Donation of Convalescent Plasma

People who have recovered from COVID-19 have antibodies – proteins the body uses to fight off infections – to the disease in their blood. Doctors call this convalescent plasma. COVID-19 convalescent plasma has not yet been approved for use by the Food and Drug Administration (FDA) and is regulated as an investigational product.  A study by Mayo Clinic researchers of 20,000 hospitalized patients transfused with investigational convalescent plasma published in June 2020 concluded there was “robust evidence” it was safe and supported earlier administration of plasma within the clinical course of COVID-19 was “more likely to reduce mortality.” The following pathways are available for the use of COVID-19 convalescent plasma:

1. Clinical Trials: Information regarding clinical trials involving use of convalescent plasma is available at clinicaltrials.gov. Not every clinical trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov website1; other clinical trial options may be available.
2. Single Patient Emergency IND (Individual): The FDA is facilitating access to COVID-19 convalescent plasma for use in patients with COVID-19 infections through a single patient emergency IND (eIND) for the individual patient. For more information, see: www.fda.gov/vaccines-bloodbiologics/investigational-new-drug-ind-or-device-exemption-ide-processcber/recommendations-investigational-covid-19-convalescent-plasma.
3. Expanded Access Treatment Protocols: Currently, the Mayo Clinic is the lead institution for the only expanded access protocol approved by the FDA. This protocol targets adults admitted to the hospital with severe2 or life-threatening illness.

National Expanded Access Treatment Protocol (www.uscovidplasma.org)

Physicians must register their institution in Mayo Clinic's database in order to obtain access to convalescent plasma for their patients under this protocol. To participate, a hospital can rely on the Mayo Clinic Institutional Review Board (IRB). A separate IRB reliance agreement is not required. Hospitals can designate one physician/principal investigator (PI) for this Expanded Access Program OR multiple physicians/ PIs can register for each site.

_{1 Note: Not all clinical trials are registered on the clinicaltrials.gov website.
2 Severe COVID-19 is defined by > 1 of the following: shortness of breath, respiratory rate ≥ 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.}

As of April 13, 2020, more than 50 Illinois hospitals have registered to participate in this protocol.

Expanded Access Treatment Protocol links

• Site Registration Form (first step, also includes IRB information)
• Physician/PI Registration Form (use only after registering your hospital)
• Patient Enrollment Form (use only after the above steps have been completed and patient has consented)

For more information, go to the Expanded Access Program website, or contact the PI at uscovidplasma@mayo.edu.

Convalescent COVID-19 plasma will be widely available under the above programs only if there is robust participation of recovered patients in the plasma donation process. Hospitals may choose to support donations by contacting and referring recovered patients.

Recovered individuals may donate 14-27 days after complete resolution of symptoms  if they have a negative nasal, nasopharyngeal or blood molecular assay. If donors wait for ≥28 days after recovery, repeat testing to document a negative specimen is not typically required, and higher antibody levels are usually present.

Alphabetic list of links to current information regarding donation of convalescent plasma through blood donation centers:

1. Central Illinois Community Blood Center
   
   • Community Blood Services of Illinois
   • Mississippi Valley Regional Blood Center:
   • https://www.bloodcenter.org/hospitals/patient-services/convalescent-plasma/
2. Red Cross:
   
   • Patient self-referral: https://www.redcrossblood.org/donate-blood/dlp/plasma-donations-from-recovered-covid-19-patients.html
3. Versiti:
   
   • https://www.versiti.org/home/convalescent-plasma-donations
4. Vitalant Patient Self-Referral:
   
   • https://www.vitalant.org/COVIDFree
5. Rock River Valley Blood Center
   
   • https://www.rrvbc.org/convalescent-plasma/

A complete list of blood donation centers in Illinois is available at https://ilabb.org/Donation.html.

Additional information regarding facilitation of donation by recovered patients will be provided in a forthcoming memo.

Last Updated:  6/22/2020