Covid-19, Respiratory Insufficiency
Conditions
Keywords
Covid-19, Convalescent plasma
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.
Detailed description
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.
Interventions
BIOLOGICALConvalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
Sponsors
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Verified diagnosis of Covid-19 * \<94% oxygen saturation * willingness to participate * ability to sign informed consent
Exclusion criteria
* unability to understand information and sign informed consent * immunosuppressed patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days in need of oxygen | 28 days | Number of days in need of oxygen within 28 days from inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days before discharge from hospital | 3 months | number of days before discharge from hospital |
| Mortality within 3 months | 3 months | death of patient |
| Number of days before need of assisted ventilation | 28 days | number of days before need of assisted ventilation |
Countries
Sweden
Contacts
Primary ContactMagnus Rasmussen, MD, Prof
Backup ContactMona Landin-Olsson, MD, Prof
Outcome results
None listed