma (CCP). For Red Cross customers, all convalescent plasma orders should be placed directly in Connect.

The blood community has collaborated to utilize a central resource sharing platform to ensure the need for CCP is met throughout the United States. Blood centers will use this network to seek available supplies should they be unable to fill an order directly. Only hospitals that do not have a regular blood supplier should contact 844-633-3226 or covidplasma@bca.coop to request product, all other hospitals should place orders with their provider.

Order fulfillment will be managed on first in, first out basis with the oldest orders being shipped first.

For further information: National Extended Access Protocol

The Single Patient Emergency Investigational New Drug (eIND) is an alternate option.  FDA has also facilitated access to convalescent plasma for use in individual patients with serious or immediately life-threatening COVID-19 infections through an eIND. This process allows the use of an investigational drug (i.e., convalescent plasma) for the treatment of an individual patient by a licensed physician upon FDA authorization. The eIND process is not for the use of COVID-19 convalescent plasma for the prevention of infection.  FDA approval should be obtained by the patient’s physician prior to requesting products from their blood supplier, however urgent needs may be communicated to us while awaiting FDA approval.  Hospitals pursuing the eIND process should follow their institutional criteria to determine if an IRB is required or if they require the consent of the patient or patient representative prior to treatment.

Registration: Hospitals should request approval from FDA by visiting Recommendations for Investigational COVID-19 Convalescent Plasma. FDA has indicated they will respond within four (4) to eight (8) hours.

Ordering Convalescent Plasma: Hospitals should contact their regular blood supplier for requests for COVID-19 Convalescent Plasma (CCP). For Red Cross customers, all convalescent plasma orders should be placed directly in Connect.

The blood community has collaborated to utilize a central resource sharing platform to ensure the need for CCP is met throughout the United States. Blood centers will use this network to seek available supplies should they be unable to fill an order directly. Only hospitals that do not have a regular blood supplier should contact 844-633-3226 or covidplasma@bca.coop to request product, all other hospitals should place orders with their provider.

Order fulfillment will be managed on first in, first out basis with the oldest orders being shipped first.

For further information: FDA eIND

We are also providing Convalescent Plasma to facilities who have their own research IND.

Ordering Convalescent Plasma: Hospitals should contact their regular blood supplier for requests for COVID-19 Convalescent Plasma (CCP). For Red Cross customers, all convalescent plasma orders should be placed directly in Connect.

The blood community has collaborated to utilize a central resource sharing platform to ensure the need for CCP is met throughout the United States. Blood centers will use this network to seek available supplies should they be unable to fill an order directly. Only hospitals that do not have a regular blood supplier should contact 844-633-3226 or covidplasma@bca.coop to request product, all other hospitals should place orders with their provider.

Order fulfillment will be managed on first in, first out basis with the oldest orders being shipped first.

A. FDA issued an EUA for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  Current evidence also suggests that benefit is most likely in patients treated early in the course of the disease. Please refer to the FDA’s EUA Fact Sheet for healthcare providers.  

A.  Donor Qualifications:

• Evidence of COVID-19 infection
• Diagnostic test (Nasopharyngeal swab) at time of illness

OR

• Positive serological test for COVID-19 antibodies after recovery, if prior testing was not performed. The American Red Cross is now performing antibody testing on collections from donors who received a diagnosis of presumptive positive but never received a positive confirmatory test.
  

List of approved testing can be found here.

AND

• Resolution of COVID-19 symptoms (return to base-line health status).
• 14 - 27 days with negative COVID-19 test results

OR

• 28+ days:  no further testing required

AND

• Donor must meet all routine allogeneic apheresis donor criteria per DHQ
• TRALI Mitigation: Males, females who are negative for anti-HLA antibodies (ARC performs this test)
• Aspirin restrictions apply if donor is undergoing a platelet/plasma-type collection (Determined at time of collection)
• Allowable collection every 7 days (for a maximum of 8 donations within a 3-month period)

Individuals who have fully recovered from coronavirus infection can learn how to be a convalescent plasma donor here.

