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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

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.


Condition or disease Intervention/treatment Phase
Covid-19 Respiratory Insufficiency Biological: Convalescent plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma in the Treatment of Covid-19
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
Experimental: Plasma treatment
Convalescent plasma 200 ml daily during three days
Biological: Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies

No Intervention: No plasma
Best conventional treatment



Primary Outcome Measures :
  1. Number of days in need of oxygen [ Time Frame: 28 days ]
    Number of days in need of oxygen within 28 days from inclusion


Secondary Outcome Measures :
  1. Number of days before discharge from hospital [ Time Frame: 3 months ]
    number of days before discharge from hospital

  2. Mortality within 3 months [ Time Frame: 3 months ]
    death of patient

  3. Number of days before need of assisted ventilation [ Time Frame: 28 days ]
    number of days before need of assisted ventilation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600440


Contacts
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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

Locations
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Sweden
Skåne University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Mona Landin-Olsson, MD, Prof    +4646171000 ext 71452    mona.landin-olsson@med.lu.se   
Contact: Magnus Rasmussen, MD, Prof    +4646171000    magnus.rasmussen@med.lu.se   
Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Mona Landin-Olsson, MD, Prof Skane University Hospital
Study Chair: Maria N Lundgren, MD Skane University Hospital
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Responsible Party: Mona Landin-Olsson, MD Prof, Senior consultant, Skane University Hospital
ClinicalTrials.gov Identifier: NCT04600440    
Other Study ID Numbers: Covid convalescent plasma
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Landin-Olsson, Skane University Hospital:
Covid-19
Convalescent plasma
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases