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Convalescent plasma from cured coronavirus disease (COVID) patients as a therapy for patients with severe COVID disease (CONCOVID)

Phase 3
Completed
Conditions
Coronavirus
COVID-19
SARS-CoV-2
10047438
Registration Number
NL-OMON50016
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
87
Inclusion Criteria

Patients
• Patients with PCR confirmed COVID disease
• The most recent PCR positive sample is <96hrs old
• Patient admitted to the hospital <7 days
• Age >=18
• Written informed consent by patient or legal patient representative

Donors:
• Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
• A history of COVID infection that was documented by PCR
• Known ABO-Resus(D) blood group
• A screening for irregular antibodies with a titer <= 1:32
• Asymptomatic for at least 14 days
• Written informed consent regarding the plasmapheresis procedure

Exclusion Criteria

Patients
• Participation in another intervention trial on the treatment of COVID-19 that
falls under the
Dutch law human research (WMO)
• Already on mechanical ventilation for >96hrs
• IgA deficiency

Donors:
• Age <18 years or age >65 years
• Weight <50 kg
• Medical history of heart failure
• History of transfusion with red blood cells, platelets or plasma after
01-01-1980
• History of organ- or tissue transplant
• A cumulative stay in the United Kingdom of >= 6 months in the period between
01-01-1980 and
31-12-1996
• A history of i.v. drug use
• Insulin dependant diabetes
• An underlying severe chronic illness (i.e. history of heart failure, cancer
or stroke)
• Tested positive for HLA- or HNA-antibodies

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>• Overall mortality until discharge from the hospital or a maximum of 60 days<br /><br>after admission whichever comes first</p><br>
Secondary Outcome Measures
NameTimeMethod
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