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

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ClinicalTrials.gov Identifier: NCT04600440
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Mona Landin-Olsson, Skane University Hospital

Tracking Information
First Submitted Date  ICMJE October 20, 2020
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE April 25, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
Number of days in need of oxygen [ Time Frame: 28 days ]
Number of days in need of oxygen within 28 days from inclusion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Number of days before discharge from hospital [ Time Frame: 3 months ]
    number of days before discharge from hospital
  • Mortality within 3 months [ Time Frame: 3 months ]
    death of patient
  • Number of days before need of assisted ventilation [ Time Frame: 28 days ]
    number of days before need of assisted ventilation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma in the Treatment of Covid-19
Official Title  ICMJE Convalescent Plasma in the Treatment of Covid-19
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Respiratory Insufficiency
Intervention  ICMJE Biological: Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
Study Arms  ICMJE
  • Experimental: Plasma treatment
    Convalescent plasma 200 ml daily during three days
    Intervention: Biological: Convalescent plasma
  • No Intervention: No plasma
    Best conventional treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Magnus Rasmussen, MD, Prof +4646171000 magnus.rasmussen@med.lu.se
Contact: Mona Landin-Olsson, MD, Prof +4646171000 ext 71452 mona.landin-olsson@med.lu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04600440
Other Study ID Numbers  ICMJE Covid convalescent plasma
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mona Landin-Olsson, Skane University Hospital
Study Sponsor  ICMJE Skane University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mona Landin-Olsson, MD, Prof Skane University Hospital
Study Chair: Maria N Lundgren, MD Skane University Hospital
PRS Account Skane University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP