TREATING PHYSICIANS: COVID-19 Patient Enrollment
Enrollment in a local IRB protocol involving CCP infusion for the treatment of adults with COVID-19, the National Expanded Access (EAP) or eIND is required.
With special support from:
Who is eligible to receive COVID-19 convalescent plasma?
The FDA has issued guidance for the administration of convalescent plasma collected from individuals who have recovered from COVID-19.
The guidance has evolved over time, and provides recommendations on the following:
- Regulatory pathways for use of investigational COVID-19 convalescent plasma
- COVID-19 patient eligibility
- Collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications
- Record keeping
If you want to participate in this study, we ask you to enroll in one of the following programs. Please note that none of these programs provide convalescent plasma units, which will remain your responsibility.
National Expanded Access (EAP) Treatment Protocol, Led by The Mayo Clinic (NCT04338360)
This protocol is the preferred path to treat adult COVID-19 patients with COVID-19 convalescent plasma (CCP). Hospitals registered with this protocol may transfuse CCP in individuals at risk of severe or life-threatening COVID-19 disease. The protocol developed by The Mayo Clinic provides guidance on how to administer convalescent plasma. The federal program will reimburse the cost of the convalescent plasma unit(s) regardless of the blood bank source. You can find more information on the EAP website.
What you need to do:
Single Patient Emergency IND (eIND)
Physicians who submit a single-patient eIND may transfuse CCP in individuals at risk of severe or life-threatening COVID-19 disease. This path does not give you as much guidance on how to transfuse COVID-19 patients as the EAP does.
- Complete the Form FDA 3926 and email it to CBER_eIND_Covid-19@FDA.HHS.gov. The FDA will review the request and, upon authorization, send the requesting physician a confirmatory email that includes the emergency IND number.
- In case of emergency, physicians can contact the FDA’s Office of Emergency Operations by phone at 1-866-300-4374. After obtaining verbal authorization, the electronic form must be submitted within 15 working days of the authorization.
Information regarding the use of convalescent plasma using local IRBs can be found at ccpp19.org or at https://covidplasma.org/resources-for-clinicians/. If you are enrolled in one of these clinical trials and wish to participate in our study, please contact us at email@example.com.
How can I obtain COVID-19 convalescent plasma (CCP)?
You are responsible for the order of convalescent plasma using your institution’s blood bank or outside providers such as Lifestream, Blood Centers of America (BCA), the American Red Cross or Vitalant. If you are registered under the EAP, the program will cover the cost of the plasma, regardless of the blood bank source.
You can help by referring known convalescent individuals to us. We will determine whether they are eligible to become plasma donors by analyzing their anti-SARS-CoV-2 antibody content. This will help develop a bank of convalescent plasma units to which you will have access. Typically, if a blood bank successfully collects plasma products from donors referred by a hospital, they will reserve up to half of the plasma products collected from the donor’s first donation for this hospital. You may not receive the plasma unit from the actual individual you referred, but from someone else who was also referred to that collection site.
Why should I participate in your study?
By referring to us known convalescent donors, you will help them get screened, and thus develop a bank of convalescent plasma units to which you will have access. This will be instrumental in supporting other institutions across the country that have an urgent need for convalescent plasma.
On the research side, by helping us analyze the plasma you infuse in COVID-19 patients and collecting data (see CRF) and blood samples from COVID-19 patients before and after infusion, you will help the scientific community understand if and how convalescent plasma can help patients. Ultimately, it may help identify biomarkers that can predict which convalescent individuals are “super donors” who can save lives.
I want to participate, what should I do?
If you want to refer confirmed convalescent plasma donors to us, please contact them and ask them to register on our portal.
If you want to participate in our research study, this is what you have to do:
- Please create a secure account on this portal by registering yourself, your institution and your support personnel.
- Confirm you are registered under a local IRB, the EAP or an eIND.
- You will then be asked to sign a reliance agreement or an Independent Investigator Agreement between City of Hope and your institution.
- Review the protocol and agree to send us a retaining sample from the convalescent plasma unit and up to 4 blood samples, and clinical data at four time points.
- Consent your patient to give us permission to collect blood samples (approximately 2.5 teaspoons) and clinical data before and after plasma infusion.
- Complete the patient information form on the portal.
- Collect and ship the samples. We will provide a shipping kit with instructions. We will send you the antibody titer values.
- Complete the CRF.
To facilitate this study, we encourage you to work with a local support person (office nurse/research coordinator/other support person) to help you fill out our questionnaires.
Protocol & Informed Consent Forms (ICF)
Relevant Papers on Convalescent Plasma
Antibody Responses In China (Zhao et al., 2020) (PDF)
CP Use COVID-19 In China (Shen et al., 2020)
CP Use In COVID-19 In China (Duan et al., 2020) (PDF)
Immunity in Rhesus Monkeys (Bao et al., 2020) (PDF)
JAMA Commentary On Use In China (Roback et al., 2020)
Clinical Characteristics of Recovered COVID-19 Patients (An et al., 2020) (PDF)
COVID-19 and Lessons from SARS and MERS (Xie and Chen, 2020) (PDF)
CP in COVID-19 Clinical Update (Zhou et al. 2020)
CP in Managing Emerging Infectious Diseases (Wong and Lee, 2020)
Manifestation of COVID-19 Animal Model (Chan et al., 2020) (PDF)
Potential Interventions for COVID-19 (Zhang and Liu, 2020)
SARS-CoV-2 Specific IgG/IgM Responses of CP (Jiang et al., 2020) (PDF)
Treatment with CP for COVID-19 (Zhang et al., 2020)
Neutralizing antibody responses to SARS-CoV-2 (Wu et al., 2020) (PDF)
Old Therapy, New Disease (Rubin, 2020)
Preparation and Transfusion of COVID-19 CP (Epstein and Burnouf, 2020)
Collecting and Evaluating CP for COVID-19 Treatment (Tiberghien et al., 2020)
First Human Vaccine Trial COVID-19 (Cai-Zhu et al., 2020) (PDF)
Convergent Antibody Responses to SARS-CoV-2 Infection in Convalescent Individuals (Robbiani et al., 2020) (PDF)
Feasibility of a Pilot Program for COVID-19 CP Collection (Li et al., 2020)
First CP RCT for COVID-19 (Li et al., 2020)
RCT of CP - Potentially hopeful signals (Casadevall et al., 2020)
CP option for containing COVID-19 (Casadevall and Pirofski, 2020) (PDF)
JCI CP for Prevention and Treatment of COVID-19 (Bloch et al., 2020)
Early Safety Indicators of COVID-19 CP in 5,000 Patients (Joyner et al., 2020) (PDF)
Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients (Joyner et al., 2020) (PDF)
What if I have more questions?
Once you register, an M.D. coordinator will be assigned to you. You will be able to contact him/her on the portal if you have any questions. If you are not registered yet, you can contact us at firstname.lastname@example.org