Trials / No Longer Available
No Longer AvailableNCT05157165
Convalescent Plasma in Hospitalized COVID-19 Patients
Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Azienda Socio Sanitaria Territoriale di Mantova · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Convalescent plasma | Hyperimmune plasma from convalescent COVID-19 donors with titre 1:80 or more |
Timeline
- First posted
- 2021-12-14
- Last updated
- 2023-07-21
Source: ClinicalTrials.gov record NCT05157165. Inclusion in this directory is not an endorsement.