Convalescent Plasma in the Treatment of Covid-19

Covid-19 Clinical Trial

— COP20  

Official title:

Convalescent Plasma in the Treatment of Covid-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600440
• Other study ID #: Covid convalescent plasma
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2020
• Source: Skane University Hospital
• Contact: Magnus Rasmussen, MD, Prof
• Phone: +4646171000
• Email: magnus.rasmussen[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Biological:
• Convalescent plasma
Plasma donated from patients recovered from Covid-19 and having high titres of antibodies

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days in need of oxygen	Number of days in need of oxygen within 28 days from inclusion	28 days
Secondary	Number of days before discharge from hospital	number of days before discharge from hospital	3 months
Secondary	Mortality within 3 months	death of patient	3 months
Secondary	Number of days before need of assisted ventilation	number of days before need of assisted ventilation	28 days