Convalescent Plasma in the Treatment of Covid-19 (COP20)
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|ClinicalTrials.gov Identifier: NCT04600440|
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 Respiratory Insufficiency||Biological: Convalescent plasma||Not Applicable|
Subjects with previous verified COVID-19 are asked to donate plasma 14 days or later after recovery. IgG antibodies against Covid-19 are measured and only subjects with high titers are accepted. Plasmaphereses is done and up to 600 ml plasma is drawn and aliquoted in 200 ml portions.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, open label|
|Masking:||None (Open Label)|
|Official Title:||Convalescent Plasma in the Treatment of Covid-19|
|Actual Study Start Date :||April 25, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Plasma treatment
Convalescent plasma 200 ml daily during three days
Biological: Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
No Intervention: No plasma
Best conventional treatment
- Number of days in need of oxygen [ Time Frame: 28 days ]Number of days in need of oxygen within 28 days from inclusion
- Number of days before discharge from hospital [ Time Frame: 3 months ]number of days before discharge from hospital
- Mortality within 3 months [ Time Frame: 3 months ]death of patient
- Number of days before need of assisted ventilation [ Time Frame: 28 days ]number of days before need of assisted ventilation
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): NCT04600440
|Contact: Magnus Rasmussen, MD, Proffirstname.lastname@example.org|
|Contact: Mona Landin-Olsson, MD, Prof||+4646171000 ext email@example.com|
|Principal Investigator:||Mona Landin-Olsson, MD, Prof||Skane University Hospital|
|Study Chair:||Maria N Lundgren, MD||Skane University Hospital|