Coronavirus COVID-19 SARS-CoV-2
Conditions
Interventions
Patients will be randomized between infusions with 300mL plasma retrieved from
donors or no plasma
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients • Patients with PCR confirmed COVID disease • The most recent PCR positive sample is =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
Exclusion criteria
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 65 years • Weight = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| • Impact of 300ml convP therapy on hospital days • Change in 8-point WHO COVID19 disease severity scale on day 15 • Change in the 8-point WHO COVID19 disease severity scale on day 30 • Change in the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) | — |
Countries
Netherlands
Outcome results
None listed