COVID-19
Conditions
Interventions
Enrolled patients will either receive convalescent thawed fresh frozen plasma 1
unit (250-325 ml) (=treatment group) or standard thawed fresh frozen plasma 1
unit (250-325 ml) (=control group).
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Maximal 3 days hospitalized patients at plasma infusion. 2. Age * 18 years and * 85 years 3. SARS-CoV-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) 4. Symptoms not expected to lead to IC transfer within 6 hours of first plasma administration 5. Written informed consent including storing of specimen for future testing
Exclusion criteria
Exclusion criteria: 1. Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months 2. Chronic obstructive lung disease (COPD), stage 4 3. Lung fibrosis with UIP pattern in CT und Severe emphysema 4. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to * 30% 5. Cardiovascular failure requiring diuretics 6. Signs of severe coagulopathy : thrombocytopenia a/o prolongation of the PT/INR, PTT a/o elevation of D-dimer, a/o decreased fibrinogen level waardes ? 7. Liver cirrhosis Child C 8. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN). 9. Any history of severe adverse reactions to plasma proteins 10. Known deficiency of immunoglobulin A 11. Pregnancy 12. Breastfeeding women 13. Volume overload until sufficiently treated 14. Pulmonary edema 15. Participation in another clinical trial for treatment of COVID-19 16. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The estimated benefit in regard of the primary endpoint is a shift in the distribution of the scores towards less mortality, less mechanical ventilation, less ICU admission and shorter than the average of 6 days hospital stay. The primary endpoint will be analyzed using a Bayesian proportional odds model. Posterior probabilities will start to be computed after 20 patients have completed their follow-up and will be computed continuously afterwards. In this way, during the study, the trial statistician monitors if superiority of the treatment arm or inferiority of the control arm evolves. At that moment, the PI and the DSMB will be able to consider an earlier stop of the trial. Primary objective: To evaluate the efficacy of convalescent plasma compared to standard plasma on an ordinal outcome consisting of duration of hospital stay, admission to the intensive care unit (ICU), need for mechanical ventilation and mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| The other effectivity parameters that are monitored as secondary endpoints are : - The ordinal endpoint at day 28 and 56. - The combined mortality at and stay at the ICU at day 41,28 and 56 - The number of hospital days Safety parameters monitored as secondary endpoints specifically looked at are possibly with plasma transfusion related side effects like: worsened respiration related to transfusion related acute lung injury (TRALI), circulatory overload by the plasma infusion (TACO), transfusion transmitted infections or allergic reactions caused by plasma proteins. | — |
Countries
Netherlands
Outcome results
None listed