Convalescent Plasma in Hospitalized COVID-19 Patients
Primary Purpose
COVID-19
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Convalescent plasma
Sponsored by
About this trial
This is an expanded access trial for COVID-19
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05157165
First Posted
December 10, 2021
Last Updated
July 19, 2023
Sponsor
Azienda Socio Sanitaria Territoriale di Mantova
1. Study Identification
Unique Protocol Identification Number
NCT05157165
Brief Title
Convalescent Plasma in Hospitalized COVID-19 Patients
Official Title
Convalescent Plasma in Hospitalized COVID-19 Patients: a Single Center Experience
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale di Mantova
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Hyperimmune plasma from convalescent COVID-19 donors with titre 1:80 or more
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
12. IPD Sharing Statement
Learn more about this trial
Convalescent Plasma in Hospitalized COVID-19 Patients
We'll reach out to this number within 24 hrs