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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05157165
Study type Expanded Access
Source Azienda Socio Sanitaria Territoriale di Mantova
Contact
Status No longer available
Phase

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