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

Primary Purpose

Covid-19, Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Covid-19, Convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Skåne University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Plasma treatment

No plasma

Arm Description

Convalescent plasma 200 ml daily during three days

Best conventional treatment

Outcomes

Primary Outcome Measures

Number of days in need of oxygen
Number of days in need of oxygen within 28 days from inclusion

Secondary Outcome Measures

Number of days before discharge from hospital
number of days before discharge from hospital
Mortality within 3 months
death of patient
Number of days before need of assisted ventilation
number of days before need of assisted ventilation

Full Information

First Posted
October 20, 2020
Last Updated
October 22, 2020
Sponsor
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04600440
Brief Title
Convalescent Plasma in the Treatment of Covid-19
Acronym
COP20
Official Title
Convalescent Plasma in the Treatment of Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Respiratory Insufficiency
Keywords
Covid-19, Convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plasma treatment
Arm Type
Experimental
Arm Description
Convalescent plasma 200 ml daily during three days
Arm Title
No plasma
Arm Type
No Intervention
Arm Description
Best conventional treatment
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
Primary Outcome Measure Information:
Title
Number of days in need of oxygen
Description
Number of days in need of oxygen within 28 days from inclusion
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of days before discharge from hospital
Description
number of days before discharge from hospital
Time Frame
3 months
Title
Mortality within 3 months
Description
death of patient
Time Frame
3 months
Title
Number of days before need of assisted ventilation
Description
number of days before need of assisted ventilation
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus Rasmussen, MD, Prof
Phone
+4646171000
Email
magnus.rasmussen@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Landin-Olsson, MD, Prof
Phone
+4646171000
Ext
71452
Email
mona.landin-olsson@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Landin-Olsson, MD, Prof
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria N Lundgren, MD
Organizational Affiliation
Skane University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Landin-Olsson, MD, Prof
Phone
+4646171000
Ext
71452
Email
mona.landin-olsson@med.lu.se
First Name & Middle Initial & Last Name & Degree
Magnus Rasmussen, MD, Prof
Phone
+4646171000
Email
magnus.rasmussen@med.lu.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
34863304
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.
Results Reference
derived

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Convalescent Plasma in the Treatment of Covid-19

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