University of Groningen
Sources of guidance on collection and use of COVID-19 convalescent plasma especially
relevant to low- and middle- income countries,
Epstein, Jay; Burnouf, Thierry; Smid, Martin
Published in:
Africa Sanguine
DOI:
10.4314/asan.v22i2.6
IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from
it. Please check the document version below.
Document Version
Publisher's PDF, also known as Version of record
Publication date:
2020
Link to publication in University of Groningen/UMCG research database
Citation for published version (APA):
Epstein, J., Burnouf, T., & Smid, M. (2020). Sources of guidance on collection and use of COVID-19
convalescent plasma especially relevant to low- and middle- income countries, Africa Sanguine, 22(2), 18.
https://doi.org/10.4314/asan.v22i2.6
Copyright
Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).
Take-down policy
If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum.
2020, Volume 22, Number 2
Africa Sanguine
© 2017 The authors. This work is licensed under the Creative Commons Attribution 4.0 International License. 1
Sources of guidance on collection and use of COVID-19
convalescent plasma especially relevant to low- and
middle- income countries
Interest in Africa on therapeutic use of COVID-19 convalescent plasma (CCP) has increased with continental spread of the pandemic of SARS -CoV-2. Consequently, blood organisations in several countries have established governmentally approved investigational protocols for collection and use of CCP. However, other countries still seek advice in this area. Sources of guidance can be found in recent publications by the Working Party on Global Blood Safety of the International Society of Blood Transfusion (ISBT), the ISBT Convalescent Plasma Working Group, and the World Health Organization.1-5 Additionally, resources on CCP policies and protocols can be found at an ISBT open-access website: http://isbtweb.org/coronaoutbreak/convalescent-plasma-covid-19-resources/.
The effectiveness and safety of CCP remain uncertain based on limitations of the available controlled studies and reported case series6 and fundamental questions regarding optimal use in patient management are unanswered.4 Nevertheless, in the absence of an established treatment for COVID-19, with promising trends supporting its safety and effectiveness,8-9 and with the potential for local production, CCP remains a priority for investigational use. In all countries, experimental collection and use of CCP require ethical oversight and the assurance of product quality and safety through an organized national program.10
Disclaimer: “Jay Epstein’s contributions to this article reflect his own views and should not be construed to represent FDA’s views or policies. Epstein J1, Burnouf T2, Smid M3 on behalf of the organising
committee of the Working Party Global Blood Safety of the International Society for Blood Transfusion.
1 US Food and Drug Administration, Silver Spring, MD, USA 2 Graduate Institute of Biomedical Materials and Tissue
Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan
3 Sanquin Consulting Services, Amsterdam, Academic Institute IDTM, Groningen, The Netherlands
Corresponding Author:
Thierry Burnouf thburnouf@gmail.com
Conflict of Interest:
The authors report no conflict of interest.
Cite as: Epstein J, Burnouf T, Smid M. Sources of guidance on
collection and use of COVID-19 convalescent plasma especially relevant to low- and middle– income countries. Africa Sanguine.
2020;22(2):18. https://dx.doi.org/10.4314/asan.v22i2.6
COVID-19 plasma guidance for LMIC
Brief Communication
REFERENCES
1. Epstein, J. and Burnouf, T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang, doi: 10.1111/vox.12939 (2020)
2. Smid, W.M., Burnouf, T., Epstein, J., Kamel, H., Smit Sibinga, C., Somuah, D., Stramer, S. L., Wendel, S. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma in low- and middle- income countries. https://www.isbtweb.org/fileadmin/user_upload/
FINAL_Points_to_consider_in_the_preparation_of_COVID_convalescent_plasma_in_LMIC.pdf
3. Bloch, E. M. et al. Guidance for the Procurement of COVID-19 Convalescent Plasma: Differences between High and Low-Middle Income Countries. Vox Sang, doi:10.1111/vox.12970 (2020).
4. Al-Riyami, A.Z, Schafer, R., van der Berg, K, et al. Clinical use of convalescent plasma in the COVID-19 pandemic; a transfusion-focussed gap analysis with recommendations for future research possibilities. https://onlinelibrary.wiley.com/doi/abs/10.1111/vox.12973
5. WHO. Guidance on maintaining a safe and adequate blood supply during the coronavirus disease 2019 (COVID-19) pandemic and on the collection of COVID-19 convalescent plasma – interim guidance (10 July 2020). https://www.who.int/publications/i/item/maintaining-a-safe-and-adequate-blood-supply-during-the-pandemic-outbreak-of-coronavirus-disease-(covid-19)
6. Piechotta, V., CHaii, K.L., Valk, S.J., et al. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Library
https://doi.org/10.1002/14651858.CD013600.pub2
7. Li L, Zhang W, Hu Y, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: a randomized clinical trial. JAMA. Published online June 3, 2020. doi:10.1001/jama.2020.10044
8. Casadevall A, Joyner MJ, Pirofski L-AA. Randomized Trial of Convalescent Plasma for COVID-19—Potentially Hopeful Signals. JAMA. doi:10.1001/jama.2020.10218 9. Joyner, M.J., Bruno, K.A., Klassen, S.A., et al. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clinic Proceedings (2020)
https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_ft95_6_8.pdf
10. Burnouf, T., Epstein, J., Smid, W.M., Somuah, D., Wendel, S. Use of COVID-19 convalescent plasma in low- and middle- income countries: a call for ethical principles and the
