Convalescent Plasma in Hospitalized COVID-19 Patients
- Conditions
- COVID-19
- Registration Number
- NCT05157165
- Lead Sponsor
- Azienda Socio Sanitaria Territoriale di Mantova
- 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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Adult patients admitted for severe COVID-19
- < 18 years
- participation in any other clinical trial of an experimental treatment for COVID-19
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method