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

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

Tracking Information

• First Submitted Date: October 20, 2020
• First Posted Date: October 23, 2020
• Last Update Posted Date: October 23, 2020
• Actual Study Start Date: April 25, 2020
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Convalescent Plasma in the Treatment of Covid-19
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, open label

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Covid-19
• Respiratory Insufficiency

Intervention

Biological: Convalescent plasma

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 22, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2022
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Sweden

Administrative Information

• NCT Number: NCT04600440
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Mona Landin-Olsson, Skane University Hospital
• Study Sponsor: Skane University Hospital
• Collaborators: Not Provided

Investigators

• 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