Resources for Clinicians
NOTE: The framework for administration of CCP is rapidly evolving and this information is provided by AABB with the intent of helping hospitals understand options and considerations for ensuring that the use of CCP is compliant with current federal directives. It is important to make sure to check relevant resources, including those linked on this page, to make sure you are following the most recent developments, options, and requirements.
Administration of COVID-19 convalescent plasma, or CCP, must take place under one of the FDA-approved pathways for this investigational new drug, or IND. While the protocols described below include patient eligibility criteria, clinicians should also review additional guidance on the indications for use of CCP, such as these recommendations from New York Blood Center.
There are currently several different IND pathways, designed to meet the needs of different patient populations and different hospitals, at different times. This framework is intended to provide wide flexibility to hospitals. General information is available from FDA.
The first two pathways described are for general clinicians and do not involve extensive clinical data reporting requirements. In addition, there are other protocols under evaluation by the FDA. These are research protocols for specific patient populations. Protocols 3-6 involve extensive reporting requirements and should only be used by academic hospitals with trained research staff.
Obtaining CCP Under National Expanded Access Treatment Protocol or For Immediate Emergency Use
National Expanded Access Treatment Protocol IND:
This protocol is offered by Mayo Clinic. Hospitals registered with this protocol may transfuse CCP for any patient with, or at risk of, severe or life-threatening COVID-19 disease. This protocol is far less cumbersome than the eIND pathway since it will cover all clinicians in a hospital and does not require qualifying patients individually with the FDA.
What physicians need to do:
The national program website has more information about the Expanded Access Program for the Treatment of Patients with COVID-19.
Emergency IND (eIND):
Approval to administer CCP under this eIND is patient-specific and limited to those who have severe or immediately life-threatening COVID-19. To determine whether a patient qualifies, FDA encourages use of the criteria in the National Expanded Access Treatment Protocol (discussed in more detail under #1 above) although pediatric patients qualify to receive CCP under this eIND pathway.
The application is simple and relatively easy to fill out, and is appropriate for situations where approval is needed within 4-8 hours.
Hospitals have reported that approval via this mechanism has typically been provided in under 4 hours. Once the form is completed it should be submitted by email.
The completed form should include:
- a brief clinical history of the patient, including:
- current therapy
- rationale for requesting the proposed investigational treatment.
- information regarding where the COVID-19 convalescent plasma will be obtained (which blood center)
- a brief clinical history of the patient, including:
Providers should complete the form to the extent possible, and FDA will work with the provider if additional information is required.
Upon approval, FDA will send the requesting physician a confirmatory email that includes the emergency IND number. IRB approval is not required ahead of time and it is recommended that hospitals notify their IRBs after the fact.
However, if approval is required in less than 4 hours, you should contact FDA’s Office of Emergency Operations by phone at 1-866-300-4374. After obtaining verbal authorization, you will still need to submit the electronic form within 15 working days of the authorization.
For Academic Hospitals Conducting Additional Clinical Trials
There are three additional protocols under evaluation by the FDA. These are research protocols for specific patient populations. The protocols involve extensive reporting requirements and should only be used by academic hospitals with trained research staff.
- The PEP protocol is designed to test CCP as a prophylactic therapy for adults who are exposed to COVID-19 (e.g., health care workers). This protocol was written by researchers at Johns Hopkins School of Medicine.
- A protocol designed to treat COVID-19 patients with mild to moderate disease was written by researchers at the Mayo Clinic in collaboration with Johns Hopkins University, Washington University in St. Louis and other parties.
- A protocol for severely ill COVID-19 patients, sponsored by Johns Hopkins University.
- A protocol has been proposed for CCP administration in pediatric patients. (Updates soon)
CCP Collections, Distribution and Funding Structure
AABB has developed flowcharts to illustrate the different collections, distribution and funding structures for the various IND pathways. As a result of funding from BARDA, hospitals do not have to pay for CCP furnished to hospitals for patients participating in the Mayo expanded access protocol.
Support CCP Donor Recruitment
Blood collectors need clinicians’ help to educate patients on the need for CCP donations, identify prospective donors and refer individuals to local blood collectors for evaluation. Please share with your colleagues the letter that AABB sent to hospitals encouraging them to collaborate with blood suppliers to identify and refer individuals who have recovered from COVID-19 for donation of CCP.