If you are an individual and you currently have or suspect that you have COVID-19 and have questions about your health, please contact your healthcare professional.

A.  FFP; FP24; Can be extended to 5 days as thawed plasma.

FROZEN Apheresis CCP

• E9754 Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|1st CONTAINER| COVID-19

• E9755 Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|2nd CONTAINER| COVID-19

• E9756 Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|3rd CONTAINER| COVID-19

• E9757 Apheresis CONVALESCENT PLASMA|ACD-A/XX/<+-18C|4th CONTAINER| COVID-19

• E9747 Apheresis CONVALESCENT PLASMA|ACD-A/XX/<=-18C|COVID-19

FROZEN Whole Blood-Derived CCP

• E9735 CONVALESCENT PLASMA|CPD/XX/<=-18C| COVID-19

• E9804 CONVALESCENT PLASMA|CPDA1/XX/<=-18C| COVID-19

THAWED Apheresis CCP

• E9752 Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|COVID-19

• E9762 Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|1st container|COVID-19

• E9763 Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|2nd container|COVID-19

• E9764 Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|3rd container|COVID-19

• E9765 Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|4th container|COVID-19

• E9781 Thawed Apheresis CONVALESCENT PLASMA|CPD/XX/refg|COVID-19

• E9782 Thawed Apheresis CONVALESCENT PLASMA|NS/XX/refg|COVID-19

THAWED Whole Blood-Derived CCP

• E9780 Thawed CONVALESCENT PLASMA|CPD/XX/refg| COVID-19

• E9811 Thawed CONVALESCENT PLASMA|CPDA1/XX/refg| COVID-19

A.  Just as for ‘regular’ frozen plasma the shelf life is one year frozen and 5 days post-thaw.

A.  Units of convalescent plasma will be approximately 200 mL.

A. Health care providers will administer COVID-19 convalescent plasma according to standard hospital procedures and institutional medical and nursing practices. Clinical dosing may first consider starting with one convalescent plasma unit (about 200 mL), with administration of additional convalescent plasma units based on the prescribing physician’s medical judgment and the patient’s clinical response. Patients with impaired cardiac function and heart failure may require a smaller volume or more prolonged transfusion times.

Please refer to EUA fact sheet for healthcare providers.

A.  No, but the donors will undergo the same screening process and infectious disease testing as our regular donors

A.  Under the EUA, the FDA defines a high-titer unit as having an S/CO 12 or greater on the Ortho VITROS IgG testing platform.

A.  Not at this time.  A specimen will be obtained at the time of collection and will be frozen for later testing.

A.  Yes. Please refer to the FDA guidelines on donor eligibility.

A.  Upon receipt of order, units will be dispatched from the nearest available distribution site or blood center. At that time, hospitals should expect to receive products within 24 – 72 hours of their online order, depending on the blood type.  The Red Cross is committed to helping patients and will strive to provide product for your orders as soon as possible.

A.  The Red Cross is not currently making liquid convalescent plasma available. Program participants and Red Cross customers will be promptly notified if Red Cross convalescent product offerings change.

A. . Yes, we are providing convalescent plasma for transfusion under the EUA, eINDs and other approved investigator-initiated INDs.  

A. A hospital may transfuse a unit of convalescent plasma to any qualifying patient per the EUA, or who has been registered via an eIND or other research pathways.  The American Red Cross does not need to be notified of this.

A. No, convalescent plasma must be transfused to a qualifying patient per the EUA or who has been registered via an eIND or other research pathways.

A. For order cancellations, please visit our cancellation page.

A. Convalescent plasma, just like all frozen products, are not eligible for return.  However, we can assist in transferring the product to another facility.

A. The American Red Cross is performing antibody testing on collections from individuals who have been prequalified by our staff to donate convalescent plasma as well as on standard blood, platelet and plasma collections. Antibody testing is not available at collection sites, and will not be performed on the general population.