corona virus COVID-19 SARS-CoV-2
Conditions
Interventions
Patients will be randomized between the transfusion of 300mL of convP versus
regular fresh frozen plasma (FFP).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • PCR-confirmed COVID-19 • Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoe, loss of taste or smell, diarrhea, falls or confusion) • 70 years or older OR 50-69 years and 1 or more of the risk factors described in table 1 Table 1: 1. A/ Medical history • Obesity with BMI 35 or higher • Born as a male person • History of cardiac or pulmonary disease (e.g. but not limited to atrial fibrillation, coronary artery disease, heart failure, COPD, asthma) • History of neurological disease (e.g. a history of stroke or any other chronic debilitating neurological disease) • Diabetes for which medical therapy is needed • Chronic kidney disease with GFR 1 year (excluding baso -or spinocellular skin cancers) • Untreated HIV and CD4 T-cells 30 • SARS-CoV-2 RT-PCR Ct value
Exclusion criteria
Exclusion criteria: • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Highest disease status on the 5-point ordinal disease severity scale in the 28 days following transfusion of convP versus FFP. Disease status is measured with a 5-point ordinal scale in which 1 = Fully recovered (no symptoms) within 7 days after transfusion 2 = Continued symptoms attributable to COVID-19 on day 7 after transfusion 3 = Admitted to hospital but no invasive ventilation needed 4 = Admitted to hospital and invasive ventilation needed 5 = Death | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluated in all patients: • Number (%) of deaths in the 28 days following transfusion of convP versus FFP. • Number (%) of hospital admissions in the 28 days following transfusion of convP versus FFP • Number (%) of ICU admissions in the 28 days following transfusion of convP versus FFP • Disease duration in days of symptoms in the 28 days following transfusion of convP versus FFP • Age and clinical frailty score stratified analysis of primary endpoint following transfusion of convP versus FFP. Evaluated in subgroups of patients: • Change in functional decline in patients over 70 years between inclusion, day 28 and month 6 following transfusion of convP versus FFP • Change in functional respiratory imaging, FVC and DLCOc, validated QoL questionnaires between day 28, month 3, 6 and 12 following transfusion of convP versus FFP • Change in proportion of detectable SARS-CoV-2 RT-PCR results at day 3, 7, 14 and 28 following transfusion of convP versus FFP. • Change in number (%) of anti-SARS-CoV-2 specific B-cell and CTL memory responses at d1, d14, d28, m3, m6, m12 followin transfusion of convP versus FFP • Number (%) of patients who fulfill the in- and exclusion criteria, number (%) of patients asked to participate in the study, number (%) of patients who do and do not participate and reasons to decline participation. • Cost-effectiveness of convP compared to FFP will be assessed by calculating the mean costs of the intervention in relation to the relative healthcare savings of convP compared to FFP. Exploratory endpoints: • Highest disease status on the 5-point ordinal disease severity scale in the 28 days following transfusion of convP versus FFP according to presence of neutralizing antibodies at baseline , symptom duration at baseline Change in proportion of detectable SARS-CoV-2 RT-PCR results at day 3, 7, 14 and 28 following transfusion according to the presence of neutralizing antibodies at baseline | — |
Countries
Netherlands
Outcome results
None listed