PrimaryDecrease COVID-19 mortalitySecondary• Evaluate the effect of 300ml convP on hospital stay and the change in WHO disease severity score• Evaluate the effect of 300ml convP on mortality in patients admitted to the ICU • Evaluate the effect of…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Overall mortality until discharge from the hospital or a maximum of 60 days
after admission whichever comes first
Secondary outcome
• 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) <80.
• Impact of 300ml convP on weaning from oxygen therapy
• Impact of 300ml convP on overall mortality in patients not admitted to the
ICU within 24 hours after admission
• Impact of 300ml convP on overall mortality in patients admitted to the ICU
within 24 hours after admission
• Difference in the effect of convP on mortality in patients with a duration of
symptoms < or * the median duration of symptoms in the study population
• Impact of 300ml convP therapy on ICU days in hospital days in patients
admitted to the ICU within 24 hours after admission
• Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways.
• Impact of CTL, B- and NK cell immunity on disease severity and the likelihood
of being protected from immune plasma transfer.
• Safety of convP therapy
• Impact of plasma therapy on risk of long term inflammation, structural lung
damage and lung function and QoL
• Development of, and predictors for, anti-SARS-CoV2 immune memory.
Background summary
Immunization with immunoglobulins is occasionally used as therapy for the
treatment of viral infectious disease. For example CMV disease, VZV disease,
rabies and hepatitis B. Neutralizing antibodies have been found against
SARS-CoV-2 present in patients who have been infected with SARS-CoV-2. During
the 2003 SARS outbreak, convalescent plasma from SARS recovered donors was
shown to increase the discharge rate. With no proven effective therapy against
COVID-19, this protocol describes use of convalescent plasma from COVID-19
recovered donors.
Study objective
Primary
Decrease COVID-19 mortality
Secondary
• Evaluate the effect of 300ml convP on hospital stay and the change in WHO
disease severity score
• Evaluate the effect of 300ml convP on mortality in patients admitted to the
ICU
• Evaluate the effect of 300ml plasma therapy on hospital days for patients
admitted to the ICU within 24 hours after admission
• Evaluate the impact of plasma therapy on the decrease in SARS-CoV2 shedding
from airways.
• Evaluate the safety of plasma therapy
• Evaluate the impact of plasma on long term inflammation, lung function,
functional impairment and QoL.
• Evaluate the impact of inflammation, immune function, and anti-SARS-CoV2
immunological responses on disease severity and plasma efficacy
• Evaluate long-term anti-SARS-CoV2 memory development
Study design
This trial is a randomized comparative trial. Patients will be randomized
between infusions with 300mL mL plasma or standard of care therapy
Intervention
Patients will be randomized between infusions with 300mL plasma retrieved from
donors or no plasma
Study burden and risks
Benefits of this study may include shorter stay in hospital and a decrease in
mortality. Risks of plasma infusion is comparable to risks associated with
regular bloodtransfusions. These include transfusion reactions, transfusion
related acute lung injury (TRALI) and transmission of (unkown) transmittable
diseases. Precautions will be taken against these risks
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73489.078.20 |