Convalescent Plasma in the Treatment of Covid-19
COP20
1 other identifier
interventional
100
1 country
1
Brief Summary
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Apr 2020
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedOctober 23, 2020
October 1, 2020
1.7 years
October 20, 2020
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days in need of oxygen
Number of days in need of oxygen within 28 days from inclusion
28 days
Secondary Outcomes (3)
Number of days before discharge from hospital
3 months
Mortality within 3 months
3 months
Number of days before need of assisted ventilation
28 days
Study Arms (2)
Plasma treatment
EXPERIMENTALConvalescent plasma 200 ml daily during three days
No plasma
NO INTERVENTIONBest conventional treatment
Interventions
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
Eligibility Criteria
You may qualify if:
- Verified diagnosis of Covid-19
- \<94% oxygen saturation
- willingness to participate
- ability to sign informed consent
You may not qualify if:
- unability to understand information and sign informed consent
- immunosuppressed patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Skåne University Hospital
Lund, SE-22185, Sweden
Related Publications (1)
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.
PMID: 34863304DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Landin-Olsson, MD, Prof
Skane University Hospital
- STUDY CHAIR
Maria N Lundgren, MD
Skane University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Prof, Senior consultant
Study Record Dates
First Submitted
October 20, 2020
First Posted
October 23, 2020
Study Start
April 25, 2020
Primary Completion
December 31, 2021
Study Completion
February 28, 2022
Last Updated
October 23, 2020
Record last verified: 2020-10