COVIDMONITORNCT04463823
"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study
An observational study of COVID, run by Oslo University Hospital at 7 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- How many people
- 500 participants
- Where
- 7 sitesNorway
- Study dates
- 6 Jul 2020to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients treated with covid-19 convalescent plasma
- patients who has provided informed consent or where nearest relative has given consent
Who cannot join
- patients included in other clinical studies of covid-19 treatment
- consent not given
- All eligible patients should be invited.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Helse Fonna
Haugesund
Sorlandet hospital
Kristiansand
Akershus University Hospital
Lørenskog
Oslo University Hospital
Oslo
Sykehuset Ostfold
Sarpsborg
Sykehuset Telemark
Skien
St.Olavs Hospital
Trondheim
About this study
Official title: Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study
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.
Read the 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.
- Conditions
- COVID
- Keywords
- Convalescent plasma
What is being measured
The primary outcome is the main question the study is designed to answer.
observation
clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start6 Jul 2020
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Telemark, Sykehuset Ostfold, University Hospital, Akershus, Sorlandet Hospital HF, Helse Fonna
- Responsible party
- Principal investigator, Lise Sofie Haug Nissen-Meyer, Oslo University Hospital
- Investigators
- Lise Sofie Haug Nissen-Meyer, Ph.D., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463823
- Sponsor's protocol ID
- 148622
- Acronym
- MONITOR
- Status last verified
- Dec 2023
- First submitted
- 3 Jul 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study
- ClinicalTrials.gov ID
- NCT04463823
- Acronym / sponsor ID
- MONITOR / 148622
- Conditions
- COVID
- Keywords
- Convalescent plasma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Telemark, Sykehuset Ostfold, University Hospital, Akershus, Sorlandet Hospital HF, Helse Fonna
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients treated with covid-19 convalescent plasma
- patients who has provided informed consent or where nearest relative has given consent
Key exclusion criteria (3 listed)
- patients included in other clinical studies of covid-19 treatment
- consent not given
- All eligible patients should be invited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Sofie Haug Nissen-Meyer, Ph.D. principal investigator
Oslo University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Oslo University Hospital at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observation (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.