Swissmedic approves first COVID-19 therapy study with convalescent plasma

Swissmedic has granted approval for a first clinical trial with COVID-19 convalescent plasma in Switzerland. The aim of the clinical trial is to gain insights into the effectiveness 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 with severe COVID-19 disease. Very different therapeutic approaches are currently being pursued in individual treatment trials and clinical trials. One option that has been known for some time for different diseases is the use of convalescent plasma. This involves blood plasma from people who have successfully survived an infectious disease such as SARS-CoV-2 infection and have 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, because unlike a vaccination, in which the vaccinated person develops the antibodies himself, in this case seriously ill people are given the antibodies of another person to support the immune system. There is some encouraging evidence of a benefit from the use of COVID-19 convalescent plasma in people with severe COVID-19 disease but controlled clinical trials have yet to be conducted. The University Hospital of Basel recently reported on a first experimental application outside clinical trials.

see press release of 31.03.2020:

The aim of the now approved study at the University Hospital of Zurich is to examine the principle of action as well as the efficacy and safety of the use of COVID-19 convalescent plasma and thus to gain important insights into this possible form of therapy

Swissmedic was already in contact with the blood donation services since February to explain regulatory aspects of such a therapy or study. This also included the definition of the requirements for the selection of such plasma donors and the manufacturing process. The donors meet all the criteria of a blood donor, as well as the current requirements and conditions of Swissmedic. They are subjected to additional tests. The product is manufactured according to a defined and validated procedure.

Thanks to the early preparation and the constructive discussions with all those involved, Swissmedic was able to approve the clinical trial of COVID-19 using convalescent plasma within four days on April 7 2020.