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"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study (MONITOR)

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ClinicalTrials.gov Identifier: NCT04463823
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborators:
St. Olavs Hospital
Sykehuset Telemark
Sykehuset Ostfold
University Hospital, Akershus
Sorlandet Hospital HF
Helse Fonna HF
Information provided by (Responsible Party):
Lise Sofie Haug Nissen-Meyer, Oslo University Hospital

Brief Summary:
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.

Condition or disease
COVID

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
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, 2022
Estimated Study Completion Date : May 31, 2025



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted to health institutions where transfusion therapy is routinely given, and who are receiving COVID-19 convalescent plasma on a clinical indication as part of their treatment
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Lise Sofie Haug Nissen-Meyer, Ph.D +47 22117828 lisoha@ous-hf.no
Contact: Tor Audun Hervig, Ph.D tor.audun.hervig@helse-fonna.no

Locations
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Norway
Helse Fonna Recruiting
Haugesund, Norway
Contact: Tor A Hervig, PhD         
Sorlandet hospital Recruiting
Kristiansand, Norway
Contact: Christine Steinsvåg, MD         
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Abid H Llohn, MD         
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Aurora Espinosa, MD         
Sykehuset Ostfold Active, not recruiting
Sarpsborg, Norway
Sykehuset Telemark Recruiting
Skien, Norway
Contact: Diana Ksenofonova-Mikova, MD         
Contact: Janniche Broby         
St.Olavs Hospital Recruiting
Trondheim, Norway
Contact: Mona H Fenstad, PhD         
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
Sykehuset Telemark
Sykehuset Ostfold
University Hospital, Akershus
Sorlandet Hospital HF
Helse Fonna HF
Investigators
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Principal Investigator: Lise Sofie Haug Nissen-Meyer, Ph.D. Oslo University Hospital
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Responsible Party: Lise Sofie Haug Nissen-Meyer, Project manager, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04463823    
Other Study ID Numbers: 148622
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lise Sofie Haug Nissen-Meyer, Oslo University Hospital:
Convalescent plasma