Convalescent Plasma in the Treatment of Covid-19

Not Applicable

• Conditions: Covid-19; Respiratory Insufficiency
• Interventions: Biological: Convalescent plasma

• Registration Number: NCT04600440
• Lead Sponsor: Skane University Hospital

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.

Study Timeline

• Study Start: 2020-04-25
• Status Verified: 2020-10
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-23
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma treatment	Convalescent plasma	Convalescent plasma 200 ml daily during three days

Primary Outcome Measures

Name	Time	Method
Number of days in need of oxygen	28 days	Number of days in need of oxygen within 28 days from inclusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Lund, Sweden