NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to evaluate efficacy and safety of the treatment, as recommended by European health authorities. Patients who receive convalescent plasma in a clinical setting will be invited to participate in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on clinical parameters including virus load and recovery time will be collected and compared to european patients in a common database for the European countries. The treated patients can be compared to a historical control group.
The NORPLASMA MONITOR study:
Main hypothesis: Plasma from selected COVID-19 convalescent blood donors contain
neutralizing/therapeutic antibodies against Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) that may prevent generalized spreading of the infection if administered in a
sufficient dose at the right time.
The aim of the monitoring study is to monitor the treatment, characterize antibody
properties, dose requirements and safety issues.
In the NORPLASMA MONITOR study, the investigators will collect data from all patients treated
with convalescent plasma in Norwegian hospitals/care institutions. The data will be compared
to historical controls to evaluate efficacy, and for all transfusions, antibody
characteristics and effective doses can be retrospectively calculated.
The complete protocol is available on our web site
https://www.ous-research.no/home/norplasma.
Patients receiving COVID-19 convalescent plasma on a clinical indication as part of their
treatment should be included in the MONITOR study.
The purpose of the monitoring study is to collect as much clinical information as possible
about patients with COVID-19 before and after administration of convalescent plasma, together
with extensive data about blood donors and their antibody properties. Because the plasma
units cannot be fully standardized before use, it is of vital importance to record enough
data to allow necessary analysis and calculations, of e.g., antibody concentration in each
recipient. Data will also be shared within the European Union (EU) to obtain results in a
more efficient way from larger materials.
For the execution of this study, the project group intends to establish cooperation with all
hospitals/care institutions with transfusion procedures where COVID-19-patients are treated.
Contact will be established via local coordinators in the blood centers, and clinical
cooperation partners in relevant hospital departments will be recruited consecutively as
COVID-19 patients where plasma treatment is considered indicated, are admitted. Since the
treatment will be offered to these patients independent of study inclusion, it is important
to communicate the value of the patient inclusion and data collection to their responsible
care providers, so that participation can be encouraged.
Inclusion Criteria:
- patients treated with covid-19 convalescent plasma
- patients who has provided informed consent or where nearest relative has given consent
Exclusion Criteria:
- patients included in other clinical studies of covid-19 treatment
- consent not given
All eligible patients should be invited.
Helse Fonna
Haugesund, Norway
Sorlandet hospital
Kristiansand, Norway
Akershus University Hospital
Lørenskog, Norway
Oslo University Hospital
Oslo, Norway
Sykehuset Ostfold
Sarpsborg, Norway
Sykehuset Telemark
Skien, Norway
St.Olavs Hospital
Trondheim, Norway
Lise Sofie Haug Nissen-Meyer, Ph.D., Principal Investigator
Oslo University Hospital