key: cord-351328-ly72scru
authors: Epstein, Jay; Burnouf, Thierry
title: Points to consider in the preparation and transfusion of COVID‐19 convalescent plasma
date: 2020-05-14
journal: Vox Sang
DOI: 10.1111/vox.12939
sha: 
doc_id: 351328
cord_uid: ly72scru

This document prepared and endorsed by the Working Party on Global Blood Safety of the International Society of Blood Transfusion presents elements, as of April 2020, to take into consideration in the preparation and transfusion of COVID-19 convalescent plasma as a possible treatment approach of COVID-19. The document covers the following important factors to have in mind when considering this treatment: (a) eligibility criteria of convalescent COVID-19 patients to donate whole blood or plasma, (b) pre-screening and pre-donation testing of convalescent COVID-19 donors; (c) criteria for collection of COVID-19 plasma; (d) post-donation treatment of plasma; and (e) it offers recommendations for plasma transfusion.

This document provides the perspective as of April 2020 of the Working Party on Global Blood Safety of the International Society of Blood Transfusion on use of COVID-19 convalescent plasma as an experimental treatment for COVID-19. The document addresses the following important factors to have in mind when considering this treatment: (A) eligibility criteria of convalescent COVID-19 patients to donate whole blood or plasma; (B) pre-screening and pre-donation testing of convalescent COVID-19 donors; (C) criteria for collection of COVID-19 plasma; (D) post-donation treatment of plasma; and (E) recommendations for plasma transfusion.

• Because the safety and efficacy of convalescent COVID-19 plasma as a treatment for COVID-19 are unproven at this time, clinical use of this product should be managed as an experimental therapy consistent with ethical and legal safeguards (informed consent of donors and patients, institutional approval, special labelling as an investigational product, compliance with applicable regulatory requirements).

• Ideally, COVID-19 plasma should be used in the context of an organized research study designed to determine its safety and efficacy in comparison with standard of care or other therapeutic interventions. Even if used empirically, it is vital to ensure monitoring of patient outcomes including clinical and laboratory indicators of safety and efficacy to maximize the knowledge that might be gained.

• Collection and retention of blood specimens from both donors and recipients (pre-and post-treatment) should be performed to permit retrospective determination of the characteristics of an effective product and dosage regimen, and the characteristics of patients most likely to benefit.

• General information on the rationale and approach to use of convalescent plasma in virus epidemics can be found in the 'WHO Blood Regulators Network Position Paper on Use of Convalescent Plasma, Serum or Immune Globulin Concentrates as an Element in Response to an Emerging Virus (2017)' [1] .

Intentional collection of convalescent plasma should be performed only by apheresis in order to avoid unnecessary red cell loss in the donor and to optimize the volume of plasma that can be generated for investigational use. In instances of routine whole blood donation by a previously infected person who meets current suitability criteria, COVID-19 convalescent plasma can be prepared by component separation and considered for investigational use if not critically needed for general patient care. Transfusion of whole blood to provide convalescent plasma should be avoided unless use of whole blood is clinically indicated. (d) Volume of plasma to be collected: at least 200-600 ml (without anticoagulant) based on the procedure and regulatory limits. (e) Plasma units intended for use as convalescent plasma should be clearly labelled (ISBT128 product description codes for convalescent plasma are available for establishments using the ISBT128 information standard). (f) The first plasma donation can be followed by further donations at a frequency compliant with local regulations and taking into full account the health status of the donor including monitoring of serum protein levels. In many jurisdictions, the interval between apheresis plasma donations of 600 ml or more should not be less than 7 days and that between whole blood donations should be at least 8 weeks. (D) Post-donation treatment of plasma:

(a) Where feasible, pathogen inactivation of plasma using a licensed technology is highly desirable to control residual risks of transfusion-transmitted infectious diseases and to allay concern about possible superinfections with SARS-CoV-2. 

WHO Blood Regulators Network: Position paper on use of convalescent plasma, serum or immune globulin concentrates as an element in response to an emerging virus

WHO Blood Regulators Network (BRN): Donor selection in case of pandemic situations

Update on transfusion-related acute lung injury

This document was endorsed by the Organizing Committee of the Working Party on Global Blood Safety of the Disclaimer Jay Epstein's contributions to this article reflect his own views and should not be construed to represent FDA's views or policies.