Convalescent Plasma in the Treatment of Covid-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Convalescent Plasma in the Treatment of Covid-19

Conditions
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Covid-19, Respiratory Insufficiency

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma treatment<br>Convalescent plasma 200 ml daily during three days | Biological: Convalescent plasma<br>* Plasma donated from patients recovered from Covid-19 and having high titres of antibodies<br>|
| No Intervention: No plasma<br>Best conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days in need of oxygen | Number of days in need of oxygen within 28 days from inclusion | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days before discharge from hospital | number of days before discharge from hospital | 3 months | 
| Mortality within 3 months | death of patient | 3 months | 
| Number of days before need of assisted ventilation | number of days before need of assisted ventilation | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Convalescent plasma