"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study (MONITOR)
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|ClinicalTrials.gov Identifier: NCT04463823|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2020
Last Update Posted : August 31, 2022
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study|
|Actual Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||May 31, 2025|
- observation [ Time Frame: up to 2 years ]clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463823
|Akershus University Hospital|
|Oslo University Hospital|
|Principal Investigator:||Lise Sofie Haug Nissen-Meyer, Ph.D.||Oslo University Hospital|