The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has authorised the second clinical study with COVID-19 reconvalescent plasma (RECOVER) in Germany.
The purpose of such clinical trials is to gain insights into the safety and efficacy of COVID-19 reconvalescent plasma in the treatment of serious COVID-19 infections. Patients to be treated include old and high-risk patients. The ethics committee has also given a favourable opinion.
A treatment option for infectious diseases that has been known for quite a long period of time is the use of reconvalescent plasma. This refers to blood plasma from persons who recovered from an infectious disease such as COVID-19 and have developed antibodies against the respective pathogen. The blood plasma of persons who underwent a COVID-19 infection contains antibodies, which bind to the surface of SARS-CoV-2, known as neutralising antibodies.
These antibodies prevent other cells in the body from becoming infected. First encouraging evidence shows the benefit of using COVID-19 reconvalescent plasma in patients with a serious COVID-19 infection, but scientifically founded evidence of the efficacy has as yet not been obtained. This can only be achieved by performing controlled clinical trials.
The authorised RECOVER study entitled “A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease” is designed to examine the safety and efficacy of using COVID-19 reconvalescent plasma in old and high-risk patients.
Support by Paul-Ehrlich-Institut in the Clinical Trials
The Paul-Ehrlich-Institut has given medicines developers the option to make use of its scientific advice service to inform themselves on the regulatory requirements starting as early as the research (discovery) stage during the entire development period up to the time of marketing authorisation.
In the post-marketing authorisation period, companies could also use scientific advice to obtain information on regulatory requirements. Preliminary advice before a clinical trial would support medicines developers in determining a targeted development strategy.
COVID-19 Reconvalescent Plasma
COVID-19 reconvalescent plasma is obtained from patients who have recovered from a COVID-19 infection and fulfil all the criteria for the current Haemotherapy Guideline with regard to a permission to donate blood as well as the conditions of the Paul-Ehrlich-Institut concerning this.
The product is prepared in accordance with predetermined manufacturing procedures and specifications for fresh frozen plasma. Additional assays such as the determination of SARS-CoV-2-specific antibodies are performed to characterise the COVID-19 reconvalescent plasma in an appropriate manner.
Paul-Ehrlich-Institut photo ChaNaWiT-MomentOpen-GettyImages