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

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.

Study Overview

• Status: Unknown
• Conditions: Covid-19; Respiratory Insufficiency
• Intervention / Treatment: Biological: Convalescent plasma

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus Rasmussen, MD, Prof; Phone Number: +4646171000; Email: magnus.rasmussen@med.lu.se
• Study Contact Backup: Name: Mona Landin-Olsson, MD, Prof; Phone Number: 71452 +4646171000; Email: mona.landin-olsson@med.lu.se

Study Locations

• Sweden
  • Lund, Sweden, SE-22185
    • Recruiting
    • Skane University Hospital
    • Contact: Magnus Rasmussen, MD, Prof; Phone Number: +4646171000; Email: magnus.rasmussen@med.lu.se
    • Contact: Mona Landin-Olsson, MD, Prof; Phone Number: 71452 +4646171000; Email: mona.landin-olsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days in need of oxygen	Number of days in need of oxygen within 28 days from inclusion	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days before discharge from hospital	number of days before discharge from hospital	3 months
Mortality within 3 months	death of patient	3 months
Number of days before need of assisted ventilation	number of days before need of assisted ventilation	28 days

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Investigators: Principal Investigator: Mona Landin-Olsson, MD, Prof, Skane University Hospital; Study Chair: Maria N Lundgren, MD, Skane University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: Covid convalescent plasma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No