Sources of guidance on collection and use of COVID-19 convalescent plasma especially relevant to low- and middle- income countries

Abstract

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. 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 series and fundamental questions regarding optimal use in patient management are unanswered. Nevertheless, in the absence of an established treatment for COVID-19, with promising trends supporting its safety and effectiveness, 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.

Disclaimer: “Jay Epstein’s contributions to this article reflect his own views and should not be construed to represent FDA’s views or policies.