Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Erasmus Medical Center
With
Prothya Biosolutions
Secondary (exploratory) objectives
* Evaluate the effect of 300ml convP on hospital stay
* Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 and 30
* Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) \<80
* 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 difference in effect of convP on mortality in patients with a duration of symptoms \< or \> the median duration of symptoms in the study population
* Evaluate the impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
* Safety of convP therapy
* Evaluate the impact of covP on long-term lung function
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with PCR confirmed COVID disease
Admitted to the hospital
The most recent PCR positive sample is \<96hrs old
Written informed consent by patient or legal patient representative
Age at least 18 years
You may not be if
Participation in another intervention trial on the treatment of COVID-19 that falls under the Dutch law human research (WMO) and in which individual patients are randomized to different treatment options
Known IgA deficiency
Invasive ventilation for already \>96 hours
Donors: Eligibility for plasma donation
Inclusions Criteria:
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
Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
Age \<18 years and \> 65 years
Weight \<50kg
Medical history of heart failure
History of transfusion with red blood cells, platelets or plasma
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 dependent diabetes
An underlying severe chronic illness (i.e. history of heart failure, cancer or stroke)
Tested positive for HLA- or HNA-antibodies
Clareo Health | Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)