Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-04-25
2022-02-28
Brief Summary
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Primary outcome is number of days the patients need oxygen within 28 days from inclusion.
Secondary outcome is number of days in hospital, number of days in respirator and mortality.
Side effects of treatment is monitored.
Detailed Description
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Patients with acute respiratory symptoms, verified Covid-19, hospitalized and in need of oxygen treatment are asked to participate in the study. The patients are randomized 50/50 to get either convalescent plasma or routine treatment without plasma. The patients randomized to get plasma will have infusion of 200 ml blood group compatible convalescent plasma daily during three days from different donors.
The clinical course will be carefully monitored and days with oxygen requirement will be compared between the groups. Secondary clinical outcomes as mortality, need of assisted ventilation, total days in hospital and side effects to treatment will be observed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plasma treatment
Convalescent plasma 200 ml daily during three days
Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
No plasma
Best conventional treatment
No interventions assigned to this group
Interventions
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Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
Eligibility Criteria
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Inclusion Criteria
* \<94% oxygen saturation
* willingness to participate
* ability to sign informed consent
Exclusion Criteria
* immunosuppressed patient
18 Years
ALL
No
Sponsors
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Skane University Hospital
OTHER
Responsible Party
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Mona Landin-Olsson
MD Prof, Senior consultant
Principal Investigators
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Mona Landin-Olsson, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Maria N Lundgren, MD
Role: STUDY_CHAIR
Skane University Hospital
Locations
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Skåne University Hospital
Lund, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Holm K, Lundgren MN, Kjeldsen-Kragh J, Ljungquist O, Bottiger B, Wiken C, Oberg J, Fernstrom N, Rosendal E, Overby AK, Wigren Bystrom J, Forsell M, Landin-Olsson M, Rasmussen M. Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden. BMC Res Notes. 2021 Dec 4;14(1):440. doi: 10.1186/s13104-021-05847-7.
Other Identifiers
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Covid convalescent plasma
Identifier Type: -
Identifier Source: org_study_id