COVID-19 Convalescent Plasma For Clinicians

The Expanded Access Protocol (EAP) is administered by Mayo Clinic. Hospitals must register their institution and enroll patients into the site under Mayo Clinic’s IRB. Hospitals will not be required to complete a separate IRB if enrolled in the EAP. Products under this program may be supplied by Red Cross or other participating blood centers (e.g., OneBlood, Vitalant, or other blood center). The goal is that over time the EAP would allow hospitals to stock convalescent plasma for anticipated need.

Registration: Hospitals can join the EAP here.

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.  Patient Eligibility:

• Laboratory-confirmed COVID-19 testing
• Severe or immediately life-threatening COVID-19, for example,
• Severe disease is defined as one or more of the following:
• shortness of breath (dyspnea),
• respiratory frequency ≥ 30/min,
• blood oxygen saturation ≤ 93%,
• partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,
• lung infiltrates > 50% within 24 to 48 hours
• Life-threatening disease is defined as one or more of the following:
• respiratory failure,
• eptic shock,
• multiple organ dysfunction or failure
• Informed consent provided by the patient or healthcare proxy.

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

• Defined COVID-19 neutralizing antibody titer (e.g. > 1:80)
• If neutralizing antibody titers cannot be obtained in advance, obtain a sample of the plasma and store for a later test date
• 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 28 days

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.

A.  Frozen apheresis plasma:

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

Thawed Plasma:

• 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

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.  There is limited data but published reports support the transfusion of one unit of convalescent plasma.

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

A.  The FDA recommends neutralizing antibody titers of at least 1:160. A titer of 1:80 may be considered acceptable if an alternative matched unit is not available.

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

A.  Yes, but they must still register for an eIND or through the EAP in order to transfuse.

A.  One convalescent plasma product per patient should be ordered, by patient ABO type.

A.  Once the convalescent plasma program is fully operational by mid-May, products will be dispatched from the nearest available distribution site or blood center. At that time, hospitals should expect to receive products within 24 hours of their online order. Until then, order times may be delayed and we appreciate your patience as the Red Cross works to qualify and collect from recovered COVID-19 donors in order to build inventories of convalescent plasma. 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 COVID convalescent plasma for the EAP, eINDs and other approved investigator-initiated INDs.  

A.  No, hospitals participating in the EAP or requesting product for a patient for whom they have obtained an eIND are not required to provide a COVID-recovered donor. We are requesting that hospitals and clinicians please direct potential donors to our COVID-19 Convalescent Plasma Donor Information Page. 

A. A hospital may transfuse a unit of convalescent plasma to any patient who has been registered via the EAP, 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 patient who has been registered via the EAP, 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. 

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