Clinical trial NCT04600440: Convalescent Plasma in the Treatment of Covid-19
Official title: Convalescent Plasma in the Treatment of Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid-19
Respiratory Insufficiency
Keywords: Covid-19
Convalescent plasma
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open label
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days in need of oxygen
timeFrame: 28 days
Secondary outcomes:
measure: Number of days before discharge from hospital
timeFrame: 3 months
measure: Mortality within 3 months
timeFrame: 3 months
measure: Number of days before need of assisted ventilation
timeFrame: 28 days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Skane University Hospital
name: Mona Landin-Olsson, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Maria N Lundgren, MD
role: STUDY_CHAIR
References:
citation: 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.