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Clinical Trials/NCT05157165
NCT05157165
No Longer Available
Not Applicable

Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience

ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Azienda Socio Sanitaria Territoriale di Mantova
Status
No Longer Available
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Expanded Access
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Massimo Franchini

Director Immunohematology and Transfusion Center

Azienda Socio Sanitaria Territoriale di Mantova

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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