COVID-19
Conditions
Brief summary
The study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized COVID-19 patients. Efficacy was measured as 28-day mortality following convalescent plasma transfusion. Safety was measured as the rate of adverse reactions. to plasma infusion.
Detailed description
Inclusion criteria: Adult inpatients with a severe form of COVID-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (RR) \> 30 breaths/min; 2) oxygen saturation (SpO2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 200 mmHg, 4) radiological picture and/or chest CT scan showing signs of interstitial disease and/or rapid progression of lung involvement. Primary outcome: Overall mortality at 28 days after hospitalization Secondary outcome: Adverse reaction to plasma transfusion.
Interventions
Hyperimmune plasma from convalescent COVID-19 donors with titre 1:80 or more
Sponsors
Eligibility
Inclusion criteria
* Adult patients admitted for severe COVID-19
Exclusion criteria
* \< 18 years * participation in any other clinical trial of an experimental treatment for COVID-19