The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has granted approval for the first clinical trial with COVID-19 convalescent plasma (CAPSID) in Germany. The aim of the clinical trial is to gain insights into the efficacy and safety of COVID-19 convalescent plasma in the treatment of severe COVID-19 diseases. The ethics committee has also issued a positive opinion.
Effective therapeutics are urgently needed for the treatment of patients suffering from severe COVID-19 disorders. There are currently pursued very different therapeutic approaches in individual treatment trials and clinical trials. One option known for some time is the use of convalescent plasma. It is blood plasma from patients who successfully survived an infectious disease such as the SARS-CoV-2 infection and developed immunity to the corresponding pathogen.
Their blood plasma contains antibodies that can specifically combat the pathogen. This form of therapy is also known as passive immunisation. Unlike a vaccination in which the vaccinated person develops the antibodies himself or herself, seriously ill persons are given the antibodies of another person to support the immune system.
There is some encouraging evidence of a benefit from using COVID-19 convalescent plasma in patients with severe COVID-19 disease, but proof of efficacy is lacking and can only be provided in controlled clinical trials. The authorised study aims to test the mode of action as well as the efficacy and safety of the use of COVID-19 convalescent plasma and thus to gain important insights.
Support of the Paul-Ehrlich-Institut on the Way to Clinical Trials
The Paul-Ehrlich-Institut offers drug developers the opportunity to obtain information about the regulatory requirements of a specific clinical trial in advance in scientific consultations (Scientific Advice) at the time of research (Discovery) and throughout the entire development process in order to determine a target-oriented development strategy.
The knowledge transfer helps to ensure that the authorisation procedures for clinical trials are carried out efficiently – without delay. Due to the intensive preparation and the constructive discussion with all parties involved, the Paul-Ehrlich-Institut was able to issue the approval of the clinical trial of COVID-19 convalescents in COVID-19 within one week.
COVID-19 Convalescent Plasma
COVID-19 convalescent plasma is obtained from recovered COVID-19 patients who meet all criteria of the current Haemotherapy Directive as well as the relevant requirements of the Paul-Ehrlich-Institut with regard to admission to blood donation. The product is manufactured according to established manufacturing procedures and specifications for frozen fresh plasma.
Additional tests, such as the determination of SARS-CoV-2 specific antibodies, are carried out in order to characterise the COVID-19 convalescent plasma accordingly.
Scientific Advice at the PEI
- Innovation PEI, Plasma Samples (Source: SciencePhotoLibrary / GettyImages)