Convalescent Plasma in the Treatment of Covid-19

NCT ID: NCT04600440

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-25

Study Completion Date

2022-02-28

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.

Conditions

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Covid-19 Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasma treatment

Convalescent plasma 200 ml daily during three days

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

Plasma donated from patients recovered from Covid-19 and having high titres of antibodies

No plasma

Best conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Convalescent plasma

Plasma donated from patients recovered from Covid-19 and having high titres of antibodies

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mona Landin-Olsson

MD Prof, Senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona Landin-Olsson, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Maria N Lundgren, MD

Role: STUDY_CHAIR

Skane University Hospital

Locations

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Skåne University Hospital

Lund, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Magnus Rasmussen, MD, Prof

Role: CONTACT

+4646171000

Mona Landin-Olsson, MD, Prof

Role: CONTACT

+4646171000 ext. 71452

Facility Contacts

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Mona Landin-Olsson, MD, Prof

Role: primary

+4646171000 ext. 71452

Magnus Rasmussen, MD, Prof

Role: backup

+4646171000

References

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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.

Reference Type DERIVED
PMID: 34863304 (View on PubMed)

Other Identifiers

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Covid convalescent plasma

Identifier Type: -

Identifier Source: org_study_id