This treatment protocol requires that physicians register their institution, themselves and potential patients in Mayo Clinic's database in order to obtain access to convalescent plasma for their patients. Enroll patients in the EAP only after your hospital and you are registered.
Patients or their families cannot self-refer into this protocol.
Using the robust database, patients can best be matched with plasma stores and receive the fastest possible treatment.
Other information to be collected retrospectively will include patient demographics and acute care facility resource utilization (such as date the patient is admitted, when they are transferred to ICU or intubated and survival to discharge).
Mayo Clinic is a nationally recognized IRB by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Your registration creates and signifies your agreement with the protocol documents.
After you register your medical facility, yourself and your patient, the online tool will create a patient code and a link to a unique patient dashboard where you will be able to complete other forms. After completing each form you will receive confirmation emails containing the link to the patient dashboard for your convenience.
Mayo Clinic will contact you to fill out short regulatory documents for you and your patient.
Please use your most frequently monitored email address and provide your personal cell phone number so Mayo can connect with you as quickly as possible.
What patients are eligible to receive convalescent plasma in this protocol?
The protocol requires the patient family member to consent to their family member receiving plasma from someone who has recovered from COVID-19. The plasma has substances that could improve chances of recovery. Only hospitalized patients referred by their health care provider can participate in this protocol.
Hospitalized patients are eligible to receive convalescent plasma if:
- They are 18+ years of age
- They have laboratory-confirmed or clinically suspected diagnosis of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19
- They are admitted to an acute care facility for the treatment of COVID-19 complications
- They have severe or life-threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
- There is informed consent provided by the patient or healthcare proxy
How to enroll your patient(s) in the COVID-19 plasma treatment study
- 1. Register your site and/or identify your hospital
- 2. Register yourself as a local physician/PI
- 3. Enroll your patient
- 4. Complete the Medical History Form
- 5. Complete the Transfusion Form (4 hours post-transfusion)
- 6. Report each Serious Adverse Event when it occurs
- 7. Document resolution of each SAE on the SAE Resolution Form
- 8. Complete the Weekly Rapid Patient Update and End of Study Form