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Convalescent Plasma in the Treatment of Covid-19 (COP20)

S

Skane University Hospital

Status

Unknown

Conditions

Respiratory Insufficiency
Covid-19

Treatments

Biological: Convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04600440
Covid convalescent plasma

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Plasma treatment
Experimental group
Description:
Convalescent plasma 200 ml daily during three days
Treatment:
Biological: Convalescent plasma
No plasma
No Intervention group
Description:
Best conventional treatment

Trial contacts and locations

1

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Central trial contact

Mona Landin-Olsson, MD, Prof; Magnus Rasmussen, MD, Prof

Data sourced from clinicaltrials.gov

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